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Biologic Immunomodulators Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-1002

This program applies to Blue Partner, Commercial, GenPlus, SourceRx and Health Insurance Marketplace formularies.      

POLICY REVIEW CYCLE

Effective Date

Date of Origin 

04-01-2024            

FDA APPROVED INDICATIONS AND DOSAGE

Agent(s)

FDA Indication(s)

Notes

Ref#

Abrilada™

(adalimumab-afzb)

Subcutaneous injection

Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA)

Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients 2 years of age and older

Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with psoriatic arthritis (PsA)

Reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS)

Treatment of moderately to severely active Crohn's disease (CD) in adults and pediatric patients 6 years of age and older

Treatment of moderately to severely active ulcerative colitis (UC) in adult patients

Limitations of Use:

  • Effectiveness has not been established in patients who have lost response to or were intolerant to tumor necrosis factor (TNF) blockers

Treatment of adult patients with moderate to severe chronic plaque psoriasis (PS) who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate

Treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients

Treatment of non-infectious intermediate, posterior, and panuveitis (UV) in adult patients

Tumor Necrosis Factor (TNF) -Alpha Inhibitor

83

Actemra®

(tocilizumab)

Intravenous infusion

Subcutaneous injection

Treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have hand an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs)

Treatment of giant cell arteritis (GCA) in adult patients

Treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older

Treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients 2 years of age and older

Treatment of chimeric antigen receptor (CAR) T-cell induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older

Slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis associated interstitial lung disease (SSc-ILD)

Limitation of use:

  • SC administration with the prefilled ACTPen autoinjector and IV administration has not been studied in SSc-ILD

Treatment of Coronavirus disease 2019 (COVID-19) in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO)

Interleukin-6 Inhibitor

1

Amjevita®

(adalimumab-atto)

Subcutaneous injection

Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA)

Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older

Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis (PSA)

Reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS)

Treatment of moderately to severely active Crohn’s disease (CD) in adults and pediatric patients 6 years of age and older

Treatment of moderately to severely active ulcerative colitis (UC) in adult patients

Limitation of use:

  • The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers

Treatment of adult patients with moderate to severe chronic plaque psoriasis (PS) who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate

Treatment of moderate to severe hidradenitis suppurativa in adult patients

Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients

Tumor Necrosis Factor (TNF) -Alpha Inhibitor

71

Bimzelx®

(bimekizumab-bkzx)

Subcutaneous injection

Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or photo therapy

Interleukin F17A and F antagonist

84

Cimzia®

(certolizumab pegol)

Subcutaneous injection

Reducing signs and symptoms of Crohn’s disease (CD) and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy

Treatment of adults with moderately to severely active rheumatoid arthritis (RA)

Treatment of adult patients with active psoriatic arthritis (PSA)

Treatment of adults with active ankylosing spondylitis (AS)

Treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation

Treatment of adults with moderate-to-severe plaque psoriasis (PS) who are candidates for systemic therapy or phototherapy

Tumor Necrosis Factor (TNF) -Alpha Inhibitor

2

Cosentyx®

(secukinumab)

Intravenous injection

Subcutaneous injection

Treatment of moderate to severe plaque psoriasis (PS) in patients 6 years and older who are candidates for systemic therapy or phototherapy

Treatment of active psoriatic arthritis (PSA) in patients 2 years of age and older

Treatment of adult patients with active ankylosing spondylitis (AS)

Treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation

Treatment of active enthesitis-related arthritis (ERA) in patients 4 years of age and older

Treatment of adults with moderate to severe hidradenitis suppurativa (HS)

Interleukin-17 Inhibitor

3

Cyltezo®/Adalimumab-adbm

Subcutaneous injection

Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA)

Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older

Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis (PSA)

Reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS)

Treatment of moderately to severely active Crohn’s disease (CD) in adults and pediatric patients 6 years of age and older

Treatment of moderately to severely active ulcerative colitis (UC) in adult patients

Limitation of use:

  • The effectiveness has not been established in patients with UC who have lost response to or were intolerant to TNF blockers

Treatment of adult patients with moderate to severe chronic plaque psoriasis (PS) who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate

Treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients 

Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients

Tumor Necrosis Factor (TNF) -Alpha Inhibitor

76

Enbrel®

(etanercept)

Subcutaneous injection

Reduce the signs and symptoms, including major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA)

Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA) in patients ages 2 and older

Reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis (PSA)

Reducing signs and symptoms in patients with active ankylosing spondylitis (AS)

Treatment of patients 4 years or older with chronic moderate to severe plaque psoriasis (PS) who are candidates for systemic therapy or phototherapy

Tumor Necrosis Factor (TNF) -Alpha Inhibitor

4

Entyvio®

(vedolizumab)

Injection for intravenous use

Injection for subcutaneous use

Treatment in adults for moderately to severely active ulcerative colitis (UC)

Treatment in adults for moderately to severely active Crohn's disease (CD)

Integrin receptor antagonist

5

Hadlima™

(adalimumab-bwwd)

Subcutaneous Injection

Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA)

Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older

Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis (PSA)

Reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS)

Treatment of moderately to severely active Crohn’s disease (CD) in adults and pediatric patients 6 years of age and older

Treatment of moderately to severely active ulcerative colitis (UC) in adult patients 

Limitation of use:

  • Effectiveness has not been established in patients with UC who have lost response to or were intolerant to TNF blockers

Treatment of adult patients with moderate to severe chronic plaque psoriasis (PS) who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate

Treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients 

Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients

Tumor Necrosis Factor (TNF) -Alpha Inhibitor

77

Hulio®/Adalimumab-fkjp

Subcutaneous injection

Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA)

Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older

Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis (PSA)

Reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS)

Treatment of moderately to severely active Crohn’s disease (CD) in adults and pediatric patients 6 years of age and older

Treatment of moderately to severely active ulcerative colitis (UC) in adult patients

Limitation of use:

  • Effectiveness  has not been established in patients with UC who have lost response to or were intolerant to TNF blockers

Treatment of adult patients with moderate to severe chronic plaque psoriasis (PS) who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate

Treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients

Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients

Tumor Necrosis Factor (TNF) -Alpha Inhibitor

74

Humira®

(adalimumab)

Subcutaneous injection

Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA)

Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older

Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis (PSA)

Reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS)

Treatment of moderately to severely active Crohn’s disease (CD) in adults and pediatric patients 6 years of age and older

Treatment of moderately to severely active ulcerative colitis (UC) in adults and pediatric patients 5 years of age and older

Limitation of use:

  • The effectiveness of Humira has not been established in patients with UC who have lost response to or were intolerant to TNF blockers

Treatment of adult patients with moderate to severe chronic plaque psoriasis (PS) who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate

Treatment of moderate to severe hidradenitis suppurativa (HS) in patients 12 years of age and older

Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older

Tumor Necrosis Factor (TNF) -Alpha Inhibitor

6

Hyrimoz®/Adalimumab-adaz

Subcutaneous injection

Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA)

Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older

Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis (PSA)

Reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS)

Treatment of moderately to severely active Crohn’s disease (CD) in adults and pediatric patients 6 years of age and older

Treatment of moderately to severely active ulcerative colitis (UC) in adult patients

Limitation of use:

  • The effectiveness has not been established in patients with UC who have lost response to or were intolerant to TNF blockers

Treatment of adult patients with moderate to severe chronic plaque psoriasis (PS) who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate

Treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients 

Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients

Tumor Necrosis Factor (TNF) -Alpha Inhibitor

80

Idacio®/Adalimumab-aacf

Subcutaneous injection

 

Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA)

Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older

Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis (PSA)

Reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS)

Treatment of moderately to severely active Crohn’s disease (CD) in adults and pediatric patients 6 years of age and older

Treatment of moderately to severely active ulcerative colitis (UC) in adult patients

Limitation of use:

  • Effectiveness has not been established in patients with UC who have lost response to or were intolerant to TNF blockers

Treatment of adult patients with moderate to severe chronic plaque psoriasis (PS) who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate

Tumor Necrosis Factor (TNF) -Alpha Inhibitor

75

Kevzara®

(sarilumab)

Subcutaneous injection

Treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs)

Treatment of adult patients with polymyalgia rheumatica who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper

Interleukin-6 Inhibitor

7

Kineret®

(anakinra)

Subcutaneous injection

Reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis (RA), in patients 18 years of age or older who have failed 1 or more disease modifying antirheumatic drugs (DMARDs)

Treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID)*

Treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA)*

Interleukin-1 Inhibitor

*- approved for use in pediatric patients as young as 1 month of age

8

Litfulo™

(ritlecitinib)

Capsules

Treatment of severe alopecia areata in adults and adolescents 12 years and older

Limitations of Use:

  • Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants

Janus Kinase (JAK) inhibitor

81

Olumiant®

(baricitinib)

Oral tablet

Treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers

Limitation of Use:

  • Not recommended for use in combination with other JAK inhibitors, biologic disease modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine

Treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO)

Treatment of adult patients with severe alopecia areata

  • Limitation of Use: Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants 

Janus Kinase (JAK) Inhibitor

9

Omvoh™

(mirikizumab-mrkz)

Intravenous injection

Subcutaneous injection

Treatment of moderately to severely active ulcerative colitis in adults

Interleukin-23 Inhibitor

86

Orencia®

(abatacept)

Intravenous infusion

Subcutaneous injection

Treatment of adult patients with moderately to severely active rheumatoid arthritis (RA)

Treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA)

Treatment patients 2 years of age and older with active psoriatic arthritis (PSA)

Prophylaxis of acute graft versus host disease (aGVHD), in combination with calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated-donor

Limitation of Use:

  • Concomitant use with other potent immunosuppressants (e.g., biologic disease modifying antirheumatic drugs [bDMARDS], Janus kinase [JAK] inhibitors) is not recommended

T-cell Costimulation Blocker

10

Rinvoq®

(upadacitinib extended release)

Oral tablet

Treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more TNF blockers

Treatment of adults with active psoriatic arthritis (PSA) who have had an inadequate response or intolerance to one or more TNF blockers

Treatment of adult and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable

Treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more TNF blockers

Treatment of adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more TNF blockers

Limitation of Use:

  • Use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine, is not recommended

Treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy

Limitation of Use:

  • Use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine, is not recommended

Treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more TNF blockers

Limitation of Use:

  • Not recommended for use in combination with other JAK inhibitors, biological therapies for Crohn's disease, or with potent immunosuppressants such as azathioprine and cyclosporine

Janus Kinase (JAK) Inhibitor

44

Siliq®

(brodalumab)

Subcutaneous injection

Treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies

Interleukin-17 Receptor Antagonist

11

Simponi®

(golimumab)

Subcutaneous injection

Treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate

Treatment of adult patients with active psoriatic arthritis (PSA)

Treatment of adult patients with active ankylosing spondylitis (AS)

Adult patients with moderately to severely active ulcerative colitis with inadequate response or intolerant to prior treatment or requiring continuous steroid therapy

  • Inducing and maintaining clinical response
  • Improving endoscopic appearance of the mucosa during induction
  • Inducing clinical remission
  • Achieving and sustaining clinical remission in induction responders

Tumor Necrosis Factor (TNF) -Alpha Inhibitor

12

Skyrizi®

(risankizumab-rzaa)

Subcutaneous injection

Treatment of moderate-to-severe plaque psoriasis (PS) in adults who are candidates for systemic therapy or phototherapy

Treatment of active psoriatic arthritis (PSA) in adults

Treatment of moderately to severely active Crohn's disease in adults

Interleukin-23 Inhibitor

43

Sotyktu®

(deucravacitinib)

Tablet

Treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy

Limitation of Use:

  • Not recommended for use in combination with other potent immunosuppressants

Tyrosine Kinase Inhibitor

67

Stelara®

(ustekinumab)

Intravenous infusion

Subcutaneous injection

Treatment of patients 6 years and older with moderate to severe plaque psoriasis (PS) who are candidates for phototherapy for systemic therapy

Treatment of patients 6 years and older with active psoriatic arthritis (PSA)

Treatment of adult patients with moderately to severely active Crohn’s disease (CD)

Treatment of adult patients with moderately to severely active ulcerative colitis (UC)

Interleukin-23 Inhibitor

13

Taltz®

(ixekizumab)

Subcutaneous injection

Treatment of patients 6 years of age and older with moderate-to severe plaque psoriasis (PS) who are candidates for systemic therapy or phototherapy

Treatment of adult patients with active psoriatic arthritis (PSA)

Treatment of adult patients with active ankylosing spondylitis (AS)

Treatment of adult patents with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation

Interleukin-17 Inhibitor

14

Tremfya®

(guselkumab)

Subcutaneous injection

Treatment of adults with moderate-to-severe plaque psoriasis (PS) who are candidates for systemic therapy or phototherapy

Treatment of adult patients with active psoriatic arthritis (PSA)

Interleukin-23 Inhibitor

15

Velsipity™

(etrasimod)

Tablets

Treatment of moderately to severely active ulcerative colitis in adults

Sphingosine 1-phosphate (SIP-1) receptor modulator

85

Xeljanz®

(tofacitinib)

Oral Solution

Treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older who have had an inadequate response or intolerance to one or more TNF blockers

Limitation of use:

  • Use of Xeljanz in combination with biologics DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended

Janus Kinase (JAK) Inhibitor

16

Xeljanz®

(tofacitinib)

Oral tablet

Treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more TNF blockers

Treatment of adult patients with active psoriatic arthritis (PSA) who have had an inadequate response or intolerance to one or more TNF blockers

Treatment of adult patients with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more TNF blockers

Treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers

Treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older who have had an inadequate response or intolerance to one or more TNF blockers

Limitation of use:

Use of Xeljanz in combination with biologics DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended

Janus Kinase (JAK) Inhibitor

16

Xeljanz® XR

(tofacitinib extended release)

Oral tablet

Treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more TNF blockers

Treatment of adult patients with active psoriatic arthritis (PSA) who have had an inadequate response or intolerance to one or more TNF blockers

Treatment of adult patients with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more TNF blockers

Treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers

Limitation of use:

Use of Xeljanz XR in combination with biologics DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended

Janus Kinase (JAK) Inhibitor

16

Yuflyma®

(adalimumab-aaty)

Subcutaneous injection

Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA)

Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older

Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis (PSA)

Reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS)

Treatment of moderately to severely active Crohn’s disease (CD) in adults and pediatric patients 6 years of age and older

Treatment of moderately to severely active ulcerative colitis (UC) in adult patients

Limitation of use:

  • Effectiveness has not been established in patients with UC who have lost response to or were intolerant to TNF blockers

Treatment of adult patients with moderate to severe chronic plaque psoriasis (PS) who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate

Treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients

Tumor Necrosis Factor (TNF) -Alpha Inhibitor

78

Yusimry™

(adalimumab-aqvh)

Subcutaneous injection

Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA)

Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older

Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis (PSA)

Reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS)

Treatment of moderately to severely active Crohn’s disease (CD) in adults and pediatric patients 6 years of age and older

Treatment of moderately to severely active ulcerative colitis (UC) in adult patients 

Limitation of use:

  • Effectiveness has not been established in patients with UC who have lost response to or were intolerant to TNF blockers

Treatment of adult patients with moderate to severe chronic plaque psoriasis (PS) who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate

Treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients 

Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients

Tumor Necrosis Factor (TNF) -Alpha Inhibitor

79

See package insert for FDA prescribing information:  https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

RHEUMATOID DISORDERS - Ankylosing spondylitis (AS)

Ankylosing spondylitis (AS) is a form of chronic inflammatory arthritis characterized by sacroiliitis, enthesitis, and a marked propensity for sacroiliac joint and spinal fusion. AS is distinguished by universal involvement with sacroiliac joint inflammation or fusion and more prevalent spinal ankylosis. Goals of treatment for AS are to reduce symptoms, maintain spinal flexibility and normal posture, reduce functional limitations, maintain work ability, and decrease disease complications. The mainstays of treatment have been nonsteroidal anti-inflammatory drugs (NSAIDs) and exercise, with the additional use of disease-modifying antirheumatic drugs (DMARDs) in patients with peripheral arthritis. The American College of Rheumatology (ACR), Spondylitis Association of America (SAA), and Spondyloarthritis Research and Treatment Network (SPARTAN) recommend the following pharmacological treatment for AS:(17,47)

  • Stable AS: First line therapy with on demand NSAIDs; there is also a conditional recommendation for continuation of TNF inhibitor as monotherapy
  • Active AS:
    • First line therapy with continuous NSAIDs with physical therapy
    • TNF inhibitor recommended for patients with active AS despite an adequate trial with NSAIDs
      • Lack of response (or intolerance) to at least 2 different NSAIDs over 1 month or incomplete response to at least 2 different NSAIDs over 2 months would be an adequate NSAID trial to judge response
    • Recommendations for nonresponse to TNF therapy (all conditional):
      • Primary nonresponse: switch to secukinumab or ixekizumab over another TNF
      • Secondary nonresponse: switch to another TNF over a non-TNF biologic
      • Recommend against addition of sulfasalazine or MTX
      • Recommend against switching to a biosimilar of the failed TNF
    • TNF-inhibitors are conditionally recommended over secukinumab or ixekizumab
    • Secukinumab or ixekizumab are conditionally recommended over DMARDs in patients that have failed NSAIDs and have contraindications to TNF-inhibitors
    • DMARDs (i.e., methotrexate [MTX], sulfasalazine) are only conditionally recommended in patients that have failed NSAIDs and have contraindications to TNF-inhibitors
    • Methotrexate is not recommended as add on therapy to TNF inhibitors in stable and active AS
    • If patient has concomitant inflammatory bowel disease (IBD) or recurrent uveitis, TNF-inhibitors are recommended over other biologics 
    • Glucocorticoids are not recommended

RHEUMATOID DISORDERS - Nonradiographic Axial Spondyloarthritis (nr-axSpA)

Nonradiographic axial spondyloarthritis (nr-axSpA) falls under the same spondyloarthritis family as ankylosing spondylitis (AS). Nr-axSpA includes patients with chronic back pain and features suggestive of spondyloarthritis (SpA), but do not meet the classification of AS. The goals of treatment are to reduce symptoms, maintain spinal flexibility and normal posture, reduce functional limitations, maintain work ability, and decrease disease complications. The mainstays of treatment have been NSAIDs and exercise, with the additional use of DMARDs in patients with peripheral arthritis. The American College of Rheumatology (ACR), Spondylitis Association of America (SAA), and Spondyloarthritis Research and Treatment Network (SPARTAN) recommendation for nr-axSpA are the same as AS:(17,47)

  • Stable SpA: conditional recommendation for on-demand treatment with NSAIDs
  • Active SpA:
    • First line therapy with continuous NSAIDs with physical therapy
    • TNF inhibitor conditionally recommended for patients with active SpA despite an adequate trial with NSAIDs
      • Lack of response (or intolerance) to at least 2 different NSAIDs over 1 month or incomplete response to at least 2 different NSAIDs over 2 months would be an adequate NSAID trial to judge response
    • TNF-inhibitors are conditionally recommended over secukinumab or ixekizumab
    • Secukinumab or ixekizumab are conditionally recommended over DMARDs in patients that have failed NSAIDs and have contraindications to TNF-inhibitors
    • Recommendations for nonresponse to TNF therapy (all conditional):
      • Primary nonresponse: switch to secukinumab or ixekizumab over another TNF
      • Secondary nonresponse: switch to another TNF over a non-TNF biologic
      • Recommend against addition of sulfasalazine or MTX
      • Recommend against switching to a biosimilar of the failed TNF
    • DMARDs (i.e., methotrexate, sulfasalazine) are only conditionally recommended in patients that have failed NSAIDs and have contraindications to TNF-inhibitors
    • Methotrexate is not recommended as add on therapy to TNF inhibitors in stable and active AS
    • If patient has concomitant inflammatory bowel disease or recurrent uveitis, TNF-inhibitors are recommended over other biologics 
    • Glucocorticoids are not recommended

RHEUMATOID DISORDERS - Rheumatoid arthritis (RA)

Rheumatoid arthritis (RA) is the most common inflammatory autoimmune arthritis in adults. The main goal of therapy is to achieve remission, but additional goals include decrease inflammation, relieve symptoms, prevent joint and organ damage, improve physical function/overall well-being, and reduce long term complications.(18,25) The choice of therapy depends on several factors, including the severity of disease activity when therapy is initiated and the response of the patient to prior therapeutic interventions.(18)

American College of Rheumatology (ACR) guidelines list the following guiding principles in the treatment of RA:(18)

  • RA requires early evaluation, diagnosis, and management
  • Treatment decisions should follow a shared decision-making process
  • Treatment decisions should be reevaluated within a minimum of 3 months based on efficacy and tolerability of the DMARD(s) chosen
  • Recommendations are limited to DMARDs approved by the US FDA for treatment of RA:
    • csDMARDs: hydroxychloroquine, sulfasalazine, methotrexate (MTX), leflunomide
    • bDMARDs: TNF inhibitors (etanercept, adalimumab, infliximab, golimumab, certolizumab pegol), T cell costimulatory inhibitor (abatacept), IL-6 receptor inhibitors (tocilizumab, sarilumab), anti-CD20 antibody (rituximab)
    • tsDMARDs: JAK inhibitors (tofacitinib, baricitinib, upadacitinib)
  • Triple therapy refers to hydroxychloroquine, sulfasalazine, and either methotrexate or leflunomide
  • Biosimilars are considered equivalent to FDA-approved originator bDMARDs
  • Recommendations referring to bDMARDs exclude rituximab unless patients have had an inadequate response to TNF inhibitors (in order to be consistent with FDA approval) or have a history of lymphoproliferative disorder for which rituximab is an approved therapy
  • Treat-to-target refers to a systematic approach involving frequent monitoring of disease activity using validated instruments and modifications of treatment to minimize disease activity with the goal of reaching a predefined target (low disease activity or remission)

ACR guidelines are broken down by previous treatment and disease activity:(18)

  • DMARD-naïve patients with moderate-to-high disease activity initial treatment:
    • MTX monotherapy is strongly recommended over hydroxychloroquine, sulfasalazine, bDMARDs monotherapy, tsDMARD monotherapy, or combination of MTX plus a non-TNF bDMARD or tsDMARD
    • MTX monotherapy is conditionally recommended over leflunomide, dual or triple csDMARD therapy, or combination MTX plus a TNF inhibitor
  • DMARD-naïve patients with low disease activity initial treatment:
    • Hydroxychloroquine is conditionally recommended over other csDMARDs
    • Sulfasalazine is conditionally recommended over MTX
    • MTX is conditionally recommended over leflunomide
  • Initial therapy in csDMARD-treated patients, but MTX naïve, with moderate-to high disease activity:
    • MTX monotherapy is conditionally recommended over combination MTX and a bDMARD or tsDMARD
  • Treatment Modifications in patients treated with DMARDs who are not at target:
    • Addition of a bDMARD or tsDMARD is conditionally recommended over triple therapy for patients taking maximally tolerated doses of MTX who are not at target
    • Switching to a bDMARD or tsDMARD of a different class is conditionally recommended over switching to a bDMARD or tsDMARD belonging to the same class for patients taking a bDMARD or tsDMARD who are not at target

Early use of DMARD, particularly MTX, is recommended as soon as possible following diagnosis of RA. Dosing of MTX for RA is once weekly dosing with starting doses at 7.5 mg or 15 mg once weekly.(26,27,28) MTX dose is increased as tolerated and as needed to control symptoms and signs of RA disease. The usual target dose is at least 15 mg weekly and the usual maximum dose is 25 mg weekly.(27,28) ACR defines optimal dosing for RA treatments as 1) dosing to achieve a therapeutic target derived from mutual patient-clinician consideration of patient priorities and 2) given for at least 3 months before therapy escalation or switching. For patients who are unable to take MTX, hydroxychloroquine, sulfasalazine, or leflunomide are other DMARD options. In patients resistant to initial MTX treatment, combination DMARD (e.g., MTX plus sulfasalazine or hydroxychloroquine or a TNF-inhibitor) is recommended.(18)

For patients who are resistant to MTX after 3 months of treatment at optimal doses (usually 25 mg per week), it is recommended to either use DMARD triple therapy with MTX plus sulfasalazine and hydroxychloroquine or combination of MTX with TNF inhibitor. Triple therapy regimen has been found to be of similar clinical efficacy to MTX with biologics in several randomized trials, including in patients with high level of disease activity or with adverse prognostic features. The use of triple therapy has been shown to be highly cost-effective compared with combining a biologic with MTX, providing comparable or near comparable clinical benefit. The use of biologic with MTX combination is preferred when patients have high disease activity and clinical benefit from a more rapid response is needed and when patients who do not achieve satisfactory response within 3 months with non-biologic triple therapy following an inadequate response to MTX therapy.(18,28)

 

RHEUMATOID DISORDERS - Polyarticular Juvenile Idiopathic Arthritis (PJIA)

Juvenile idiopathic arthritis (JIA) is arthritis that begins before the 16th birthday and persists for at least 6 weeks with other known conditions excluded. Polyarticular juvenile idiopathic arthritis (PJIA) is a subset of JIA. The ACR defines PJIA as arthritis in more than 4 joints during their disease course and excludes systemic JIA. Treatment goals are aimed at achieving clinically inactive disease and to prevent long-term morbidities, including growth disturbances, joint contractures and destruction, functional limitations, and blindness or visual impairment from chronic uveitis.(34,35)

The ACR 2019 guidelines recommend the following treatment approach for PJIA:(34,35)

  • NSAIDs are conditionally recommended as adjunct therapy
  • DMARD therapy:
    • Methotrexate (MTX) is conditionally recommended over leflunomide and sulfasalazine
    • Subcutaneous MTX is conditionally recommended over oral MTX
  • Intraarticular glucocorticoids are conditionally recommended as adjunct therapy and conditionally recommended for bridging only in patients with moderate to high disease activity
  • Strongly recommend against chronic low-dose glucocorticoid use, irrespective of disease activity and/or risk factors
  • Strongly recommend combination use of a DMARD and infliximab
  • Initial therapy for all patients:
    • DMARD is strongly recommended over NSAID monotherapy
    • MTX monotherapy is conditionally recommended over triple DMARD therapy
    • DMARD is conditionally recommended over a biologic
    • Initial biologic therapy may be considered for patients with risk factors and involvement of high-risk joints (e.g., cervical spine, wrist, hip), high disease activity, and/or those judged by their physician to be at high risk of disabling joint damage
  • Subsequent therapy:
    • Low disease activity:
      • Escalating therapy (e.g., intraarticular glucocorticoid injections, optimization of DMARD dose, trial of MTX if not already done, and adding or changing biologic agent)
    • Moderate to high disease activity:
      • Add a biologic to original DMARD over changing to a second DMARD or changing to triple DMARD therapy
      • Switch to a non-TNF biologic if currently treated with first TNF +/- DMARD over switching to another TNF (unless the patient had good initial response to first TNF)
      • TNF, abatacept, or tocilizumab (depending on prior biologics received) over rituximab after trial of second biologic

RHEUMATOID DISORDERS - Systemic Juvenile Idiopathic Arthritis (SJIA)

Systemic juvenile idiopathic arthritis (SJIA) is a subset of JIA. SJIA is distinct from all other categories of JIA due to fever, rash, and visceral involvement. Disease pathogenesis and cytokine involvement in SJIA are different than other JIA categories. Up to 40% of cases of SJIA are associated with macrophage activation syndrome (MAS), a secondary hemophagocytic syndrome that is a life-threatening complication requiring urgent recognition and treatment. MAS presents with fevers, high ferritin levels, cytopenias, elevated liver enzyme levels, low fibrinogen levels, and high triglyceride levels. As it may occur at any point during the disease course careful monitoring is necessary for children with or without MAS at presentation. Goals of therapy for SJIA includes control of active inflammation and symptoms, and the prevention of a number of disease and/or treatment related morbidities, such as growth disturbances, joint damage, and functional limitations.(19)

SJIA is defined as:(19)

  • Patient age 6 months to 18 years
  • Fever of at least 2 weeks duration (daily fever is not required but at some point exhibit a quotidian (daily) fever pattern, defined as a fever that rises to greater than or equal to 39 degrees Celsius at least once a day and returns to less than or equal to 37 degrees Celsius between fever peaks
  • Arthritis in greater than or equal to 1 joint  
  • Accompanied by one or more of the following:
    • Evanescent erythematous rash
    • Generalized lymphadenopathy
    • Hepatomegaly or splenomegaly
    • Pericarditis, pleuritis and/or peritonitis

SJIA without MAS

The American College of Rheumatology conditionally recommends IL-1 or IL-6 inhibitors and/or a brief trial of scheduled non-steroidal anti-inflammatories (NSAIDs) for initial treatment for SJIA without MAS. Studies suggest that a small proportion of patients with systemic JIA will respond to NSAIDs alone. If clinical response is not rapid and complete, rapid escalation of therapy is recommended. There is no consensus on the appropriate duration of initial use of NSAIDs before escalating therapy, as many prescribers prefer that the use of NSAIDs be avoided altogether for SJIA. Oral glucocorticoids are conditionally recommended against use in this population (the recommendation is conditional, as IL-1 or IL-6 inhibitors may not always be immediately available, and glucocorticoids may help control systemic and joint manifestations until IL-1 or IL-6 inhibitors can be started. Conventional synthetic disease modifying antirheumatic drugs (DMARDs) are strongly recommended against as initial therapy in this population. For subsequent therapy IL-1 and IL-6 inhibitors are strongly recommended over a single or combination of conventional synthetic DMARDs for inadequate response to intolerance of NSAIDs and/or glucocorticoids.(19)

SJIA with MAS

The American College of Rheumatology conditionally recommends IL-1 or IL-6 inhibitors over calcineurin inhibitors alone to achieve inactive disease and resolution of MAS. Glucocorticoids are conditionally recommended as part of initial treatment in patients with SJIA with MAS. Systemic glucocorticoids may be necessary for severely ill patients because they can have rapid onset of action. Longer-term glucocorticoids therapy in children is not appropriate because of its effects on bone health and growth.(19)

RHEUMATOID DISORDERS - Enthesitis Related Arthritis

Juvenile idiopathic arthritis (JIA) is a group of heterogenous forms of arthritis characterized by onset before 16 years of age, involving one or more joints, and lasting 6 weeks or more. Enthesitis related arthritis (ERA) is one form of JIA in which patients have predominately enthesitis, enthesitis and arthritis, juvenile ankylosing spondylitis, or inflammatory bowel disease associated arthropathy. The International League Against Rheumatism as arthritis and enthesitis that lasts at least 6 weeks in a child less than 16 years OR arthritis or enthesitis with two of the following features: sacroiliac tenderness or inflammatory spinal pain, HLA-B27 positivity, onset of arthritis in a male patient older than 6 years, and family history of HLA-B27 associated disease. Enthesitis is a distinct feature of ERA and is defined as inflammation of an enthesis, which is a site where a tendon, ligament, or joint capsule attaches to bone. (55)

The ACR 2019 guidelines recommend the following treatment approach for ERA:

  • NSAIDs are strongly recommended over no treatment in children and adolescents (34)
  • TNF inhibitors are conditionally recommended over methotrexate or sulfasalazine in children and adolescents with active enthesitis despite treatment with NSAIDs (34)
  • First line therapy with continuous NSAIDs and physical therapy for adult patients (47)
  • DMARDs (i.e., methotrexate [MTX], sulfasalazine) are only conditionally recommended in patients that have failed NSAIDs and have contraindications to TNF-inhibitors (47)
    • Lack of response (or intolerance) to at least 2 different NSAIDs over 1 month or incomplete response to at least 2 different NSAIDs over 2 months would be an adequate NSAID trial to judge response (17)

RHEUMATOID DISORDERS - Psoriatic Arthritis (PsA)

Psoriatic arthritis (PsA) is a chronic inflammatory musculoskeletal disease associated with psoriasis, most commonly presenting with peripheral arthritis, dactylitis, enthesitis, and spondylitis. Treatment involves the use of a variety of interventions, including many agents used for the treatment of other inflammatory arthritis, particularly spondyloarthritis and RA, and other management strategies of the cutaneous manifestations of psoriasis.(29)

The American Academy of Dermatology (AAD) recommends initiating MTX in most patients with moderate to severe PsA. After 12 to 16 weeks of MTX therapy with appropriate dose escalation, the AAD recommends adding or switching to a TNF inhibitor if there is minimal improvement on MTX monotherapy.(30)

The American College of Rheumatology (ACR) and the National Psoriasis Foundation (NPF) guidelines for PsA recommend a treat-to-target approach in therapy, regardless of disease activity, and the following:(29)

  • Active PsA is defined as symptoms at an unacceptably bothersome level as reported by the patient and health care provider to be due to PsA based on the presence of one of the following:
    • Actively inflamed joints
    • Dactylitis
    • Enthesitis
    • Axial disease
    • Active skin and/or nail involvement
    • Extraarticular manifestations such as uveitis or inflammatory bowel disease
  • Disease severity includes level of disease activity at a given time point and the presence/absence of poor prognostic factors and long-term damage
  • Severe PsA disease includes the presence of 1 or more of the following:
    • Erosive disease
    • Elevated markers of inflammation (ESR, CRP) attributable to PsA
    • Long-term damage that interferes with function (i.e., joint deformities)
    • Highly active disease that causes a major impairment in quality of life
    • Active PsA at many sites including dactylitis, enthesitis
    • Function limiting PsA at a few sites
    • Rapidly progressive disease
  • Symptomatic treatments include nonsteroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, local glucocorticoid injections
  • Treatment recommendations for active disease:
    • Treatment naïve patients first line options include oral small molecules (OSM), TNF biologics, IL-17 inhibitor, and IL-12/23 inhibitor
      • OSM (i.e., methotrexate [MTX], sulfasalazine, cyclosporine, leflunomide, apremilast) should be considered if the patient does not have severe PsA, does not have severe psoriasis, prefers oral therapy, has concern over starting a biologic, or has contraindications to TNF inhibitor
      • Biologics (i.e., TNF biologic, IL-17 inhibitor, IL-12/23 inhibitor) are recommended as a first line option in patients with severe PsA and/or severe psoriasis
    • Previous treatment with OSM and continued active disease:
      • Switch to a different OSM (except apremilast) in patients without severe PsA or severe PS, contraindications to TNF biologics, prefers oral therapy OR add on apremilast to current OSM therapy
      • May add another OSM (except apremilast) to current OSM therapy for patients that have exhibited partial response to current OSM in patients without severe PsA or severe PS, contraindications to TNF biologics, or prefers oral therapy 
      • Biologic (i.e., TNF biologic, IL-17 inhibitor, IL-12/23 inhibitor) monotherapy
    • Previous treatment with a biologic (i.e., TNF biologic, IL-17 inhibitor, IL-12/23 inhibitor) and continued active disease:
      • Switch to another biologic (i.e., TNF biologic, IL-17 inhibitor, IL-12/23 inhibitor, abatacept, or tofacitinib) monotherapy or add MTX to the current TNF biologic

RHEUMATOID DISORDERS - Polymyalgia Rheumatica (PMR)

Polymyalgia rheumatica (PMR) is an inflammatory condition that causes widespread aching and stiffness, often without associated joint inflammation. PMR is often associated with giant cell arteritis, with roughly 15% of patients developing giant cell arteritis. Symptoms of PMR tend to abruptly appear, starting overnight to over a few weeks, and may continue for years. PMR generally affects patients over 50 years of age, with the majority of patients developing PMR after age 70. The underlying pathology has not been determined, but it is hypothesized that infections and/or the aging process play a significant role. There may be evidence of subclinical arterial inflammation via ultrasonography, MRI, CT and/or PET scan. The inflammation occurs typically in the proximal articular and the periarticular structures (i.e., bursae and tendons). The diagnosis of PMR can be difficult and often requires a rheumatologist for diagnosis and management. Diagnosis is often based on symptoms associated with PMR and labs. Inflammatory markers may be elevated, such as erythrocyte sedimentation rate (ESR) and/or C-reactive protein (CRP).(72)

The American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) guidelines recommend the following for the treatment of PMR: (73)

  • Strongly recommends using glucocorticoids over NSAIDs for long term care of patients with PMR and used for the minimum effective duration
  • Conditionally recommends using the minimum effective glucocorticoid dose within a range of 12.5–25 mg prednisone equivalent daily as the initial treatment of PMR. A higher initial prednisone dose within this range may be considered in patients with a high risk of relapse and low risk of adverse events, whereas in patients with relevant comorbidities (e.g., diabetes, osteoporosis, glaucoma, etc.) and other risk factors for glucocorticoid -related side effects, a lower dose may be preferred. The guideline discourages conditionally the use of initial doses less than or equal to 7.5 mg/day and strongly recommends against the use of initial doses greater than 30 mg/day.
  • Strongly recommends individualizing dose tapering schedules, predicated to regular monitoring of patient disease activity, laboratory markers and adverse events. The following principles of glucocorticoid dose tapering are suggested:
    • Initial tapering: Taper dose to an oral dose of 10 mg/day prednisone equivalent within 4–8 weeks.
    • Relapse therapy: Increase oral prednisone to the pre-relapse dose and decrease it gradually (within 4–8 weeks) to the dose at which the relapse occurred.
    • Tapering once remission is achieved (following initial and relapse therapies): Taper daily oral prednisone by 1 mg every 4 weeks (or by 1.25 mg decrements using schedules such as 10/7.5 mg alternate days, etc.) until discontinuation given that remission is maintained.
  • Conditionally recommends considering intramuscular (IM) methylprednisolone as an alternative to oral glucocorticoids. The choice between oral glucocorticoids and IM methylprednisolone remains at the discretion of the prescriber.
  • Conditionally recommends using a single rather than divided daily doses of oral glucocorticoids for the treatment of PMR, except for special situations such as prominent night pain while tapering glucocorticoids below the low-dose range (prednisone or equivalent less than 5 mg daily).
  • Conditionally recommends considering early introduction of methotrexate (MTX) in addition to glucocorticoids, particularly in patients at a high risk for relapse and/or prolonged therapy as well as in cases with risk factors, comorbidities and/or concomitant medications where glucocorticoid-related adverse events are more likely to occur. MTX may also be considered during follow-up of patients with a relapse, without significant response to glucocorticoid or experiencing glucocorticoid-related adverse events.
  • Strongly recommends against the use of TNFa blocking agents for treatment of PMR.

DERMATOLOGICAL DISORDERS - Alopecia Areata

Alopecia areata (AA) is a chronic, inflammatory disorder that affects hair follicles and sometimes nails. Initial presentation generally involves patches of hair loss on the scalp, but any hair-bearing skin may be involved. Short broken hairs, also known as exclamation point hairs, may be seen around the margins of the patches. The hair follicles in the growth phase prematurely transition to the non-proliferative involution and resting phases. This leads to hair shedding and inhibition of hair growth. The integrity of hair follicles are preserved, allowing for the potential regrowth of hair even in longstanding disease. Roughly 34-50% of patients will spontaneously recover within a year from symptom onset. AA often remits in patients with almost all patients experiencing multiple episodes of the disease, and roughly 14-50% of patients will progress to total scalp hair loss, known as alopecia totalis (AT), or total loss of scalp and body hair, known as alopecia universalis (AU). Severity at initial presentation is a strong predictor of long-term outcomes of the disease, with more severe disease progressing to AT or AU. Diagnosis is based off of clinical presentation and patient history. Other causes of alopecia need to be ruled out, and some patients may require a biopsy for diagnosis.(65,66)

The management of AA involves counseling, and potentially antidepressants, due to the psychological effects associated with hair loss. Pharmacologic treatments are often temporary and do not alter the long-term course of the disease. Spontaneous remission rates also make it difficult to assess treatment efficacy, especially in patients with mild disease. Very potent topical corticosteroids have been used to treat patchy AA spots, but there is limited evidence to support long-term use. Intralesional corticosteroids are also an option for patchy AA spots and have shown more sustained hair growth. Systemic corticosteroids are generally reserved for patients with more extensive hair loss, but adverse effects tend to limit duration of use. Hair loss frequently recurs when these treatments are stopped. Conventional systemic immunomodulators and JAK inhibitors are often used for patients with disease that is refractory to corticosteroids and topical immunotherapy.(65,66)

DERMATOLOGICAL DISORDERS - Psoriasis (PS)

Psoriasis (PS) is a chronic inflammatory skin condition that is often associated with systemic manifestations, especially arthritis. Diagnosis is usually clinical, based on the presence of typical erythematous scaly patches, papules, and plaques that are often pruritic and sometimes painful. 

Treatment goals for psoriasis include improvement of skin, nail, and joint lesions plus enhanced quality of life.(20)

The American Academy of Family Physicians (AAFP) categorizes psoriasis severity into mild to moderate (less than 5% of body surface area [BSA]) and moderate to severe (5% or more of BSA). The AAFP psoriasis treatment guidelines recommend basing treatment on disease severity:(20)

  • Mild to moderate (less than 5% of BSA and sparing the genitals, hands, feet, and face):
    • Candidate for intermittent therapy: topical corticosteroids, vitamin D analogs (calcipotriene and calcitriol), or tazarotene (Tazorac)
    • Candidate for continuous therapy: calcineurin inhibitors (tacrolimus and pimecrolimus)
  • Severe (5% or more of BSA or involving the genitals, hands, feet, and face):
    • Less than 20% of BSA affected: vitamin D analogs (calcipotriene and calcitriol) with or without phototherapy. These agents have a slower onset of action but a longer disease-free interval than topical corticosteroids
    • 20% or more of BSA affected: systemic therapy with MTX, cyclosporine, acitretin, or biologics. Biologics are recommended for those with concomitant PsA
  • Less commonly used topical therapies include non-medicated moisturizers, salicylic acid, coal tar, and anthralin

The American Academy of Dermatology (AAD) and National Psoriasis Foundation (NPF) categorize psoriasis severity as limited or mild (less than 3% of BSA), moderate (3% to 10% of BSA), or severe (great than 10% of BSA). The AAD/NPF guidelines also note that psoriasis can be considered severe irrespective of BSA when is occurs in select locations (e.g., hands, feet, scalp, face, or genital area) or when it causes intractable pruritus.(31) The AAD psoriasis treatment guidelines recommend the following:(30,33)

  • Limited disease (less than 5% of BSA):
    • Topical corticosteroids are first line as either monotherapy or in conjunction with non-steroidal topical agents
    • Vitamin D analogs, calcipotriene, calcipotriol, and calcitriol, are other first line agents and are often used in combination with topical corticosteroids
    • Tazarotene is a corticosteroid sparing agent and can be used in combination with topical corticosteroids to produce a synergistic effect and longer durations of treatment benefit and remission
    • Phototherapy is another first line option for limited disease, and allows for selective targeting of localized lesions and resistant areas such as the scalp and skin folds, leaving surrounding, non-lesional skin unaffected
    • Calcineurin inhibitors (tacrolimus and pimecrolimus) may also be considered first line for intertriginous, inverse, face, and genital psoriasis
    • Systemic agents are considered second line and only for short term use
  • Moderate to severe disease without PsA (more than 5% of BSA or psoriasis in vulnerable areas [e.g., face, genitals, hands, and feet] that adversely affects quality of life):
    • UV-therapy is considered first line as monotherapy or in combination with acitretin or MTX
    • If UV-therapy is unavailable, first line therapies include MTX, cyclosporine, acitretin, and biologics
    • Second line systemic agents include leflunomide, sulfasalazine, and tacrolimus
  • Biologics are routinely used when one or more traditional systemic agents fail to produce adequate response, but are considered first line in patients with moderate to severe psoriasis with concomitant severe PsA

The National Psoriasis Foundation (NPF) medical board recommend a treat-to-target approach to therapy for psoriasis that include the following:(32)

  • The preferred assessment instrument for determining disease severity is BSA
  • Target response after treatment initiation should be BSA less than or equal to 1% after 3 months
  • Acceptable response is either a BSA less than or equal to 3% or a BSA improvement greater than or equal to 75% from baseline at 3 months after treatment initiation

DERMATOLOGICAL DISORDERS - Hidradenitis Suppurativa (HS)

Hidradenitis suppurativa (HS) is a chronic inflammatory disease causing painful, nodules to form in the folds of the skin and often secrete puss and blood. HS can be described as mild (single or few lesions in one area of the skin, Hurley Stage I), moderate (repeated cycles of enlarged lesions that break open and occur in more than one area of the skin, Hurley Stage II), and severe (widespread lesions, scarring, and chronic pain; Hurley Stage III).(45,46)   

Pharmacological treatment for mild HS includes topical clindamycin, oral tetracyclines, hormonal treatment, retinoids, intralesional corticosteroid injections (i.e., triamcinolone), and deroofing. Oral tetracyclines are recommended for mild to moderate HS for at least a 12 weeks course or as long-term maintenance. Combination clindamycin and rifampin is effective second-line therapy for mild to moderate HS, or as first-line or adjunct therapy for severe HS. Combination rifampin, moxifloxacin, and metronidazole are recommended as second or third-line therapy for moderate to severe disease. Dapsone may be effective for a minority of patients with mild to moderate HS as long-term maintenance therapy. Oral retinoids, such as acitretin and isotretinoin, have also been used for mild HS as second or third-line therapy. Hormonal therapy may be considered in female patients for mild to moderate disease as monotherapy, or as adjunct therapy for severe disease. such as hormonal contraceptives, metformin, finasteride, and spironolactone.(45,46)

Treatment recommendations for moderate to severe and refractory HS include immunosuppressants (e.g., cyclosporine and low dose systemic corticosteroids) and biologic agents. The TNF-inhibitors that are recommended are adalimumab, at doses within FDA labeling, and infliximab, but optimal doses have not been established. Anakinra and ustekinumab may be effective, but require dose ranging studies to determine optimal doses for management.(45,46) 

DERMATOLOGICAL DISORDERS - Atopic Dermatitis

Atopic dermatitis (AD), also known as atopic eczema, is a chronic, pruritic inflammatory dermatosis affecting up to 25% of children and 1-5% of adults. AD follows a relapsing course and is associated with elevated serum immunoglobulin (IgE) levels and a personal or family history of type I allergies, allergic rhinitis, and/or asthma. Onset is most common between 3 and 6 months of age, with approximately 60% of patients developing the eruption in the first year of life and 90% by age 5. While the majority of affected individuals have resolution of disease by adulthood, 10 to 30% do not, and a smaller percentage first develop symptoms as adults. AD has a complex pathogenesis involving genetic, immunologic, and environmental factors, which lead to a dysfunctional skin barrier and dysregulation of the immune system. Clinical findings include erythema, edema, xerosis, erosions/excoriations, oozing and crusting, and lichenification. These clinical findings vary by patient age and chronicity of lesions. Pruritus is a hallmark of the condition that is responsible for much of the disease burden borne by patients and their families. Typical patterns include facial, neck and extensor involvement in infants and children; flexure involvement in any age group, with sparing of groin and axillary regions.(56)

Goals of treatment are to reduce symptoms (pruritus and dermatitis), prevent exacerbations, and minimize therapeutics risks.(60) Despite its relapsing and remitting nature, the majority of patients with AD can achieve clinical improvement and disease control with nonpharmacological interventions (e.g., emollient use), conventional topical therapies (including corticosteroids and calcineurin inhibitors) and environmental and occupational modifications, when necessary.(58,59,60) The American Academy of Dermatology (AAD) guidelines suggest application of moisturizers should be an integral part of the treatment of patients with AD as there is strong evidence that their use reduces disease severity and need for pharmacologic intervention. They are an important component of maintenance treatment and prevention of flares.(58) The AAD recommends topical corticosteroids (TCS) for patients who fail to respond to good skin care and regular use of emollients alone. Proactive, intermittent use (1-2 times weekly) of topical corticosteroids as maintenance therapy on areas that commonly flare is recommended to help prevent relapses and is more effective than use of emollients alone. Monitoring by physical exam for cutaneous side effects during long-term, potent steroid use is suggested. Proactive, once to twice weekly application of mid-potency TCS for up to 40 weeks has not demonstrated adverse events (e.g., purpura, telangiectasia, striae, focal hypertrichosis, acneiform/rosacea-like eruptions, skin atrophy) in clinical trials.(58) It is recommended that patients with acute flares use super high or high potency topical corticosteroids for one to two weeks, and then replace these with lower potency preparations until the lesions resolve.(61) AAD notes that mid- to higher potency topical corticosteroids are appropriate for short courses to gain rapid control of symptoms, but long-term management should use the least-potent corticosteroid that is effective.(58) In general, if AD is not responding after 2 weeks of treatment, evaluation to determine other treatment plans is indicated.(61)

Topical calcineurin inhibitors (TCIs) (e.g., pimecrolimus, tacrolimus) are recommended by the AAD as second-line therapy and are effective for acute and chronic treatment. They are particularly useful in selected clinical situations such as recalcitrance to steroids; for sensitive areas (face, anogenital, skin folds); for steroid-induced atrophy; and when there is long-term uninterrupted topical steroid use. TCIs are recommended for use on actively affected areas as a steroid-sparing agent. Proactive, intermittent use of TCIs as maintenance therapy (2-3 times per week) on areas that commonly flare is recommended to help prevent relapses while reducing need for topical corticosteroids and is more effective than use of emollients alone. (58) Prescribing information for Elidel® (pimecrolimus) cream and Protopic® (tacrolimus) ointment indicate evaluation after 6 weeks if symptoms of AD do not improve for adults and pediatrics.(62,63)

Phototherapy is recommended as a treatment for both acute and chronic AD in children and adults, after failure of the mentioned above. Systemic immunomodulator agents are indicated and recommended for the subset of adult and pediatric patients in whom optimized topical regimens using emollients, topical anti-inflammatory therapies, adjunctive methods, and/or phototherapy do not adequately control the signs and symptoms of disease. Photo therapy and systemic immunomodulating agents may also be used in patients whose medical, physical, and/or psychological states are greatly affected by their skin disease. Oral cyclosporine, azathioprine, methotrexate, and mycophenolate mofetil are the most commonly used systemic immunomodulators and most efficacious for treating AD. The AAD recommends that systemic corticosteroids should be avoided if possible and should exclusively be reserved for acute, severe exacerbations and as a short-term bridge to other systemic, steroid sparing therapies.(59,64)

There is no clear consensus on how to operationalize a definition of the FDA indication for treatment of patients with "moderate to severe" AD. The severity of AD can vary substantially over time and, from a patient's perspective, can include a complex combination of intensity of itch, location, body surface area (BSA) involvement, and degree of skin impairment. Given the variability of patient phenotype and lack of familiarity among clinicians with scoring systems used in clinical trials, it is advisable to create a broad clinically relevant definition inclusive of multiple specific measures of disease intensity for example:(82)

one of the following:

  • affected BSA greater than or equal to 10%
  • Investigator Global Assessment (IGA) greater than or equal to 3
  • Eczema Area and Severity Index (EASI) greater than or equal to 16

OR

one of the following:

  • affected BSA greater than or equal to 10%
  • involvement of body sites that are difficult to treat with prolonged topical corticosteroid therapy (e.g., hands, feet, face, neck, scalp, genitals/groin, skin folds)
  • severe itch that has been unresponsive to topical therapies

