BlueCross BlueShield of Tennessee Medical Policy Manual

Certolizumab Pegol (Cimzia®)

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.

 

POLICY

INDICATIONS

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-Approved Indications

Compendial Use

Immune checkpoint inhibitor-related toxicity - inflammatory arthritis

DOCUMENTATION

Submission of the following information is necessary to initiate the prior authorization review:

Rheumatoid Arthritis (RA)

Polyarticular Juvenile Idiopathic Arthritis (pJIA)

Ankylosing Spondylitis (AS), Non-Radiographic Axial Spondyloarthritis (nr-axSpA), Psoriatic Arthritis (PsA), and Immune Checkpoint Inhibitor-Related Toxicity

Crohn’s Disease (CD)

Plaque Psoriasis (PsO)

PRESCRIBER SPECIALTIES

This medication must be prescribed by or in consultation with one of the following:

COVERAGE CRITERIA

Rheumatoid Arthritis (RA)

Authorization of 12 months may be granted for adult members who have previously received a biologic or targeted synthetic drug (e.g., Rinvoq, Xeljanz) indicated for moderately to severely active rheumatoid arthritis.

Authorization of 12 months may be granted for adult members for treatment of moderately to severely active RA when both of the following criteria are met:

Polyarticular Juvenile Idiopathic Arthritis (pJIA)

Authorization of 12 months may be granted for members 2 years of age or older who have previously received a biologic or targeted synthetic drug (e.g., Xeljanz) indicated for moderately to severely active polyarticular juvenile idiopathic arthritis.

Authorization of 12 months may be granted for members 2 years of age or older for treatment of moderately to severely active polyarticular juvenile idiopathic arthritis when any of the following criteria is met:

Psoriatic Arthritis (PsA)

Authorization of 12 months may be granted for adult members who have previously received a biologic or targeted synthetic drug (e.g., Rinvoq, Otezla) indicated for active psoriatic arthritis.

Authorization of 12 months may be granted for adult members for treatment of active psoriatic arthritis when either of the following criteria is met:

Ankylosing Spondylitis (AS) and Non-Radiographic Axial Spondyloarthritis (nr-axSpA)

Authorization of 12 months may be granted for adult members who have previously received a biologic or targeted synthetic drug (e.g., Rinvoq, Xeljanz) indicated for active ankylosing spondylitis or active non-radiographic axial spondyloarthritis.

Authorization of 12 months may be granted for adult members for treatment of active ankylosing spondylitis or active non-radiographic axial spondyloarthritis when either of the following criteria is met:

Crohn’s Disease (CD)

Authorization of 12 months may be granted for adult members for treatment of moderately to severely active Crohn’s disease.

Plaque Psoriasis (PsO)

Authorization of 12 months may be granted for adult members who have previously received a biologic or targeted synthetic drug (e.g., Sotyktu, Otezla) indicated for the treatment of moderate to severe plaque psoriasis.

Authorization of 12 months may be granted for adult members for treatment of moderate to severe plaque psoriasis when any of the following criteria is met:

Immune Checkpoint Inhibitor-Related Toxicity

Authorization of 12 months may be granted for treatment of immune checkpoint inhibitor-related toxicity when the member has moderate or severe immunotherapy-related inflammatory arthritis and meets either of the following:

CONTINUATION OF THERAPY  

Rheumatoid Arthritis (RA)

Authorization of 12 months may be granted for all adult members (including new members) who are using the requested medication for moderately to severely active rheumatoid arthritis and who achieve or maintain a positive clinical response as evidenced by disease activity improvement of at least 20% from baseline in tender joint count, swollen joint count, pain, or disability.

Polyarticular Juvenile Idiopathic Arthritis (pJIA)

Authorization of 12 months may be granted for all members 2 years of age or older (including new members) who are using the requested medication for moderately to severely active polyarticular juvenile idiopathic arthritis and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition when there is improvement in any of the following from baseline:

Psoriatic Arthritis (PsA)

Authorization of 12 months may be granted for all adult members (including new members) who are using the requested medication for psoriatic arthritis and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition when there is improvement in any of the following from baseline:

Ankylosing Spondylitis (AS) and Non-Radiographic Axial Spondyloarthritis (nr-axSpA)

Authorization of 12 months may be granted for all adult members (including new members) who are using the requested medication for ankylosing spondylitis or non-radiographic axial spondyloarthritis and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition when there is improvement in any of the following from baseline:

Crohn’s Disease (CD)

Authorization of 12 months may be granted for all adult members (including new members) who are using the requested medication for moderately to severely active Crohn’s disease and who achieve or maintain remission.

