ph-0028
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Cimzia (certolizumab pegol)

Policy Number: PH-0028

(Subcutaneous)

 

 

Last Review Date: 05/01/2019

Date of Origin:  11/28/2011

Dates Reviewed:  12/2011, 11/2012, 11/2013, 12/2013, 08/2014, 03/2015, 06/2015, 09/2015, 12/2015, 03/2016, 06/2016, 09/2016, 12/2016, 03/2017, 06/2017, 09/2017, 12/2017, 03/2018, 06/2018, 07/2018, 10/2018, 05/2019

 

  1. Length of Authorization

          Coverage will be provided for 6 months and may be renewed.

  1. Dosing Limits
  1. Quantity Limit (max daily dose) [Pharmacy Benefit]:
  • Loading Dose
  • Cimzia 200 mg powder for injection: 6 vials first 29 days
  • Cimzia 200 mg prefilled syringes: 6 syringes first 29 days
  • Maintenance/Flat Dosing
  • Cimzia 200 mg powder for injection: 2 vials every 14 days
  • Cimzia 200 mg prefilled syringes: 2 syringes every 14 days
  1. Max Units (per dose and over time) [Medical Benefit]:
  • Plaque Psoriasis
    • 400 billable units every other week
  • All Other Indications
    • Loading Dose
      • 400 billable units on weeks 0, 2 and 4
    • Maintenance Dose
      • 400 billable units every 4 weeks
  1. Initial Approval Criteria
  • Patient has been evaluated and screened for the presence of latent TB infection prior to initiating treatment; AND
  • Patient has been evaluated and screened for the presence of hepatitis B virus (HBV) prior to initiating treatment; AND
  • Patient does not have an active infection, including clinically important localized infections; AND
  • Must not be administered concurrently with live vaccines; AND
  • Patient is not on concurrent treatment with another TNF-inhibitor, biologic response modifier or other non-biologic agent (i.e., apremilast, tofacitinib, baricitinib); AND
  • Patient aged 18 years or older; AND
  • Physician has assessed baseline disease severity utilizing an objective measure/tool; AND

  Rheumatoid Arthritis (RA) †

  • Documented moderate to severe active disease; AND
  • Patient has had at least a 3 month trial and failed previous therapy with ONE oral disease modifying anti-rheumatic agent (DMARD) such as methotrexate, azathioprine, auranofin, hydroxychloroquine, penicillamine, sulfasalazine, or leflunomide; AND
  • Prescribed in combination with methotrexate unless contraindicated

 

  Crohn’s Disease (CD) †

  • Documented moderate to severe active disease; AND
  • Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum (3) month trial of corticosteroids or immunomodulators (e.g. azathioprine, 6-mercaptopurine, or methotrexate)

  Psoriatic Arthritis (PsA) †

  • Documented moderate to severe active disease; AND
  • For patients with predominantly axial disease OR active enthesitis and/or dactylitis, an adequate trial and failure of at least TWO (2) non-steroidal anti-inflammatory agents (NSAIDs), unless use is contraindicated; OR
  • For patients with peripheral arthritis, a trial and failure of at least a 3 month trial of ONE oral disease-modifying anti-rheumatic agent (DMARD) such as methotrexate, azathioprine, sulfasalazine, or hydroxychloroquine

 Ankylosing Spondylitis †

  • Documented active disease; AND
  • Patient had an adequate trial and failure of at least TWO (2) non-steroidal anti-inflammatory agents (NSAIDs), unless use is contraindicated

 Non-radiographic Axial Spondyloarthritis (nr-axSpA) †

  • Patient has objective signs of inflammation noted by an elevation of C-reactive protein (CRP) above the upper limit of normal or sacroiliitis on magnetic resonance imaging (MRI) without definitive radiographic evidence of structural damage on sacroiliac joints; AND
  • Patient has active disease as defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4 and spinal pain ≥4 on a 0 to 10 Numerical Rating Scale (NRS); AND
  • Patient had an adequate trial and failure of at least TWO (2) non-steroidal anti-inflammatory agents (NSAIDs), unless use is contraindicated

Plaque Psoriasis †

  • Patient has moderate to severe plaque psoriasis for at least 6 months with at least one of the following:
  • Involvement of at least 10% of body surface area (BSA); OR
  • Psoriasis Area and Severity Index (PASI) score of 10 or greater; OR
  • Incapacitation due to plaque location (i.e. head and neck, palms, soles or genitalia); AND
  • Patient did not respond adequately (or is not a candidate) to a 3 month minimum trial of topical agents (i.e., anthralin, coal tar preparations, corticosteroids, emollients, immunosuppressives, keratolytics, retinoic acid derivatives, and/or vitamin D analogues); AND
  • Patient did not respond adequately (or is not a candidate) to a 3 month minimum trial of at least one systemic agent (i.e., immunosuppressives, retinoic acid derivatives, and/or methotrexate); AND
  • Patient did not respond adequately (or is not a candidate) to a 3 month minimum trial of phototherapy (i.e., psoralens with UVA light (PUVA) or UVB with coal tar or dithranol); AND

*Note: Patients with body weight ≤ 90 kg should initiate therapy at the lower dosing regimen of 200 mg every other week plus loading doses.

FDA Approved Indication(s)

  1. Renewal Criteria

          Coverage can be renewed based upon the following criteria:

  • Patient continues to meet criteria identified in section III; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: severe hypersensitivity reactions, serious infection, cardiotoxicity/heart failure, lupus-like syndrome, demyelinating disease, cytopenias, development of malignancies, Hepatitis B reactivation, etc.; AND
  • Patient is receiving ongoing monitoring for presence of TB or other active infections; AND

          Rheumatoid Arthritis

  • Disease response as indicated by improvement in signs and symptoms compared to baseline such as the number of tender and swollen joint counts, reduction of C-reactive protein, improvement of patient global assessment, and/or an improvement on a disease activity scoring tool [e.g. an improvement on a composite scoring index such as Disease Activity Score-28 (DAS28) of 1.2 points or more or a ≥20% improvement on the American College of Rheumatology-20 (ACR20) criteria].

          Crohn’s Disease

  • Disease response as indicated by improvement in signs and symptoms compared to baseline such as endoscopic activity, number of liquid stools, presence and severity of abdominal pain, presence of abdominal mass, body weight compared to IBW, hematocrit, presence of extra intestinal complications, use of anti-diarrheal drugs, tapering of corticosteroids or discontinuation of corticosteroid therapy, and/or an improvement on a disease activity scoring tool [e.g. an improvement on the Crohn’s Disease Activity Index (CDAI) score or the Harvey-Bradshaw Index score]. 

          Psoriatic Arthritis

  • Disease response as indicated by improvement in signs and symptoms compared to baseline such as the number of tender and swollen joint counts and/or an improvement on a disease activity scoring tool [e.g. defined as an improvement in at least 2 of the 4 Psoriatic Arthritis Response Criteria (PsARC), 1 of which must be joint tenderness or swelling score, with no worsening in any of the 4 criteria.]

          Ankylosing Spondylitis

  • Disease response as indicated by improvement in signs and symptoms compared to baseline such as total back pain, physical function, morning stiffness, and/or an improvement on a disease activity scoring tool (e.g. ≥ 1.1 improvement on the Ankylosing Spondylitis Disease Activity Score (ASDAS) or an improvement of ≥ 2 on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)).

           Non-radiographic Axial Spondyloarthritis

  • Disease response as indicated by improvement in signs and symptoms compared to baseline such as total back pain, physical function, reduction of C-reactive protein, and/or an improvement on a disease activity scoring tool (e.g. ≥ 1.1 improvement on the Ankylosing Spondylitis Disease Activity Score (ASDAS), achievement of an ASDAS-Major Improvement (ASDAS-MI e.g. improvement of ≥ 2.0 is the ASDAS and/or reaching the lowest possible ASDAS),  improvement of ≥ 2 on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)), or improvement of the Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) score from baseline.

            Plaque Psoriasis

  • Disease response as indicated by improvement in signs and symptoms compared to baseline such as redness, thickness, scaliness, and/or the amount of surface area involvement (a total BSA involvement ≤1%), and/or an improvement on a disease activity scoring tool [e.g. a 75% reduction in the PASI score from when treatment started (PASI 75) or a 50% reduction in the PASI score (PASI 50) and a four-point reduction in the DLQI from when treatment started; AND
  • Dose escalation (up to the maximum dose and frequency specified below) may occur upon clinical review on a case by case basis provided that the patient has:
    • Shown an initial response to therapy; AND
    • Received the three loading doses at the dose and interval specified below; AND
    • Received a minimum of one maintenance dose at the dose and interval specified below; AND
    • Responded to therapy (by treatment week 6) with subsequent loss of response
  1. Dosage/Administration

Indication

Dose

Rheumatoid Arthritis

Loading

400 mg, subcutaneously, at weeks 0, 2 and 4; then

Maintenance

200 mg subcutaneously, every other week, thereafter (or 400 mg every 4 weeks)

Crohn’s Disease

Loading

400 mg, subcutaneously, at weeks 0, 2 and 4; then

Maintenance

400 mg, subcutaneously, every 4 weeks, thereafter

Psoriatic Arthritis

Loading

400 mg, subcutaneously, at weeks 0, 2 and 4; then

Maintenance

200 mg, subcutaneously, every other week, thereafter (or 400 mg every 4 weeks)

Plaque Psoriasis

400 mg (given as 2 subcutaneous injections of 200 mg each) every other week

Optional alternate dosing for patients with body weight ≤ 90 kg

  • Loading: 400 mg (given as 2 subcutaneous injections of 200 mg each) at Weeks 0, 2 and 4
  • Maintenance: 200 mg every other week thereafter

Ankylosing Spondylitis

Loading

400 mg, subcutaneously, at weeks 0, 2 and 4; then

Maintenance

200 mg, subcutaneously, every other week, thereafter (or 400 mg every 4 weeks)

Non-radiographic Axial Spondyloarthritis

Loading

400 mg, subcutaneously, at weeks 0, 2 and 4; then

Maintenance

200 mg, subcutaneously, every other week, thereafter (or 400 mg every 4 weeks)

  1. Billing Code/Availability Information

    Jcode:

  • J0717* – Injection, certolizumab pegol, 1 mg; 1 billable unit = 1mg

* Code may be used for medicare when drug is administered under the direct supervision of a physician; not to be used when drug is self-administered

 

    NDC:

  • Cimzia 400 mg Kit-powder for injection; SDV: 50474-0700-xx
  • Cimzia 200 mg prefilled syringe and Starter Kit; SDV: 50474-0710-xx
  1. References
  1. Cimzia [package insert]. Smyrna, GA; UCB, Inc; April 2019; Accessed April 2019.
  2. Sandborn WJ, Feagan BG, Stoinov S, et al. Certolizumab Pegol for the Treatment of Crohn’s Disease (PRECISE 1). NEJM 2007; 357:228-38.
  3. Schreiber S, Khaliq-Kareemi M, Lawrance IC, et al; PRECISE 2 Study Investigators. Maintenance therapy with certolizumab pegol for Crohn’s disease. NEJM 2007 July 19; 357(3):239-50.
  4. Keystone E, Heijde D, Mason D Jr, et al. Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: findings of a fifty-two-week, phase III, multicenter, randomized, double-blind, placebo controlled, parallel-group study. Arthritis Rheum. 2008 Nov; 58(11):3319-29.
  5. Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2015 Nov 6. doi: 10.1002/acr.22783.
  6. Gottlieb A, Korman NJ, Gordon KB, Feldman SR, Lebwohl M, Koo JY, Van Voorhees AS, Elmets CA, Leonardi CL, Beutner KR, Bhushan R, Menter A. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 2. Psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics. J Am Acad Dermatol 2008 May; 58(5):851-64.
  7. Gossec L, Smolen JS, Ramiro S, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis. 2015 Dec pii: annrheumdis-2015-208337. doi: 10.1136/annrheumdis-2015-208337.
  8. Terdiman JP, Gruss CB, Heidelbaugh JJ, et al. American Gastroenterological Association Institute guideline on the use of thiopurines, methotrexate, and anti-TNF-α biologic drugs for the induction and maintenance of remission in inflammatory Crohn's disease. Gastroenterology. 2013 Dec; 145(6):1459-63. doi: 10.1053/j.gastro.2013.10.047.
  9. Ward MM, Deodhar, A, Akl, EA, et al. American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network 2015 Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis Rheumatol. 2015 Sep 24. doi: 10.1002/art.39298.
  10. Lichtenstein GR, Hanauer SB, Sandborn WJ, Practice Parameters Committee of American College of Gastroenterology. Management of Crohn’s disease in adults. Am J Gastroenterol. 2009; 104(2):465.
  11. Smolen JS, Landewé R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017 Mar 6. pii: annrheumdis-2016-210715.
  12. Ramiro S, Smolen JS, Landewé R, et al. Pharmacological treatment of psoriatic arthritis: a systematic literature review for the 2015 update of the EULAR recommendations for the management of psoriatic arthritis.  Ann Rheum Dis 2016;75:490-498 doi:10.1136/annrheumdis-2015-208466​
  13. Van Der Heijde D, Ramiro S, Landewe R, et al. 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis.  Ann Rheum Dis doi:10.1136/annrheumdis-2016-210770
  14. National Institute for Health and Care Excellence. NICE 2016. Certolizumab pegol for treating rheumatoid arthritis after inadequate response to a TNF-alpha inhibitor. Published 26 Oct 2016. Technology Appraisal Guidance [TA415]. https://www.nice.org.uk/guidance/ta415/chapter/1-Recommendations. Accessed August 2017.
  15. National Institute for Health and Care Excellence. NICE 2017. Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs. Published 24 May 2017. Technology Appraisal Guidance [TA445]. https://www.nice.org.uk/guidance/TA445/chapter/1-Recommendations. Accessed August 2017.
  16. National Institute for Health and Care Excellence. NICE 2009. Rheumatoid Arthritis in Adults: Management. Published 25 February 2009. Clinical Guideline [CG79]. https://www.nice.org.uk/guidance/cg79/resources/rheumatoid-arthritis-in-adults-management-pdf-975636823525.
  17. National Institute for Health and Care Excellence. NICE 2010. Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after failure of a TNF inhibitor. Published 10 October 2012. Clinical Guideline [TA195]. https://www.nice.org.uk/guidance/ta195/resources/adalimumab-etanercept-infliximab-rituximab-and-abatacept-for-the-treatment-of-rheumatoid-arthritis-after-the-failure-of-a-tnf-inhibitor-pdf-82598558287813.
  18. Ward MM, Guthri LC, Alba MI. Rheumatoid Arthritis Response Criteria And Patient-Reported Improvement in Arthritis Activity: Is an ACR20 Response Meaningful to Patients”. Arthritis Rheumatol. 2014 Sep; 66(9): 2339–2343. doi:  10.1002/art.38705
  19. National Institute for Health and Care Excellence. NICE 2012. Crohn’s Disease: Management. Published 10 October 2012. Clinical Guideline [CG152]. https://www.nice.org.uk/guidance/cg152/resources/crohns-disease-management-pdf-35109627942085.
  20. Lichtenstein GR, Loftus EV, Isaacs KI, et al. ACG Clinical Guideline: Management of Crohn’s Disease in Adults. Am J Gastroenterol 2018; 113:481–517; doi: 10.1038/ajg.2018.27
  21. National Institute for Health and Care Excellence. NICE 2008. Infliximab for the treatment of adults with psoriasis. Published 23 January 2008. Technology Appraisal Guidance [TA134]. https://www.nice.org.uk/guidance/ta134/resources/infliximab-for-the-treatment-of-adults-with-psoriasis-pdf-82598193811141.
  22. Smith CH, Jabbar-Lopez ZK, Yiu ZK, et al. British Association of Dermatologists guidelines for biologic therapy for psoriasis 2017. Br J Dermatol. 2017 Sep;177(3):628-636. doi: 10.1111/bjd.15665.
  23. Felson DT, Smolen JS, Wells G, et al. American College of Rheumatology/European League Against Rheumatism Provisional Definition of Remission in Rheumatoid Arthritis for Clinical Trials, Arthritis and Rheumatism. 2011 Mar; 63(3): 573–586.
  24. Singh J, Reston J, Gladman D, et al. American College of Rheumatology (ACR) and National Psoriasis Foundation (NPF) Psoriatic Arthritis Guideline. 2016 Nov; https://www.rheumatology.org/Portals/0/Files/ACR-NPF%20Psoriatic%20Arthritis%20Guideline%20Project%20Plan.pdf

Appendix 1 – Covered Diagnosis Codes

 

ICD-10

ICD-10 Description

K50.00

Crohn's disease of small intestine without complications

K50.011

Crohn's disease of small intestine with rectal bleeding

K50.012

Crohn's disease of small intestine with intestinal obstruction

K50.013

Crohn's disease of small intestine with fistula

K50.014

Crohn's disease of small intestine with abscess

K50.018

Crohn's disease of small intestine with other complication

K50.019

Crohn's disease of small intestine with unspecified complications

K50.10

Crohn's disease of large intestine without complications

K50.111

Crohn's disease of large intestine with rectal bleeding

K50.112

Crohn's disease of large intestine with intestinal obstruction

K50.113

Crohn's disease of large intestine with fistula

K50.114

Crohn's disease of large intestine with abscess

K50.118

Crohn's disease of large intestine with other complication

K50.119

Crohn's disease of large intestine with unspecified complications

K50.80

Crohn's disease of both small and large intestine without complications

K50.811

Crohn's disease of both small and large intestine with rectal bleeding

K50.812

Crohn's disease of both small and large intestine with intestinal obstruction

K50.813

Crohn's disease of both small and large intestine with fistula

K50.814

Crohn's disease of both small and large intestine with abscess

K50.818

Crohn's disease of both small and large intestine with other complication

K50.819

Crohn's disease of both small and large intestine with unspecified complications

K50.90

Crohn's disease, unspecified, without complications

K50.911

Crohn's disease, unspecified, with rectal bleeding

K50.912

Crohn's disease, unspecified, with intestinal obstruction

K50.913

Crohn's disease, unspecified, with fistula

K50.914

Crohn's disease, unspecified, with abscess

K50.918

Crohn's disease, unspecified, with other complication

K50.919

Crohn's disease, unspecified, with unspecified complications

L40.0

Psoriasis vulgaris

L40.50

Arthropathic psoriasis, unspecified

L40.51

Distal interphalangeal psoriatic arthropathy

L40.52

Psoriatic arthritis mutilans

L40.53

Psoriatic spondylitis

L40.59

Other psoriatic arthropathy

M05.10

Rheumatoid lung disease with rheumatoid arthritis of unspecified site

M05.111

Rheumatoid lung disease with rheumatoid arthritis of right shoulder

M05.112

Rheumatoid lung disease with rheumatoid arthritis of left shoulder

M05.119

Rheumatoid lung disease with rheumatoid arthritis of unspecified shoulder

M05.121

Rheumatoid lung disease with rheumatoid arthritis of right elbow

M05.122

Rheumatoid lung disease with rheumatoid arthritis of left elbow

M05.129

Rheumatoid lung disease with rheumatoid arthritis of unspecified elbow

M05.131

Rheumatoid lung disease with rheumatoid arthritis of right wrist

M05.132

Rheumatoid lung disease with rheumatoid arthritis of left wrist

M05.139

Rheumatoid lung disease with rheumatoid arthritis of unspecified wrist

M05.141

Rheumatoid lung disease with rheumatoid arthritis of right hand

M05.142

Rheumatoid lung disease with rheumatoid arthritis of left hand

M05.149

Rheumatoid lung disease with rheumatoid arthritis of unspecified hand

M05.151

Rheumatoid lung disease with rheumatoid arthritis of right hip

M05.152

Rheumatoid lung disease with rheumatoid arthritis of left hip

M05.159

Rheumatoid lung disease with rheumatoid arthritis of unspecified hip

M05.161

Rheumatoid lung disease with rheumatoid arthritis of right knee

M05.162

Rheumatoid lung disease with rheumatoid arthritis of left knee

M05.169

Rheumatoid lung disease with rheumatoid arthritis of unspecified knee

M05.171

Rheumatoid lung disease with rheumatoid arthritis of right ankle and foot

M05.172

Rheumatoid lung disease with rheumatoid arthritis of left ankle and foot

M05.179

Rheumatoid lung disease with rheumatoid arthritis of unspecified ankle and foot

M05.19

Rheumatoid lung disease with rheumatoid arthritis of multiple sites

M05.20

Rheumatoid vasculitis with rheumatoid arthritis of unspecified site

M05.211

Rheumatoid vasculitis with rheumatoid arthritis of right shoulder

M05.212

Rheumatoid vasculitis with rheumatoid arthritis of left shoulder

M05.219

Rheumatoid vasculitis with rheumatoid arthritis of unspecified shoulder

M05.221

Rheumatoid vasculitis with rheumatoid arthritis of right elbow

M05.222

Rheumatoid vasculitis with rheumatoid arthritis of left elbow

M05.229

Rheumatoid vasculitis with rheumatoid arthritis of unspecified elbow

M05.231

Rheumatoid vasculitis with rheumatoid arthritis of right wrist

M05.232

Rheumatoid vasculitis with rheumatoid arthritis of left wrist

M05.239

Rheumatoid vasculitis with rheumatoid arthritis of unspecified wrist

M05.241

Rheumatoid vasculitis with rheumatoid arthritis of right hand

M05.242

Rheumatoid vasculitis with rheumatoid arthritis of left hand

M05.249

Rheumatoid vasculitis with rheumatoid arthritis of unspecified hand

M05.251

Rheumatoid vasculitis with rheumatoid arthritis of right hip

M05.252

Rheumatoid vasculitis with rheumatoid arthritis of left hip

M05.259

Rheumatoid vasculitis with rheumatoid arthritis of unspecified hip

M05.261

Rheumatoid vasculitis with rheumatoid arthritis of right knee

M05.262

Rheumatoid vasculitis with rheumatoid arthritis of left knee

M05.269

Rheumatoid vasculitis with rheumatoid arthritis of unspecified knee

M05.271

Rheumatoid vasculitis with rheumatoid arthritis of right ankle and foot

M05.272

Rheumatoid vasculitis with rheumatoid arthritis of left ankle and foot

M05.279

Rheumatoid vasculitis with rheumatoid arthritis of unspecified ankle and foot

M05.29

Rheumatoid vasculitis with rheumatoid arthritis of multiple sites

M05.30

Rheumatoid heart disease with rheumatoid arthritis of unspecified site

M05.311

Rheumatoid heart disease with rheumatoid arthritis of right shoulder

M05.312

Rheumatoid heart disease with rheumatoid arthritis of left shoulder

M05.319

Rheumatoid heart disease with rheumatoid arthritis of unspecified shoulder

M05.321

Rheumatoid heart disease with rheumatoid arthritis of right elbow

M05.322

Rheumatoid heart disease with rheumatoid arthritis of left elbow

M05.329

Rheumatoid heart disease with rheumatoid arthritis of unspecified elbow

M05.331

Rheumatoid heart disease with rheumatoid arthritis of right wrist

M05.332

Rheumatoid heart disease with rheumatoid arthritis of left wrist

M05.339

Rheumatoid heart disease with rheumatoid arthritis of unspecified wrist

M05.341

Rheumatoid heart disease with rheumatoid arthritis of right hand

M05.342

Rheumatoid heart disease with rheumatoid arthritis of left hand

M05.349

Rheumatoid heart disease with rheumatoid arthritis of unspecified hand

M05.351

Rheumatoid heart disease with rheumatoid arthritis of right hip

M05.352

Rheumatoid heart disease with rheumatoid arthritis of left hip

M05.359

Rheumatoid heart disease with rheumatoid arthritis of unspecified hip

M05.361

Rheumatoid heart disease with rheumatoid arthritis of right knee

M05.362

Rheumatoid heart disease with rheumatoid arthritis of left knee

M05.369

Rheumatoid heart disease with rheumatoid arthritis of unspecified knee

M05.371

Rheumatoid heart disease with rheumatoid arthritis of right ankle and foot

M05.372

Rheumatoid heart disease with rheumatoid arthritis of left ankle and foot

M05.379

Rheumatoid heart disease with rheumatoid arthritis of unspecified ankle and foot

M05.39

Rheumatoid heart disease with rheumatoid arthritis of multiple sites

M05.40

Rheumatoid myopathy with rheumatoid arthritis of unspecified site

M05.411

Rheumatoid myopathy with rheumatoid arthritis of right shoulder

M05.412

Rheumatoid myopathy with rheumatoid arthritis of left shoulder

M05.419

Rheumatoid myopathy with rheumatoid arthritis of unspecified shoulder

M05.421

Rheumatoid myopathy with rheumatoid arthritis of right elbow

M05.422

Rheumatoid myopathy with rheumatoid arthritis of left elbow

M05.429

Rheumatoid myopathy with rheumatoid arthritis of unspecified elbow

M05.431

Rheumatoid myopathy with rheumatoid arthritis of right wrist

M05.432

Rheumatoid myopathy with rheumatoid arthritis of left wrist

M05.439

Rheumatoid myopathy with rheumatoid arthritis of unspecified wrist

M05.441

Rheumatoid myopathy with rheumatoid arthritis of right hand

M05.442

Rheumatoid myopathy with rheumatoid arthritis of left hand

M05.449

Rheumatoid myopathy with rheumatoid arthritis of unspecified hand

M05.451

Rheumatoid myopathy with rheumatoid arthritis of right hip

M05.452

Rheumatoid myopathy with rheumatoid arthritis of left hip

M05.459

Rheumatoid myopathy with rheumatoid arthritis of unspecified hip

M05.461

Rheumatoid myopathy with rheumatoid arthritis of right knee

M05.462

Rheumatoid myopathy with rheumatoid arthritis of left knee

M05.469

Rheumatoid myopathy with rheumatoid arthritis of unspecified knee

M05.471

Rheumatoid myopathy with rheumatoid arthritis of right ankle and foot

M05.472

Rheumatoid myopathy with rheumatoid arthritis of left ankle and foot

M05.479

Rheumatoid myopathy with rheumatoid arthritis of unspecified ankle and foot

M05.49

Rheumatoid myopathy with rheumatoid arthritis of multiple sites

M05.50

Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified site

M05.511

Rheumatoid polyneuropathy with rheumatoid arthritis of right shoulder

M05.512

Rheumatoid polyneuropathy with rheumatoid arthritis of left shoulder

M05.519

Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified shoulder

M05.521

Rheumatoid polyneuropathy with rheumatoid arthritis of right elbow

M05.522

Rheumatoid polyneuropathy with rheumatoid arthritis of left elbow

M05.529

Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified elbow

M05.531

Rheumatoid polyneuropathy with rheumatoid arthritis of right wrist

M05.532

Rheumatoid polyneuropathy with rheumatoid arthritis of left wrist

M05.539

Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified wrist

M05.541

Rheumatoid polyneuropathy with rheumatoid arthritis of right hand

M05.542

Rheumatoid polyneuropathy with rheumatoid arthritis of left hand

M05.549

Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified hand

M05.551

Rheumatoid polyneuropathy with rheumatoid arthritis of right hip

M05.552

Rheumatoid polyneuropathy with rheumatoid arthritis of left hip

M05.559

Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified hip

M05.561

Rheumatoid polyneuropathy with rheumatoid arthritis of right knee

M05.562

Rheumatoid polyneuropathy with rheumatoid arthritis of left knee

M05.569

Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified knee

M05.571

Rheumatoid polyneuropathy with rheumatoid arthritis of right ankle and foot

M05.572

Rheumatoid polyneuropathy with rheumatoid arthritis of left ankle and foot

M05.579

Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified ankle and foot

M05.59

Rheumatoid polyneuropathy with rheumatoid arthritis of multiple sites

M05.60

Rheumatoid arthritis of unspecified site with involvement of other organs and systems

M05.611

Rheumatoid arthritis of right shoulder with involvement of other organs and systems

M05.612

Rheumatoid arthritis of left shoulder with involvement of other organs and systems

M05.619

Rheumatoid arthritis of unspecified shoulder with involvement of other organs and systems

M05.621

Rheumatoid arthritis of right elbow with involvement of other organs and systems

M05.622

Rheumatoid arthritis of left elbow with involvement of other organs and systems

M05.629

Rheumatoid arthritis of unspecified elbow with involvement of other organs and systems

M05.631

Rheumatoid arthritis of right wrist with involvement of other organs and systems

M05.632

Rheumatoid arthritis of left wrist with involvement of other organs and systems

M05.639

Rheumatoid arthritis of unspecified wrist with involvement of other organs and systems

M05.641

Rheumatoid arthritis of right hand with involvement of other organs and systems

M05.642

Rheumatoid arthritis of left hand with involvement of other organs and systems

M05.649

Rheumatoid arthritis of unspecified hand with involvement of other organs and systems

M05.651

Rheumatoid arthritis of right hip with involvement of other organs and systems

M05.652

Rheumatoid arthritis of left hip with involvement of other organs and systems

M05.659

Rheumatoid arthritis of unspecified hip with involvement of other organs and systems

M05.661

Rheumatoid arthritis of right knee with involvement of other organs and systems

M05.662

Rheumatoid arthritis of left knee with involvement of other organs and systems

M05.669

Rheumatoid arthritis of unspecified knee with involvement of other organs and systems

M05.671

Rheumatoid arthritis of right ankle and foot with involvement of other organs and systems

M05.672

Rheumatoid arthritis of left ankle and foot with involvement of other organs and systems

M05.679

Rheumatoid arthritis of unspecified ankle and foot with involvement of other organs and systems

M05.69

Rheumatoid arthritis of multiple sites with involvement of other organs and systems

M05.70

Rheumatoid arthritis with rheumatoid factor of unspecified site without organ or systems involvement

M05.711

Rheumatoid arthritis with rheumatoid factor of right shoulder without organ or systems involvement

M05.712

Rheumatoid arthritis with rheumatoid factor of left shoulder without organ or systems involvement

M05.719

Rheumatoid arthritis with rheumatoid factor of unspecified shoulder without organ or systems involvement

M05.721

Rheumatoid arthritis with rheumatoid factor of right elbow without organ or systems involvement

M05.722

Rheumatoid arthritis with rheumatoid factor of left elbow without organ or systems involvement

M05.729

Rheumatoid arthritis with rheumatoid factor of unspecified elbow without organ or systems involvement

M05.731

Rheumatoid arthritis with rheumatoid factor of right wrist without organ or systems involvement

M05.732

Rheumatoid arthritis with rheumatoid factor of left wrist without organ or systems involvement

M05.739

Rheumatoid arthritis with rheumatoid factor of unspecified wrist without organ or systems involvement

M05.741

Rheumatoid arthritis with rheumatoid factor of right hand without organ or systems involvement

M05.742

Rheumatoid arthritis with rheumatoid factor of left hand without organ or systems involvement

M05.749

Rheumatoid arthritis with rheumatoid factor of unspecified hand without organ or systems involvement

M05.751

Rheumatoid arthritis with rheumatoid factor of right hip without organ or systems involvement

M05.752

Rheumatoid arthritis with rheumatoid factor of left hip without organ or systems involvement

M05.759

Rheumatoid arthritis with rheumatoid factor of unspecified hip without organ or systems involvement

M05.761

Rheumatoid arthritis with rheumatoid factor of right knee without organ or systems involvement

M05.762

Rheumatoid arthritis with rheumatoid factor of left knee without organ or systems involvement

M05.769

Rheumatoid arthritis with rheumatoid factor of unspecified knee without organ or systems involvement

M05.771

Rheumatoid arthritis with rheumatoid factor of right ankle and foot without organ or systems involvement

M05.772

Rheumatoid arthritis with rheumatoid factor of left ankle and foot without organ or systems involvement

M05.779

Rheumatoid arthritis with rheumatoid factor of unspecified ankle and foot without organ or systems involvement

M05.79

Rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems involvement

M05.80

Other rheumatoid arthritis with rheumatoid factor of unspecified site

M05.811

Other rheumatoid arthritis with rheumatoid factor of right shoulder

M05.812

Other rheumatoid arthritis with rheumatoid factor of left shoulder

M05.819

Other rheumatoid arthritis with rheumatoid factor of unspecified shoulder

M05.821

Other rheumatoid arthritis with rheumatoid factor of right elbow

M05.822

Other rheumatoid arthritis with rheumatoid factor of left elbow

M05.829

Other rheumatoid arthritis with rheumatoid factor of unspecified elbow

M05.831

Other rheumatoid arthritis with rheumatoid factor of right wrist

M05.832

Other rheumatoid arthritis with rheumatoid factor of left wrist

M05.839

Other rheumatoid arthritis with rheumatoid factor of unspecified wrist

M05.841

Other rheumatoid arthritis with rheumatoid factor of right hand

M05.842

Other rheumatoid arthritis with rheumatoid factor of left hand

M05.849

Other rheumatoid arthritis with rheumatoid factor of unspecified hand

M05.851

Other rheumatoid arthritis with rheumatoid factor of right hip

M05.852

Other rheumatoid arthritis with rheumatoid factor of left hip

M05.859

Other rheumatoid arthritis with rheumatoid factor of unspecified hip

M05.861

Other rheumatoid arthritis with rheumatoid factor of right knee

M05.862

Other rheumatoid arthritis with rheumatoid factor of left knee

M05.869

Other rheumatoid arthritis with rheumatoid factor of unspecified knee

M05.871

Other rheumatoid arthritis with rheumatoid factor of right ankle and foot

M05.872

Other rheumatoid arthritis with rheumatoid factor of left ankle and foot

M05.879

Other rheumatoid arthritis with rheumatoid factor of unspecified ankle and foot

M05.89

Other rheumatoid arthritis with rheumatoid factor of multiple sites

M05.9

Rheumatoid arthritis with rheumatoid factor, unspecified

M06.00

Rheumatoid arthritis without rheumatoid factor, unspecified site

M06.011

Rheumatoid arthritis without rheumatoid factor, right shoulder

M06.012

Rheumatoid arthritis without rheumatoid factor, left shoulder

M06.019

Rheumatoid arthritis without rheumatoid factor, unspecified shoulder

M06.021

Rheumatoid arthritis without rheumatoid factor, right elbow

M06.022

Rheumatoid arthritis without rheumatoid factor, left elbow

M06.029

Rheumatoid arthritis without rheumatoid factor, unspecified elbow

M06.031

Rheumatoid arthritis without rheumatoid factor, right wrist

M06.032

Rheumatoid arthritis without rheumatoid factor, left wrist

M06.039

Rheumatoid arthritis without rheumatoid factor, unspecified wrist

M06.041

Rheumatoid arthritis without rheumatoid factor, right hand

M06.042

Rheumatoid arthritis without rheumatoid factor, left hand

M06.049

Rheumatoid arthritis without rheumatoid factor, unspecified hand

M06.051

Rheumatoid arthritis without rheumatoid factor, right hip

M06.052

Rheumatoid arthritis without rheumatoid factor, left hip

M06.059

Rheumatoid arthritis without rheumatoid factor, unspecified hip

M06.061

Rheumatoid arthritis without rheumatoid factor, right knee

M06.062

Rheumatoid arthritis without rheumatoid factor, left knee

M06.069

Rheumatoid arthritis without rheumatoid factor, unspecified knee

M06.071

Rheumatoid arthritis without rheumatoid factor, right ankle and foot

M06.072

Rheumatoid arthritis without rheumatoid factor, left ankle and foot

M06.079

Rheumatoid arthritis without rheumatoid factor, unspecified ankle and foot

M06.08

Rheumatoid arthritis without rheumatoid factor, vertebrae

M06.09

Rheumatoid arthritis without rheumatoid factor, multiple sites

M06.80

Other specified rheumatoid arthritis, unspecified site

M06.811

Other specified rheumatoid arthritis, right shoulder

M06.812

Other specified rheumatoid arthritis, left shoulder

M06.819

Other specified rheumatoid arthritis, unspecified shoulder

M06.821

Other specified rheumatoid arthritis, right elbow

M06.822

Other specified rheumatoid arthritis, left elbow

M06.829

Other specified rheumatoid arthritis, unspecified elbow

M06.831

Other specified rheumatoid arthritis, right wrist

M06.832

Other specified rheumatoid arthritis, left wrist

M06.839

Other specified rheumatoid arthritis, unspecified wrist

M06.841

Other specified rheumatoid arthritis, right hand

M06.842

Other specified rheumatoid arthritis, left hand

M06.849

Other specified rheumatoid arthritis, unspecified hand

M06.851

Other specified rheumatoid arthritis, right hip

M06.852

Other specified rheumatoid arthritis, left hip

M06.859

Other specified rheumatoid arthritis, unspecified hip

M06.861

Other specified rheumatoid arthritis, right knee

M06.862

Other specified rheumatoid arthritis, left knee

M06.869

Other specified rheumatoid arthritis, unspecified knee

M06.871

Other specified rheumatoid arthritis, right ankle and foot

M06.872

Other specified rheumatoid arthritis, left ankle and foot

M06.879

Other specified rheumatoid arthritis, unspecified ankle and foot

M06.88

Other specified rheumatoid arthritis, vertebrae

M06.89

Other specified rheumatoid arthritis, multiple sites

M06.9

Rheumatoid arthritis, unspecified

M45.0

Ankylosing spondylitis of multiple sites in spine

M45.1

Ankylosing spondylitis of occipito-atlanto-axial region

M45.2

Ankylosing spondylitis of cervical region

M45.3

Ankylosing spondylitis of cervicothoracic region

M45.4

Ankylosing spondylitis of thoracic region

M45.5

Ankylosing spondylitis of thoracolumbar region

M45.6

Ankylosing spondylitis lumbar region

M45.7

Ankylosing spondylitis of lumbosacral region

M45.8

Ankylosing spondylitis sacral and sacrococcygeal region

M45.9

Ankylosing spondylitis of unspecified sites in spine

M46.81

Other specified inflammatory spondylopathies, occipito-atlanto-axial region

M46.82

Other specified inflammatory spondylopathies, cervical region

M46.83

Other specified inflammatory spondylopathies, cervicothoracic region

M46.84

Other specified inflammatory spondylopathies, thoracic region

M46.85

Other specified inflammatory spondylopathies, thoracolumbar region

M46.86

Other specified inflammatory spondylopathies, lumbar region

M46.87

Other specified inflammatory spondylopathies, lumbosacral region

M46.88

Other specified inflammatory spondylopathies, sacral and sacrococcygeal region

M46.89

Other specified inflammatory spondylopathies, multiple sites in spine

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD): N/A

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC