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Biologic Immunomodulators Prior Authorization with Quantity Limit with Preferred Products Program Summary

Policy Number: PH-99999991002

This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace.

Biologic Immunomodulators Prior Authorization with Quantity Limit – (with a preferred option)

TARGET AGENT(S)

Preferred and Nonpreferred Biologic Immunomodulators (See table below)

(NOTE: For Otezla- please see Otezla PAQL)

Actemra® (tocilizumab)

Cimzia® (certolizumab pegol)

Cosentyx® (secukinumab)

Enbrel® (etanercept)

Humira® (adalimumab)

Kevzara® (sarilumab)

Kineret® (anakinra)

Olumiant® (baricitinib)

Orencia® (abatacept)

Rinvoq (upadacitinib extended release)

Siliq (brodalumab)

Simponi® (golimumab)

Skyrizi (risankizumab-rzaa)

Stelara® (ustekinumab)

Taltz® (ixekizumab)

Tremfya® (guselkumab)

Xeljanz® (tofacitinib)

Xeljanz XR® (tofacitinib extended release)

                                                                                                           

Disease State

Step 1 (Preferred)

Step 2 (Non-preferred directed to ONE step 1 agent)

Step 3a (Non-preferred directed to TWO step 1 agents)

Step 3b (Non-preferred directed to TWO agents from step 1 and/or step 2)

Step 3c (Non-preferred directed to THREE step 1 agents)

Rheumatoid Disorders

Ankylosing Spondylitis (AS)

SQ: Cosentyx, Enbrel, Humira

N/A

SQ: Cimzia, Simponi, Taltz

N/A

N/A

Nonradiographic Axial Spondyloarthritis (nr-axSpA)

SQ: Cimzia, Cosentyx

N/A

SQ: Taltz

N/A

N/A

Polyarticular Juvenile Idiopathic Arthritis (PJIA)

SQ: Enbrel, Humira

Oral: Xeljanz

SQ: Actemra (Humira is required Step 1 agent)

N/A

SQ: Orencia

N/A

Psoriatic Arthritis (PsA)

SQ: Cosentyx, Enbrel, Humira, Stelara,

Tremfya

Oral: Otezla, Xeljanz, Xeljanz XR

N/A

SQ: Cimzia, Orencia, Simponi, Taltz

N/A

N/A

Rheumatoid Arthritis

SQ: Enbrel, Humira

Oral: Rinvoq, Xeljanz, Xeljanz XR

SQ: Actemra

(Humira is required Step 1 agent)

Oral: Olumiant

SQ: Cimzia, Kevzara, Kineret, Orencia, Simponi

N/A

N/A

Dermatological Disorder

Hidradenitis Suppurativa (HS)

SQ: Humira

N/A

N/A

N/A

N/A

Psoriasis (PS)

SQ: Cosentyx,

Enbrel, Humira, Skyrizi, Stelara, Tremfya

Oral: Otezla

N/A

SQ: Cimzia,  Siliq

N/A

SQ: Taltz

Inflammatory Bowel Disease

Crohn’s Disease

SQ: Humira, Stelara

SQ: Cimzia (Humira is required Step 1 agent)

N/A

N/A

N/A

Ulcerative Colitis

SQ: Humira, Stelara

SQ: Simponi (Humira is required Step 1 agent)

Oral: Xeljanz, Xeljanz XR

N/A

N/A

N/A

Other

Uveitis

SQ: Humira

N/A

N/A

N/A

N/A

Indications Without Preferred Agents Required

Deficiency of IL-1 Receptor Antagonist (DIRA)

Giant Cell Arteritis (GCA)

Neonatal-Onset Multisystem Inflammatory Disease (NOMID)

Systemic Juvenile Idiopathic Arthritis (SJIA)

N/A

N/A

N/A

N/A

N/A

*Note: A trial of either or both Xeljanz products (Xeljanz and Xeljanz XR) collectively counts as ONE product

QUANTITY LIMITS FOR TARGET AGENTS

Brand (generic)

GPI

Quantity Limit (per day or as listed)

Multisource Code

Actemra (tocilizumab)

162 mg/0.9 mL autoinjector

6650007000D520

4 autoinjectors (3.6 mL)/28 days

M, N, O, or Y

162 mg/0.9 mL syringe

6650007000E520

4 syringes (3.6 mL)/28 days

M, N, O, or Y

Cimzia (certolizumab)

2 x 200 mg/mL syringe, kit

52505020106440

2 kits/28 days

M, N, O, or Y

6 X 200 mg/mL syringe, starter kit

52505020106460

1 starter kit (3)/180 days

M, N, O, or Y

Cosentyx (secukinumab)

300 mg/2 mL (2 x 150 mg/mL) pen

9025057500D530

2 pens/28 days

M, N, O, or Y

150 mg/mL pen

9025057500D520

1 pen/28 days

M, N, O, or Y

150 mg/mL syringe

9025057500E520

1 syringe/28 days

M, N, O, or Y

300 mg/2 mL (2 x 150 mg/mL) syringe

9025057500E530

2 syringes/28 days

M, N, O, or Y

Enbrel (etanercept)

25 mg/0.5 mL single use vial

66290030002015 

8 vials/28 days

M, N, O, or Y

25 mg/vial, kit

66290030002120

8 vials/28 days

M, N, O, or Y

50 mg/mL SureClick autoinjector

6629003000D530

4 autoinjectors (4 mL)/28 days

M, N, O, or Y

50 mg/mL Mini injector cartridge

6629003000E230

4 cartridges (4 mL)/28 days

M, N, O, or Y

25 mg/0.5 mL syringe

6629003000E525

4 syringes (2.04) mL)/28 days

M, N, O, or Y

50 mg/mL syringe

6629003000E530

4 syringes (4 mL)/28 days

M, N, O, or Y

Humira (adalimumab)

10 mg/0.1 mL syringe

6627001500F804 

2 syringes/28 days

M, N, O, or Y

10 mg/0.2 mL syringe

6627001500F805

2 syringes/28 days

M, N, O, or Y

20 mg/0.2 mL syringe

6627001500F809 

2 syringes/28 days

M, N, O, or Y

20 mg/0.4 mL syringe, kit

6627001500F810

2 syringes/28 days

M, N, O, or Y

40 mg/0.8 mL syringe, kit

6627001500F820

2 syringes/28 days

M, N, O, or Y

40/0.4 mL syringe

6627001500F830 

2 syringes/28 days

M, N, O, or Y

Pediatric Crohn’s Disease Starter kit (80 mg/0.8 mL syringe)

6627001500F840 

1 kit (3 syringes)/180 days

M, N, O, or Y

Pediatric Crohn’s Disease Starter kit (40 mg/0.4 mL and 80 mg/0.8 mL syringe)

6627001500F880 

1 kit (2 syringes)/180 days

M, N, O, or Y

40 mg/0.8 mL pen

6627001500F420

(NDC 00074433902)

2 pens/28 days

M, N, O, or Y

Psoriasis, Uveitis Starter kit

40 mg/0.8 mL pen,

6627001500F420

(NDC 00074433907)

1 kit (4 pens)/180 days

M, N, O, or Y

Crohn’s Disease, Ulcerative Colitis, or Hidradenitis Starter kit 40 mg/0.8 mL pen,

6627001500F420

(NDC 00074433906)

1 kit (6 pens)/180 days

M, N, O, or Y

40 mg/0.4 mL pen

6627001500F430 

2 pens/28 days

M, N, O, or Y

80 mg/0.8 mL pen

6627001500F440

(NDC 00074012402)

2 pens/28 days

M, N, O, or Y

80 mg/0.8 mL pen, Crohn’s disease, ulcerative colitis, or hidradenitis suppurativa Starter kit

6627001500F440 (NDC 00074012403)

1 kit (3 pens)/180 days

M, N, O, or Y

80 mg/0.8 mL pen, Pediatric ulcerative colitis Starter kit

6627001500F440

(NDC 00074012404)

1 kit (4 pens)/180 days

M, N, O, or Y

80 mg/0.8 mL and 40 mg/0.4 mL pen, Psoriasis, uveitis Starter kit

6627001500F450

1 kit (3 pens)/180 days

M, N, O, or Y

Kevzara (sarilumab)