Authorization of 12 months may be granted for all adult members (including new members) who are using the requested medication for moderately to severely active Crohn’s disease and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition when there is improvement in any of the following from baseline:

Plaque Psoriasis (PsO)

Authorization of 12 months may be granted for all adult members (including new members) who are using the requested medication for moderate to severe plaque psoriasis and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition when either of the following is met:

Immune Checkpoint Inhibitor-Related Toxicity

Authorization of 12 months may be granted for all members (including new members) who are using the requested medication for immunotherapy-related inflammatory arthritis and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition.

OTHER

For all indications: Member has had a documented negative tuberculosis (TB) test (which can include a tuberculosis skin test [TST] or an interferon-release assay [IGRA]) within 12 months of initiating therapy for persons who are naïve to biologic drugs or targeted synthetic drugs associated with an increased risk of TB.

If the screening testing for TB is positive, there must be further testing to confirm there is no active disease (e.g., chest x-ray). Do not administer the requested medication to members with active TB infection. If there is latent disease, TB treatment must be started before initiation of the requested medication.

For all indications: Member cannot use the requested medication concomitantly with any other biologic drug or targeted synthetic drug for the same indication.

DOSAGE AND ADMINISTRATION

Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines.

APPENDIX

Appendix A: Examples of Clinical Reasons to Avoid Pharmacologic Treatment with Methotrexate, Cyclosporine, Acitretin, or Leflunomide

Appendix B: Risk Factors for Articular Juvenile Idiopathic Arthritis

MEDICATION QUANTITY LIMITS

Drug Name

Diagnosis

Maximum Dosing Regimen

Cimzia (Certolizumab)

Ankylosing Spondylitis or Axial Spondyloarthritis

Route of Administration: Subcutaneous

≥18 Years

Initial: 400mg on weeks 0, 2, and 4

Maintenance: 200mg every 2 weeks or 400 mg every 4 weeks

Cimzia (Certolizumab)

Crohn's Disease

Route of Administration: Subcutaneous

≥18 Years

Initial: 400mg on weeks 0, 2, and 4

Maintenance: 400mg every 4 weeks

Cimzia (Certolizumab)

Immune Checkpoint Inhibitor-Related Toxicities: Inflammatory Arthritis

Route of Administration: Subcutaneous
≥18 Years
Initial: 400mg on weeks 0, 2, and 4

Maintenance: 200mg every 2 weeks

Cimzia (Certolizumab)

Plaque Psoriasis

Route of Administration: Subcutaneous

≥18 Years

400mg every 2 weeks

Cimzia (Certolizumab)

Polyarticular Juvenile Idiopathic Arthritis

Route of Administration: Subcutaneous

≥2 year(s)

10 - <20kg

Initial: 100mg on weeks 0, 2, and 4

Maintenance: 50mg every 2 weeks

≥2 year(s)

20 - <40kg

Initial: 200mg on weeks 0, 2, and 4

Maintenance: 100mg every 2 weeks

≥2 year(s)

≥40kg

Initial: 400mg on weeks 0, 2, and 4

Maintenance: 200mg every 2 weeks

Cimzia (Certolizumab)

Psoriatic Arthritis

Route of Administration: Subcutaneous

≥18 Years

Initial: 400mg on weeks 0, 2, and 4

Maintenance: 200mg every 2 weeks or 400 mg every 4 weeks

Cimzia (Certolizumab)