INFLAMMATORY BOWEL DISEASE - Crohn's Disease (CD)

Crohn’s Disease (CD) is an inflammatory condition that can affect any portion of the gastrointestinal tract from the mouth to the perianal area. Choice of therapy is dependent on the anatomic location of disease, the severity of disease, and whether the treatment goal is to induce remission or maintain remission.(21,36) The American Gastroenterological Association (AGA) 2021 guideline recommends the following:(21)

  • Biologic therapy:
    • The AGA suggest early introduction with a biologic, with or without an immunomodulator, rather than delaying their use until after failure of 5-aminosalicylates and/or corticosteroids
    • Anti-TNF (i.e., infliximab or adalimumab) and ustekinumab are recommended over no treatment for the induction and maintenance of remission
    • Vedolizumab is suggested over no treatment for the induction and maintenance of remission
    • AGA suggests against the use of natalizumab over no treatment for the induction and maintenance of remission
    • Patients naïve to biologic therapy, the AGA recommends infliximab, adalimumab, or ustekinumab over certolizumab pegol and suggests the use of vedolizumab over certolizumab pegol for the induction of remission
    • Patients with primary non-response to anti-TNF, the AGA recommends ustekinumab and suggests vedolizumab for induction of remission
    • Patients with secondary non-response to infliximab, the AGA recommends use of adalimumab or ustekinumab and suggests the use of vedolizumab for the induction of remission (if adalimumab was the first line drug, there is indirect evidence to suggest using infliximab as a second-line agent)
  • DMARD therapy:
    • Corticosteroids are suggested over no treatment for the induction of remission, and are recommended against for maintenance of remission
    • Patients in corticosteroid induced remission or with quiescent moderate to severe CD, the AGA suggests thiopurines for maintenance of remission
    • Subcutaneous or intramuscular methotrexate are suggested over no treatment for the induction and maintenance of remission
    • The AGA recommends against the use of 5-aminosalicylates or sulfasalazine over no treatment for the induction or maintenance of remission
    • The AGA suggests against the use of thiopurines over no treatment for achieving remission and recommends biologic drug monotherapy over thiopurine monotherapy for induction of remission
    • The AGA suggests against the use of oral methotrexate monotherapy over no treatment for the induction and maintenance of remission
  • Combination therapy:
    • Patients that are naïve to biologics and immunomodulators, the AGA suggest use of infliximab in combination with thiopurines over infliximab monotherapy for the induction and maintenance of remission (combination infliximab with methotrexate may be more effective over infliximab monotherapy)
    • Patients that are naïve to biologics and immunomodulators, the AGA suggest use of adalimumab in combination with thiopurines over adalimumab monotherapy for the induction and maintenance of remission (combination adalimumab with methotrexate may be more effective over adalimumab monotherapy)
    • No recommendations are being made regarding the use of ustekinumab or vedolizumab in combination with thiopurines or methotrexate over biologic monotherapy for induction or maintenance or remission

The 2018 American College of Gastroenterology (ACG) guideline recommends the following(36):

  • Mild to moderately severe disease/low risk disease:
    • Sulfasalazine (in doses of 3-6 grams daily) is effective in colonic and/or ileocolonic CD, but not those with isolated small bowel disease
    • 5-aminosalicylic (ASA) suppositories and enema preparations are effective for induction and maintenance of remission in rectal and sigmoid disease
    • Conventional corticosteroids are primarily used for the treatment of flares, and are often used as a bridge until immunomodulators and/or biologic agents become effective
    • Controlled ileal release budesonide is effective for induction of remission in ileocecal disease
  • Moderate to severe disease/moderate to high-risk disease
    • Corticosteroids are effective for short-term use in alleviating signs and symptoms of moderate to severely active CD, but do not induce mucosal healing and should be used sparingly
    • Azathioprine, 6-mercaptopurine, or MTX (15 mg once weekly) may be used in treatment of active disease and as adjunctive therapy for reducing immunogenicity against biologic therapy
    • TNF inhibitors should be used to treat CD that is resistant to treatment with corticosteroids and that is refractory to thiopurines or MTX
    • Vedolizumab with or without an immunomodulator should be considered for induction of symptomatic remission for patients with moderate to severely active CD and objective evidence of active disease
    • Ustekinumab should be used in patients that have failed previous treatment with corticosteroids, thiopurines, MTX, or TNF inhibitors, or in patients with no prior TNF inhibitor exposure
  • Severe/fulminant disease:
    • IV corticosteroids should be used
    • TNF inhibitors can be considered
  • Maintenance therapy:
    • Thiopurines or methotrexate should be considered once remission is induced with corticosteroids
    • TNF inhibitors, specifically infliximab, adalimumab, and certolizumab pegol, should be used in combination with azathioprine, MTX, or 6-mercaptopurine to maintain remission of TNF induced remission
    • Vedolizumab should be used for maintenance of remission of vedolizumab induced remission
    • Ustekinumab should be used for maintenance of remission of ustekinumab induced remission

INFLAMMATORY BOWEL DISEASE - Ulcerative Colitis (UC)

Ulcerative colitis (UC) is a chronic immune-mediated inflammatory condition affecting the large intestine associated with inflammation of the rectum, but that can extend to involve additional areas of the colon. The American College of Gastroenterology (ACG) recommends a treat-to-target approach and recommend therapeutic management should be guided by diagnosis (i.e., Montreal classification), assessment of disease activity (i.e., mild, moderate, and severe), and disease prognosis. The ACG treatment recommendations are further broken down into induction therapies and maintenance of remission. The 2019 ACG treatment guidelines recommend the following for therapeutic management of UC(37):

Induction of remission:

  • Mildly active disease:
    • Rectal 5-ASA at a dose of 1 g/day with or without oral 5-ASA at a dose of at least 2 g/day for left-sided UC
    • Rectal 5-ASA at a dose of 1 g/day for ulcerative proctitis
    • Oral 5-ASA at a dose of at least 2 g/day for extensive UC
    • Add oral budesonide multi-matrix (MMX) 9 mg/day for patients that are intolerant or non-responsive to oral and/or rectal and oral 5-ASA at appropriate doses
  • Moderately active disease:
    • Oral budesonide multi-matrix (MMX) 9 mg/day for induction of remission
  • Moderately to severely active disease:
    • Oral systemic corticosteroids, TNF inhibitors (i.e., adalimumab, golimumab, or infliximab), tofacitinib, or vedolizumab to induce remission
    • Combination of infliximab with thiopurine therapy when using infliximab for induction
    • Switch to tofacitinib or vedolizumab for induction in patients that have failed TNF inhibitors
    • Patients with initial response to TNF inhibitors that lose response should have antibody levels and serum drug levels tested to assess reason for loss of response. If serum levels are adequate, use of another TNF inhibitor is not likely to be of benefit. 

Maintenance of remission:

  • Previously mildly active disease:
    • Rectal 5-ASA at a dose of 1 g/day in patients with ulcerative proctitis
    • Oral 5-ASA at a dose of at least 2 g/day in patients with left-sided or extensive UC
  • Previously moderately to severely active disease:
    • Thiopurines in patients that achieved remission due to corticosteroid induction
    • Continue TNF inhibitors (i.e., adalimumab, golimumab, or infliximab) for remission due to TNF induction
    • Continue vedolizumab for remission due to vedolizumab induction
    • Continue tofacitinib for remission due to tofacitinib induction

The American Gastroenterology Association (AGA) published recommendations for the management of mild to moderate UC(38):

  • Use either standard-dose mesalamine (2-3 g/day) or diazo-bonded 5-ASA for patients with extensive UC for induction of remission and maintenance of remission
  • May add rectal mesalamine to oral 5-ASA in patients with extensive or left-sided UC for induction of remission and maintenance of remission
  • Use high dose mesalamine (greater than 3 g/day) with rectal mesalamine in patients with suboptimal response to standard-dose mesalamine, diazo-bonded 5-ASA, or with moderate disease activity for induction of remission and maintenance of remission
  • Add either oral prednisone or budesonide MMX in patients that are refractory to optimized oral and rectal 5-ASA regardless of disease extent

The American Gastroenterology Association (AGA) published recommendations for the management of moderate to severe UC(48):

  • Standard of care is to continue agents initiated for induction therapy as maintenance therapy, if they are effective (excluding corticosteroids and cyclosporine)
  • Adult outpatients with moderate to severe UC:
    • Infliximab, adalimumab, golimumab, vedolizumab, tofacitinib or ustekinumab are strongly recommended over no treatment
    • Biologic naïve patients:
      • infliximab or vedolizumab are conditionally recommended over adalimumab for induction of remission
      • Recommend tofacitinib only be used in the setting of a clinical or registry study
    • Previous exposure to infliximab, particularly those with primary non-response, ustekinumab or tofacitinib are conditionally recommended over vedolizumab or adalimumab for induction of remission
    • Conditionally recommend against use of thiopurine monotherapy for induction, but may be used for maintenance of remission over no treatment

OTHER DISORDERS - Uveitis

Uveitis is inflammation of the uvea, which is the middle layer of the eye, leading to tissue damage and vision loss. There are three types of uveitis: anterior, intermediate and posterior. Uveitis frequently occurs in association with other systemic medical conditions, especially infections and inflammatory disease, but may occur as an isolated process.(39) Treatment of non-infectious uveitis depends on the location of inflammation. Anterior uveitis is generally treated with topical glucocorticoids, such as prednisolone ophthalmic drops.(22,39) Uveitis that is primarily posterior to the lens is generally not responsive to topical medication, although some experts are increasingly using difluprednate.(22) Oral corticosteroids continue to be the mainstay of treatment for noninfectious intermediate, posterior, and pan uveitis. Intraocular and periocular injections of triamcinolone or glucocorticoids are also options, although patients may decline the injections. Systemic treatment is generally reserved for resistant inflammation and may be indicated in patients with glaucoma who cannot be treated with local injection. If remission has been achieved for 6 to 12 months with systemic glucocorticoids, the maintenance dose may be gradually discontinued.(22,42) The American Academy of Ophthalmology recommends the use of immunosuppressive agents, such as methotrexate, azathioprine, mycophenolate, cyclosporine, and tacrolimus, for patients that are intolerant and/or resistant to systemic corticosteroids. TNF-inhibitors, such as adalimumab, are recommended if the patient is inadequately controlled by corticosteroids and non-corticosteroid systemic immunomodulatory therapies.(22,42)

OTHER DISORDERS - Giant Cell Arteritis (GCA)

Giant cell arteritis (GCA) is a blood vessel disease that commonly occurs with polymyalgia rheumatica. It is a type of vasculitis involving mostly the arteries of the scalp and head, especially the arteries over the temples. Eyesight can be affected if GCA spreads to the blood vessels that supply the eye. Treatment should begin as soon as possible to prevent loss of vision.(23)

The American College of Rheumatology/Vasculitis Foundation guidelines recommend High-dose systemic glucocorticoids as the mainstay of therapy for GCA. The guidelines provide the following recommendations for the medical management of GCA(40):

  • Patients with newly diagnosed active GCA with visual symptoms/loss or critical cranial ischemia:
    • High dose IV pulse corticosteroids followed by high dose oral corticosteroids with or without a non-corticosteroid immunosuppressive agent (i.e., methotrexate or tocilizumab)
    • Taper oral corticosteroids in patients that achieve remission
    • Consider adding on or changing non-corticosteroid immunosuppressive agent in patients that have not achieved remission
  • Patients with newly diagnosed active GCA without visual symptoms/loss or critical cranial ischemia:
    • High dose oral corticosteroids with or without a non-corticosteroid immunosuppressive agent (i.e., methotrexate or tocilizumab)
    • Taper oral corticosteroids in patients that achieve remission
    • Consider adding on or changing non-corticosteroid immunosuppressive agent in patients that have not achieved remission

OTHER DISORDERS - Cryopyrin-Associated Periodic Syndromes (CAPS)/Neonatal-Onset Multisystem Inflammatory Disease

Cryopyrin-associated periodic syndrome (CAPS) is a rare autosomal dominant hereditary autoimmune disorder associated with a defect in the cryopyrin protein. CAPS syndrome is caused by a gain of function mutation in the NLRP3 gene leading to over secretion of fever causing cytokine IL-1B. The CAPS spectrum includes mild, moderate, and severe phenotypes. The mild phenotype is called familial cold autoinflammatory syndrome (FCAS), the moderate phenotype is also known as Muckle-Wells syndrome (MWS), the neonatal-onset multisystem inflammatory disease (NOMID)/chronic infantile neurologic cutaneous articular syndrome (CINCA) describes the severe phenotype. CAPS is diagnosed clinically and genetically. There are more than 240 sequence variants of the NLRP3 gene and  mutations in this gene are not inclusive of a CAPS diagnosis. The diagnostic criteria of CAPS recognize that all but a few patients with CAPS have detectable systemic inflammation and use unique CPS-specific clinical features along the whole disease spectrum to achieve reasonable specificity and sensitivity to aid clinicians in making the CAPS diagnosis. These diagnostic criteria do not include genetic confirmation, and therefore can be applied in places where genetic testing is not available. The diagnostic criteria for CAPS are as follows:(24)

  • Raised inflammatory markers (CRP/SAA)
  • The presence of at least two of the following signs/symptoms:
    • Urticaria-like rash
    • Cold/stress triggered episodes
    • Sensorineural hearing loss
    • Musculoskeletal symptoms of arthralgia/arthritis/myalgia
    • Chronic aseptic meningitis
    • Skeletal abnormalities of epiphyseal overgrowth/frontal bossing

FCAS is characterized by episodes of rash, fever. and joint pain following generalized exposure to cold. Attacks usually occur 1-2 hours after exposure and last less than 24.(49) Patients experience urticaria, arthralgia, fever with chills, severe thirst, red-eyes, and headache after a general cold exposure, including air conditioning. In MWS, inflammation can occur spontaneously as well as from triggers, such as stress, cold, or exercise, with episodes lasting from one to three days. MWS shares the same characteristics as FCAS, but is also characterized by renal amyloidosis, sensorineural hearing loss, and conjunctivitis. Hearing loss, partial or complete, often develop by teenage years.(41)  

NOMID is a rare chronic inflammatory disease. NOMID is characterized by fever, urticarial rash, aseptic meningitis, deforming arthropathy, hearing loss, and intellectual disability. An urticaria-like rash develops within the first six weeks of life, and a characteristic bony overgrowth predominantly involving the knees develops in most affected children. Therapies are aimed at suppressing inflammation and have included high-dose corticosteroids, disease-modifying antirheumatic drugs, and biologic agent targeting tumor necrosis factor (TNF). Selective blockade of interleukin-1B is effective in the pathophysiology and organ-specific manifestations of NMOSD, in particular the CNS manifestations of the disease.(57)

Treatment aims are to suppress systemic inflammation, to improve functionality, to prevent organ damage, and to increase patients' quality of life. To achieve these aims, cytokine targeting drugs are important and evidence-based treatment. Since IL-1 plays a central role in CAPS pathogenesis, the anti-IL1 treatments (anakinra, canakinumab, and rilonacept) are recommended for the whole CAPS spectrum.(24)

OTHER DISORDERS Deficiency of the IL-1 Receptor Antagonist (DIRA)

Systemic autoinflammatory diseases (SAIDs) are a group of multisystem immunodysregulatory disorders caused primarily by the dysfunction of the innate immune system. Currently, SAIDs are comprised of a wide range of disorders with systemic and organ-specific inflammation in the absence of infections or autoimmunity. In a subset of genetically defined SAIDs, the pathogenesis is driven by increased release or signaling of the pro-inflammatory cytokine IL-1.(51)  

Patients with DIRA present with early-onset pustular rashes that can be triggered by mechanical stress (pathergy), with sterile osteomyelitis, and nail changes (onychomadesis). Although inflammatory markers are typically highly elevated, fever may be absent. Vertebral involvement can include odontoid osteomyelitis resulting in destruction and neck instability, vertebral block formation and gibbus-like spinal changes that need to be screened for by MRI or CT. The differential diagnosis for DIRA includes chronic recurrent multifocal osteomyelitis (CRMO), synovitis, acne, pustulosis, hyperostosis, osteitis (SAPHO) syndrome and pustular psoriasis. Genetic testing for monogenic defects with overlapping clinical features should include LPIN2, FGR, FBLIM1 for CRMO, CARD14 for CARD14-Mediated Psoriasis (CAMPS), IL36RN for Deficiency of IL-36 Receptor Antagonist (DITRA), AP1S3 for other pustular psoriasis and MEFV for Pyrin-Associated Autoinflammation with Neutrophilic Dermatosis (PAAND).(51)

Aims of therapy are early control of disease activity, prevention of disease and treatment related damage, and optimal health-related quality of life. The ultimate goal of a treat-to-target approach is complete remission. In absence of a consensus definition of remission or minimal disease activity for these diseases, remission has been defined for clinical studies and clinical monitoring as an absence of clinical symptoms and normal inflammatory markers. Anakinra and rilonacept both block IL-1α and IL-1β and should be used for DIRA patients.(51) 

OTHER DISORDERS- Systemic Sclerosis (Scleroderma)-Associated Interstitial Lung Disease (ILD)

