Mass General Brigham Health Plan Cimzia Prior Auth

Coverage Criteria for Cimzia (certolizumab pegol)

Rheumatoid arthritis (RA) - Initial Therapy

Covered when ALL of the following are met for rheumatoid arthritis (RA):

RA criteria: 1) Diagnosis of moderately to severely active rheumatoid arthritis (RA). 2) Trial of methotrexate. 3) The member has a minimum duration of 3-month trial and failure, contraindication, or intolerance to ONE of the following conventional therapies at maximally tolerated doses: leflunomide OR sulfasalazine.

Plaque Psoriasis (PsO) - Initial Therapy

Covered when ALL of the following are met for moderate to severe plaque psoriasis (PsO):

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

Psoriatic Arthritis (PsA) - Initial Therapy

Covered when ALL of the following are met for active psoriatic arthritis (PsA):

PsA criteria: 1) Diagnosis of active psoriatic arthritis (PsA) with features such as actively inflamed joints, dactylitis, enthesitis, axial disease, or active skin and/or nail involvement.

Conventional therapy requirement removed per document history.

Ankylosing Spondylitis (AS) - Initial Therapy

Covered when ALL of the following are met for active ankylosing spondylitis (AS):

AS criteria: 1) Diagnosis of active ankylosing spondylitis. 2) Minimum 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.

Non-radiographic Axial Spondyloarthritis - Initial Therapy

Covered when ALL of the following are met for non-radiographic axial spondyloarthritis (nr-axSpA):

nr-axSpA criteria: 1) Diagnosis of active non-radiographic axial spondyloarthritis. 2) Objective signs of inflammation (e.g., C-reactive protein [CRP] above the upper limit of normal and/or sacroiliitis on MRI). 3) Minimum 1-month trial and failure, contraindication, or intolerance to TWO different non-steroidal anti-inflammatory drugs (NSAIDs) at maximally tolerated doses.

Crohn's Disease (CD) - Initial Therapy

Covered when ONE of the following for Crohn's disease (CD):

Crohn's disease criteria: 1) Diagnosis of moderately to severely active Crohn's disease AND trial and failure, intolerance, or contraindication to ONE conventional therapy: 6-mercaptopurine OR azathioprine OR methotrexate OR corticosteroids; OR 2) Disease severity warrants systemic biologic as first-line therapy.

Effective 07/01/2025 update removed disease characteristic requirement.

Polyarticular Juvenile Idiopathic Arthritis (pJIA) - Initial Therapy

Covered when ALL of the following are met for polyarticular juvenile idiopathic arthritis (pJIA):

pJIA criteria: 1) Diagnosis of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years and older. 2) Minimum 6-week trial and failure, contraindication, or intolerance to ONE conventional therapy at maximally tolerated doses: leflunomide OR methotrexate.

Continuation of Therapy

Continuation of therapy - reauthorization:

Continuation criteria: Documentation of improvement in the member's condition as evidenced by low disease activity or improvement in signs and symptoms must be submitted for reauthorization. Approvals and reauthorizations will be granted for 24 months.

Initial and reauthorization durations are 24 months.

This medication is designated specialty and must be filled through a contracted specialty pharmacy. Non-specialty dispensing is not allowed; providers should route Cimzia (certolizumab pegol) orders to the plan's contracted specialty pharmacy to ensure benefit coverage and proper handling.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Cimzia (certolizumab pegol). Members new to the plan who are currently receiving the requested medication may be authorized for up to 90 days while transitioning to the plan (this does not apply to product obtained as samples or through manufacturer patient assistance programs).

Prior authorization required for all indications.
90‑day allowance for members new to the plan currently receiving therapy (excludes samples and manufacturer patient assistance programs).
Specialty medication — must be filled through contracted specialty pharmacy per plan directions.

Documentation Required

Reauthorization documentation

Requests for reauthorization (continuation of therapy) must include documentation demonstrating clinical benefit. Submitted documentation should show low disease activity or improvement in signs and symptoms compared to baseline. Reauthorization will be granted only when this documentation supports ongoing medical necessity.

Step Therapy Requirements

Indication	Required prior trials (documented trial and failure, contraindication, or intolerance) or justification for first‑line biologic	Minimum trial duration
Rheumatoid arthritis (moderately to severely active)	Methotrexate AND trial and failure, contraindication, or intolerance to ONE of the following conventional therapies at maximally tolerated doses: leflunomide OR sulfasalazine; OR documentation that disease severity warrants biologic as first‑line therapy	Minimum 3‑month trial for conventional therapy
Plaque psoriasis (moderate to severe)	Minimum trial and failure, contraindication, or intolerance to ONE topical therapy (e.g., high‑potency corticosteroids, vitamin D analogs, tazarotene, calcineurin inhibitors, anthralin, coal tar); OR severe psoriasis that warrants a biologic DMARD as first‑line therapy	Minimum 4‑week topical trial
Psoriatic arthritis (active)	Requirement removed for specific conventional therapies per document; approval requires diagnosis of active PsA and either prior conventional therapy trial with failure/contraindication/intolerance or documentation that disease severity warrants biologic as first‑line	Varies by therapy as clinically appropriate (see policy)
Ankylosing spondylitis (active)	Trial and failure, contraindication, or intolerance to TWO different NSAIDs (e.g., ibuprofen, naproxen) at maximally tolerated doses; OR documentation that disease severity warrants biologic as first‑line	Minimum 1‑month trial for each NSAID (two different NSAIDs)
Non‑radiographic axial spondyloarthritis (active) with objective signs of inflammation	Objective signs of inflammation required (e.g., elevated CRP and/or MRI evidence of sacroiliitis) AND trial and failure, contraindication, or intolerance to TWO different NSAIDs at maximally tolerated doses; OR documentation that disease severity warrants biologic as first‑line	Minimum 1‑month trial for each NSAID (two different NSAIDs)
Crohn's disease (moderately to severely active)	Trial and failure, contraindication, or intolerance to ONE conventional therapy (6‑mercaptopurine, azathioprine, methotrexate, or corticosteroids); OR disease severity that warrants systemic biologic as first‑line therapy (per 07/01/2025 update)	Varies by agent; policy allows first‑line biologic when disease severity warrants
Polyarticular juvenile idiopathic arthritis (pJIA) (patients ≥2 years)	Trial and failure, contraindication, or intolerance to ONE conventional therapy at maximally tolerated doses (leflunomide OR methotrexate); OR documentation that disease severity warrants biologic as first‑line	Minimum 6‑week trial

Coding and Clinical Thresholds

Psoriasis body surface area (BSA) threshold

Psoriasis BSA threshold>= 3% body surface area (BSA)

Alternate qualifying involvementInvolvement of crucial body areas (hands, feet, face, neck, scalp, genitals/groin, intertriginous)

Required topical therapy trialMinimum 4-week trial and failure, contraindication, or intolerance to ONE topical therapy (e.g., high‑potency corticosteroids, vitamin D analogs, tazarotene, calcineurin inhibitors, anthralin, coal tar)

Quantity Limits for Cimzia

Cimzia 200 mg/mL syringe — quantity limit

Quantity limit (syringe)2 syringes per 28 days

Dose formCimzia 200 mg/mL prefilled syringe

Approval durationInitial approvals and reauthorizations granted for 24 months

Cimzia 200 mg/mL vial — quantity limit

Quantity limit (vial)2 vials per 28 days

Dose formCimzia 200 mg/mL vial

Approval durationInitial approvals and reauthorizations granted for 24 months

Site of Care and Dispensing

Billing Rule

Specialty pharmacy dispensing required

This medication is designated specialty and must be dispensed through a contracted specialty pharmacy; non‑specialty dispensing is not allowed.

See specialty pharmacy contact information in the policy for prior authorization submission and dispensing.

Initial Therapy Overview and Indication-Specific Requirements

Initial Therapy

Initial approval requires meeting indication-specific step therapy trials or justification for first-line biologic based on severity.

Initial therapy general: Member must meet diagnosis-specific criteria including required prior trials (durations specified) of conventional therapies or NSAIDs where applicable, or documented rationale for biologic as first-line when disease severity warrants.

See individual indication nodes for specifics.

Continuation / Reauthorization Criteria

Continuation/Reauthorization

Reauthorization requirements and durations

Reauthorization: Documentation of clinical improvement (low disease activity or improvement in signs and symptoms) is required for reauthorization. Approvals and reauthorizations will be granted for 24 months.

Definitions and Clinical Terms

Objective signs of inflammation (nr-axSpA)

DefinitionObjective signs of inflammation include elevated C‑reactive protein (CRP) above the upper limit of normal and/or MRI evidence of sacroiliitis indicative of inflammatory disease

ContextRequired for diagnosis of active non‑radiographic axial spondyloarthritis (nr‑axSpA)

PurposeUsed to distinguish inflammatory nr‑axSpA when radiographic changes are absent

Background

Cimzia (certolizumab pegol) is a tumor necrosis factor (TNF) blocker indicated for multiple inflammatory conditions. The policy covers Cimzia for indications including moderately to severely active rheumatoid arthritis, moderate to severe plaque psoriasis, active psoriatic arthritis, active ankylosing spondylitis, non-radiographic axial spondyloarthritis with objective signs of inflammation, moderately to severely active Crohn's disease, and polyarticular juvenile idiopathic arthritis (pJIA) in patients aged 2 years and older.

Clinical and utilization criteria in this policy reflect review history and updates from the plan's P&T actions; indication-specific step therapy and age requirements (for example, pJIA criteria added in October 2024) and other changes are incorporated into the coverage criteria.

Revision History and Policy Changes

2025-07-01policy_revisionLatest

Updated Crohn's disease criteria to remove the disease characteristic requirement and allow approval when disease severity warrants systemic biologic as first-line therapy.

2025-01-01policy_update

Clarified diagnosis of non-radiographic axial spondyloarthritis as 'active' and added criteria for polyarticular juvenile idiopathic arthritis (pJIA) during Oct 2024 P&T; effective date listed as 01/01/2025.

2024-01-01

OpenPayer

Cimzia (certolizumab pegol) prior authorization and quantity limits