150 mg/1.14 mL pen

6650006000D520

2 pens (2.28 mL)/28 days

M, N, O, or Y

200 mg/1.14 mL pen

6650006000D530

2 pens (2.28 mL)/28 days

M, N, O, or Y

150 mg/1.14 mL syringe

6650006000E520

2 syringes (2.28 mL)/28 days

M, N, O, or Y

200 mg/1.14 mL syringe

6650006000E530

2 syringes (2.28 mL)/28 days

M, N, O, or Y

Kineret (anakinra)

100 mg syringe

6626001000E520

28 syringes (18.76 mL)/28 days

M, N, O, or Y

Olumiant (baricitinib)

1 mg tablets

66603010000310

1 tablet/day

M, N, O, or Y

2 mg tablets

66603010000320

1 tablet/day

M, N, O, or Y

Orencia (abatacept)

50 mg/0.4 mL syringe

6640001000E510

4 syringes (1.6 mL)/28 days

M, N, O, or Y

87.5 mg/ 0.7 mL syringe

6640001000E515

4 syringes (2.8 mL)/28 days

M, N, O, or Y

125 mg/mL syringe

6640001000E520

4 syringes (4 mL)/28 days

M, N, O, or Y

125 mg/mL ClickJect autoinjector

6640001000D520

4 autoinjectors (4 mL)/28 days

M, N, O, or Y

Rinvoq (upadacitinib)

15 mg tablet

66603072007520

1 tablet/day

M, N, O, or Y

Siliq (brodalumab)

210 mg/1.5 mL syringe

9025052000E520

2 syringes (3 mL)/28 days

M, N, O, or Y

Simponi (golimumab)

50 mg/0.5 mL auto-injector

6627004000D520

1 auto-injector (0.5 mL)/28 days

M, N, O, or Y

50 mg/0.5 mL syringe

6627004000E520

1 syringe (0.5 mL)/28 days

M, N, O, or Y

100 mg/1 mL auto-injector

6627004000D540

1 auto-injector (1 mL)/28 days

M, N, O, or Y

  100 mg/1 mL syringe

6627004000E540

1 syringe (1 mL)/28 days

M, N, O, or Y

Skyrizi (risankizumab-rzaa)

150 mg/mL auto-injector

9025057070D520 

1 pen/84 days

M, N, O, or Y

150 mg/mL prefilled syringe

9025057070E540 

1 syringe/84 days

M, N, O, or Y

2 x 75 mg/0.83 mL syringe, kit

9025057070F820 

1 kit/84 days

M, N, O, or Y

Stelara (ustekinumab)

  45 mg/0.5 mL vial

90250585002020

1 vial (0.5 mL)/84 days

M, N, O, or Y

  45 mg/0.5 mL syringe

9025058500E520

1 syringe (0.5 mL)/84 days

M, N, O, or Y

  90 mg/1 mL syringe

9025058500E540

1 syringe (1 mL)/56 days

M, N, O, or Y

Taltz (ixekizumab)

  80 mg/mL autoinjector

9025055400D520

1 syringe/28 days

M, N, O, or Y

  80 mg/mL syringe

9025055400E520

1 syringe/28 days

M, N, O, or Y

Tremfya (guselkumab)

100 mg/mL pen

9025054200D220

1 pen/56 days

M, N, O, or Y

100 mg/mL syringe

9025054200E520

1 syringe/56 days

M, N, O, or Y

Xeljanz (tofacitinib)

5 mg tablet

66603065100320

2 tablets/day

M, N, O, or Y

10 mg tablet

66603065100330

224 tablets/365 days

M, N, O, or Y

1 mg/mL oral solution

66603065102020

240 mL/30 days

M, N, O, or Y

Xeljanz XR (tofacitinib extended release)

11 mg tablet

66603065107530

1 tablet/day

M, N, O, or Y

22 mg tablet

66603065107550

112 tablets/365 days

M, N, O, or Y

PRIOR AUTHORIZATION CRITERIA FOR APPROVAL

Initial Evaluation

Target Agent(s) will be approved when ALL of the following are met:

  1. ONE of the following:
    1. The requested agent is eligible for continuation of therapy AND ONE of the following:
      1. Information has been provided that indicates the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days

OR

      1. The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed

Agents Eligible for Continuation of Therapy

All target agents are eligible for continuation of therapy

                 OR

    1. ALL of the following:
      1. The patient has an FDA labeled indication or an indication supported in DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a for the requested agent and route of administration

AND

      1. ONE of the following:
        1. The patient’s age is within FDA labeling for the requested indication for the requested agent

OR

        1. The prescriber has provided information in support of using the requested agent for the patient’s age

AND

      1. ONE of the following:
        1. The patient has a diagnosis of moderately to severely active rheumatoid arthritis (RA) AND BOTH of the following:
          1. ONE of the following:
            1. The patient has tried and had an inadequate response to maximally tolerated methotrexate (e.g., titrated to 25 mg weekly) for at least 3-months

OR

            1. The patient has tried and had an inadequate response to another conventional agent (i.e., hydroxychloroquine, leflunomide, sulfasalazine) used in the treatment of RA for at least 3-months

OR

            1. The patient has an intolerance or hypersensitivity to ONE of the following conventional agents (i.e., maximally tolerated methotrexate, hydroxychloroquine, leflunomide, sulfasalazine) used in the treatment of RA

         OR

            1. The patient has an FDA labeled contraindication to ALL of the following conventional agents (i.e., methotrexate, hydroxychloroquine, leflunomide, sulfasalazine) used in the treatment of RA

OR

            1. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a for the treatment of RA

AND

          1. If the request is for Simponi, ONE of the following:
            1. The patient will be taking the requested agent in combination with methotrexate

                 OR

            1. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to methotrexate

OR

        1. The patient has a diagnosis of active psoriatic arthritis (PsA) AND ONE of the following:
          1. The patient has tried and had an inadequate response to ONE conventional agent (i.e., cyclosporine, leflunomide, methotrexate, sulfasalazine) used in the treatment of PsA for at least 3-months

OR

          1. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of PsA

OR

          1. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of PsA

OR

          1. The patient has severe active PsA (e.g., erosive disease, elevated markers of inflammation [e.g., ESR, CRP] attributable to PsA, long-term damage that interferes with function [i.e., joint deformities], rapidly progressive)

OR

          1. The patient has concomitant severe psoriasis (PS) (e.g., greater than 10% body surface area involvement, occurring on select locations [i.e., hands, feet, scalp, face, or genitals], intractable pruritus, serious emotional consequences)  

OR

          1. The patient’s medication history indicates use of another biologic immunomodulator agent OR Otezla that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a for the treatment of PsA

OR

        1. The patient has a diagnosis of moderate to severe plaque psoriasis (PS) AND ONE of the following:
          1. The patient has tried and had an inadequate response to ONE conventional agent (i.e., acitretin, anthralin, calcipotriene, calcitriol, coal tar products, cyclosporine, methotrexate, pimecrolimus, PUVA [phototherapy], tacrolimus, tazarotene, topical corticosteroids) used in the treatment of PS for at least 3-months

OR

          1. The patient has an intolerance or hypersensitivity to ONE conventional agent used in the treatment of PS

OR

          1. The patient has an FDA labeled contraindication to ALL conventional agents used in the treatment of PS

OR

          1. The patient has severe active PS (e.g., greater than 10% body surface area involvement, occurring on select locations [i.e., hands, feet, scalp, face, or genitals], intractable pruritus, serious emotional consequences)  

OR

          1. The patient has concomitant severe psoriatic arthritis (PsA) (e.g., erosive disease, elevated markers of inflammation [e.g., ESR, CRP] attributable to PsA, long-term damage that interferes with function [i.e., joint deformities], rapidly progressive)

OR

          1. The patient’s medication history indicates use of another biologic immunomodulator agent OR Otezla that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a for the treatment of PS

OR

        1. The patient has a diagnosis of moderately to severely active Crohn’s disease (CD) AND ONE of the following:
          1. The patient has tried and had an inadequate response to ONE conventional agent (i.e., 6-mercaptopurine, azathioprine, corticosteroids [e.g., prednisone, budesonide EC capsule], methotrexate, sulfasalazine) used in the treatment of CD for at least 3-months

OR

          1. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of CD

OR

          1. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of CD

OR

          1. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a for the treatment of CD

OR

        1. The patient has a diagnosis of moderately to severely active ulcerative colitis (UC) AND ONE of the following:
          1. The patient has tried and had an inadequate response to ONE conventional agent (i.e., 6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, sulfasalazine) used in the treatment of UC for at least 3-months