Systemic sclerosis (SSc) is a connective tissue disease (CTD) that affects numerous organ systems, including skin, blood vessels, heart, lungs, kidneys, gastrointestinal, and musculoskeletal. Pulmonary disease is the leading cause of death in patients with systemic sclerosis, and ILD is a common manifestation that tends to occur early in the course of systemic sclerosis.(52)

The American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) collaborated on classification criteria for the diagnosis of systemic sclerosis, in which they note that systemic sclerosis-associated ILD is diagnosed when there is radiographic evidence of diffuse parenchymal lung disease in patients with systemic sclerosis. The ACR/EULAR criteria note that ILD is defined as pulmonary fibrosis seen on HRCT or chest radiography, most pronounced in the basilar portions of the lungs.(54)

The American College of Rheumatology (ACR) published a treatment algorithm for systemic sclerosis and related conditions. The ACR recommends the following treatment options for ILD associated with systemic sclerosis:(53)

Induction therapy:

  • Mycophenolate mofetil (MMF) as first line therapy
  • IV cyclophosphamide (CYC) as second line therapy
  • Rituximab as third line therapy
  • Lung transplant or hemopoietic stem cell transplant for select patients as fourth line therapy 

Maintenance therapy:

  • MMF as first line therapy
  • Azathioprine as second line therapy
  • IV or oral CYC as third line therapy

Recent recommendations from the American College of Rheumatology suggest early first line treatment with tocilizumab based on the efficacy and safety from phase II and phase III clinical trials. MMF and CYC are alternative options, but do not have clinical trial data showing efficacy and safety for patients with subclinical ILD. Patients that have clinical evidence of skin and/or musculoskeletal manifestations and inactive disease, MMF, CYC, and nintedanib are the preferred first line options for patients with SSc-ILD. Patients with clinical evidence of skin and/or musculoskeletal manifestations and active disease, tocilizumab, MMF, and CYC are suggested as initial therapy. After treatment is initiated, patients should be followed up every 4 months until disease stabilization. Patients that achieve stabilization on first line therapy, should continue first line therapy for maintenance therapy.(70)

Efficacy

Cosentyx

Psoriatic Arthritis

The safety and efficacy of Cosentyx were assessed in 1999 patients, in 3 randomized, double-blind, placebo-controlled studies (PsA1, PsA2 and PsA3) in adult patients, age 18 years and older with active psoriatic arthritis (greater than or equal to 3 swollen and greater than or equal to 3 tender joints) despite non-steroidal anti-inflammatory drug (NSAID), corticosteroid or disease modifying anti-rheumatic drug (DMARD) therapy. In PsA1, patients treated with 150 mg or 300 mg Cosentyx demonstrated a greater clinical response, including ACR20, ACR50, and ACR70 compared to placebo at Week 24 (Table 6). Responses were similar in patients regardless of concomitant methotrexate treatment. Responses were seen regardless of prior anti-TNFα exposure. Patients on placebo who received Cosentyx without a loading regimen achieved similar ACR20 responses over time (data not shown).(3)

In PsA3 Study, inhibition of progression of structural damage was assessed radiographically and expressed by the modified mTSS and its components, the Erosion Score (ES) and Joint Space Narrowing Score (JSN), at Week 24 compared to baseline. Cosentyx 150 mg without load, 150 mg with load and 300 mg with load treatment significantly inhibited progression of peripheral joint damage compared with placebo treatment as measured by change from baseline in mTSS at Week 24. The percentage of patients with no disease progression (defined as a change from baseline in mTSS of less than or equal to 0.0) from randomization to Week 24 was 75.7%, 70.9%, and 76.5% for Cosentyx 150 mg without load, 150 mg, 300 mg, respectively versus 68.2% for placebo. (3)

Future 4 and Future 5 trials assessed the efficacy and safety of Cosentyx 150 mg with or without loading dose in patients with active psoriatic arthritis.(3)

Future 4 trial was a randomized, double-blind, placebo-controlled phase 3 multicenter study of Cosentyx 150 mg, with and without a loading regimen, assessed the efficacy, safety and tolerability in patients with active psoriatic arthritis over 104 weeks. The primary end point was met by both secukinumab treatment regimens (150 mg and 150 mg no-loading dose), demonstrating a significantly higher ACR20 response with secukinumab compared with placebo at week 16. Both secukinumab 150 mg and 150 mg no-loading dose regimens improved other clinically important end points including DAS28-CRP, PASI 75, SF36 PCS, ACR50, ACR70, PASI 90, MDA, FACIT-Fatigue and HAQ-DI response and resolution of enthesitis and dactylitis through 2 years.(3)

Future 4 Trial

Primary Endpoint

150 mg with loading dose

 

150 mg without loading dose

 

16 weeks

52 weeks

16 weeks

52 weeks

ACR 20

41.2%

60.5%

39.8%

57.5%

ACR 50

22.8%

40.4%

16.8%

22.8%

ACR 70

7.9%

32.7%

8.8%

18.6%

The Future 4 trial indicated that there was no statistically significant difference between the loading dose and non-loading dose for all primary and secondary endpoints.(68)

Future 5 was a double-blind, placebo-controlled, parallel-group phase III trial of Cosentyx 150 mg, with and without a loading regimen, and Cosentyx 300 mg, to assess the efficacy, safety and tolerability in patients with active psoriatic arthritis over 24 weeks. The primary endpoint, ACR20 response at week 16, was met for all secukinumab regimens, and secondary endpoints were significant for all secukinumab doses except for enthesitis and dactylitis resolution in the 150mg without LD group.

Future 5 Trial

Primary Endpoint

150 mg with loading dose

150 mg without loading dose

 

16 weeks

24 weeks

16 weeks

24 weeks

ACR 20

55.5%

53.2%

59.5%

53.2%

ACR 50

35.9%

39%

32.0%

36%

ACR 70

18.2%

24.1%

14.9%

18.5%

The Future 5 trial did not assess if there was statistically significant differences between the loading vs non-loading doses for any endpoints.(69)

Ankylosing Spondylitis

The safety and efficacy of Cosentyx were assessed in 816 patients in three randomized, double-blind, placebo-controlled studies (AS1, AS2, and AS3) in adult patients 18 years of age and older with active ankylosing spondylitis. In AS1, patients treated with 150 mg Cosentyx demonstrated greater improvements in ASAS20 and ASAS40 responses compared to placebo at Week 16. Responses were similar in patients regardless of concomitant therapies. Patients on placebo who received Cosentyx without a loading regimen achieved similar ASAS20 responses over time. At Week 16, the ASAS20 and ASAS40 responses were 58.1% and 40.5% for 150 mg and 60.5% and 42.1% for 300 mg, respectively. Cosentyx treated patients showed improvement compared to placebo-treated patients in health-related quality of life as assessed by ASQoL at Week 16.(3)

Non-Radiographic Axial Spondyloarthritis

The safety and efficacy of Cosentyx were assessed in 555 patients in one randomized, double-blind, placebo-controlled phase 3 study (nr-axSpA1, NCT02696031) in adult patients 18 years of age and older with active non-radiographic axial spondyloarthritis. Patients were treated with Cosentyx 150 mg subcutaneous treatment with load (Weeks 0, 1, 2, 3, and 4) or without a load (Weeks 0 and 4) followed by the same dose every 4 weeks or placebo. In nr-axSpA1 Study, treatment with Cosentyx 150 mg resulted in significant improvements in the measure of disease activity compared to placebo at Week 16 and Week 52.

Number of subjects with ASAS40 response (%)

Cosentyx 150 mg without load (n = 184)

Cosentyx 150 mg with load (n = 185)

Placebo (n = 186)

Difference from Placebo (95% CI)

Cosentyx 150 mg without load

Cosentyx 150 mg with load

Week 16

75 (41)

74 (40)

52 (28)

13 (3, 22)

12 (2, 22)

Week 52

70 (38)

62 (34)

36 (19)

19 (10, 28)

14 (5, 23)

COSENTYX treated patients showed improvement in both load and without load arms compared to placebo-treated patients at Week 16 in health-related quality of life as measured by ASQoL (LS mean change: Week 16: -3.5 and -3.6 vs - 1.8, respectively).(3)

Safety

Actemra(1)

Tocilizumab has the following boxed warning:

  • Increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, and other opportunistic infections. Perform test for latent TB, and if positive, start treatment for TB prior to initiating therapy. Monitor all patients for active TB during treatment, even if initial latent TB test is negative.

Tocilizumab is contraindicated in patients with a known hypersensitivity reaction to tocilizumab.

Adalimumab(6,71,74,75,76,77,78,79,80,83)

Adalimumab products have the following boxed warnings:

  • Increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, and other opportunistic infections. Perform test for latent TB, and if positive, start treatment for TB prior to initiating therapy. Monitor all patients for active TB during treatment, even if initial latent TB test is negative.
  • Lymphoma and other malignancies, some fatal have been reported in children and adolescent patients treated with TNF blockers.
  • Post marketing cases of hepatosplenic T-cell lymphoma have occurred in adolescents and young adults with inflammatory bowel disease treated with TNF blockers

Bimzelx(84)

Bimekizumab-bkzx has no FDA labeled contraindications.

Cimzia(2)

Certolizumab has the following boxed warnings:

  • Increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, and other opportunistic infections. Perform test for latent TB, and if positive, start treatment for TB prior to initiating therapy. Monitor all patients for active TB during treatment, even if initial latent TB test is negative.
  • Lymphoma and other malignancies, some fatal have been reported in children and adolescent patients treated with TNF blockers. Cimzia is not indicated for use in pediatric patients.

Certolizumab is contraindicated in patients with a severe hypersensitivity to certolizumab pegol or to any of the excipients.

Cosentyx(3)

Secukinumab is contraindicated in patients with a serious hypersensitivity reaction to secukinumab or to any of the excipients.

Enbrel(4)

Etanercept has the following boxed warnings:

  • Increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, and other opportunistic infections. Perform test for latent TB, and if positive, start treatment for TB prior to initiating therapy. Monitor all patients for active TB during treatment, even if initial latent TB test is negative.
  • Lymphoma and other malignancies, some fatal have been reported in children and adolescent patients treated with TNF blockers.

Etanercept is contraindicated for use in patients with sepsis.

 

Entyvio

Vedolizumab is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to Entyvio or any of its excipients.

Kevzara(7)

Sarilumab has the following boxed warning:

  • Increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, and other opportunistic infections. Perform test for latent TB, and if positive, start treatment for TB prior to initiating therapy. Monitor all patients for active TB during treatment, even if initial latent TB test is negative.

Sarilumab is contraindicated in patients with a known hypersensitivity to sarilumab or any of the inactive ingredients.

Kineret(8)

Anakinra is contraindicated in patients with a known hypersensitivity to E.coli-derived proteins, anakinra, or any component of the product.

Litfulo(81)

Ritlecitinib is contraindicated in patients with known hypersensitivity to ritlecitinib or any of its exciepents.

Olumiant(9)

Baricitinib has the following boxed warnings:

  • Increased risk of serious bacterial, fungal, viral, and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment with Olumiant if serious infection occurs until the infection is controlled. Test for latent TB before and during therapy, and if positive, start treatment for TB prior to use. Monitor all patients for active TB during treatment, even if initial latent TB test is negative.
  • Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus Kinase (JAK) inhibitor vs tumor necrosis factor (TNF) blockers in RA patients
  • Malignancies have occurred in patients treated with Olumiant. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs TNF blockers in RA patients
  • Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another JAK inhibitor vs TNF blockers in RA patients
  • Thrombosis has occurred in patients treated with Olumiant. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs TNF blockers.

Baricitinib does not have any FDA labeled contraindications for use.

Omvoh(86)

Mirikizumab is contraindicated in patients with a history of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients.

Orencia(10)

Abatacept does not have any FDA labeled contraindications for use.

Rinvoq(44)

Upadacitinib has the following boxed warnings:

  • Increased risk of serious bacterial, fungal, viral, and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment with Rinvoq if serious infection occurs until the infection is controlled. Test for latent TB before and during therapy, and if positive, start treatment for TB prior to use. Monitor all patients for active TB during treatment, even if initial latent TB test is negative.
  • Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus Kinase (JAK) inhibitor vs tumor necrosis factor (TNF) blockers in RA patients
  • Malignancies have occurred in patients treated with Rinvoq. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs TNF blockers in RA patients
  • Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another JAK inhibitor vs TNF blockers in RA patients
  • Thrombosis has occurred in patients treated with Rinvoq. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs TNF blockers.

Upadacitinib is contraindicated in patients with known hypersensitivity to upadacitinib or any of its excipients.  

Siliq(11)

Brodalumab has the following boxed warning:

  • Suicidal ideation and behavior, including completed suicides, have occurred in patients.

Simponi(12)

Golimumab has the following boxed warnings:

  • Increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, and other opportunistic infections. Perform test for latent TB, and if positive, start treatment for TB prior to initiating therapy. Monitor all patients for active TB during treatment, even if initial latent TB test is negative.
  • Lymphoma and other malignancies, some fatal have been reported in children and adolescent patients treated with TNF blockers.

Skyrizi(43)

Risankizumab is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients.

Sotyktu(67)

Deucravacitinib is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in Sotyktu. 

Stelara(13)

Ustekinumab is contraindicated for use in patients with clinically significant hypersensitivity to ustekinumab or to any of the excipients.

Taltz(14)

Ixekizumab is contraindicated for use in patients with serious hypersensitivity reaction to ixekizumab or to any of the excipients.

Tremfya(15)

Guselkumab is contraindicated for use in patients with serious hypersensitivity reaction to guselkumab or to any of the excipients.

Velsipity(85) 

Etrasimod is contraindicated in:

  • Patient who in the last 6 months, experienced myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III or IV heart failure
  • History or presence of Mobitz type II second-degree or third-degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker

Xeljanz/Xeljanz XR(16)

Tofacitinib has the following boxed warnings:

  • Increased risk serious bacterial, fungal, viral, and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment with Xeljanz/Xeljanz XR if serious infection occurs until the infection is controlled. Test for latent TB before and during therapy, and if positive, start treatment for TB prior to initiating therapy. Monitor all patients for active TB during treatment, even if initial latent TB test is negative.
  • Higher rate of all-cause mortality, including sudden cardiovascular death with Xeljanz vs TNF blockers in RA patients
  • Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with Xeljanz vs TNF blockers in RA patients.
  • Thrombosis has occurred in patients treated with Xeljanz. Increased incidence of pulmonary embolism, venous and arterial thrombosis with Xeljanz vs TNF blockers in RA patients.
  • Malignancies have occurred in patients treated with Xeljanz. Higher rate of lymphomas and lung cancers with Xeljanz vs TNF blockers in RA patients.

Tofacitinib does not have any FDA labeled contraindications for use.

REFERENCES

Number

Reference

1

Actemra prescribing information. Genentech, Inc. December 2022.

2

Cimzia prescribing information. UCB, Inc. December 2022.

3

Cosentyx prescribing information. Novartis Pharmaceuticals Corp. October 2023.

4

Enbrel prescribing information. Immunex Corporation. June 2023.

5

Entyvio prescribing information. Takeda Pharmaceuticals U.S.A., Inc. September 2023.

6

Humira prescribing information. AbbVie, Inc. February 2021.

7

Kevzara prescribing information. Regeneron Pharmaceuticals, Inc/ Sanofi-Aventis U.S. LLC. February 2023.

8

Kineret prescribing information. Swedish Orphan Biovitrum. December 2020.

9

Olumiant prescribing information. Eli Lilly and Company. June 2022.

10

Orencia prescribing information. Bristol-Myers Squibb. October 2023.

11

Siliq prescribing information. Bausch Health US LLC. June 2020.

12

Simponi prescribing information. Janssen Biotech, Inc. September 2019.

13

Stelara prescribing information. Janssen Biotech, Inc. September 2022.

14

Taltz prescribing information. Eli Lilly and Company. September 2022.

15

Tremfya prescribing information. Janssen Biotech, Inc. July 2020.

16

Xeljanz and Xeljanz XR prescribing information. Pfizer, Inc. January 2022.

17

Ward, Michael M, M.D., M.PH., et al. American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network 2015 Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis Rheumatol. 2016 February; 68(2): 282–298.

18

Fraenkel, Liana, Bathon, Joan, M, et al. 2021 American College of Rheumatology Guideline for the treatment of Rheumatoid Arthritis. Arthritis Care and Research 2021.

19

Onel KB, Horton DB, Lovell DJ, Shenoi S, Cuello CA, Angeles-Han ST, Becker ML, Cron RQ, Feldman BM, Ferguson PJ, Gewanter H, Guzman J, Kimura Y, Lee T, Murphy K, Nigrovic PA, Ombrello MJ, Rabinovich CE, Tesher M, Twilt M, Klein-Gitelman M, Barbar-Smiley F, Cooper AM, Edelheit B, Gillispie-Taylor M, Hays K, Mannion ML, Peterson R, Flanagan E, Saad N, Sullivan N, Szymanski AM, Trachtman R, Turgunbaev M, Veiga K, Turner AS, Reston JT. 2021 American College of Rheumatology Guideline for the Treatment of Juvenile Idiopathic Arthritis: Therapeutic Approaches for Oligoarthritis, Temporomandibular Joint Arthritis, and Systemic Juvenile Idiopathic Arthritis. Arthritis Rheumatol. 2022 Apr;74(4):553-569. doi: 10.1002/art.42037. Epub 2022 Mar 1. PMID: 35233993; PMCID: PMC10161784.