Rheumatoid Arthritis

Route of Administration: Subcutaneous

≥18 Years

Initial: 400mg on weeks 0, 2, and 4

Maintenance: 200mg every 2 weeks or 400 mg every 4 weeks

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

REFERENCES

  1. Cimzia [package insert]. Smyrna, GA: UCB, Inc.; September 2024.   
  2. van der Heijde D, Ramiro S, Landewe R, et al. 2016 Update of the international ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis. 2017;0:1-14.
  3. Smolen JS, Landewé RBM, Bijlsma JWJ, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis. 2020;79(6):685-699. doi:10.1136/annrheumdis-2019-216655.
  4. Singh JASaag KGBridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Rheumatol. 2016;68(1)1-26.  
  5. Saag KG, Teng GG, Patkar NM, et al. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum. 2008;59(6):762-784.
  6. Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 6: Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol. 2011;65(1):137-174.
  7. Gossec L, Baraliakos X, Kerschbaumer A, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies; 2019 update.  Ann Rheum Dis. 2020;79(6):700-712.
  8. Gladman DD, Antoni C, Mease P, et al. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005;64(Suppl II):ii14–ii17.
  9. Coates LC, Soriano ER, Corp N, et al. Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA): updated treatment recommendations for psoriatic arthritis 2021. Nat Rev Rheumatol. 2022;18(8):465-479.
  10. Braun J, van den Berg R, Baraliakos X, et al. 2010 update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis. 2011;70:896–904.
  11. Landewe R, Braun J, Deodhar A, et al. Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis: 24-week results of a double-blind randomised placebo-controlled Phase 3 study. Ann Rheum Dis. 2014;73(1):39-47.
  12. Ward MM, Deodhar A, Gensler LS, 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;71(10):1599-1613. doi:10.1002/art.41042.
  13. Talley NJ, Abreu MT, Achkar J, et al. An evidence-based systematic review on medical therapies for inflammatory bowel disease. Am J Gastroenterol. 2011;106(Suppl 1):S2-S25.
  14. Lichtenstein GR, Loftus Jr EV, Isaacs KI, et al. ACG Clinical Guideline: Management of Crohn’s Disease in Adults. Am J Gastroenterol. 2018;113:481-517.
  15. Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80(4):1029-1072.
  16. Testing for TB Infection. Centers for Disease Control and Prevention. Retrieved on August 5, 2024 from: https://www.cdc.gov/tb/testing/index.html.
  17. Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis Rheumatol. 2019;71(1):5-32. doi:10.1002/art.40726.
  18. Menter A, Cordero KM, Davis DM, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis in pediatric patients. J Am Acad Dermatol. 2020;82(1):161-201.
  19. Menter A, Gelfand JM, Connor C, et al. Joint AAD-NPF guidelines of care for the management of psoriasis with systemic nonbiologic therapies. J Am Acad Dermatol. 2020;82(6): 1445-86.
  20. Aletaha D, Neogi T, Silman AJ, et al. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010;62(9):2569-81.
  21. Smolen JS, Aletaha D. Assessment of rheumatoid arthritis activity in clinical trials and clinical practice. In: UpToDate, Post TW (Ed), UpToDate, Waltham, MA. Available with subscription. URL: www.uptodate.com. Accessed March 19, 2021.
  22. Feuerstein J, Ho E, Shmidt E, et al. AGA Clinical Practice Guidelines on the Medical Management of Moderate to Severe Luminal and Perianal Fistulizing Crohn’s Disease. Gastroenterology. 2021; 160:2496-2508.
  1. Elmets C, Korman N, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. J Am Acad Dermatol. 2021; 84(2):432-470.
  2. Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthrit Care Res. 2021;0:1-16.
  3. The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed August 13, 2024.
  4. Ringold S, Angeles-Han ST, Beukelman T, et al. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Treatment of Juvenile Idiopathic Arthritis: Therapeutic Approaches for Non-Systemic Polyarthritis, Sacroiliitis, and Enthesitis. Arthritis Care Res. 2019;71(6):717-734. doi:10.1002/acr.23870.
  5. Onel KB, Horton DB, Lovell DJ, et al. 2021 American College of Rheumatology guideline for the treatment of juvenile idiopathic arthritis: therapeutic approaches for oligoarthritis, temporomandibular joint arthritis, and systemic juvenile idiopathic arthritis. Arthritis Rheumatol. 2022;74(4):553-569.

ORIGINAL EFFECTIVE DATE: 12/13/2008

MOST RECENT REVIEW DATE: 5/31/2025

ID_CHS

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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