OR

          1. The patient has severely active ulcerative colitis

OR

          1. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of UC

OR

          1. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of UC

OR

          1. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a for the treatment of UC

OR

        1. The patient has a diagnosis of non-infectious intermediate uveitis, posterior uveitis, or panuveitis AND ONE of the following:
          1. BOTH of the following:
            1. ONE of the following:
              1. The patient has tried and had an inadequate response to oral corticosteroids used in the treatment of non-infectious intermediate uveitis, posterior uveitis, or panuveitis for a minimum of 2 weeks

OR

              1. The patient has tried and had an inadequate response to periocular or intravitreal corticosteroid injections in the treatment of non-infectious intermediate uveitis, posterior uveitis, or panuveitis

OR

              1. The patient has an intolerance or hypersensitivity to oral corticosteroids OR periocular or intravitreal corticosteroid injections used in the treatment of non-infectious intermediate uveitis, posterior uveitis, or panuveitis

OR

              1. The patient has an FDA labeled contraindication to BOTH oral corticosteroids and periocular/intravitreal corticosteroids 

AND

            1. ONE of the following:
              1. The patient has tried and had an inadequate response to ONE conventional systemic agent (i.e., azathioprine, mycophenolate, methotrexate, cyclosporine, tacrolimus) used in the treatment of non-infectious intermediate uveitis, posterior uveitis, or panuveitis for at least 3-months

OR

              1. the patient has an intolerance or hypersensitivity to ONE conventional systemic agent used in the treatment of non-infectious intermediate uveitis, posterior uveitis, or panuveitis

OR

              1. The patient has an FDA labeled contraindication to ALL conventional systemic agents used in the treatment of non-infectious intermediate uveitis, posterior uveitis, or panuveitis

OR

          1. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a for the treatment of non-infectious intermediate uveitis, posterior uveitis, or panuveitis

OR

        1. The patient has a diagnosis of giant cell arteritis (GCA) AND ONE of the following:
          1. The patient has tried and had an inadequate response to systemic corticosteroids (e.g., prednisone, methylprednisolone) used in the treatment of GCA for at least 7-10 days

OR

          1. The patient has an intolerance or hypersensitivity to systemic corticosteroids used in the treatment of GCA

OR

          1. The patient has an FDA labeled contraindication to ALL systemic corticosteroids

OR

          1. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a for the treatment of GCA

OR

        1. The patient has a diagnosis of active ankylosing spondylitis (AS) AND ONE of the following:
          1. The patient has tried and had an inadequate response to two different NSAIDs used in the treatment of AS for at least a 4-week total trial

OR

          1. The patient has an intolerance or hypersensitivity to two different NSAIDs used in the treatment of AS

OR

          1. The patient has an FDA labeled contraindication to ALL NSAIDs used in the treatment of AS

OR

          1. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a for the treatment of AS

OR

        1. The patient has a diagnosis of active non-radiographic axial spondyloarthritis (nr-axSpA) AND ONE of the following:
          1. The patient has tried and had an inadequate response to two different NSAIDs used in the treatment of nr-axSpA for at least a 4-week total trial

OR

          1. The patient has an intolerance or hypersensitivity to two different NSAIDs used in the treatment of nr-axSpA

OR

          1. The patient has an FDA labeled contraindication to ALL NSAIDs used in the treatment of nr-axSpA

OR

          1. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a for the treatment of nr-axSpA

OR

        1. The patient has a diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA) AND ONE of the following:
          1. The patient has tried and had an inadequate response to ONE conventional agent (i.e., methotrexate, leflunomide) used in the treatment of PJIA for at least 3-months

OR

          1. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of PJIA

OR

          1. The patient has an FDA labeled contraindication ALL of the conventional agents used in the treatment of PJIA

OR

          1. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a for the treatment of PJIA

OR

        1. The patient has a diagnosis of active systemic juvenile idiopathic arthritis (SJIA) AND ONE of the following:
          1. The patient has tried and had an inadequate response to at least ONE NSAID (e.g., ibuprofen, celecoxib) used in the treatment of SJIA for at least 1-month

OR

          1. The patient has an intolerance or hypersensitivity to NSAIDs used in the treatment of SJIA

OR

          1. The patient has an FDA labeled contraindication to ALL NSAIDs used in the treatment of SJIA

OR

          1. The patient has tried and had an inadequate response to another conventional agent (i.e., methotrexate, leflunomide, systemic corticosteroids) used in the treatment of SJIA for at least 3-months

OR

          1. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of SJIA

OR

          1. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of SJIA

OR

          1. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a for the treatment of SJIA

OR

        1. The patient has a diagnosis of moderate to severe hidradenitis suppurative (HS) AND ONE of the following:
          1. The patient has tried and had an inadequate response to ONE conventional agent (i.e., oral tetracyclines [doxycycline, minocycline, tetracycline]; oral contraceptives [females only]; metformin [females only]; finasteride [females only]; spironolactone [females only]; intralesional corticosteroids [triamcinolone]; clindamycin in combination with rifampin; combination of rifampin, moxifloxacin, and metronidazole; cyclosporine, oral retinoids) used in the treatment of HS for at least 3-months

OR

          1. The patient has an intolerance or hypersensitivity to ONE conventional agent used in the treatment of HS

OR

          1. The patient has an FDA labeled contraindication to ALL conventional agents used in the treatment of HS

OR

          1. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a for the treatment of HS

OR

        1. The patient has another FDA labeled indication or an indication supported in DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a for the requested agent and route of administration not mentioned previously 

AND

      1. ONE of the following (reference Step Table):
        1. The requested agent is a Step 1 agent for the requested indication

OR

        1. The requested indication does NOT require any prerequisite biologic immunomodulator agents

OR

        1. If the requested agent is a Step 2 agent for the requested indication, then ONE of the following:
          1. The patient has tried and had an inadequate response to ONE of the required Step 1 agents for the requested indication for at least 3-months (See Step 2)

OR

          1. The patient has an intolerance (defined as an intolerance to the drug or its excipients, not to the route of administration) or hypersensitivity to ONE of the required Step 1 agents for the requested indication

OR

          1. The patient has an FDA labeled contraindication to ALL required Step 1 agents for the requested indication

OR

          1. BOTH of the following:
            1. The prescriber has provided information indicating why ALL of the required Step 1 agents are not clinically appropriate for the patient

AND

            1. The prescriber has provided a complete list of previously tried agents for the requested indication

OR

        1. If the requested agent is a Step 3a agent for the requested indication, then ONE of the following (chart notes required):
          1. The patient has tried and had an inadequate response to TWO of the Step 1 agents for the requested indication for at least 3-months (See Step 3a)

OR

          1. The patient has an intolerance (defined as an intolerance to the drug or its excipients, not to the route of administration or hypersensitivity to TWO of the Step 1 agents for the requested indication

OR

          1. The patient has an FDA labeled contraindication to ALL of the Step 1 agents for the requested indication

OR

          1. BOTH of the following:
            1. The prescriber has provided information indicating why ALL of the Step 1 agents are not clinically appropriate for the patient

AND

            1. The prescriber has provided a complete list of previously tried agents for the requested indication

OR

        1. If the requested agent is a Step 3b agent for the requested indication, then ONE of the following (chart notes required):
          1. The patient has tried and had an inadequate response to TWO agents from Step 1 and/or Step 2 for the requested indication for at least 3-months (See Step 3b)

OR

          1. The patient has an intolerance (defined as an intolerance to the drug or its excipients, not to the route of administration) or hypersensitivity to TWO agents from Step 1 and/or Step 2 for the requested indication

OR

          1. The patient has an FDA labeled contraindication to ALL of the Step 1 AND Step 2 agents for the requested indication

OR

          1. BOTH of the following:
            1. The prescriber has provided information indicating why ALL of the Step 1 AND Step 2 agents are not clinically appropriate for the patient

AND

            1. The prescriber has provided a complete list of previously tried agents for the requested indication

OR

        1. If the requested agent is a Step 3c agent for the requested indication, then ONE of the following (chart notes required):
          1. The patient has tried and had an inadequate response to THREE of the Step 1 agents for the requested indication for at least 3-months (See Step 3c)

OR

          1. The patient has an intolerance (defined as an intolerance to the drug or its excipients, not to the route of administration) or hypersensitivity to THREE of the Step 1 agents for the requested indication

OR

          1. The patient has an FDA labeled contraindication to ALL of the Step 1 agents for the requested indication

OR

          1. BOTH of the following:
            1. The prescriber has provided information indicating why ALL of the Step 1 agents are not clinically appropriate for the patient

AND

            1. The prescriber has provided a complete list of previously tried agents for the requested indication

AND

      1. If Cosentyx 300 mg every 4 weeks is requested as maintenance dosing, ONE of the following:
        1. The patient has a diagnosis of moderate to severe plaque psoriasis with or without coexistent active psoriatic arthritis 

OR

        1. The patient has a diagnosis of active psoriatic arthritis or active ankylosing spondylitis AND has tried and had an inadequate response to Cosentyx 150 mg every 4 weeks for at least 3-months

AND

  1. If Stelara 90 mg is requested, ONE of the following:
    1. The patient has a diagnosis of psoriasis AND weighs >100kg

            OR

    1. The patient has a dual diagnosis of psoriasis AND psoriatic arthritis AND the patient is >100kg

OR

    1. The patient has a diagnosis of Crohn’s disease or ulcerative colitis

AND

  1. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., rheumatologist for JIA, PsA, RA; gastroenterologist for CD, UC; dermatologist for PS) or has consulted with a specialist in the area of the patient’s diagnosis

AND

  1. The patient will NOT be using the requested agent in combination with another biologic immunomodulator agent or Otezla

AND

  1. The patient does NOT have any FDA labeled contraindications to the requested agent

AND

  1. The patient has been tested for latent tuberculosis (TB) when required by the prescribing information for the requested agent AND if positive the patient has begun therapy for latent TB

AND

  1. ONE of the following:
    1. The requested quantity (dose) does NOT exceed the program quantity limit

OR

    1. If the requested agent is Xeljanz/Xeljanz XR for a diagnosis of ulcerative colitis, then BOTH of the following:
      1. The prescriber has provided information in support of therapy for the dose exceeding the quantity limit [e.g., patient has lost response to the FDA labeled maintenance dose (i.e., 5 mg twice daily or 11 mg once daily) during maintenance treatment; requires restart of induction therapy] (medical records required)

AND

      1. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength and/or package size that does not exceed the program quantity limit

OR

    1. If the requested agent is Xeljanz oral solution for a diagnosis of polyarticular course juvenile idiopathic arthritis, then ONE of the following:
      1. BOTH of the following:
        1. The requested quantity (dose) does not exceed the maximum FDA labeled dose (i.e., 5 mg twice daily) NOR the maximum compendia supported dose (i.e., DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a)

AND

        1. The prescriber has provided information stating why the patient cannot take Xeljanz 5 mg tablets 

OR

      1. BOTH of the following:
        1. The requested quantity (dose) is greater than the maximum FDA labeled dose AND the maximum compendia supported dose (i.e., DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a) for the requested indication

AND

        1. The prescriber has provided information in support of therapy with a higher dose or shortened dosing interval for the requested indication (submitted copy required; e.g., clinical trials, phase III studies, guidelines required)

OR

    1. If the requested agent is NOT Xeljanz/Xeljanz XR for a diagnosis of ulcerative colitis or polyarticular course juvenile idiopathic arthritis, then ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit

AND

      1. ONE of the following:
        1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose

OR

        1. BOTH of the following:
          1. The requested quantity (dose) does NOT exceed the maximum compendia supported dose (i.e., DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a) for the requested indication

AND

          1. If the requested quantity (dose) is greater than the maximum FDA labeled dose, the patient has tried and had an inadequate response to at least a 3 month trial of the maximum FDA labeled dose (medical records required)

AND

      1. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength and/or package size that does not exceed the program quantity limit

OR

    1. If the requested agent is NOT Xeljanz/Xeljanz XR for a diagnosis of ulcerative colitis or polyarticular course juvenile idiopathic arthritis, then ALL of the following:
  1. The requested quantity (dose) is greater than the program quantity limit

AND

  1. The requested quantity (dose) is greater than the maximum FDA labeled dose AND the maximum compendia supported dose (i.e., DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a) for the requested indication

AND

  1. The patient has tried and had an inadequate response to at least a 3 month trial of the maximum FDA labeled dose (medical records required)

AND

  1. The prescriber has provided information in support of therapy with a higher dose or shortened dosing interval for the requested indication (submitted copy required; e.g., clinical trials, phase III studies, guidelines required)

Length of approval: 12 months for all agents EXCEPT Humira (adalimumab) for ulcerative colitis (UC), Siliq for plaque psoriasis (PS), Xeljanz and Xeljanz XR for induction therapy for UC, and the agents with indications that require loading doses for new starts. For agents that require a loading dose for a new start, approve the loading dose noted in the table AND the maintenance dose for the remainder of the 12 months. Humira for UC may be approved for 12 weeks, Siliq for PS for 16 weeks, Xeljanz and Xeljanz XR for UC may be approved for 16 weeks.

**NOTE: Cosentyx for the diagnoses of AS, nr-axSpA, and PSA loading doses are not approvable.

Renewal Evaluation

Target Agent(s) will be approved when ALL of the following are met:

  1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process (*please note Stelara renewal must be for the same strength as the initial approval)

AND

  1. The patient has had clinical benefit with the requested agent

AND

  1. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., rheumatologist for JIA, PsA, RA; gastroenterologist for CD, UC; dermatologist for PS) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis

AND

  1. The patient will NOT be using the requested agent in combination with another biologic immunomodulator agent or Otezla

AND

  1. If Cosentyx 300 mg every 4 weeks is requested as maintenance dosing, ONE of the following:
        1. The patient has a diagnosis of moderate to severe plaque psoriasis with or without coexistent active psoriatic arthritis 

OR

        1. The patient has a diagnosis of active psoriatic arthritis or active ankylosing spondylitis AND has tried and had an inadequate response to Cosentyx 150 mg every 4 weeks for at least 3-months

          AND

  1. The patient does NOT have any FDA labeled contraindications to the requested agent

            AND

  1. ONE of the following:
  1. The requested quantity (dose) does NOT exceed the program quantity limit

OR

  1. If the requested agent is Xeljanz/Xeljanz XR for a diagnosis of ulcerative colitis,    then BOTH of the following:
  1. The prescriber has provided information in support of therapy for the dose exceeding the quantity limit [e.g., patient has lost response to the FDA labeled maintenance dose (i.e., 5 mg twice daily or 11 mg once daily) during maintenance treatment; requires restart of induction therapy] (medical records required)

AND

  1. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength and/or package size that does not exceed the program quantity limit

OR

  1. If the requested agent is Xeljanz oral solution for a diagnosis of polyarticular course juvenile idiopathic arthritis, then ONE of the following:
  1. BOTH of the following:
  1. The requested quantity (dose) does not exceed the maximum FDA labeled dose (i.e., 5 mg twice daily) NOR the maximum compendia supported dose (i.e., DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a)

AND

  1. The prescriber has provided information stating why the patient cannot take Xeljanz 5 mg tablets 

OR

  1. BOTH of the following:
  1. The requested quantity (dose) is greater than the maximum FDA labeled dose AND the maximum compendia supported dose (i.e., DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a) for the requested indication

AND

  1. The prescriber has provided information in support of therapy with a higher dose or shortened dosing interval for the requested indication (submitted copy required; e.g., clinical trials, phase III studies, guidelines required)

OR

  1. If the requested agent is NOT Xeljanz/Xeljanz XR for a diagnosis of ulcerative colitis or polyarticular course juvenile idiopathic arthritis, then ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit

AND

      1. ONE of the following:
        1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose

OR

        1. BOTH of the following:
          1. The requested quantity (dose) does NOT exceed the maximum compendia supported dose (i.e., DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a) for the requested indication

AND

          1. If the requested quantity (dose) is greater than the maximum FDA labeled dose, the patient has tried and had an inadequate response to at least a 3 month trial of the maximum FDA labeled dose (medical records required)

AND

      1. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength and/or package size that does not exceed the program quantity limit

OR

  1. If the requested agent is NOT Xeljanz/Xeljanz XR for a diagnosis of ulcerative colitis or polyarticular course juvenile idiopathic arthritis, then ALL of the following:
  1. The requested quantity (dose) is greater than the program quantity limit

AND

  1. The requested quantity (dose) is greater than the maximum FDA labeled dose AND the maximum compendia supported dose (i.e., DrugDex with 1 or 2a level of evidence, AHFS, or NCCN compendium recommended use 1 or 2a) for the requested indication

AND

  1. The patient has tried and had an inadequate response to at least a 3 month trial of the maximum FDA labeled dose (medical records required)

AND

  1. The prescriber has provided information in support of therapy with a higher dose or shortened dosing interval for the requested indication (submitted copy required; e.g., clinical trials, phase III studies, guidelines required)

Length of approval:  12 months for all agents.

**NOTE: Cosentyx for the diagnoses of AS, nr-axSpA, and PSA loading doses are not approvable.

 

Table 1: Agents with Loading Doses

Actemra

(tocilizumab)

subcutaneous injection

No loading doses required

Cimzia (certolizumab)

subcutaneous injection

AS, nr-axSpA: Initial dose of 400 mg on day 1 and at week 2 and week 4, followed by maintenance dose of 200 mg every 2 weeks or 400 mg every 4 weeks

CD: Initial dosing of 400 mg on day 1 and at week 2 and week 4, followed by maintenance dose of 400 mg every 4 weeks

PsA and RA: Initial dosing of 400 mg on day 1 and at week 2 and week 4, followed by maintenance dose 200 mg every two weeks or 400 mg every 4 weeks

PS: patients body weight ≤90 kg – initial dose of 400 mg on day 1 and at week 2 and week 4, followed by maintenance dose of 200 mg every 2 weeks may be considered

Cosentyx (secukinumab)

subcutaneous injection

PS and PS with PSA: Initial dosing of 300 mg at weeks 0, 1, 2, 3, and 4, followed by maintenance dose of 300 mg every 4 weeks or 150 mg every 4 weeks

AS, nr-axSpA, PSA: Loading doses are not approvable

Enbrel (etanercept)

subcutaneous injection

Adult PS: Initial dose 50 mg twice weekly for 3 months, then maintenance dose 50 mg weekly

Adult AS, PSA, RA: no loading dose required

Pediatric PJIA, PS: no loading dose required

Humira (adalimumab)

subcutaneous injection

Adult AS, PSA, RA: no loading dose required

PJIA, adolescent uveitis: no loading dose required

Adult CD, UC: Initial dose of 160 mg on day 1, 80 mg on day 15, then maintenance dose of 40 mg every 2 weeks starting on day 29

Pediatric CD:

  • 17kg to <40kg: Initial dose of 80 mg on day 1, 40 mg on day 15, then maintenance dose of 20 mg every 2 weeks starting on day 29
  • ≥40kg: 160 mg on day 1, 80 mg on day 15, then maintenance dose of 40 mg every 2 weeks starting on day 29

Pediatric UC:

  • weight 20 kg to <40 kg: 80 mg SC on day 1, 40 mg on days 8 and 15, then 20 mg every week or 40 mg every other week starting on day 29
  • weight ≥40 kg: 160 mg SC on day 1, 80 mg on days 8 and 15, then 40 mg every week or 80 mg every other week starting on day 29

PS, Adult uveitis: Initial dose of 80 mg, then maintenance dose of 40 mg every 2 weeks starting one week after the initial dose

Adult HS: Initial dose of 160 mg day 1, 80 mg on day 15, then maintenance dose of 40 mg weekly or 80 mg every 2 weeks starting on day 29

Pediatric HS:

  • 30 kg to <60 kg: Initial dose of 80 mg on day 1, then maintenance dose of 40 mg every 2 weeks starting on day 8
  • ≥60 kg: 160 mg on day 1, 80 mg on day 15, then maintenance dose of 40 mg weekly or 80 mg every 2 weeks starting on day 29

Kevzara (sarilumab)

subcutaneous injection

Loading dose not required

Kineret

(anakinra)

subcutaneous injection

Loading dose not required

Olumiant

(baricitinib)

tablet

Loading dose not required

Orencia

(abatacept)

subcutaneous injection

subcutaneous formulations of Orencia do not have loading doses

Rinvoq (upadacitinib)

Loading dose not required

Siliq (brodalumab)

subcutaneous injection

PS: Initial dose of 210 mg given at week 0, 1, and 2, followed by maintenance dose of 210 mg every 2 weeks

Simponi (golimumab)

subcutaneous injection

AS, PSA, RA: no loading dose required

UC: Initial dose of 200 mg at week 0, 100 mg at week 2, then maintenance dose of 100 mg every 4 weeks

Skyrizi

(risankizumab-rzaa)

subcutaneous injection

PS: 150 mg SC at weeks 0 and 4, then every 12 weeks thereafter

Stelara (ustekinumab)

subcutaneous injection

Adult CD or UC: Initial dose is a single IV weight-based dose, followed by maintenance dose with subcutaneous injection of 90 mg 8 weeks after initial IV dose, then every 8 weeks thereafter

Adult PS: Initial dose is weight based as noted below at day 0 and week 4, then maintenance dose every 12 weeks

  • ≤100 kg: 45 mg
  • >100 kg: 90 mg

Pediatric PS: Initial dose is weight based as noted below at day 0 and week 4, then maintenance dose every 12 weeks

  • <60 kg: 0.75 mg/kg
  • 60-100 kg: 45 mg
  • >100 kg: 90 mg

PSA: Initial dose 45 mg at day 0 and week 4, then maintenance dose 45 mg every 12 weeks

PS with PSA and >100kg: 90 mg at day 0 and week 4, then maintenance dose 90 mg every 12 weeks

Taltz (ixekizumab)

subcutaneous injection

AS: Initial dose of 160 mg at week 0, followed by 80 mg every 4 weeks

Adult PS, PS with PSA: Initial dose of 160 mg at week 0, followed by 80 mg at weeks 2, 4, 6, 8, 10, and 12, then maintenance dose of 80 mg every 4 weeks thereafter

Pediatric (6 to <18 years) PS: starting dose given at week 0, then every 4 weeks (patients weighing 50 kg or less, doses must be prepared and administered by a health care professional; use prefilled syringe only)

  • weight >50 kg: 160 mg, then 80 mg
  • weight 25 to 50 kg: 80 mg, then 40 mg
  • weight <25 kg: 40 mg, then 20 mg

PSA: Initial dose of 160 mg (2 x 80 mg injections) at week 0, followed by maintenance dose 80mg every 4 weeks

nr-axSpA: no loading dose required

Tremfya (guselkumab)

subcutaneous injection

PS, PSA: Initial dose of 100 mg at week 0 and week 4, followed by maintenance dose 100 mg every 8 weeks thereafter

Xeljanz

(tofacitinib)

oral tablet,

oral solution

Loading dose not required

Xeljanz XR

(tofacitinib)

oral tablet

Loading dose not required

AS=Ankylosing Spondylitis, CAPS/NOMID= Cryopyrin Associated Periodic Syndrome/ Neonatal-Onset Multisystem Inflammatory Disease, CD=Crohn’s Disease, CRS = Cytokine Release Syndrome, GCA = Giant Cell Arteritis, HS= Hidradenitis Suppurativa, JIA=Juvenile Idiopathic Arthritis, PJIA=Polyarticular Juvenile Idiopathic Arthritis, PS=Psoriasis, PSA=Psoriatic Arthritis, RA=Rheumatoid Arthritis, SJIA=Systemic Juvenile Idiopathic Arthritis, UC=Ulcerative Colitis, nr-axSpA=Nonradiographic Axial Spondyloarthritis, pcJIA= Polyarticular course Juvenile Idiopathic Arthritis

         

Agents Contraindicated as Concomitant Therapy

Actemra (tocilizumab)

Avsola (infliximab-axxq)

Cimzia (certolizumab)

Cosentyx (secukinumab)

Enbrel (etanercept)

Entyvio (vedolizumab)

Humira (adalimumab)

Ilumya (tildrakizumab-asmn)

Inflectra (infliximab-dyyb)

Kevzara (sarilumab)

Kineret (anakinra)

Olumiant (baricitinib)

Orencia (abatacept)

Otezla (apremilast)

Remicade (infliximab)

Renflexis (infliximab-abda)

Riabni (rituximab-arrx)

Rinvoq (upadacitinib)

Rituxan (rituximab)a

Rituxan Hycela (rituximab/hyaluronidase human)a

Ruxience (rituximab-pvvr)

Siliq (brodalumab)

Simponi (golimumab)

Simponi ARIA (golimumab)

Skyrizi (risankizumab-rzaa)

Stelara (ustekinumab)

Taltz (ixekizumab)

Tremfya (guselkumab)

Truxima (rituximab-abbs)a

Xeljanz (tofacitinib)

Xeljanz XR (tofacitinib extended release)

Tysabri (natalizumab)a

Arcalyst (rilonacept)a

Ilaris (canakinumab)a

  a – Rituxan (rituximab), Rituxan Hycela (rituximab/hyaluronidase human), Ruxience (rituximab-pvvr), Truxima (rituximab-abbs), Tysabri (natalizumab), Arcalyst (rilonacept), and Ilaris (canakinumab) are not targets in this program but will be included as a biologic immunomodulator contraindicated in the 30 day washout period.

FDA APPROVED INDICATIONS AND DOSAGE1-16,43,44

Agent(s)

FDA Indication(s) b

Dosing and administration a

Actemra®
(tocilizumab)

Intravenous infusion Subcutaneous injection

IV: CRS (≥2 yrs), PJIA (≥2 yrs), SJIA (≥2 yrs), RA

SQ: GCA, PJIA (≥2 yrs), SJIA (≥2 yrs), RA

CRS IV: IV over 60 min for up to 4 doses with interval between consecutive doses of at least 8 hours, not to exceed 800mg per infusion

  • weight <30 kg: 12 mg/kg
  • weight ≥30 kg: 8 mg/kg 

GCA SC: 162 mg once weekly, in combination with a tapering course of glucocorticoids, every 2-week dosing may be considered

PJIA IV: IV over 60 min every 4 weeks

  • weight <30 kg: 10 mg/kg
  • weight ≥30 kg: 8 mg/kg

PJIA SC:

  • weight <30 kg: 162 mg every 3 weeks
  • weight ≥30 kg: 162 mg every 2 weeks

RA IV: 4 mg/kg IV over 60 min every 4 weeks, may increase to 8 mg/kg every 4 weeks

RA SC:

  • weight <100 kg: 162 mg every 2 weeks, may increase to weekly  
  • weight ≥100 kg: 162 mg once weekly

SJIA IV: IV over 60 min every 2 weeks

  • weight <30 kg: 12 mg/kg
  • weight ≥30 kg: 8 mg/kg 

SJIA SC:

  • weight <30 kg: 162 mg every 2 weeks
  • weight ≥30 kg: 162 mg once weekly

Cimzia® (certolizumab pegol)

Subcutaneous injection

AS, CD, PS, PSA, RA, nr-axSpA

AS, nr-axSpA: 400 mg SC at day 0, week 2, and week 4, then 200 mg every 2 weeks or 400 mg every 4 weeks

CD: 400 mg SC at day 0, week 2, and week 4, then 400 mg every 4 weeks

RA, PSA: 400 mg SC at day 0, week 2 and 4, then 200 mg every 2 weeks or 400 mg every 4 weeks

PS: 400 mg every 2 weeks; for some patients (body weight ≤90 kg) 400 mg SC at day 0, week 2, and week 4, then 200 mg every 2 weeks can be considered

Cosentyx® (secukinumab)

Subcutaneous injection

AS, nr-axSpA, PS, PSA

PS, PSA with PS: 300 mg SC at weeks 0, 1, 2, 3, and 4, then 300 mg every 4 weeks or 150 mg every 4 weeks.

PSA, AS, nr-axSpA:

  • With loading dose: 150 mg SC at weeks 0, 1, 2, 3, and 4, then every 4 weeks thereafter
  • Without loading dose: 150 mg SC every 4 weeks
  • May consider 300 mg for patients that continue to have active PSA and AS

Enbrel® (etanercept)

Subcutaneous injection

AS, PJIA (2 yrs), PS (≥4 yrs), PSA, RA

RA, PSA, AS: 50 mg SC weekly

Adult PS: 50 mg SC twice weekly for 3 months, then 50 mg SC weekly

Pediatric PS, PJIA:

  • weight <63 kg: 0.8 mg/kg SC weekly
  • weight ≥63 kg: 50 mg SC weekly

Humira® (adalimumab)

Subcutaneous injection

AS, CD (≥6 yrs), HS (≥12 yrs), PJIA (≥2 yrs), PS, PSA, RA, UC (≥5 yrs), non-infectious intermediate, posterior and panuveitis (≥2 yrs)

AS, PSA, RA: 40 mg SC every 2 weeks; those with RA not on methotrexate may increase to 40 mg weekly or 80 mg every 2 weeks

Adult HS: 160 mg SC on day 1, 80 mg on day 15, then 40 mg every week or 80 mg every 2 weeks starting day 29

Pediatric HS:

  • weight 30 kg to <60 kg: 80 mg SC on day 1, then 40 mg every 2 weeks starting on day 8
  • weight ≥60 kg: 160 mg SC on day 1, 80 mg on day 15, then 40 mg every week or 80 mg every 2 weeks starting on day 29

Adult CD, UC: 160 mg SC on day 1, 80 mg on day 15, then 40 mg every 2 weeks starting on day 29

Pediatric CD:

  • weight 17 kg to <40 kg: 80 mg SC on day 1, 40 mg on day 15, then 20 mg every 2 weeks starting on day 29
  • weight ≥40 kg: 160 mg SC on day 1, 80 mg on day 15, then 40 mg every 2 weeks starting on day 29

Pediatric UC:

  • weight 20 kg to <40 kg: 80 mg SC on day 1, 40 mg on days 8 and 15, then 20 mg every week or 40 mg every other week starting on day 29
  • weight ≥40 kg: 160 mg SC on day 1, 80 mg on days 8 and 15, then 40 mg every week or 80 mg every other week starting on day 29

PJIA, adolescent uveitis:

  • weight 10 kg to <15 kg: 10 mg SC every 2 weeks
  • weight 15 kg to <30 kg: 20 mg SC every 2 weeks
  • weight ≥30 kg: 40 mg SC every 2 weeks

PS, Adult uveitis: 80 mg SC day 0, then 40 mg every 2 weeks starting one week after the initial dose

Kevzara® (sarilumab)

Subcutaneous injection

RA

RA: 200 mg SC once every 2 weeks

Kineret®
(anakinra)

Subcutaneous injection

DIRAc, NOMIDc, RA

DIRA: initial dose of 1-2 mg/kg SC daily, titrated up in 0.5-1 mg/kg increments to a max of 8 mg/kg daily

NOMID: 1-2 mg/kg SC daily; maximum 8 mg/kg daily

RA: 100 mg SC daily

Olumiant®

(baricitinib)

Oral tablet

RA

RA: 2 mg orally per day

Orencia® (abatacept)

Intravenous infusion

Subcutaneous injection

PJIA (≥6 yrs, IV; ≥2 yrs SC), PSA, RA

PSA SC: 125mg once weekly without the need for an IV loading dose

RA IV, PSA IV: IV over 30 min given at 0, 2, and 4 weeks, then every 4 weeks thereafter

  • weight <60 kg: 500 mg
  • weight 60 kg to 100 kg: 750 mg
  • weight >100 kg: 1000 mg

RA SC­­:  125 mg once weekly, with or without IV loading dose

PJIA IV: IV over 30 min given at 0, 2, and 4 weeks, then every 4 weeks thereafter

  • weight <75 kg: 10 mg/kg
  • weight >75 kg: same as adult RA/PSA IV dosing noted above, not to exceed 1000 mg

PJIA SC: without the need for IV loading dose

  • weight 10 kg to <25 kg: 50 mg weekly
  • weight 25 kg to <50 kg: 87.5mg weekly
  • weight ≥50 kg: 125 mg weekly

Rinvoq (upadacitinib extended release)

Oral tablet

RA

RA: 15 mg orally once daily

Siliq (brodalumab)

Subcutaneous injection

PS

PS: 210 mg SC given at 0, 1, and 2 weeks, followed by 210 mg every 2 weeks

Simponi® (golimumab)

Subcutaneous injection

AS, PSA, RA, UC

AS, PSA, RA: 50 mg SC once monthly

UC: 200 mg SC at week 0, 100 mg at week 2, then 100 mg every 4 weeks

Skyrizi

(risankizumab-rzaa)

Subcutaneous injection

PS

PS: 150 mg SC at weeks 0 and 4, then every 12 weeks thereafter

Stelara® (ustekinumab)

Intravenous infusion

Subcutaneous injection

IV: CD, UC (induction therapy only)

SQ: CD, PS (≥6 yrs), PSA, UC

CD and UC IV: IV over 60 min single induction infusion

  • weight ≤55 kg: 260mg
  • weight >55 kg to 85 kg: 390 mg
  • weight >85 kg: 520 mg

CD and UC SC: 90 mg SC 8 weeks after initial IV induction, then every 8 weeks thereafter

Pediatric PS SC: given at 0 and 4 weeks, then every 12 weeks

  • weight <60 kg: 0.75 mg/kg
  • weight 60 kg to 100 kg: 45 mg
  • weight >100 kg: 90 mg

Adult PS SC: given at 0 and 4 weeks, then every 12 weeks

  • weight ≤100 kg: 45 mg 
  • weight >100 kg: 90 mg

PSA SC: 45 mg at 0 and 4 weeks, then every 12 weeks

Adult PS with PSA SC: weight >100 kg: 90 mg at 0 and 4 weeks, then every 12 weeks

Taltz®
(ixekizumab)

Subcutaneous injection

AS, PS (≥6 yrs), PSA, nr-axSpA

AS: 160 mg SC at week 0, then 80 mg every 4 weeks

Adult PS, Adult PS with PSA: 160 mg SC at week 0, 80 mg at weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks

Pediatric (6 to <18 years) PS: starting dose given at week 0, then every 4 weeks (patients weighing 50 kg or less, doses must be prepared and administered by a health care professional; use prefilled syringe only)

  • weight >50 kg: 160 mg, then 80 mg
  • weight 25 to 50 kg: 80 mg, then 40 mg
  • weight <25 kg: 40 mg, then 20 mg

PSA: 160 mg SC at week 0, then 80mg every 4 weeks

nr-axSpA: 80 mg SC every 4 weeks

Tremfya® (guselkumab)

Subcutaneous

injection

PS, PSA

PS, PSA: 100 mg SC at 0 and 4 weeks, then every 8 weeks thereafter

Xeljanz® (tofacitinib)

Oral tablet

Oral solution

pcJIA (≥2 yrs), PSA, RA, UC

pcJIA:

10 kg to <20 kg: 3.2 mg oral solution twice daily

20 kg to <40 kg: 4 mg oral solution twice daily

≥40 kg: 5 mg (tablet or oral solution) twice daily

PSA, RA: 5 mg orally twice daily

UC: 10 mg orally twice daily for 8 weeks (may continue for a max of 16 weeks), then 5 twice daily. Discontinue after 16 weeks of 10mg twice daily, if adequate therapeutic benefit is not achieved

Xeljanz® XR (tofacitinib extended release)

Oral tablet

PSA, RA, UC

PSA, RA: 11 mg orally once daily

UC: 22 mg once daily for at least 8 weeks. Evaluate response and transition to maintenance therapy, if needed may continue for a maximum of 16 weeks, then maintenance dose of 11 mg once daily

AS=Ankylosing Spondylitis, CAPS/NOMID= Cryopyrin Associated Periodic Syndrome/ Neonatal-Onset Multisystem Inflammatory Disease, CD=Crohn’s Disease, CRS = Cytokine Release Syndrome, DIRA= deficiency of Interleukin-1 Receptor Antagonist, GCA = Giant Cell Arteritis, HS= Hidradenitis Suppurativa, JIA=Juvenile Idiopathic Arthritis, PJIA=Polyarticular Juvenile Idiopathic Arthritis, PS=Psoriasis, PSA=Psoriatic Arthritis, RA=Rheumatoid Arthritis, SJIA=Systemic Juvenile Idiopathic Arthritis, UC=Ulcerative Colitis, nr-axSpA=Nonradiographic Axial Spondyloarthritis, pcJIA= Polyarticular course Juvenile Idiopathic Arthritis

a - Concomitant use of abatacept or anakinra with TNF antagonists has been shown to increase the risk of infection without improving efficacy.  As a result, FDA labeling recommends against combination therapy of two or more biologics.

b - If age is not specified, label indicates for “adult” patients

c – Approved for use in pediatric patients as young as 1 month of age

CLINICAL RATIONALE

RHEUMATOID DISORDERS

Ankylosing spondylitis (AS)17,47

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 mainstay of treatment has 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) recommend the following pharmacological treatment for AS:

  • 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 and 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, leflunomide, pamidronate, thalidomide, apremilast) 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

Nonradiographic Axial Spondyloarthritis (nr-axSpA)17,47

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 mainstay of treatment has 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:

  • Stable SpA: conditional recommendation for on-demand treatment with NSAIDs
  • Active SpA:
    • First line therapy with continuous NSAIDs and 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, leflunomide, pamidronate, thalidomide, apremilast) 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 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 recommend a treat-to-target approach in therapy, regardless of disease activity. ACR guidelines categorize therapy for those with early RA (disease duration <6 months) or established RA (disease duration ≥6 months) as follows:18

  • In general, MTX is the preferred initial DMARD therapy for most patients with RA with active disease. 
  • For early RA patients, the ACR recommends the following:
    • Naïve to therapy: DMARDs, methotrexate (MTX) preferred, as initial, monotherapy therapy unless contraindicated. Other DMARD monotherapy options include sulfasalazine, hydroxychloroquine, and leflunomide.
    • Moderate or high disease activity despite DMARD monotherapy: treatment with combination DMARDs or a TNF-inhibitor (e.g., adalimumab, certolizumab pegol, etanercept, golimumab, or infliximab) or a non-TNF inhibitor (abatacept, rituximab, or tocilizumab [excludes anakinra]), with or without MTX.
    • Moderate or high disease activity despite the previous DMARD or biologic therapy: addition of low-dose glucocorticoid (≤10 mg/day of prednisone or equivalent) to bridge therapy until therapeutic effects of DMARD is reached. ACR also recommends short-term (<3 months) with lowest dose of glucocorticoids for flares.
  • For established RA patients, the ACR recommends the following:
    • Low disease activity and is DMARD naïve: DMARD monotherapy, MTX preferred, is recommended over a TNF-inhibitor.
    • Moderate or high disease and is DMARD naïve: DMARD monotherapy, MTX preferred, is recommended over double or triple DMARD therapy and tofacitinib.
    • Moderate-high disease activity despite DMARD monotherapy: combination DMARD therapy OR the addition of TNF inhibitor, non-TNF biologic, or tofacitinib with or without MTX is recommended rather than continuing DMARD monotherapy. Combination biologic therapy and MTX is recommended over biologic monotherapy.
    • Moderate or high disease despite TNF-inhibitor and not on DMARD: addition of one or two DMARD, rather than TNF-inhibitor monotherapy

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.26-28 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

Polyarticular Juvenile Idiopathic Arthritis (PJIA)34,35

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.

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

  • 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

 

Systemic Juvenile Idiopathic Arthritis (SJIA)19

Systemic juvenile idiopathic arthritis (SJIA) is a subset of JIA. The ACR defines SJIA as arthritis in ≥1 joint for at least 6 weeks’ duration in a child less than 16 years of age with or preceded by a fever of at least 2 weeks’ duration that is documented to be daily (“quotidian”) for at least 3 days and accompanied by one or more of the following: evanescent erythematous rash, generalized lymphadenopathy, hepatomegaly or splenomegaly, and serositis. 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.

SJIA treatment depends on the presence of active systemic features and physician global assessment score (MD global) and active joint count (AJC):

  • Active systemic features and varying degrees of synovitis:
    • Initial therapy: anakinra, glucocorticoids (oral or IV) monotherapy, or NSAID monotherapy
    • Continued disease activity despite initial therapy:
      • 1 month of anakinra: canakinumab, tocilizumab, MTX, leflunomide, or TNF inhibitor
      • 2 weeks of glucocorticoids (GC): anakinra, canakinumab, tocilizumab, MTX, or leflunomide
      • 1 month of NSAIDs: GC monotherapy, anakinra, canakinumab, or tocilizumab
  • Without active systemic features and varying degrees of synovitis:
    • Initial therapy: MTX, leflunomide, NSAID monotherapy, or intra-articular GC
    • Continued disease activity despite initial therapy:
      • 3 months of MTX or leflunomide: abatacept, anakinra, TNF inhibitor, or tocilizumab
      • 1 month of NSAIDs: anakinra, MTX, or leflunomide
      • Following initial intra-articular GC joint injection: anakinra, MTX, or leflunomide
    • Continued disease activity despite second line therapy:
      • 1 month of anakinra: abatacept, MTX, leflunomide, TNF inhibitor, or tocilizumab
      • 3 months of MTX or leflunomide: abatacept, anakinra, TNF inhibitor, or tocilizumab

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

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 ≤1% after 3 months
  • Acceptable response is either a BSA ≤3% or a BSA improvement ≥75% from baseline at 3 months after treatment initiation

Hidradenitis Suppurativa (HS)45,46

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).  

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.

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. 

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) 2013 guideline recommends the following:21

  • Induction of remission in moderately severe CD:
    • Anti-TNF (i.e., infliximab or adalimumab), as monotherapy or in combination with thiopurines, is recommended in patients refractory to standard therapies (mesalamine, antibiotics, corticosteroids and immunomodulators) in moderately severe disease
    • Thiopurines or methotrexate may be added to corticosteroids for induction to maintain a steroid induced remission in moderately severe disease
  • Maintenance of remission in moderately severe CD:
    • Following steroid-induced remission, thiopurine or MTX are preferred over no therapy
    • Following steroid induced or anti-TNF drug induced remission, anti-TNF with or without thiopurine to maintain remission is preferred over no therapy

The 2018 American College of Gastroenterology (ACG) guidelines recommend the following36:

  • 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

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 UC37:

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 UC38:

  • 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 (>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 UC48:

  • 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

Giant Cell Arteritis (GCA) 23,40

Giant cell arteritis (GCA), also known as Horton disease, cranial arteritis, and temporal arteritis, 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. Due to the risk of vision loss, treatment should begin as soon as possible. High-dose systemic glucocorticoids are the mainstay of therapy for GCA. Indications for the addition of a glucocorticoid-sparing agents includes presence of significant premorbid disease, emergence of significant glucocorticoid-related side effects during treatment, or a relapsing course necessitating protracted glucocorticoid use. Methotrexate or tocilizumab are recommended options for glucocorticoid sparing agents.

Cryopyrin-Associated Periodic Syndromes (CAPS)/Neonatal-Onset Multisystem Inflammatory Disease24,41   

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.50 There are three distinct phenotypes related to a defect in the same gene but differ in the organs involved and disease severity. Familial cold autoinflammatory syndrome (FCAS) is the mildest form and more common in the United States. Muckle-Wells syndrome (MWS) is the intermediate phenotype and more common in Europe. Neonatal-onset multisystem inflammatory disease (NOMID) is the least common disease and is the most severe form. An international task force recommends both of the following diagnostic criteria need to be present for a diagnosis of CAPS and its subtypes49:

  • 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 a hive-like rash that is associated with exposure to cold and other environmental triggers and with symptoms lasting up to 24 hours. 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. 

NOMID is characterized by neonatal onset of cutaneous symptoms along with fever with inflammation in multiple organ systems. NOMID shares most of the same characteristics with FCAS and MWS, but also has more severe arthropathy, chronic urticaria, and CNS involvement. CNS manifestations range from hearing loss to aseptic meningitis and mental disabilities. Arthropathy typically affects the large joints, resulting in joint enlargement and functional disability.

Interleukin (IL)-1-beta inhibitors (e.g., anakinra, rilonacept, and canakinumab) have shown effectiveness in preventing and alleviating symptoms of CAPS and reducing levels of inflammatory indices, including serum amyloid A. Treatment with non-steroidal anti-inflammatory drugs, disease modifying antirheumatic drugs, and glucocorticoids offered only some patients partial symptom control.

Deficiency of the IL-1 Receptor Antagonist (DIRA)

Deficiency of the IL-1 Receptor Antagonist (DIRA) syndrome is a relatively new autoinflammatory disease linked to activation of the IL-1 pathway. The DIRA syndrome is distinct from the cryopyrinopathies by its neonatal onset of sterile multifocal osteomyelitis, periostitis, and neutrophilic pustulosis. DIRA is caused by a loss of function of the endogenous IL-1 receptor antagonist, which results in unopposed proinflammatory signaling via cytokines IL-1alpha and IL-1beta on IL-1 receptor type 1. There has been a common homozygous mutation in the IL1RN gene detected in a number of patients. DIRA has similar cutaneous and systemic features as infantile pustular psoriasis and SAPHO (synovitis, acne, pustulosis, hyperostosis, and osteitis) syndrome. The diagnosis of DIRA can be confirmed via genetic testing.50 DIRA is extremely responsive to IL-1 blockade and anakinra has been used empirically. The FDA approved anakinra as treatment for DIRA and rilonacept as maintenance therapy once a patient has achieved remission of DIRA.51 

Safety1-16,43,44

Actemra

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.

Cimzia

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

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

Enbrel

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.

Humira

Adalimumab 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.
  • Post marketing cases of hepatosplenic T-cell lymphoma have occurred in adolescents and young adults with inflammatory bowel disease treated with TNF blockers

Kevzara

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

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

Olumiant

Baricitinib 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 have been reported in patients.
  • Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis, some fatal, have occurred in patients.

Rinvoq

Upadacitinib 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 have been reported in patients.
  • Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis, some fatal, have occurred in patients treated with Janus kinase inhibitors.

Siliq

Brodalumab has the following boxed warning:

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

Simponi

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.

Stelara

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

Taltz

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

Tremfya

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

Xeljanz/Xeljanz XR

Tofacitinib 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.
  • Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis, some fatal, have occurred in patients treated with Janus kinase inhibitors. RA patients with at least one cardiovascular risk factor had a higher rate of all-cause mortality and thrombosis with Xeljanz 10 mg twice daily vs 5 mg twice daily or TNF blockers.
  • Lymphoma and other malignancies, some fatal have been reported, including an increased rate of Epstein Barr Virus-associated post-transplant lymphoproliferative disorder.

 

REFERENCES

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  3. Cosentyx prescribing Information. Novartis Pharmaceuticals Corp. June 2020.
  4. Enbrel prescribing information. Immunex Corporation. August 2020.
  5. Entyvio prescribing information. Takeda Pharmaceuticals America, Inc. May 2019.
  6. Humira prescribing information. AbbVie, Inc. February 2021.
  7. Kevzara prescribing information. Regeneron Pharmaceuticals, Inc/ Sanofi-Aventis U.S. LLC. April 2018.
  8. Kineret prescribing information. Swedish Orphan Biovitrum. December 2020.
  9. Olumiant prescribing information. Eli Lilly and Company. July 2020.
  10. Orencia prescribing information. E.R. Squibb & Sons. June 2020.
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  13. Stelara prescribing information. Janssen Biotech, Inc. July 2020.
  14. Taltz prescribing information. Eli Lilly and Company.  May 2020.
  1. Tremfya prescribing information. Janssen Biotech, Inc. July 2020.
  2. Xeljanz and Xeljanz XR prescribing information.  Pfizer, Inc. September 2020.
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  12. Methotrexate prescribing information. Sun Pharmaceutical Industries, Inc. April 2018.
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  1. 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.
  1. 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.
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  1. 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.
  2. 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.
  3. 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. Retrieved March 8, 2019, from http://s3.gi.org/physicians/guidelines/UlcerativeColitis.pdf
  4. 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. Retrieved March 8, 2019, from https://www.gastrojournal.org/article/S0016-5085(18)35407-6/pdf.  
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  6. Bhana, S., MD. (2017, March). Giant Cell Arteritis. Retrieved March 15, 2019, from https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Giant-Cell-Arteritis.
  7. 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.
  8. 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.
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  10. Rinvoq prescribing information. AbbVie Inc. July 2020.
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  13. 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.
  14. Feuerstein, Joseph D. et al. AGA Clinical Practice Guidelines on the Management of Moderate to Severe Ulcerative Colitis. Gastroenterology, Volume 0, Issue 0.
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  16. Cowen EW, Goldbach-Mansky R. DIRA, DITRA, and new insights into pathways of skin inflammation: what's in a name? Arch Dermatol 2012; 148:381.
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This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
 
The purpose of pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
 
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

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