20

Weigle, Nancy, M.D., et al. Psoriasis. American Academy of Family Physicians. May 2013. 87 (9): 626-633.

21

Feuerstein, Joseph D., et al. American Gastroenterological Association Clinical Practice Guideline on the Medical Management of Moderate to Severe Luminal and Perianal Fistulizing Crohn’s Disease. Gastroenterology 2021; 160: 2496-2508.

22

Papaliodis, George N., M.D., et al. Uveitis: Treatment. UpToDate. Last updated October 2022. Literature review current through November 2022.

23

American College of Rheumatology Committee on Communications and Marketing. (2021, December). Giant Cell Arteritis. Giant cell arteritis - American College of Rheumatology. https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Giant-Cell-Arteritis

24

Welzel T, Kuemmerle-Deschner JB. Diagnosis and Management of the Cryopyrin-Associated Periodic Syndromes (CAPS): What Do We Know Today? J Clin Med. 2021 Jan 1;10(1):128. doi: 10.3390/jcm10010128. PMID: 33401496; PMCID: PMC7794776. 

25

Rheumatoid Arthritis: Causes, Symptoms, Treatments and more. (n.d.). Last updated October 2021. https://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/treatment.php.

26

Methotrexate prescribing information. Sun Pharmaceutical Industries, Inc. November 2021.

27

Visser K, van der Heijde D. Optimal dosage and route of administration of methotrexate in rheumatoid arthritis: a systematic review of the literature. Ann Rheum Dis 2009; 68:1094.

28

O'Dell JR, Mikuls TR, Taylor TH, et al. Therapies for active rheumatoid arthritis after methotrexate failure. N Engl J Med 2013; 369:307.

29

Singh, J. A., et al. (2019). 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis Care Res, 71: 2-29. doi:10.1002/acr.23789.

30

Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. J Am Acad Dermatol. 2011;65(1):137–174.

31

Menter, Alan et al. (2019). Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. Journal of the American Academy of Dermatology. doi: https://doi.org/10.1016/j.jaad.2018.11.057 .

32

Armstrong AW, Siegel MP, Bagel J, et al. From the medical board of the National Psoriasis Foundation: treatment targets for plaque psoriasis. Journal of the American Academy of Dermatology. 2017;76(2):290-298. doi: 10.1016/j.jaad.2016.10.017.

33

Menter A, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. Journal of the American Academy of Dermatology. 2008; 58:826–850. doi: 10.1016/j.jaad.2008.02.039.

34

Ringold, S., et al. (2019). 2019 American College of Rheumatology/Arthritis Foundation Guidelines for the Treatment of Juvenile Idiopathic Arthritis: Therapeutic Approaches for Non-Systemic Polyarthritis, Sacroiliitis, and Enthesitis. Arthritis care & research, 1-18. https://www.rheumatology.org/Portals/0/Files/JIA-Guideline-2019.pdf.

35

Ringold, S., et al. Juvenile Idiopathic Arthritis Research Committee of the Childhood Arthritis and Rheumatology Research Alliance (2014). Childhood Arthritis and Rheumatology Research Alliance consensus treatment plans for new-onset polyarticular juvenile idiopathic arthritis. Arthritis care & research, 66(7), 1063-72.

36

Lichtenstein G. R., Loftus E. V., Isaacs K. L., Regueiro M.D., Gerson L. B., Sands B. E. ACG clinical guideline: management of Crohn's disease in adults. The American Journal of Gastroenterology. 2018;113(4):481–517. doi: 10.1038/ajg.2018.27.

37

Rubin, D. T., MD, FACG, Ananthakrishnan, A. N., M.D., M.PH., Siegel, C. A., M.D., M.S., Sauer, B. G., M.D., M.Sc., FACG, & Long, M.D., M.PH., FACG. ACG Clinical Guideline: Ulcerative Colitis in Adults. The American Journal of Gastroenterology. 2019; 114:384-413. http://s3.gi.org/physicians/guidelines/UlcerativeColitis.pdf

38

Ko, Cynthia W., Crockett, Seth, et al. AGA Clinical Practice Guidelines on the Management of Mild-to-Moderate Ulcerative Colitis. Gastroenterology. 2019; 156(3):748-764. https://www.gastrojournal.org/article/S0016-5085(18)35407-6/pdf.

39

Facts About Uveitis. (2021, November 16). https://nei.nih.gov/health/uveitis/uveitis.

40

Maz, M., Chung, S. A., Abril, A., Langford, C. A., Gorelik, M., Guyatt, G., Archer, A. M., Conn, D. L., Full, K. A., Grayson, P. C., Ibarra, M. F., Imundo, L. F., Kim, S., Merkel, P. A., Rhee, R. L., Seo, P., Stone, J. H., Sule, S., Sundel, R. P., … Mustafa, R. A. (2021). 2021 American College of Rheumatology/Vasculitis Foundation Guideline for the Management of Giant Cell Arteritis and Takayasu Arteritis. Arthritis & Rheumatology.

41

Yu, J. R., & Leslie, K. S. (2010). Cryopyrin-associated periodic syndrome: an update on diagnosis and treatment response. Current allergy and asthma reports, 11(1), 12-20.

42

Dick AD, Rosenbaum JT, Al-Dhibi HA, Belfort R, Brézin AP, Chee SP, et al. Guidance on noncorticosteroid systemic immunomodulatory therapy in noninfectious uveitis. fundamentals of care for UveitiS (FOCUS) initiative. Ophthalmology (2018) 125:757–73. 10.1016/j.ophtha.2017.11.017.

43

Skyrizi prescribing information. AbbVie Inc. May 2023.

44

Rinvoq prescribing information. AbbVie Inc. June 2023.

45

Alikhan, A., et. al. North American clinical management guidelines for hidradenitis suppurativa: A publication from the United States and Canadian Hidradenitis Suppurativa Foundations: Part I: Diagnosis, evaluation, and the use of complementary and procedural management. Journal of the American Academy of Dermatology, 81(1):76-90.

46

Alikhan, A., et. al. North American clinical management guidelines for hidradenitis suppurativa: A publication from the United States and Canadian Hidradenitis Suppurativa Foundations: Part II: Topical, intralesional, and systemic medical management. Journal of the American Academy of Dermatology, 81(1):91-101.

47

Ward, Michael M, M.D., M.PH., et al. 2019 Update of the American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis Rheumatol. 2019 October; 71(10): 1599-1613.

48

Feuerstein, Joseph D. et al. AGA Clinical Practice Guidelines on the Management of Moderate to Severe Ulcerative Colitis. Gastroenterology, Volume 0, Issue 0.

49

Hoffman HM, Wanderer AA, Broide DH. Familial cold autoinflammatory syndrome: phenotype and genotype of an autosomal dominant periodic fever. J Allergy Clin Immunol. 2001 Oct;108(4):615-20. doi: 10.1067/mai.2001.118790. PMID: 11590390; PMCID: PMC4321996.

50

Reference no longer used

51

Romano M, Arici ZS, Piskin D, Alehashemi S, Aletaha D, Barron K, Benseler S, Berard RA, Broderick L, Dedeoglu F, Diebold M, Durrant K, Ferguson P, Foell D, Hausmann JS, Jones OY, Kastner D, Lachmann HJ, Laxer RM, Rivera D, Ruperto N, Simon A, Twilt M, Frenkel J, Hoffman HM, de Jesus AA, Kuemmerle-Deschner JB, Ozen S, Gattorno M, Goldbach-Mansky R, Demirkaya E. The 2021 EULAR/American College of Rheumatology Points to Consider for Diagnosis, Management and Monitoring of the Interleukin-1 Mediated Autoinflammatory Diseases: Cryopyrin-Associated Periodic Syndromes, Tumour Necrosis Factor Receptor-Associated Periodic Syndrome, Mevalonate Kinase Deficiency, and Deficiency of the Interleukin-1 Receptor Antagonist. Arthritis Rheumatol. 2022 Jul;74(7):1102-1121. doi: 10.1002/art.42139. Epub 2022 May 27. PMID: 35621220; PMCID: PMC9531906.

52

Update of EULAR Recommendations for the Treatment of Systemic Sclerosis. Ann Rheum Dis. 2017;76:1327-1339.

53

Fernández‐Codina A, Walker KM, Pope JE. Treatment Algorithms for Systemic Sclerosis According to Experts. Arthritis Rheum. 2018 Nov;70(11):1820-1828.

54

van den Hoogen F, Khanna D, Fransen J, et al. Classification Criteria for Systemic Sclerosis: An American College of Rheumatology/European League Against Rheumatism Collaborative Initiative. Arthritis Rheum. 2013 Nov;65(11):2737–2747.

55

Weiss P. F. (2012). Diagnosis and treatment of enthesitis-related arthritis. Adolescent health, medicine and therapeutics2012(3), 67–74. https://doi.org/10.2147/AHMT.S25872.

56

Eichenfield LF, Tom WL, Chamlin SL, Feldman SR, Hanifin JM, Simpson EL, et al. Guidelines of Care for the Management of Atopic Dermatitis: Section 1. Diagnosis and Assessment of Atopic Dermatitis. J Am Acad Dermatol. 2014 Feb;70(2):338-51.

57

Goldbach-Mansky R, Dailey NJ, Canna SW, Gelabert A, Jones J, Rubin BI, Kim HJ, Brewer C, Zalewski C, Wiggs E, Hill S, Turner ML, Karp BI, Aksentijevich I, Pucino F, Penzak SR, Haverkamp MH, Stein L, Adams BS, Moore TL, Fuhlbrigge RC, Shaham B, Jarvis JN, O'Neil K, Vehe RK, Beitz LO, Gardner G, Hannan WP, Warren RW, Horn W, Cole JL, Paul SM, Hawkins PN, Pham TH, Snyder C, Wesley RA, Hoffmann SC, Holland SM, Butman JA, Kastner DL. Neonatal-onset multisystem inflammatory disease responsive to interleukin-1beta inhibition. N Engl J Med. 2006 Aug 10;355(6):581-92. doi: 10.1056/NEJMoa055137. PMID: 16899778; PMCID: PMC4178954.

58

Eichenfield L, Tom W, Berger T, et al. Guidelines of care for the management of atopic dermatitis. Section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol 2014;71(1):116-32.

59

Sidbury, Robert, MD., et al. Guidelines of Care for the Management of Atopic Dermatitis. Section 3. Management and Treatment with Phototherapy and Systemic Agents. J Am Acad Dermatol 2014; 71 (2): 327-349.

60

Sidbury R, Tom WL, Bergman JN, Cooper KD, Silverman RA, Berger TG, et al. Guidelines of care for the management of atopic dermatitis: Section 4. Prevention of disease flares and use of adjunctive therapies and approaches. J Am Acad Dermatol. 2014 Dec;71(6):1218-33.

61

Schneider L, Tilles S, Lio P, et al. Atopic dermatitis: a practice parameter update 2012. J Allergy Clin Immunol 2013; 131:295.

62

Elidel prescribing information. Bausch Helath US, LLC. September 2020.

63

Protopic prescribing information. LEO Pharma Inc. February 2019.

64

European Task Force on Atopic Dermatitis (ETFAD) / European Academy of Dermatology and Venereology (EADV) Eczema Task Force Position Paper on Diagnosis and Treatment of Atopic Dermatitis in Adults and Children. J Eur Acad Dermatol Venereol. 2020;34(12):2717-2744.

65

Messenger AG, McKillop J, Farrant P, et al. British Association of Dermatologists' guidelines for the management of alopecia areata 2012. Br J Dermatol 2012; 166:916.

66

Messenger AG. Alopecia areata: Management. In: UpToDate, Post TW (Ed), UpToDate, Waltham, MA. Literature review current through December 2022. Last updated December 2022.

67

Sotyktu prescribing information. Bristol-Myers Squibb Company. September 2022.

68

Kivitz AJ, Nash P, Tahir H, Everding A, Mann H, Kaszuba A, Pellet P, Widmer A, Pricop L, Abrams K. Efficacy and Safety of Subcutaneous Secukinumab 150 mg with or Without Loading Regimen in Psoriatic Arthritis: Results from the FUTURE 4 Study. Rheumatol Ther. 2019 Sep;6(3):393-407. doi: 10.1007/s40744-019-0163-5. Epub 2019 Jun 21. PMID: 31228101; PMCID: PMC6702584.

69

Mease P, van der Heijde D, Landewé R, Mpofu S, Rahman P, Tahir H, Singhal A, Boettcher E, Navarra S, Meiser K, Readie A, Pricop L, Abrams K. Secukinumab improves active psoriatic arthritis symptoms and inhibits radiographic progression: primary results from the randomised, double-blind, phase III FUTURE 5 study. Ann Rheum Dis. 2018 Jun;77(6):890-897. doi: 10.1136/annrheumdis-2017-212687. Epub 2018 Mar 17. PMID: 29550766; PMCID: PMC5965348.

70

Khanna, D., Lescoat, A., Roofeh, D., Bernstein, E.J., Kazerooni, E.A., Roth, M.D., Martinez, F., Flaherty, K.R. and Denton, C.P. (2022), Systemic Sclerosis–Associated Interstitial Lung Disease: How to Incorporate Two Food and Drug Administration–Approved Therapies in Clinical Practice. Arthritis Rheumatol, 74: 13-27. https://doi.org/10.1002/art.41933

71

Amjevita prescribing information. Amgen Inc. August 2023.

72

American College of Rheumatology Committee on Communications and Marketing. (2021, December). Polymyalgia Rheumatica - American college of rheumatologyhttps://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Polymyalgia-Rheumatica

73

Dejaco C, Singh YP, Perel P, et al. European League Against Rheumatism/American College of Rheumatology. 2015 recommendations for the management of polymyalgia rheumatica: a European League Against Rheumatism/American College of Rheumatology collaborative initiative. Arthritis Rheumatol. 2015 Oct;67(10):2569-80. doi: 10.1002/art.39333. PMID: 26352874.

74

Hulio prescribing information. Mylan Pharmaceuticals. August 2023.

75

Idacio prescribing information. Fresenius Kabi USA, LLC. November 2023.

76

Cyltezo prescribing information. Boehringer Ingelheim Pharmaceuticals, Inc. June 2023.

77

Hadlima prescribing information. Organon LLC. July 2023.

78

Yuflyma prescribing information. Celltrion, Inc. September 2023.

79

Yusimry prescribing information. Coherus BioSciences, Inc. September 2023.

80

Hyrimoz prescribing information. Sandoz Inc. September 2023.

81

Litfulo prescribing information. Pfizer Labs. June 2023.

82

Institute For Clinical and Economic Review (ICER). JAK inhibitors and Monoclonal Antibodies for the Treatment of Atopic Dermatitis: Effectiveness and Value. Final Evidence Report. August 2021. Updated February 2023.

83

Abrilada prescribing information. Pfizer Laboratories Div Pfizer Inc. October 2023.

84

Bimzelx prescribing information. UCB, Inc. October 2023.

85

Velsipity prescribing information. Pfizer Labs. October 2023.

86

Omvoh prescribing information. Eli Lilly and Company. October 2023.

