CurrentmhnPolicy CP.PHAR.247

Clinical Policy: Certolizumab (Cimzia)

Defines medical necessity criteria, prescriber requirements, prior authorization notes, dosing limits, indications (AS, nr-axSpA, Crohn's disease, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis), continued therapy criteria, non‑covered combinations, and coding implications for certolizumab (Cimzia) for Medicaid line of business.

Policy Summary

Payermhn

PolicyClinical Policy: Certolizumab (Cimzia)

Policy CodePolicy CP.PHAR.247

Change TypeMultiple annual reviews and SDC updates

Effective Date08.16

Next Review Date

Key ActionProvider must submit documentation supporting that member meets all approval criteria; prior authorization may be required for redirect agents and specified biologics.

POLICY UPDATE CHANGES

2Q 2021 annual review: added PsO criteria per 2019 AAD/NPF specifying ≥3% BSA or involvement of critical areas; added combination bDMARDs under Section III; updated CDAI table to prevent overlap.

Per August SDC/prior guidance: modified PsA, RA, AS redirect requirements including preferred adalimumab products; added preferred Taltz and Xeljanz requirements for AS and preferred Taltz for nr-axSpA.

2Q 2022 annual review: for RA added redirection to Olumiant; for PsO allowed phototherapy as alternative to systemic DMARD if contraindicated; reiterated prohibition of combination use with bDMARD or JAKi.

2Q 2023 annual review: for PsA and RA, added TNFi criteria to allow bypass if member has history of failure of two TNF agents.

Per July SDC: updated preferred adalimumab product list and required trials for multiple indications; updated Appendix B therapeutic alternatives.

2Q 2024 annual review: updated Appendix D with removal of CRADLE trial supplemental info and added multiple agents to Section III.B (Bimzelx, Zymfentra, Omvoh, Tofidence, Sotyktu, Wezlana, Velsipity).

Added TNFi criteria to allow bypass for PsA and RA when member failed two TNF agents.

Removed requirement to use Enbrel for PsA and RA.

Required use of one adalimumab product and listed preferred adalimumab examples for multiple indications.

Added pJIA indication criteria and Appendix H with cJADAS-10.

Removed minimum cJADAS-10 > 8.5 requirement and baseline/response cJADAS-10 documentation for pJIA initial and continued therapy.

Added requirement to use one preferred Stelara biosimilar for PsO, PsA, CD.

Allowed bypass of conventional therapies if member has failed a biologic and extended initial approval durations to 12 months for chronic conditions.

Updated Section III.B to add several therapeutic alternatives and updated appendices (removal of CRADLE trial info; added multiple products).

8FDA-approved indications listed

12Appendix B therapeutic alternatives (sample drugs listed)

12Named redirected agents or classes referenced

pJIAAdded Indication

12 moInitial approval duration for chronic conditions

Coverage Summary

Policy CP.PHAR.247 covers certolizumab pegol (Cimzia) as covered_with_criteria for FDA‑listed indications including ankylosing spondylitis (AS), non‑radiographic axial spondyloarthritis (nr‑axSpA), Crohn's disease, plaque psoriasis (PsO), psoriatic arthritis (PsA), rheumatoid arthritis (RA), and polyarticular juvenile idiopathic arthritis (pJIA). Prescriber requirements and prior authorization documentation are required (eg, consultation by or prescribing specialist per indication). The policy prohibits combination use with other biological DMARDs or Janus kinase inhibitors due to additive immunosuppression risk and related safety concerns. Dosing limits and approval durations are specified by indication (examples: adult loading 400 mg at weeks 0, 2, and 4 with maintenance dosing per indication; pJIA weight‑based loading/maintenance dosing) and initial/continued approvals for chronic conditions are generally authorized for 12 months.

Initial Therapy Criteria

Continuation Therapy Criteria

Continued Therapy — All Indications

must meet all

Continuity of care: One of: Currently receiving medication via Centene benefit or previously met initial approval criteria; OR Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations
Refer to state addendums where applicable
Evidence of response: One of: For RA: member is responding as evidenced by decrease in CDAI or RAPID3 from baseline OR medical justification stating inability to conduct CDAI re-assessment and submission of RAPID3 score similar to initial CDAI or improved; For all other indications: member is responding positively to therapy (medical justification required)
See Appendices F and G for score interpretation
Combination exclusion: No combination use with biological DMARDs or Janus kinase inhibitors (see Section III for prohibited combinations)
Requests will be denied if combination use present
Dose increase limits: If request is for a dose increase, new dose does not exceed one of the following: For CD, RA, PsA, AS, nr-axSpA: 400 mg every 4 weeks; For pJIA: 200 mg every 2 weeks; For PsO: 400 mg every 2 weeks
Approval duration: 12 months

Unproven / Exclusions

Combination use prohibition and off-label handling

must meet all

Exclusionary criteria and off-label handling

Combination therapy prohibition: No combination use with biological disease-modifying antirheumatic drugs (bDMARDs) or Janus kinase inhibitors (JAKi); combination use with listed agents in Section III.B and similar potent immunosuppressants is not authorized due to additive immunosuppression and increased infection risk
See Section III for examples and list of prohibited agents
Denial risk: Requests will be denied if combination use with biological DMARDs or Janus kinase inhibitors or other prohibited agents listed in Section III is present
Off-label use handling: For non‑FDA approved indications or uses not listed in policy, refer to off-label use policy CP.PMN.53 (Medicaid) or no coverage/non-formulary policies CP.PMN.255 / CP.PMN.16 as applicable

Applicable Codes

J-code for administration under physician supervision (informational)HCPCS

J0717

Injection, certolizumab pegol, 1 mg (code may be used for Medicare when drug administered under the direct supervision of a physician, not for use when drug is self-administered)

Preferred adalimumab products / examplesmixed

Yusimry	preferred adalimumab product example (brand/biosimilar name included in policy text)
Hadlima	preferred adalimumab product example
unbranded adalimumab-fkjp	preferred adalimumab example
unbranded adalimumab-adaz	preferred adalimumab example
adalimumab-adbm	added to listed examples of preferred adalimumab products (12.06.23)
Simlandi	added to listed examples of preferred adalimumab products (06.24 SDC)
unbranded adalimumab-aaty	added to listed examples of preferred adalimumab products (07.23.24)

Preferred Stelara biosimilars (required for PsO, PsA, CD)mixedCovered

Otulfi	preferred ustekinumab biosimilar example
Pyzchiva	preferred ustekinumab biosimilar (branded) example
Selarsdi	preferred ustekinumab biosimilar example
Yesintek	preferred ustekinumab biosimilar example
Steqeyma	preferred ustekinumab biosimilar example

Products added to Section III.B (therapeutic alternatives / references)mixed

Bimzelx	added to section III.B
Zymfentra	added to section III.B
Omvoh	added to section III.B
Tofidence	added to section III.B
Sotyktu	added to section III.B
Wezlana	added to section III.B
Velsipity	added to section III.B
Spevigo	updated verbiage in Section III.B with Spevigo and biosimilar verbiage

Provider Actions

Prior Authorization

Prior authorization and documentation required

Prior authorization may be required for certain comparator agents depending on indication. Providers should obtain prior authorization when required for adalimumab products, Taltz, ustekinumab products, Xeljanz/Xeljanz XR, Actemra, Otezla, and other listed agents to avoid delays in therapy initiation.

Prior authorization may be required for adalimumab products (e.g., Hadlima, Simlandi, Yusimry, adalimumab-aaty, adalimumab-adaz, adalimumab-adbm, adalimumab-fkjp) depending on indication
Prior authorization may be required for Taltz (ixekizumab), ustekinumab products, Xeljanz/Xeljanz XR (tofacitinib), Actemra (tocilizumab), Otezla (apremilast) and other listed agents depending on indication

Documentation Required

Baseline disease activity documentation for RA

For rheumatoid arthritis (RA) initial requests, submit a baseline disease activity score. For continuation requests, submit evidence of response. If CDAI cannot be performed, provide documentation explaining why and alternative assessment results.

Clinical Evidence & References

Evidence sources cited in the policy include the Cimzia Prescribing Information (Sept 2024) and guideline documents referenced in the policy (eg, ACR, AAD‑NPF, EULAR, ASAS‑EULAR, AGA, ACG, ACR JIA guideline documents). Metric cards or internal stat figures are not duplicated in this summary; no notable trial/metric figures were provided in the brief to report here.

Background

Background: Certolizumab pegol is a tumor necrosis factor (TNF) blocker with multiple FDA‑approved indications (Crohn's disease, RA, PsA, AS, nr‑axSpA, plaque psoriasis, and pJIA). The policy aligns coverage to evidence of prior trials of conventional DMARDs, specified biologics, or documented contraindications/intolerance as applicable per indication. Combination therapy with other biologic DMARDs or JAK inhibitors is prohibited because of the risk of additive immunosuppression, neutropenia, and serious infections. The policy references appendices for therapeutic alternatives (Appendix D) and pJIA disease activity guidance (Appendix H).

Definitions (short glossary): DMARD = disease‑modifying antirheumatic drug; CDAI = Clinical Disease Activity Index (RA activity score); RAPID3 = Routine Assessment of Patient Index Data 3 (patient‑reported RA index); pJIA = polyarticular juvenile idiopathic arthritis; SDC = Stakeholder/Subject matter Change (policy update context); P&T = Pharmacy & Therapeutics committee approval date.

Revision History

02.23.21 / 05.21 P&Trevised

2Q 2021 annual review: added PsO criteria per 2019 AAD/NPF specifying ≥3% BSA or involvement of critical areas; added combination bDMARDs under Section III; updated CDAI table to prevent overlap.

08.25.21 / 11.21 P&Trevised

Per August SDC/prior guidance: modified PsA and RA redirect requirements (removed Simponi as redirect option for PsA; added Actemra as redirect option for RA and required trials).

02.16.22 / 05.22 P&Trevised

Policy Summary

Payermhn

PolicyClinical Policy: Certolizumab (Cimzia)

Policy CodePolicy CP.PHAR.247

Change TypeMultiple annual reviews and SDC updates

Effective Date08.16

Next Review Date

Key ActionProvider must submit documentation supporting that member meets all approval criteria; prior authorization may be required for redirect agents and specified biologics.

On This Page

Initial RA requests: submit Clinical Disease Activity Index (CDAI) score (see Appendix F) or RAPID3 score (see Appendix G)
Continuation RA requests: submit evidence of response such as a decrease in CDAI or RAPID3 from baseline
If CDAI cannot be performed, document reason and submit alternative objective assessment (e.g., RAPID3) or clinical justification

Billing Rule

Dose limits and administration

Dose limits and administration details must be followed. Use appropriate HCPCS/J‑codes and observe indication-specific maxima; billing must reflect actual administered dose. Note special billing guidance for J0717 when applicable.

J0717 usage note: ensure correct billing when using single-use vials or scenarios requiring J0717 per payer billing guidance
Adult dosing maxima (all applicable indications unless otherwise specified): do not exceed 400 mg at weeks 0, 2, and 4, followed by maintenance 400 mg every 4 weeks
Plaque psoriasis dosing note: do not exceed 400 mg every 2 weeks where specified by indication
pJIA (polyarticular juvenile idiopathic arthritis) pediatric dosing: adhere to weight-based dosing limits per product labeling and Appendix H disease activity documentation requirements

Denial Risk

Combination therapy exclusion

Requests will be denied when the member is receiving concurrent biological DMARDs or a Janus kinase (JAK) inhibitor. Verify current medications and discontinue conflicting agents prior to approval.

Concurrent use of biological disease-modifying antirheumatic drugs (biologic DMARDs) is excluded
Concurrent use of Janus kinase inhibitors (e.g., Xeljanz/Xeljanz XR) is excluded

Prior Authorization

Redirect/step therapy requirements; preferred biologic use; prior biologic failures; initial approval duration

Document prior biologic failures or intolerances as required by indication. Where step therapy or preferred biologic/biosimilar requirements apply, document trials of required agents. For chronic conditions, request 12-month authorizations when criteria are met.

Redirect/step therapy requirements: document trials and failures of required prior therapies (e.g., preferred adalimumab biosimilars where listed) before approval; prior authorization for the preferred agent may be required
Use of preferred biologic/biosimilar required in certain indications: when policy specifies preferred adalimumab or other preferred products, document trial and failure or intolerance to those agents as applicable
Bypass of conventional therapies after biologic failure: when applicable, document failure of conventional therapies and prior biologic failures per indication specifics to support bypassing step therapy
Initial approval duration for chronic conditions: when criteria are met, request 12-month authorization (approval duration = 12 months for applicable chronic indications such as PsA, RA, etc.)

Documentation Required

pJIA disease activity documentation (Appendix H)

pJIA disease activity must be documented per Appendix H. Include objective measures of high disease activity and supporting clinical documentation when requesting therapy for polyarticular juvenile idiopathic arthritis.

For pJIA requests, include documentation demonstrating high disease activity as defined in Appendix H (e.g., active joint counts, relevant scoring or assessments)
Include supporting rheumatology consultation notes and prior therapy trials (e.g., methotrexate, leflunomide, sulfasalazine) or documented intolerance/contraindication

02.08.23 / 05.23 P&Tadded

2Q 2023 annual review: for PsA and RA, added TNFi criteria to allow bypass if member has history of failure of two TNF agents.

07.25.23revised

Per July SDC: removed requirement to use Enbrel for PsA and RA; required use of one adalimumab product and listed preferred adalimumab examples; added preferred Taltz and Xeljanz requirements for AS and preferred Taltz for nr-axSpA; updated Appendix B therapeutic alternatives.

12.06.23 / 02.24 P&Trevised

Per December SDC: added adalimumab-adbm to listed examples of preferred adalimumab products and related updates.

01.22.24 / 05.24 P&Trevised

2Q 2024 annual review: updated Appendix D with removal of CRADLE trial supplemental information and added multiple agents to Section III.B (Bimzelx, Zymfentra, Omvoh, Tofidence, Sotyktu, Wezlana, Velsipity); Appendix B/therapeutic alternatives updated.

09.19.24 / 11.24 P&Tadded

Added pJIA indication criteria and Appendix H with cJADAS-10 (polyarticular juvenile idiopathic arthritis initial coverage criteria and disease activity guidance).

01.23.25 / 05.25 P&Tremoved

2Q 2025 annual review: removed minimum cJADAS-10 > 8.5 requirement and removed baseline/response cJADAS-10 documentation for pJIA initial and continued therapy.

04.23.25 / 06.25 P&Tadded

Per April SDC: added requirement to use one preferred Stelara (ustekinumab) biosimilar (Otulfi, Pyzchiva (branded), Selarsdi, Yesintek, Steqeyma) for PsO, PsA, and CD.

09.08.25 / 11.25 P&TaddedLatest

Allowed bypass of conventional therapies if member has failed a biologic agent to avoid stepping back to conventional therapy and extended initial approval durations to 12 months for chronic conditions (applies to AS, CD, PsO, RA, pJIA).

Policy revisions and coverage intent (summary): historical and recent amendments have added and refined indication‑specific redirection and step therapy requirements (eg, adding PsO criteria per AAD‑NPF, requiring trials of specified adalimumab products and preferred examples), introduced TNFi bypass criteria when members have failed two TNF agents, updated preferred biologic/biosimilar lists (including preferred Stelara biosimilars), added the pJIA indication with Appendix H (cJADAS‑10), removed certain prior cJADAS‑10 thresholds for pJIA in 2Q 2025, and clarified that conventional therapy step requirements may be bypassed after biologic failure while extending initial approvals for chronic conditions to 12 months.