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    v1.0.28
    OpenPayerPolicy UpdatesImmunology/RheumatologyMass General Brigham Health Plan Cimzia Prior Auth…
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    CurrentMass General Brigham Health PlanPolicy N/A

    Cimzia (certolizumab pegol) prior authorization and coverage

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    Prior authorization policy for Cimzia (certolizumab pegol) under the Commercial/Exchange pharmacy benefit at Mass General Brigham Health Plan; defines indications, coverage criteria, trial requirements, reauthorization, and quantity limits for affected members and providers.

    Policy Summary
    PayerMass General Brigham Health Plan
    PolicyCimzia (certolizumab pegol) prior authorization and coverage
    Policy CodePolicy N/A
    Change TypeBenefit moved to pharmacyadded starter-pack limitclarified reauthorization records
    Effective DateMay 1, 2026
    Last ReviewMay 14, 2025
    Next Review Date
    Key ActionObtain prior authorization and submit medical records (e.g., chart notes) showing improvement or low disease activity for reauthorization.
    SourceLink
    POLICY UPDATE CHANGES

    Updated reauthorization language to require submission of medical records (e.g., chart notes) demonstrating improvement in condition.

    Added quantity limit for Cimzia Starter Pack (1 pack = 6 injections per 365 days).

    Policy updated to indicate it will no longer apply to the medical benefit and applies under pharmacy benefit only.

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    Commercial/ExchangePlan applicability
    24 monthsApproval length
    2/28 daysCimzia 200 mg syringe
    2/28 daysCimzia 200 mg vial
    1/365 daysStarter pack limit

    Coverage Criteria for Indications and Continuation

    Moderately to severely active rheumatoid arthritis (RA)

    Covered when ALL of the following are met:

    RA criteria: 1. Diagnosis of moderately to severely active rheumatoid arthritis (RA). 2. The member has a minimum duration 3-month trial and failure, contraindication, or intolerance to ONE of the following conventional therapies at maximally tolerated doses: a. Methotrexate; b. Leflunomide; c. Sulfasalazine.3 months trial

    Members must have trial/failure/contraindication/intolerance to one listed conventional therapy.

    Moderate to severe plaque psoriasis (PsO)

    Covered when ALL of the following are met:

    PsO criteria: 1. Diagnosis of moderate to severe plaque psoriasis (PsO). 2. Member has at least 3% of body surface area (BSA) affected OR crucial body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) are affected. 3. Member meets ONE of the following: a. Minimum duration of 4-week trial and failure, contraindication, or intolerance to ONE topical therapy (examples: corticosteroids; vitamin D analogs; tazarotene; calcineurin inhibitors; anthralin; coal tar); OR b. Member has severe psoriasis that warrants a biologic DMARD as first-line therapy.4 weeks for topical trial

    BSA threshold: >= 3% or crucial body areas affected.

    Active psoriatic arthritis (PsA)

    Covered when ALL of the following are met:

    PsA criteria: 1. Diagnosis of active psoriatic arthritis (PsA). 2. The member meets ONE of the following: a. Actively inflamed joints; b. Dactylitis; c. Enthesitis; d. Axial disease; e. Active skin and/or nail involvement.

    No conventional DMARD trial required in policy for PsA.

    Active ankylosing spondylitis (AS)

    Covered when ALL of the following are met:

    AS criteria: 1. Diagnosis of active ankylosing spondylitis (AS). 2. Member has a minimum duration 1-month trial and failure, contraindication, or intolerance to TWO different non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, naproxen) at maximally tolerated doses.1 month; two NSAIDs

    Examples of NSAIDs: ibuprofen, naproxen.

    Non-radiographic axial spondyloarthritis (nr-axSpA)

    Covered when ALL of the following are met:

    nr-axSpA criteria: 1. Diagnosis of active non-radiographic axial spondyloarthritis (nr-axSpA). 2. Member has objective signs of inflammation (e.g., CRP above the upper limit of normal and/or sacroiliitis on MRI). 3. Member has a minimum duration 1-month trial and failure, contraindication, or intolerance to TWO different NSAIDs (e.g., ibuprofen, naproxen) at maximally tolerated doses.1 month; two NSAIDs

    Objective inflammation examples: elevated CRP and/or sacroiliitis on MRI.

    Moderately to severely active Crohn's disease (CD)

    Covered when ALL of the following are met:

    CD criteria: 1. Diagnosis of moderately to severely active Crohn's disease (CD). AND 2. ONE of the following: a. Member has had trial and failure, intolerance, or contraindication to ONE of the following conventional therapies: 6-mercaptopurine; azathioprine; corticosteroids (e.g., prednisone); methotrexate; OR b. Disease severity warrants systemic biologic as first-line therapy.

    Allows biologic first-line when disease severity warrants.

    Polyarticular juvenile idiopathic arthritis (pJIA)

    Covered when ALL of the following are met:

    pJIA criteria: 1. Diagnosis of active polyarticular juvenile idiopathic arthritis (pJIA). 2. The member has a minimum duration 6-week trial and failure, contraindication, or intolerance to ONE of the following conventional therapies at maximally tolerated doses: a. Leflunomide; b. Methotrexate.6 weeks

    Applies to patients per labeled indications (e.g., age criteria in prescribing information).

    Continuation of Therapy (Reauthorization)

    Reauthorization requests for all diagnoses will be granted when ALL of the following are met:

    Reauthorization: Submission of medical records (e.g., chart notes) demonstrating an improvement in the member's condition, as evidenced by low disease activity or improvement in signs and symptoms of the condition.

    Initial and reauthorization approvals will be granted for up to 24 months per policy limitations.

    This medication is designated as a specialty product and must be filled at a contracted specialty pharmacy. The policy applies to the Pharmacy Benefit only and does not provide coverage under the medical benefit. Prior authorization is required for Commercial/Exchange members requesting Cimzia under the pharmacy benefit.

    Quantity limits and approval durations are specified in the Limitations section: initial and reauthorization approvals are for 24 months, and product-specific quantity limits apply (e.g., Cimzia Starter Pack: 1 pack per 365 days; 200 mg/mL syringe: 2 syringes per 28 days; 200 mg/mL vial: 2 vials per 28 days).

    Use of Cimzia is considered not medically necessary when the member does not meet the diagnosis-specific coverage criteria, required prior therapy trials (or documented contraindication/intolerance), or the documentation requirements for prior authorization. This includes failure to provide evidence of required conventional therapy trials or documented reasons for initiating biologic therapy as first-line where allowed.

    For members new to the plan, lack of submitted medical records demonstrating current treatment with the requested drug (when applicable) may result in the request being denied. Likewise, reauthorization requests lacking clinical documentation of improvement or low disease activity per the policy's reauthorization requirements may be considered not medically necessary.

    Provider Requirements, Prior Authorization, and Documentation

    Prior Authorization

    Prior Authorization and Specialty Pharmacy Requirement

    Prior authorization required. Cimzia (certolizumab pegol) is covered under the pharmacy benefit for Commercial/Exchange members and is designated a specialty medication that must be dispensed by a contracted specialty pharmacy.

    • Plan: Commercial/Exchange (pharmacy benefit only)
    • Prior authorization program type applies
    • Specialty medication — must be filled at contracted specialty pharmacy
    • Pharmacy benefit contact: Phone 800-711-4555; Fax 844-403-1029
    • Medical benefit contact (for questions): Phone 833-895-2611; Fax 888-656-6671
    Documentation Required

    Required medical records for new members and reauthorization

    Authorization for new members or reauthorization requires submission of medical records. For members new to the plan (coverage effective date ≤ 90 days), include medical records demonstrating the member is currently receiving the requested drug (exclude samples or manufacturer patient assistance program supplies). For reauthorization, submit chart notes or similar documentation showing clinical improvement (e.g., low disease activity or improved signs/symptoms).

    Measurement, Coding, and Body Surface Area (BSA)

    Psoriasis Body Surface Area (BSA)
    BSA threshold>= 3% of body surface area (BSA)
    Alternative to BSAInvolvement of crucial body areas (hands, feet, face, neck, scalp, genitals/groin, intertriginous areas)
    Topical trial requirementMinimum 4-week trial and failure, contraindication, or intolerance to one topical therapy OR severe disease warranting biologic as first-line

    Clinical Definitions and Important Terms

    Objective signs of inflammation
    Elevated CRPC-reactive protein (CRP) above the upper limit of normal as objective evidence of inflammation
    Sacroiliitis on MRISacroiliitis detected by MRI indicating inflammatory disease without definitive radiographic sacroiliac joint damage
    Context of nr-axSpAObjective signs of inflammation required for non-radiographic axial spondyloarthritis coverage
    Crucial body areas
    Hands and feetInvolvement of hands or feet counts as crucial body area involvement
    Face and neckInvolvement of face or neck counts as crucial body area involvement

    Background — Drug and Indications

    Cimzia (certolizumab pegol) is a tumor necrosis factor (TNF) inhibitor indicated for multiple inflammatory conditions. The agent is included in this prior authorization policy with coverage criteria that align with its labeled indications for conditions such as rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis with objective inflammation, Crohn's disease, and polyarticular juvenile idiopathic arthritis.

    Clinical documentation requirements and indication-specific prior therapy trials are outlined in the policy to support appropriate use of Cimzia in its approved inflammatory disease indications.

    Policy Revision History and Changes

    2026-05-01policy_effective_dateLatest

    Policy effective date updated to 05/01/2026 and applies under the pharmacy benefit only (no medical benefit coverage).

    2026-03-11administrative_update

    Administrative wording change to reauthorization criteria to specify 'submission of medical records (e.g., chart notes...)' and clarification for new-to-plan members; added starter pack quantity limit to Limitations section.

    2025-10-08
    Policy Summary
    PayerMass General Brigham Health Plan
    PolicyCimzia (certolizumab pegol) prior authorization and coverage
    Policy CodePolicy N/A
    Change TypeBenefit moved to pharmacyadded starter-pack limitclarified reauthorization records
    Effective DateMay 1, 2026
    Last ReviewMay 14, 2025
    Next Review Date
    Key ActionObtain prior authorization and submit medical records (e.g., chart notes) showing improvement or low disease activity for reauthorization.
    SourceLink
    On This Page
    Coverage Criteria for Indications and ContinuationProvider Requirements, Prior Authorization, and DocumentationMeasurement, Coding, and Body Surface Area (BSA)Clinical Definitions and Important TermsBackground — Drug and IndicationsPolicy Revision History and Changes
    • New-to-plan threshold: coverage effective date ≤ 90 days — provide medical records showing current receipt of Cimzia
    • Acceptable records: chart notes, progress notes, medication administration/dispensing records, relevant lab or imaging supporting diagnosis and treatment response
    • Reauthorization requirement: documentation of clinical improvement (low disease activity or improved signs/symptoms)
    Step Therapy

    Required prior therapy trials per indication

    Authorization is contingent on meeting diagnosis-specific prior therapy requirements. Trials must be at maximally tolerated doses and documented as trial and failure, contraindication, or intolerance, unless disease severity justifies biologic therapy as first-line per the indication-specific rules.

    • Rheumatoid arthritis (RA): ≥ 3 months trial and failure/contraindication/intolerance to ONE conventional therapy (methotrexate, leflunomide, or sulfasalazine).
    • Plaque psoriasis (PsO): ≥ 3% BSA affected or involvement of crucial body areas, and failure/contraindication/intolerance to a ≥ 4-week trial of ONE topical therapy (high-potency corticosteroids, vitamin D analogs, tazarotene, calcineurin inhibitors, anthralin, coal tar) OR severe psoriasis warranting biologic as first-line.
    • Ankylosing spondylitis (AS): ≥ 1-month trial and failure/contraindication/intolerance to TWO different NSAIDs at maximally tolerated doses.
    • Non-radiographic axial spondyloarthritis (nr-axSpA): objective signs of inflammation (e.g., elevated CRP and/or MRI sacroiliitis) plus ≥ 1-month trial and failure/contraindication/intolerance to TWO different NSAIDs.
    • Crohn's disease (CD): trial and failure/intolerance/contraindication to ONE conventional therapy (6-mercaptopurine, azathioprine, corticosteroids, or methotrexate) OR disease severity that warrants systemic biologic as first-line.
    • Polyarticular juvenile idiopathic arthritis (pJIA): ≥ 6-week trial and failure/contraindication/intolerance to ONE conventional therapy (leflunomide or methotrexate).
    Denial Risk

    Failure to meet diagnosis-specific prior therapy requirements

    Failure to document required prior therapies, trials, contraindications/intolerances, or the necessary medical records may result in denial of the authorization request. Ensure documentation clearly states duration, agent(s) tried, dosing (or reason for intolerance/contraindication), and objective evidence of disease where applicable (e.g., BSA for psoriasis; CRP or MRI for nr-axSpA).

    • Denial risk if prior therapy trials or necessary clinical documentation are incomplete or absent
    • Include dates, doses, and reason for discontinuation (failure, intolerance, or contraindication) for prior therapies
    • Provide objective measures when required by indication (e.g., BSA % for PsO; CRP or MRI evidence for nr-axSpA)
    Scalp
    Scalp involvement counts as crucial body area involvement
    Genitals/groinGenitals or groin involvement counts as crucial body area involvement
    Intertriginous areasIntertriginous areas (skin folds) involvement counts as crucial body area involvement
    benefit_designation_change

    Policy updated to indicate it will no longer apply to the medical benefit and applies under the pharmacy benefit only; minor verbiage updates to trial language for ankylosing spondylitis and nr-axSpA.

    2025-05-14clinical_criteria_update

    Reviewed at May P&T and updated Crohn's disease criteria to allow approval when disease severity warrants systemic biologic as first-line therapy (removal of specific disease characteristic requirement); effective 07/01/2025.

    2024-10-09criteria_addition

    Reviewed and updated at October P&T; added criteria for polyarticular juvenile idiopathic arthritis (pJIA) and clarified diagnosis of active non-radiographic axial spondyloarthritis; effective 01/01/2025.

    2024-01-01initial_update

    Reviewed and updated for Nov P&T with multiple changes including expansion of conventional therapies for RA and PsO BSA threshold change from 5% to 3%; effective 01/01/2024.