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Target Brand Agent(s)

Target Generic Agent(s)

Strength

Targeted MSC

Available MSC

Final Age Limit

Preferred Status

Orencia clickject

abatacept subcutaneous soln auto-injector

125 MG/ML

M ; N ; O ; Y

N

Orencia

abatacept subcutaneous soln prefilled syringe

125 MG/ML ; 50 MG/0.4ML ; 87.5 MG/0.7ML

M ; N ; O ; Y

N

Humira ; Humira pediatric crohns d ; Humira pen ; Humira pen-cd/uc/hs start ; Humira pen-pediatric uc s ; Humira pen-ps/uv starter

adalimumab pen-injector kit  ; adalimumab prefilled syringe kit

10 MG/0.1ML ; 20 MG/0.2ML ; 40 MG/0.4ML ; 40 MG/0.8ML ; 80 MG/0.8ML ; 80 MG/0.8ML & 40MG/0.4ML

M ; N ; O ; Y

N

Idacio ; Idacio starter package fo

adalimumab-aacf auto-injector kit  ; adalimumab-aacf prefilled syringe kit

40 MG/0.8ML

M ; N ; O ; Y

N

Yuflyma ; Yuflyma 1-pen kit ; Yuflyma 2-pen kit ; Yuflyma 2-syringe kit ; Yuflyma cd/uc/hs starter

adalimumab-aaty auto-injector kit  ; adalimumab-aaty prefilled syringe kit

40 MG/0.4ML ; 80 MG/0.8ML

M ; N ; O ; Y

N

Hyrimoz ; Hyrimoz crohn's disease a ; Hyrimoz pediatric crohn's ; Hyrimoz pediatric crohns ; Hyrimoz plaque psoriasis ; Hyrimoz sensoready pens

adalimumab-adaz soln auto-injector  ; adalimumab-adaz soln prefilled syr  ; adalimumab-adaz soln prefilled syringe

10 MG/0.1 ML ; 20 MG/0.2ML ; 40 MG/0.4ML ; 40 MG/0.8ML ; 80 MG/0.8ML ; 80 MG/0.8ML & 40MG/0.4ML

M ; N ; O ; Y

N

Cyltezo ; Cyltezo starter package f

adalimumab-adbm auto-injector kit  ; adalimumab-adbm prefilled syringe kit

10 MG/0.2ML ; 20 MG/0.4ML ; 40 MG/0.8ML

M ; N ; O ; Y

N

Abrilada ; Abrilada 1-pen kit ; Abrilada 2-pen kit

adalimumab-afzb auto-injector kit  ; adalimumab-afzb prefilled syringe kit

20 MG/0.4ML ; 40 MG/0.8ML

M ; N ; O ; Y

N

Yusimry

adalimumab-aqvh soln pen-injector

40 MG/0.8ML

M ; N ; O ; Y

N

Amjevita

adalimumab-atto soln auto-injector  ; adalimumab-atto soln prefilled syringe

10 MG/0.2ML ; 20 MG/0.2ML ; 20 MG/0.4ML ; 40 MG/0.4ML ; 40 MG/0.8ML ; 80 MG/0.8ML

M ; N ; O ; Y

N

Hadlima ; Hadlima pushtouch

adalimumab-bwwd soln auto-injector  ; adalimumab-bwwd soln prefilled syringe

40 MG/0.4ML ; 40 MG/0.8ML

M ; N ; O ; Y

N

Hulio

adalimumab-fkjp auto-injector kit  ; adalimumab-fkjp prefilled syringe kit

20 MG/0.4ML ; 40 MG/0.8ML

M ; N ; O ; Y

N

Kineret

anakinra subcutaneous soln prefilled syringe

100 MG/0.67ML

M ; N ; O ; Y

N

Olumiant

baricitinib tab

1 MG ; 2 MG ; 4 MG

M ; N ; O ; Y

N

Bimzelx

bimekizumab-bkzx subcutaneous soln auto-injector  ; bimekizumab-bkzx subcutaneous soln prefilled syr

160 MG/ML

M ; N ; O ; Y

N

Siliq

brodalumab subcutaneous soln prefilled syringe

210 MG/1.5ML

M ; N ; O ; Y

N

Cimzia ; Cimzia starter kit

certolizumab pegol for inj kit  ; certolizumab pegol prefilled syringe kit

200 MG ; 200 MG/ML

M ; N ; O ; Y

N

Sotyktu

deucravacitinib tab

6 MG

M ; N ; O ; Y

N

Enbrel ; Enbrel mini ; Enbrel sureclick

etanercept for subcutaneous inj  ; etanercept subcutaneous inj  ; etanercept subcutaneous soln prefilled syringe  ; etanercept subcutaneous solution auto-injector  ; etanercept subcutaneous solution cartridge

25 MG ; 25 MG/0.5ML ; 50 MG/ML

M ; N ; O ; Y

N

Velsipity

etrasimod arginine tab

2 MG

M ; N ; O ; Y

N

Simponi

golimumab subcutaneous soln auto-injector

100 MG/ML ; 50 MG/0.5ML

M ; N ; O ; Y

N

Simponi

golimumab subcutaneous soln prefilled syringe

100 MG/ML ; 50 MG/0.5ML

M ; N ; O ; Y

N

Tremfya

guselkumab soln pen-injector  ; guselkumab soln prefilled syringe

100 MG/ML

M ; N ; O ; Y

N

Taltz

ixekizumab subcutaneous soln auto-injector  ; ixekizumab subcutaneous soln prefilled syringe

80 MG/ML

M ; N ; O ; Y

N

Omvoh

mirikizumab-mrkz subcutaneous soln auto-injector

100 MG/ML

M ; N ; O ; Y

N

Skyrizi ; Skyrizi pen

risankizumab-rzaa sol prefilled syringe  ; risankizumab-rzaa soln auto-injector  ; risankizumab-rzaa soln prefilled syringe

150 MG/ML ; 75 MG/0.83ML

M ; N ; O ; Y

N

Skyrizi

risankizumab-rzaa subcutaneous soln cartridge

180 MG/1.2ML ; 360 MG/2.4ML

M ; N ; O ; Y

N

Litfulo

ritlecitinib tosylate cap

50 MG

M ; N ; O ; Y

N

Kevzara

sarilumab subcutaneous soln prefilled syringe  ; sarilumab subcutaneous solution auto-injector

150 MG/1.14ML ; 200 MG/1.14ML

M ; N ; O ; Y

N

Cosentyx ; Cosentyx sensoready pen ; Cosentyx unoready

secukinumab iv soln  ; secukinumab subcutaneous auto-inj  ; secukinumab subcutaneous pref syr  ; secukinumab subcutaneous soln auto-injector  ; secukinumab subcutaneous soln prefilled syringe

125 MG/5ML ; 150 MG/ML ; 300 MG/2ML ; 75 MG/0.5ML

M ; N ; O ; Y

N

Actemra actpen

tocilizumab subcutaneous soln auto-injector

162 MG/0.9ML

M ; N ; O ; Y

N

Actemra

tocilizumab subcutaneous soln prefilled syringe

162 MG/0.9ML

M ; N ; O ; Y

N

Xeljanz ; Xeljanz xr

tofacitinib citrate oral soln  ; tofacitinib citrate tab  ; tofacitinib citrate tab er

1 MG/ML ; 10 MG ; 11 MG ; 22 MG ; 5 MG

M ; N ; O ; Y

N

Rinvoq

upadacitinib tab er

15 MG ; 30 MG ; 45 MG

M ; N ; O ; Y

N

Stelara

ustekinumab inj  ; ustekinumab soln prefilled syringe

45 MG/0.5ML ; 90 MG/ML

M ; N ; O ; Y

N

Entyvio

vedolizumab soln pen-injector

108 MG/0.68ML

M ; N ; O ; Y

N

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

QL Amount

Dose Form

Day Supply

Duration

Addtl QL Info

Allowed Exceptions

Targeted NDCs When Exclusions Exist

Abrilada

adalimumab-afzb prefilled syringe kit

20 MG/0.4ML

2

Syringes

28

DAYS

Abrilada

adalimumab-afzb prefilled syringe kit

40 MG/0.8ML

2

Syringes

28

DAYS

Abrilada 1-pen kit ; Abrilada 2-pen kit

adalimumab-afzb auto-injector kit

40 MG/0.8ML

2

Pens

28

DAYS

Actemra

Tocilizumab Subcutaneous Soln Prefilled Syringe 162 MG/0.9ML

162 MG/0.9ML

4

Syringes

28

DAYS

Actemra actpen

Tocilizumab Subcutaneous Soln Auto-injector 162 MG/0.9ML

162 MG/0.9ML

4

Pens

28

DAYS

Amjevita

adalimumab-atto soln auto-injector

40 MG/0.4ML

2

Pens

28

DAYS

Amjevita

adalimumab-atto soln auto-injector

40 MG/0.8ML

2

Pens

28

DAYS

Amjevita

adalimumab-atto soln auto-injector

80 MG/0.8ML

2

Pens

28

DAYS

Amjevita

adalimumab-atto soln prefilled syringe

10 MG/0.2ML

2

Syringes

28

DAYS

Amjevita

adalimumab-atto soln prefilled syringe

20 MG/0.2ML

2

Syringes

28

DAYS

Amjevita

adalimumab-atto soln prefilled syringe

20 MG/0.4ML

2

Syringes

28

DAYS

Amjevita

adalimumab-atto soln prefilled syringe

40 MG/0.4ML

2

Syringes

28

DAYS

Amjevita

adalimumab-atto soln prefilled syringe

40 MG/0.8ML

2

Syringes

28

DAYS

Bimzelx

bimekizumab-bkzx subcutaneous soln auto-injector

160 MG/ML

2

Pens

56

DAYS

Bimzelx

bimekizumab-bkzx subcutaneous soln prefilled syr

160 MG/ML

2

Syringes

56

DAYS

Cimzia

Certolizumab Pegol Prefilled Syringe Kit

200 MG/ML

2

Kits

28

DAYS

6 syringes allowed for 28 days of therapy (Week 0, 2, 4) of 400 mg dosing

Cimzia starter kit

Certolizumab Pegol Prefilled Syringe Kit

200 MG/ML

1

Kit

180

DAYS

Cosentyx

Secukinumab Subcutaneous Pref Syr 150 MG/ML (300 MG Dose)

150 MG/ML

2

Syringes

28

DAYS

Cosentyx

Secukinumab Subcutaneous Soln Prefilled Syringe

75 MG/0.5ML

1

Syringe

28

DAYS

Cosentyx

Secukinumab Subcutaneous Soln Prefilled Syringe 150 MG/ML

150 MG/ML

1

Syringe

28

DAYS

Cosentyx sensoready pen

Secukinumab Subcutaneous Auto-inj 150 MG/ML (300 MG Dose)

150 MG/ML

2

Pens

28

DAYS

Cosentyx sensoready pen

Secukinumab Subcutaneous Soln Auto-injector 150 MG/ML

150 MG/ML

1

Pen

28

DAYS

Cosentyx unoready

secukinumab subcutaneous soln auto-injector

300 MG/2ML

1

Pen

28

DAYS

Cyltezo

adalimumab-adbm auto-injector kit

40 MG/0.8ML

2

Pens

28

DAYS

00597037597 ; 00597054522

Cyltezo

adalimumab-adbm prefilled syringe kit

10 MG/0.2ML

2

Syringes

28

DAYS

Cyltezo

adalimumab-adbm prefilled syringe kit

20 MG/0.4ML

2

Syringes

28

DAYS

Cyltezo

adalimumab-adbm prefilled syringe kit

40 MG/0.8ML

2

Syringes

28

DAYS

Cyltezo starter package f

adalimumab-adbm auto-injector kit

40 MG/0.8ML

6

Pens

180

DAYS

00597037516 ; 00597054566

Cyltezo starter package f

adalimumab-adbm auto-injector kit

40 MG/0.8ML

4

Pens

180

DAYS

00597037523 ; 00597054544

Enbrel

Etanercept For Subcutaneous Inj 25 MG

25 MG

8

Vials

28

DAYS

Enbrel

Etanercept Subcutaneous Inj 25 mg/0.5ml

25 MG/0.5ML

8

Vials

28

DAYS

Enbrel

Etanercept Subcutaneous Soln Prefilled Syringe 25 MG/0.5ML

25 MG/0.5ML

4

Syringes

28

DAYS

58406-455-04

Enbrel

Etanercept Subcutaneous Soln Prefilled Syringe 25 MG/0.5ML

25 MG/0.5ML

4

Syringes

28

DAYS

Enbrel

Etanercept Subcutaneous Soln Prefilled Syringe 50 MG/ML

50 MG/ML

4

Syringes

28

DAYS

Enbrel mini

Etanercept Subcutaneous Solution Cartridge 50 MG/ML

50 MG/ML

4

Cartridges

28

DAYS

Enbrel sureclick

Etanercept Subcutaneous Solution Auto-injector 50 MG/ML

50 MG/ML

4

Syringes

28

DAYS

Entyvio

vedolizumab soln pen-injector

108 MG/0.68ML

2

Pens

28

DAYS

Hadlima

adalimumab-bwwd soln prefilled syringe

40 MG/0.4ML

2

Syringes

28

DAYS

Hadlima

adalimumab-bwwd soln prefilled syringe

40 MG/0.8ML

2

Syringes

28

DAYS

Hadlima pushtouch

adalimumab-bwwd soln auto-injector

40 MG/0.4ML

2

Pens

28

DAYS

Hadlima pushtouch

adalimumab-bwwd soln auto-injector

40 MG/0.8ML

2

Pens

28

DAYS

Hulio

adalimumab-fkjp auto-injector kit

40 MG/0.8ML

2

Pens

28

DAYS

Hulio

adalimumab-fkjp prefilled syringe kit

20 MG/0.4ML

2

Syringes

28

DAYS

Hulio

adalimumab-fkjp prefilled syringe kit

40 MG/0.8ML

2

Syringes

28

DAYS

Humira

Adalimumab Prefilled Syringe Kit 10 MG/0.1ML

10 MG/0.1ML

2

Syringes

28

DAYS

Humira

Adalimumab Prefilled Syringe Kit 20 MG/0.2ML

20 MG/0.2ML

2

Syringes

28

DAYS

Humira

Adalimumab Prefilled Syringe Kit 40 MG/0.4ML

40 MG/0.4ML

2

Syringes

28

DAYS

Humira

Adalimumab Prefilled Syringe Kit 40 MG/0.8ML

40 MG/0.8ML

2

Syringes

28

DAYS

Humira pediatric crohns d

Adalimumab Prefilled Syringe Kit 80 MG/0.8ML

80 MG/0.8ML

1

Kit

180

DAYS

Humira pediatric crohns d

Adalimumab Prefilled Syringe Kit 80 MG/0.8ML & 40 MG/0.4ML

80 MG/0.8ML & 40MG/0.4ML

1

Kit

180

DAYS

Humira pen

adalimumab pen-injector kit

40 MG/0.8ML

2

Pens

28

DAYS

00074-4339-02

00074433902 ; 50090448700

Humira pen

adalimumab pen-injector kit

80 MG/0.8ML

2

Pens

28

DAYS

00074-0124-02

00074012402

Humira pen

Adalimumab Pen-injector Kit 40 MG/0.4ML

40 MG/0.4ML

2

Pens

28

DAYS

Humira pen ; Humira pen-cd/uc/hs start

adalimumab pen-injector kit

40 MG/0.8ML

1

Kit

180

DAYS

00074-4339-06

00074433906 ; 50090448700

Humira pen ; Humira pen-ps/uv starter

adalimumab pen-injector kit

40 MG/0.8ML

1

Kit

180

DAYS

00074-4339-07

00074433907 ; 50090448700

Humira pen-cd/uc/hs start

adalimumab pen-injector kit

80 MG/0.8ML

1

Kit

180

DAYS

00074-0124-03

00074012403

Humira pen-pediatric uc s

adalimumab pen-injector kit

80 MG/0.8ML

1

Kit

180

DAYS

00074-0124-04

00074012404

Humira pen-ps/uv starter

Adalimumab Pen-injector Kit 80 MG/0.8ML & 40 MG/0.4ML

80 MG/0.8ML & 40MG/0.4ML

1

Kit

180

DAYS

Hyrimoz

adalimumab-adaz soln auto-injector

40 MG/0.4ML

2

Pens

28

DAYS

Hyrimoz

adalimumab-adaz soln auto-injector

40 MG/0.8ML

2

Pens

28

DAYS

Hyrimoz

adalimumab-adaz soln prefilled syringe

10 MG/0.1 ML

2

Syringes

28

DAYS

Hyrimoz

adalimumab-adaz soln prefilled syringe

20 MG/0.2ML

2

Syringes

28

DAYS

Hyrimoz

adalimumab-adaz soln prefilled syringe

40 MG/0.4ML

2

Syringes

28

DAYS

Hyrimoz

adalimumab-adaz soln prefilled syringe

40 MG/0.8ML

2

Syringes

28

DAYS

Hyrimoz ; Hyrimoz sensoready pens

adalimumab-adaz soln auto-injector

80 MG/0.8ML

2

Pens

28

DAYS

61314045420 ; 83457010701

Hyrimoz crohn's disease a ; Hyrimoz sensoready pens

adalimumab-adaz soln auto-injector

80 MG/0.8ML

1

Starter Kit

180

DAYS

61314045436 ; 83457011301

Hyrimoz pediatric crohn's

adalimumab-adaz soln prefilled syr

80 MG/0.8ML & 40MG/0.4ML

2

Syringes

180

DAYS

Hyrimoz pediatric crohns

adalimumab-adaz soln prefilled syringe

80 MG/0.8ML

3

Syringes

180

DAYS

Hyrimoz plaque psoriasis

adalimumab-adaz soln auto-injector

80 MG/0.8ML & 40MG/0.4ML

1

Starter Kit

180

DAYS

Idacio

adalimumab-aacf auto-injector kit

40 MG/0.8ML

1

Kit

28

DAYS

65219055408 ; 65219061299

Idacio

adalimumab-aacf prefilled syringe kit

40 MG/0.8ML

1

Kit

28

DAYS

Idacio starter package fo

adalimumab-aacf auto-injector kit

40 MG/0.8ML

1

Kit

180

DAYS

65219055428

Idacio starter package fo

adalimumab-aacf auto-injector kit

40 MG/0.8ML

1

Kit

180

DAYS

65219055438

Kevzara

Sarilumab Subcutaneous Soln Prefilled Syringe 150 MG/1.14ML

150 MG/1.14ML

2

Syringes

28

DAYS

Kevzara

Sarilumab Subcutaneous Soln Prefilled Syringe 200 MG/1.14ML

200 MG/1.14ML

2

Syringes

28

DAYS

Kevzara

Sarilumab Subcutaneous Solution Auto-injector 150 MG/1.14ML

150 MG/1.14ML

2

Pens

28

DAYS

Kevzara

Sarilumab Subcutaneous Solution Auto-injector 200 MG/1.14ML

200 MG/1.14ML

2

Pens

28

DAYS

Kineret

Anakinra Subcutaneous Soln Prefilled Syringe 100 MG/0.67ML

100 MG/0.67ML

28

Syringes

28

DAYS

Litfulo

ritlecitinib tosylate cap

50 MG

28

Capsules

28

DAYS

Olumiant

Baricitinib Tab

4 MG

30

Tablets

30

DAYS

Olumiant

Baricitinib Tab 1 MG

1 MG

30

Tablets

30

DAYS

Olumiant

Baricitinib Tab 2 MG

2 MG

30

Tablets

30

DAYS

Omvoh

mirikizumab-mrkz subcutaneous soln auto-injector

100 MG/ML

2

Pens

28

DAYS

Orencia

Abatacept Subcutaneous Soln Prefilled Syringe 125 MG/ML

125 MG/ML

4

Syringes

28

DAYS

Orencia

Abatacept Subcutaneous Soln Prefilled Syringe 125 MG/ML

125 MG/ML

4

Syringes

28

DAYS

Orencia

Abatacept Subcutaneous Soln Prefilled Syringe 50 MG/0.4ML

50 MG/0.4ML

4

Syringes

28

DAYS

Orencia

Abatacept Subcutaneous Soln Prefilled Syringe 87.5 MG/0.7ML

87.5 MG/0.7ML

4

Syringes

28

DAYS

Orencia clickject

Abatacept Subcutaneous Soln Auto-Injector 125 MG/ML

125 MG/ML

4

Pens

28

DAYS

Rinvoq

Upadacitinib Tab ER

45 MG

84

Tablets

365

DAYS

Rinvoq

Upadacitinib Tab ER 24HR 15 MG

15 MG

30

Tablets

30

DAYS

Siliq

Brodalumab Subcutaneous Soln Prefilled Syringe 210 MG/1.5ML

210 MG/1.5ML

2

Syringes

28

DAYS

Simponi

Golimumab Subcutaneous Soln Auto-injector 100 MG/ML

100 MG/ML

1

Syringe

28

DAYS

Simponi

Golimumab Subcutaneous Soln Auto-injector 50 MG/0.5ML

50 MG/0.5ML

1

Syringe

28

DAYS

Simponi

Golimumab Subcutaneous Soln Prefilled Syringe 100 MG/ML

100 MG/ML

1

Syringe

28

DAYS

Simponi

Golimumab Subcutaneous Soln Prefilled Syringe 50 MG/0.5ML

50 MG/0.5ML

1

Syringe

28

DAYS

Skyrizi

Risankizumab-rzaa Sol Prefilled Syringe 2 x 75 MG/0.83ML Kit

75 MG/0.83ML

1

Box

84

DAYS

Skyrizi

Risankizumab-rzaa Soln Prefilled Syringe

150 MG/ML

1

Syringe

84

DAYS

Skyrizi

Risankizumab-rzaa Subcutaneous Soln Cartridge

180 MG/1.2ML

1

Cartridge

56

DAYS

Skyrizi

Risankizumab-rzaa Subcutaneous Soln Cartridge

360 MG/2.4ML

1

Cartridge

56

DAYS

Skyrizi pen

Risankizumab-rzaa Soln Auto-injector

150 MG/ML

1

Pen

84

DAYS

Sotyktu

Deucravacitinib Tab

6 MG

30

Tablets

30

DAYS

Stelara

Ustekinumab Inj 45 MG/0.5ML

45 MG/0.5ML

1

Vial

84

DAYS

Plaque psoriasis: less than or equal to 100kg: 45 mg SC on weeks 0,4 and every 12 weeks thereafter

Stelara

Ustekinumab Soln Prefilled Syringe 45 MG/0.5ML

45 MG/0.5ML

1

Syringe

84

DAYS

Plaque psoriasis: less than or equal to 100kg: 45 mg SC on weeks 0,4 and every 12 weeks thereafter

Stelara

Ustekinumab Soln Prefilled Syringe 90 MG/ML

90 MG/ML

1

Syringe

56

DAYS

Plaque psoriasis: greater than 100kg: 90 mg SC on weeks 0,4 and then every 12 weeks thereafter

Taltz

Ixekizumab Subcutaneous Soln Auto-injector 80 MG/ML

80 MG/ML

1

Syringe

28

DAYS

Taltz

Ixekizumab Subcutaneous Soln Prefilled Syringe 80 MG/ML

80 MG/ML

1

Syringe

28

DAYS

Tremfya

Guselkumab Soln Pen-Injector 100 MG/ML

100 MG/ML

1

Pen

56

DAYS

Tremfya

Guselkumab Soln Prefilled Syringe 100 MG/ML

100 MG/ML

1

Syringe

56

DAYS

Velsipity

etrasimod arginine tab

2 MG

30

Tablets

30

DAYS

Xeljanz

Tofacitinib Citrate Oral Soln

1 MG/ML

240

mLs

30

DAYS

Xeljanz

Tofacitinib Citrate Tab 10 MG (Base Equivalent)

10 MG

240

Tablets

365

DAYS

Xeljanz

Tofacitinib Citrate Tab 5 MG (Base Equivalent)

5 MG

60

Tablets

30

DAYS

Xeljanz xr

Tofacitinib Citrate Tab ER 24HR 11 MG (Base Equivalent)

11 MG

30

Tablets

30

DAYS

Xeljanz xr

Tofacitinib Citrate Tab ER 24HR 22 MG (Base Equivalent)

22 MG

120

Tablets

365

DAYS

Yuflyma

adalimumab-aaty auto-injector kit

80 MG/0.8ML

2

Pens

28

DAYS

72606002304

Yuflyma 1-pen kit ; Yuflyma 2-pen kit

adalimumab-aaty auto-injector kit

40 MG/0.4ML

2

Pens

28

DAYS

Yuflyma 2-syringe kit

adalimumab-aaty prefilled syringe kit

40 MG/0.4ML

2

Syringes

28

DAYS

1 kit/28 days, per RX claims

Yuflyma cd/uc/hs starter

adalimumab-aaty auto-injector kit

80 MG/0.8ML

1

Kit

180

DAYS

72606002307

Yusimry

adalimumab-aqvh soln pen-injector

40 MG/0.8ML

2

Pens

28

DAYS

Rinvoq

Upadacitinib Tab ER

30 MG

30

Tablets

30

DAYS

ADDITIONAL QUANTITY LIMIT INFORMATION

Wildcard

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Additional QL Information

Targeted NDCs When Exclusions Exist

Effective Date

Term Date

6629003000E525

Enbrel

Etanercept Subcutaneous Soln Prefilled Syringe 25 MG/0.5ML

25 MG/0.5ML

58406-455-04

6627001500F420

Humira pen

adalimumab pen-injector kit

40 MG/0.8ML

00074-4339-02

00074433902 ; 50090448700

6627001500F440

Humira pen

adalimumab pen-injector kit

80 MG/0.8ML

00074-0124-02

00074012402

6627001500F420

Humira pen ; Humira pen-cd/uc/hs start

adalimumab pen-injector kit

40 MG/0.8ML

00074-4339-06

00074433906 ; 50090448700

6627001500F420

Humira pen ; Humira pen-ps/uv starter

adalimumab pen-injector kit

40 MG/0.8ML

00074-4339-07

00074433907 ; 50090448700

6627001500F440

Humira pen-cd/uc/hs start

adalimumab pen-injector kit

80 MG/0.8ML

00074-0124-03

00074012403

6627001500F440

Humira pen-pediatric uc s

adalimumab pen-injector kit

80 MG/0.8ML

00074-0124-04

00074012404

6627001503F830

Yuflyma 2-syringe kit

adalimumab-aaty prefilled syringe kit

40 MG/0.4ML

1 kit/28 days, per RX claims

CLIENT SUMMARY – PRIOR AUTHORIZATION

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Abrilada ; Abrilada 1-pen kit ; Abrilada 2-pen kit

adalimumab-afzb auto-injector kit  ; adalimumab-afzb prefilled syringe kit

20 MG/0.4ML ; 40 MG/0.8ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Actemra

tocilizumab subcutaneous soln prefilled syringe

162 MG/0.9ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Actemra actpen

tocilizumab subcutaneous soln auto-injector

162 MG/0.9ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Amjevita

adalimumab-atto soln auto-injector  ; adalimumab-atto soln prefilled syringe

10 MG/0.2ML ; 20 MG/0.2ML ; 20 MG/0.4ML ; 40 MG/0.4ML ; 40 MG/0.8ML ; 80 MG/0.8ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Bimzelx

bimekizumab-bkzx subcutaneous soln auto-injector  ; bimekizumab-bkzx subcutaneous soln prefilled syr

160 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Cimzia ; Cimzia starter kit

certolizumab pegol for inj kit  ; certolizumab pegol prefilled syringe kit

200 MG ; 200 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Cosentyx ; Cosentyx sensoready pen ; Cosentyx unoready

secukinumab iv soln  ; secukinumab subcutaneous auto-inj  ; secukinumab subcutaneous pref syr  ; secukinumab subcutaneous soln auto-injector  ; secukinumab subcutaneous soln prefilled syringe

125 MG/5ML ; 150 MG/ML ; 300 MG/2ML ; 75 MG/0.5ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Cyltezo ; Cyltezo starter package f

adalimumab-adbm auto-injector kit  ; adalimumab-adbm prefilled syringe kit

10 MG/0.2ML ; 20 MG/0.4ML ; 40 MG/0.8ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Enbrel ; Enbrel mini ; Enbrel sureclick

etanercept for subcutaneous inj  ; etanercept subcutaneous inj  ; etanercept subcutaneous soln prefilled syringe  ; etanercept subcutaneous solution auto-injector  ; etanercept subcutaneous solution cartridge

25 MG ; 25 MG/0.5ML ; 50 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Entyvio

vedolizumab soln pen-injector

108 MG/0.68ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Hadlima ; Hadlima pushtouch

adalimumab-bwwd soln auto-injector  ; adalimumab-bwwd soln prefilled syringe

40 MG/0.4ML ; 40 MG/0.8ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Hulio

adalimumab-fkjp auto-injector kit  ; adalimumab-fkjp prefilled syringe kit

20 MG/0.4ML ; 40 MG/0.8ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Humira ; Humira pediatric crohns d ; Humira pen ; Humira pen-cd/uc/hs start ; Humira pen-pediatric uc s ; Humira pen-ps/uv starter

adalimumab pen-injector kit  ; adalimumab prefilled syringe kit

10 MG/0.1ML ; 20 MG/0.2ML ; 40 MG/0.4ML ; 40 MG/0.8ML ; 80 MG/0.8ML ; 80 MG/0.8ML & 40MG/0.4ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Hyrimoz ; Hyrimoz crohn's disease a ; Hyrimoz pediatric crohn's ; Hyrimoz pediatric crohns ; Hyrimoz plaque psoriasis ; Hyrimoz sensoready pens

adalimumab-adaz soln auto-injector  ; adalimumab-adaz soln prefilled syr  ; adalimumab-adaz soln prefilled syringe

10 MG/0.1 ML ; 20 MG/0.2ML ; 40 MG/0.4ML ; 40 MG/0.8ML ; 80 MG/0.8ML ; 80 MG/0.8ML & 40MG/0.4ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Idacio ; Idacio starter package fo

adalimumab-aacf auto-injector kit  ; adalimumab-aacf prefilled syringe kit

40 MG/0.8ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Kevzara

sarilumab subcutaneous soln prefilled syringe  ; sarilumab subcutaneous solution auto-injector

150 MG/1.14ML ; 200 MG/1.14ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Kineret

anakinra subcutaneous soln prefilled syringe

100 MG/0.67ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Litfulo

ritlecitinib tosylate cap

50 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Olumiant

baricitinib tab

1 MG ; 2 MG ; 4 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Omvoh

mirikizumab-mrkz subcutaneous soln auto-injector

100 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Orencia

abatacept subcutaneous soln prefilled syringe

125 MG/ML ; 50 MG/0.4ML ; 87.5 MG/0.7ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Orencia clickject

abatacept subcutaneous soln auto-injector

125 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Rinvoq

upadacitinib tab er

15 MG ; 30 MG ; 45 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Siliq

brodalumab subcutaneous soln prefilled syringe

210 MG/1.5ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Simponi

golimumab subcutaneous soln auto-injector

100 MG/ML ; 50 MG/0.5ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Simponi

golimumab subcutaneous soln prefilled syringe

100 MG/ML ; 50 MG/0.5ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Skyrizi

risankizumab-rzaa subcutaneous soln cartridge

180 MG/1.2ML ; 360 MG/2.4ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Skyrizi ; Skyrizi pen

risankizumab-rzaa sol prefilled syringe  ; risankizumab-rzaa soln auto-injector  ; risankizumab-rzaa soln prefilled syringe

150 MG/ML ; 75 MG/0.83ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Sotyktu

deucravacitinib tab

6 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Stelara

ustekinumab inj  ; ustekinumab soln prefilled syringe

45 MG/0.5ML ; 90 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Taltz

ixekizumab subcutaneous soln auto-injector  ; ixekizumab subcutaneous soln prefilled syringe

80 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Tremfya

guselkumab soln pen-injector  ; guselkumab soln prefilled syringe

100 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Velsipity

etrasimod arginine tab

2 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Xeljanz ; Xeljanz xr

tofacitinib citrate oral soln  ; tofacitinib citrate tab  ; tofacitinib citrate tab er

1 MG/ML ; 10 MG ; 11 MG ; 22 MG ; 5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Yuflyma ; Yuflyma 1-pen kit ; Yuflyma 2-pen kit ; Yuflyma 2-syringe kit ; Yuflyma cd/uc/hs starter

adalimumab-aaty auto-injector kit  ; adalimumab-aaty prefilled syringe kit

40 MG/0.4ML ; 80 MG/0.8ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Yusimry

adalimumab-aqvh soln pen-injector

40 MG/0.8ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Abrilada

adalimumab-afzb prefilled syringe kit

40 MG/0.8ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Abrilada

adalimumab-afzb prefilled syringe kit

20 MG/0.4ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Abrilada 1-pen kit ; Abrilada 2-pen kit

adalimumab-afzb auto-injector kit

40 MG/0.8ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Actemra

Tocilizumab Subcutaneous Soln Prefilled Syringe 162 MG/0.9ML

162 MG/0.9ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Actemra actpen

Tocilizumab Subcutaneous Soln Auto-injector 162 MG/0.9ML

162 MG/0.9ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Amjevita

adalimumab-atto soln auto-injector

80 MG/0.8ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Amjevita

adalimumab-atto soln auto-injector

40 MG/0.4ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Amjevita

adalimumab-atto soln auto-injector

40 MG/0.8ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Amjevita

adalimumab-atto soln prefilled syringe

40 MG/0.4ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Amjevita

adalimumab-atto soln prefilled syringe

20 MG/0.2ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Amjevita

adalimumab-atto soln prefilled syringe

10 MG/0.2ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Amjevita

adalimumab-atto soln prefilled syringe

20 MG/0.4ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Amjevita

adalimumab-atto soln prefilled syringe

40 MG/0.8ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Bimzelx

bimekizumab-bkzx subcutaneous soln auto-injector

160 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Bimzelx

bimekizumab-bkzx subcutaneous soln prefilled syr

160 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Cimzia

Certolizumab Pegol Prefilled Syringe Kit

200 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Cimzia starter kit

Certolizumab Pegol Prefilled Syringe Kit

200 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Cosentyx

Secukinumab Subcutaneous Pref Syr 150 MG/ML (300 MG Dose)

150 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Cosentyx

Secukinumab Subcutaneous Soln Prefilled Syringe

75 MG/0.5ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Cosentyx

Secukinumab Subcutaneous Soln Prefilled Syringe 150 MG/ML

150 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Cosentyx sensoready pen

Secukinumab Subcutaneous Auto-inj 150 MG/ML (300 MG Dose)

150 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Cosentyx sensoready pen

Secukinumab Subcutaneous Soln Auto-injector 150 MG/ML

150 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Cosentyx unoready

secukinumab subcutaneous soln auto-injector

300 MG/2ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Cyltezo

adalimumab-adbm auto-injector kit

40 MG/0.8ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Cyltezo

adalimumab-adbm prefilled syringe kit

20 MG/0.4ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Cyltezo

adalimumab-adbm prefilled syringe kit

10 MG/0.2ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Cyltezo

adalimumab-adbm prefilled syringe kit

40 MG/0.8ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Cyltezo starter package f

adalimumab-adbm auto-injector kit

40 MG/0.8ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Cyltezo starter package f

adalimumab-adbm auto-injector kit

40 MG/0.8ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Enbrel

Etanercept For Subcutaneous Inj 25 MG

25 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Enbrel

Etanercept Subcutaneous Inj 25 mg/0.5ml

25 MG/0.5ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Enbrel

Etanercept Subcutaneous Soln Prefilled Syringe 25 MG/0.5ML

25 MG/0.5ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Enbrel

Etanercept Subcutaneous Soln Prefilled Syringe 25 MG/0.5ML

25 MG/0.5ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Enbrel

Etanercept Subcutaneous Soln Prefilled Syringe 50 MG/ML

50 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Enbrel mini

Etanercept Subcutaneous Solution Cartridge 50 MG/ML

50 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Enbrel sureclick

Etanercept Subcutaneous Solution Auto-injector 50 MG/ML

50 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Entyvio

vedolizumab soln pen-injector

108 MG/0.68ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Hadlima

adalimumab-bwwd soln prefilled syringe

40 MG/0.4ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

Hadlima

adalimumab-bwwd soln prefilled syringe

40 MG/0.8ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx