Cimzia (certolizumab pegol) — prior authorization and coverage criteria
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Defines prior authorization, coverage criteria, and documentation requirements for Cimzia (prefilled syringes and lyophilized powder) for Wellmark/Blue Cross Blue Shield members; affects prescribers and pharmacy/medical benefit claim reviewers.
No material clinical or coverage changes in this revision.
Coverage Criteria
Ankylosing spondylitis initial approval
Ankylosing spondylitis — initial approval
see chunk 8
Axial spondyloarthritis initial approval
Axial spondyloarthritis — initial approval
see chunk 9
pJIA initial approval
Polyarticular juvenile idiopathic arthritis (pJIA) — initial approval
see chunk 10
Psoriatic arthritis initial approval
Psoriatic arthritis — initial approval
see chunk 11
Rheumatoid arthritis initial approval
Rheumatoid arthritis — initial approval
see chunk 12
Crohn's disease initial approval
Crohn's disease — initial approval
see chunk 13
Plaque psoriasis initial approval
Plaque psoriasis — initial approval
see chunk 14
Lyophilized powder indication-specific criteria
Cimzia Lyophilized Powder — indication-specific initial approval when preferred IV/office-administered products are addressed
see chunk 15
see chunk 16
see chunk 17
see chunk 18
see chunk 19
Initial Therapy — Rheumatoid arthritis
Initial approval — Moderately to severely active rheumatoid arthritis (RA)
RA initial approval pathway A2
- Biomarker requirement: Member meets either positive testing for RF or anti-CCP OR has been tested for RF, anti-CCP, and CRP and/or ESR
see chunk 22
- Methotrexate trial or intolerance: Member has either had inadequate response to at least a 3-month trial of methotrexate titrated to >=15 mg/week OR has intolerance/contraindication to methotrexate (see Appendix A)>=3 months
see chunk 22 and 37
Initial Therapy — pJIA
Initial approval — Polyarticular juvenile idiopathic arthritis (pJIA)
see chunk 23
Initial Therapy — Psoriatic arthritis
Initial approval — Psoriatic arthritis (PsA)
see chunk 24
Initial Therapy — AS / nr-axSpA
Initial approval — Ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)
see chunk 25
Initial Therapy — Crohn's disease
Initial approval — Crohn's disease
see chunks 26 and 33
Initial Therapy — Plaque psoriasis
Initial approval — Moderate to severe plaque psoriasis (PsO)
see chunks 27 and 20
Continuation Therapy
Continuation/renewal criteria (all indicated conditions)
see chunks 28-31, 34
Benefits and coverage for Cimzia are subject to the member’s specific plan and contract. Benefit determinations are based on the applicable contract language in effect at the time of service; exclusions, limitations, or exceptions may apply. This policy may not apply to Federal Employee Program (FEP) members — FEP benefits are determined by the Federal Employee Program and should be verified separately before making coverage decisions.
Prior to initiation, members must have documented tuberculosis screening. Obtain a documented negative TB test (tuberculin skin test, interferon-gamma release assay, or chest x-ray) within 12 months for patients naïve to biologic or targeted synthetic therapies. Do not administer Cimzia to members with active tuberculosis; if latent TB is detected, treatment must be started prior to initiation. Concomitant use of Cimzia with any other biologic or targeted synthetic drug for the same indication is not permitted.
When methotrexate or leflunomide is part of the treatment pathway, consider documented contraindications or clinical reasons to avoid these agents. Examples include: chronic liver disease or alcohol use disorder, breastfeeding or pregnancy (or planning pregnancy), blood dyscrasias, elevated transaminases, renal impairment, significant drug interactions, history of intolerance or hypersensitivity, interstitial pneumonitis, or other significant comorbidities that prohibit systemic therapy. Where such contraindications or clinical reasons exist, alternative treatment pathways and documentation should be considered in accordance with the appendices.
Cimzia is considered not medically necessary for members who do not meet the coverage criteria and requirements described in this policy, including screening, prior therapy trials, and required documentation.
Initial Therapy Requirements
Initial therapy requirements — general top-level options
Initial approval criteria generally require one of the following:
Specific lists of preferred products differ by indication and are detailed per indication.
Initial Therapy — alternative pathways
Initial approval alternative pathways:
see chunks 18-20
see chunks 18-20
see chunks 18-20
Continuation / Renewal Criteria
Continuation therapy requirements (general)
Continuation requests
Must meet Preferred Drug Plan Design and Criteria for Initial Approval/Continuation when applicable.
Continuation Therapy — Cimzia
Renewal/continuation criteria by indication
chunk 28
chunk 29
chunk 30
chunk 31
chunk 34
Step Therapy and Prior Trials
| Requirement | Details |
|---|---|
| Step therapy requirement | |
| Trials of two preferred products are required prior to approval of non-preferred Cimzia (prefilled syringes) for indications where preferred products are available; exceptions: member is currently receiving the requested non-preferred product through insurance with a positive therapeutic outcome, the member is pregnant or breastfeeding, or only one preferred product exists for the indication. |
| Requirement | Details |
|---|---|
| Prior therapy trials or documentation of intolerance/contraindication | |
| Approval requires documentation of inadequate response or intolerable adverse events to the indicated prior therapies specified by indication (examples: failure of listed preferred biologics for RA, Crohn's disease, and plaque psoriasis; inadequate response to ≥2 NSAIDs for ankylosing spondylitis; inadequate response or intolerance to methotrexate/csDMARDs for arthritis indications). Where applicable, chart notes detailing outcomes, intolerable adverse events, contraindications, or exclusions to preferred products must be submitted. |
Provider Actions, Documentation & Authorization
Prior Authorization Required
Prior Authorization Required: Prior authorization is required for Cimzia (certolizumab pegol). Approval duration and renewal: when criteria are met, initial and continuation approvals are generally authorized for 12 months.
- Authorization duration: 12 months when approval criteria met for applicable indications (RA, pJIA, PsA, AS/nr-axSpA, Crohn's disease, moderate-to-severe plaque psoriasis).
- Denial trigger: Missing required trials, documentation, positive TB testing without further evaluation, active TB, or concurrent use with another biologic/targeted synthetic for same indication may result in denial.
Required Documentation
Documentation must be submitted to initiate and support the prior authorization review. Provide objective evidence of prior therapies, outcomes, and any contraindications or intolerances to preferred products.
- Required for initial requests: chart notes, medical record documentation, or claims history documenting prior medications tried and response (or clinical reason to avoid).
- Laboratory results/biomarker testing when applicable (e.g., RF, anti-CCP, CRP, ESR).
- For continuation requests: chart notes or medical record documentation supporting positive clinical response (e.g., reduced BSA, symptom improvement, low disease activity).
- For plaque psoriasis: documentation of affected area(s) and body surface area (BSA) when applicable.
Preferred Biologic Trial Requirement
Preferred Biologic Trial Requirement: For many indications the policy requires trials of the health plan's preferred products prior to approval of non-preferred Cimzia, unless clinical exceptions apply.
- General rule: Use of two preferred products is typically required before non-preferred product use, unless all preferred products are contraindicated, member is already receiving the non-preferred product with positive outcome, or only one preferred product exists for the indication.
- Examples of preferred products for prefilled syringe indications: Adalimumab-aacf, Enbrel, Entyvio, Cosentyx, Otezla, Otulfi (ustekinumab-aauz), Rinvoq, Simponi, Skyrizi, Tremfya, Velsipity, Xeljanz/Xeljanz XR.
- Specialized preferred list for provider-administered (lyophilized) context: Avsola, Inflectra, Entyvio, Ilumya, Stelara, Skyrizi, Simponi Aria.
Consideration of Prior/Concurrent Therapies
Consideration of prior and concurrent therapies: Assess prior medication trials, adequate dosing and duration, and clinical reasons that preclude use of preferred agents. Document intolerances, contraindications, or lack of efficacy.
- For RA: inadequate response to a 3-month trial of methotrexate at adequate dosing (≥15 mg/week) or intolerance/contraindication to methotrexate (see Appendix A).
- For pJIA: inadequate response to methotrexate or another conventional synthetic DMARD (or NSAIDs/intra-articular steroids plus risk factors) as appropriate.
- For PsA: inadequate response to methotrexate, leflunomide, or another conventional synthetic DMARD, or intolerance/contraindication.
- For AS/nr-axSpA: inadequate response to at least two NSAIDs or intolerance/contraindication to two or more NSAIDs.
- For plaque psoriasis: prior phototherapy or systemic agents trialed or clinical reason to avoid them per Appendix B.
- Concurrent therapy rule: do not use requested medication concomitantly with any other biologic drug or targeted synthetic drug for the same indication.
Denial Triggers / Billing and Quantity Limits
Operational notes and denial risks: Missing required trials, absence of supporting documentation of outcomes or contraindications, or exceeding stated quantity limits may result in denial or not medically necessary determinations.
- Quantity limits apply — initiation and maintenance kit limits differ by indication; requests exceeding limits may be denied.
- TB screening: documented negative TB test within 12 months required for biologic/targeted synthetic–naïve persons; positive screens require further testing and active TB is a contraindication.
- Clinical exception documentation: chart notes detailing outcomes of prior treatments, intolerable adverse events, contraindications, or exclusions to preferred products must be submitted where applicable.
Billing and Coding
| J0717 | Injection, certolizumab pegol, 1 mg (code may be used when drug administered under the direct supervision of a physician, not for use when drug is self-administered) |
Quantity Limits
Administration Site and Billing
Office/infusion billing — use J0717 for supervised administration
When Cimzia is administered in an office or infusion center under direct physician supervision, report the administration using HCPCS code J0717.
- J0717 is for injection of certolizumab pegol, 1 mg, and may be used when drug is administered under direct physician supervision (not for self‑administered doses).
Biosimilar / Reference Products
Avsola listed as preferred comparator for lyophilized‑powder pathways
When evaluating requests for Cimzia lyophilized powder, Avsola is listed as a preferred alternative product for certain indications and must be addressed per the lyophilized‑powder criteria.
- Lyophilized powder initial criteria list Avsola as a preferred product to trial or document failure/intolerance to, depending on the indication.
Inflectra listed as preferred comparator for lyophilized‑powder pathways
When evaluating requests for Cimzia lyophilized powder, Inflectra is listed as a preferred alternative product for certain indications and must be addressed per the lyophilized‑powder criteria.
- Lyophilized powder initial criteria list Inflectra as a preferred product to trial or document failure/intolerance to, depending on the indication.
Definitions and Clinical Notes
Background
Cimzia (certolizumab pegol) is a tumor necrosis factor (TNF) inhibitor approved for multiple immune‑mediated inflammatory conditions, including Crohn’s disease, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis (pJIA), psoriatic arthritis, ankylosing spondylitis/non‑radiographic axial spondyloarthritis, and moderate‑to‑severe plaque psoriasis. The policy is intended to ensure appropriate patient selection by requiring indication‑specific criteria, prior trials of preferred therapies where applicable, appropriate screening (for example, TB testing prior to biologic initiation), and documentation of therapeutic response for continuation.
Revision History
Policy revision effective — current policy effective date set to May 29, 2026 following April 2026 review/revision.
Policy was reviewed and revised in April 2026 (document notes 'Reviewed: April 2026' and 'Revised: April 2026').
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