Certolizumab pegol (Cimzia) — Coverage Criteria
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Defines medical necessity, site-of-care, dosing limits, and documentation requirements for certolizumab pegol (Cimzia) subcutaneous injection for patients treated for labeled indications under Blue Cross NC.
Allowed patients currently established on an FDA‑approved biologic or systemic immunomodulator for the requested indication to continue Cimzia when they have had positive clinical benefit.
For Crohn's disease removed requirement for trial/failure of conventional therapy and replaced with required demonstration of moderately to severely active disease using specific clinical and objective inflammation evidence or extent/corticosteroid-dependence.
Phototherapy conventional agent examples for psoriasis explicitly include both PUVA and UVB.
Coverage and Medical Necessity Criteria
Rheumatoid Arthritis (RA) — Initial/Continuing therapy
Covered when ALL of the following are met
RA initial/continuation
- Prior therapy or continuation: One of: inadequate response to maximally tolerated methotrexate for at least 3 months; OR inadequate response to another conventional agent (e.g., hydroxychloroquine, leflunomide, sulfasalazine) for at least 3 months; OR intolerance/hypersensitivity to one conventional agent; OR FDA-labeled contraindication to all conventional agents; OR currently established on an FDA-approved biologic or systemic immunomodulator for RA with documented positive clinical benefittreatment history as specified
Medical record documentation required to support prior trials/failures, intolerances, contraindications, or positive clinical benefit for continuation.
Psoriatic Arthritis (PsA) — Initial/Continuing therapy criteria
Covered when ALL of the following are met
PsA initial/continuation
- Prior therapy or exception: One of: inadequate response to one conventional agent (e.g., cyclosporine, leflunomide, methotrexate, sulfasalazine) for at least 3 months; OR intolerance/hypersensitivity to one conventional agent; OR FDA-labeled contraindication to all conventional agents; OR severe active PsA (e.g., erosive disease, elevated ESR/CRP attributable to PsA, long-term damage interfering with function, highly active disease causing major impairment, active disease at many sites, function-limiting disease at a few sites, rapidly progressive); OR concomitant severe psoriasis (e.g., >10% BSA or involvement of hands/feet/scalp/face/genitals, intractable pruritus, serious emotional consequences); OR currently established on an FDA-approved biologic or systemic immunomodulator for PsA with documented positive clinical benefittreatment history or severity
Medical record documentation required to support prior trials/failures, severity, or positive clinical benefit.
Plaque Psoriasis (PS) — Initial/Continuing therapy criteria
Covered when ALL of the following are met
PS initial/continuation
- Prior therapy or exception: One of: inadequate response to one conventional agent (e.g., acitretin, anthralin, calcipotriene, calcitriol, coal tar products, cyclosporine, methotrexate, pimecrolimus, phototherapy including PUVA or UVB, tacrolimus, tazarotene, topical corticosteroids) for at least 3 months; OR intolerance/hypersensitivity to one conventional agent; OR FDA-labeled contraindication to all conventional agents; OR severe active PS (e.g., >10% BSA, select locations, intractable pruritus, serious emotional consequences); OR currently established on an FDA-approved biologic or systemic immunomodulator for PS with documented positive clinical benefittreatment history or severity
Medical record documentation required.
Crohn's Disease (CD) — Initial/Continuing therapy criteria
Covered when ALL of the following are met
CD criteria
- Objective evidence of active disease: One of: (1) Symptoms consistent with active CD (e.g., diarrhea, abdominal pain, weight loss, fatigue, fever, anemia, deficiencies, nausea/vomiting) AND evidence of active inflammation on cross-sectional imaging (MRE, CTE), intestinal ultrasound, or pelvic MRI for perianal disease (e.g., bowel wall thickening, ulceration, hyperenhancement, fistula, abscess); OR (2) Biomarker evidence indicative of inflammation (e.g., elevated fecal calprotectin, elevated CRP, elevated ESR, low serum albumin); OR (3) Significant extent of disease or upper GI involvement on radiographic or endoscopic assessment (e.g., large/deep mucosal lesions, fistulas/perianal abscesses, strictures, extensive disease >40 cm ileal involvement or pancolitis, prior bowel resection); OR (4) Corticosteroid-dependence or refractory to oral corticosteroidsdocumentation of symptoms plus objective inflammation or extent/corticosteroid-dependence
Medical record documentation required.
- Continuation allowance: Patient currently established on an FDA-approved biologic or systemic immunomodulator for CD with documented positive clinical benefit may continue Cimziadocumented positive benefit
Allowance added July 2026 to permit continuation without requiring failure of conventional therapy; medical record documentation required.
Ankylosing Spondylitis (AS) and Non-radiographic axial spondyloarthritis (nr-axSpA) — Initial/Continuing therapy criteria
Covered when ALL of the following are met
AS/nr-axSpA criteria
- NSAID trial or exceptions: One of: inadequate response to two different NSAIDs for at least a 4-week total trial; OR intolerance/hypersensitivity to two different NSAIDs; OR FDA-labeled contraindication to all NSAIDs; OR currently established on an FDA-approved biologic or systemic immunomodulator for AS or nr-axSpA with documented positive clinical benefitNSAID trial or exception
Medical record documentation required.
Polyarticular Juvenile Idiopathic Arthritis (PJIA) — Initial/Continuing therapy criteria
Covered when ALL of the following are met
PJIA criteria
- Prior therapy or exception: One of: inadequate response to one conventional agent (methotrexate or leflunomide) for at least 3 months; OR intolerance/hypersensitivity to one conventional agent; OR FDA-labeled contraindication to all conventional agents; OR currently established on an FDA-approved biologic or systemic immunomodulator for PJIA with documented positive clinical benefittreatment history or continuation
Medical record documentation required.
General conditions for all indications
Medical record documentation required; duration of approval = 365 days.
Dosing and maximum units
Dosing per FDA label and maximum units apply
See label-specific table in policy for exact maximum units by indication and weight-based PJIA dosing.
Certolizumab pegol (Cimzia) must not be used in combination with another biologic immunomodulator agent or with Otezla (apremilast). This prohibition is a general condition that applies to all indications and is required for consideration of medical necessity.
Administration of certolizumab pegol in an inpatient setting solely for the purpose of delivering the injection or infusion is not considered medically necessary. Inpatient or outpatient hospital administration is permitted only when the general medical necessity criteria are met and the admission is not solely for administration, or when one of the specified Site of Care exceptions applies (e.g., history of severe adverse event, increased risk for severe events, inability to adhere, new-to-therapy or re‑initiation, requirement for formulation change). If Site of Care criteria are not met, administration should occur in a home infusion or physician office setting.
Billing Codes and Quantity Limits
| J0717 | certolizumab pegol, subcutaneous injection |
Prior Authorization, Documentation, and Operational Guidance
Prior Authorization Required
Prior authorization is required for certolizumab pegol (Cimzia®). Approval duration is 365 days (1 year). Requests that exceed the indication-specific maximum units listed in the policy (see dosing/maximum units table) will be reviewed and may be denied. For requests for injection or infusion administration in an inpatient or outpatient hospital setting, Site of Care criteria applies and will be evaluated.
- Approval duration: 365 days
- Requests exceeding maximum units for the duration of approval will be flagged (see Maximum Units per indication)
- Site of Care criteria applies for inpatient/outpatient hospital administration
Step Therapy and Exceptions
For adult indications where step therapy is specified, members must have tried the required conventional agents and had an inadequate response, intolerance, or contraindication as documented in the medical record before approval will be granted. Exceptions to step therapy include patients currently established on a biologic or systemic immunomodulator agent with documented clinical benefit.
- Step-therapy applies to adult RA, PsA, and PS indications as described in criteria
- Exception: Established patients on an FDA‑approved biologic with documented benefit are eligible without meeting conventional agent trials
Required Documentation
Medical record documentation is required to support all prior therapy trials, intolerances, hypersensitivities, contraindications, and evidence of clinical benefit when the patient is established on a biologic or systemic immunomodulator. Documentation should include trial duration, agent(s) used, reason for discontinuation (e.g., inadequate response, intolerance), and objective evidence where applicable (e.g., imaging, inflammatory markers, extent of disease).
- Document trial length (e.g., ≥3 months for conventional agents unless otherwise specified) and maximally tolerated dose where applicable (e.g., methotrexate titrated to 25 mg weekly)
- If claiming intolerance or FDA‑labeled contraindication, include supporting documentation in the medical record
- For established biologic/systemic immunomodulator use, include objective evidence of positive clinical benefit (signs/symptoms improvement, reduced disease severity)
Provider Actions: Requests Exceeding Maximums & Site-of-Care
If the requested quantity exceeds the policy's maximum units for the indicated diagnosis, or the request does not meet Site of Care requirements for hospital administration, the request will be subject to denial. Providers should verify the indication-specific maximum units and include clear documentation to justify any exception or medical necessity beyond the listed maximums.
- Verify maximum units by indication before submission (see dosing/Maximum Units table)
- Include justification and supporting records if requesting quantities above the policy maximums
- Noncompliance with Site of Care criteria for inpatient/outpatient hospital administrations may result in denial
Definitions and Site-of-Care Criteria
Background and Drug Information
Certolizumab pegol (Cimzia) is a tumor necrosis factor (TNF) inhibitor available as a subcutaneous injection and approved for multiple inflammatory conditions. The prescriber must be a specialist or consult a specialist for the patient’s diagnosis, and routine pre‑treatment requirements such as TB testing per the prescribing information apply.
Policy Changes and Revision History
Allowed continuation of Cimzia for patients currently established on an FDA‑approved biologic or systemic immunomodulator for the requested indication when there is documentation of positive clinical benefit; operationalized continuation without requiring failure of conventional therapy for established patients across RA, PsA, PS, CD, AS, nr-axSpA, and PJIA.
For plaque psoriasis, phototherapy conventional agent examples explicitly include both PUVA and UVB.
Updated Site of Care medical necessity criteria to add an additional bypass for patients with history of severe adverse events or conditions increasing risk for severe adverse events to align with Place of Service for Medical Infusions policy.
Added newly approved indication for active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older and added associated dosing to the FDA label reference table.
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