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 Maintenance: 200mg every 2 weeks |
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
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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