CurrentMass General Brigham Health PlanPolicy N/A

Simponi (golimumab)

Prior authorization policy for Simponi (golimumab) on the pharmacy benefit for Commercial/Exchange members; defines diagnosis-specific initial and continuation criteria, specialty fill requirement, quantity limit, and reauthorization requirements.

Policy Summary

PayerMass General Brigham Health Plan

PolicySimponi (golimumab)

Policy CodePolicy N/A

Change Typeclarified; revised (UC); revised (AS)

Effective DateMay 1, 2026

Next Review Date

Key ActionPrior authorization is required for Simponi on the pharmacy benefit for Commercial/Exchange members; requests must follow the diagnosis-specific criteria or provide documentation of current therapy if member is new to plan.

SourceLink

POLICY UPDATE CHANGES

Administrative update changed reauthorization verbiage to 'submission of medical records (e.g., chart notes...)' and updated language for members new to the Plan.

Updated ulcerative colitis criteria to remove corticosteroid dependence as an approvable condition to align with labeling.

Minor verbiage updates to trial language for ankylosing spondylitis; intent remains the same.

4Covered Indications

24 moApproval Duration

1/28 daysQuantity Limit

Specialty

Coverage Summary

Prior authorization required for Simponi (golimumab) on the pharmacy benefit for Commercial/Exchange members; covered_with_criteria. Scope: defines diagnosis-specific initial and continuation criteria (RA, PsA, AS, UC), specialty fill requirement, quantity limit, and reauthorization requirements.

Quick Facts / Limits

New-to-plan documentation windowCoverage effective date <= 90 days (submit medical records documenting current receipt of the requested drug; excludes samples or manufacturer patient assistance)

RA conventional therapy trial durationMinimum 3-month trial and failure, intolerance, or contraindication to ONE conventional therapy (methotrexate, leflunomide, or sulfasalazine)

AS NSAID trial durationMinimum 1-month trial and failure, intolerance, or contraindication to TWO different NSAIDs at maximally tolerated doses

Quantity limit1 Simponi injection per 28 days (prefilled syringe/autoinjector)

Approval durationInitial approvals and reauthorizations granted for 24 months

Specialty fill requirementMedication designated specialty and must be filled at a contracted specialty pharmacy

Initial Therapy Criteria

Continuation Therapy Criteria (Reauthorization)

Continuation of Therapy (Reauthorization)

Requests for reauthorizations for all diagnoses will be granted when ALL of the following criteria are met:

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

Operational limits: Initial approvals and reauthorizations are granted for 24 months. Pharmacy benefit quantity limit: 1 injection per 28 days for Simponi prefilled syringe/autoinjector. The medication is designated specialty and must be filled at a contracted specialty pharmacy.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Simponi on the pharmacy benefit for Commercial/Exchange members; requests must follow the diagnosis-specific criteria or provide documentation of current therapy if member is new to plan.

Documentation Required

Documentation for New-to-Plan Members

If member's coverage effective date is <= 90 days, submit medical records documenting current receipt of the requested drug (excluding samples or manufacturer assistance).

New-to-plan documentation window: coverage effective date <= 90 days

Applicable Codes & Benefit Program

Benefit / Programmixed

Program

Prior Authorization required; Pharmacy Benefit; Specialty

Clinical Evidence

Background: Simponi (golimumab) is a TNF inhibitor indicated for RA, PsA, AS, and UC (including pediatric patients ≥15 kg for UC). This policy outlines prior authorization criteria requiring either documentation of current therapy for members new to the plan or diagnosis-specific trials of conventional therapies (e.g., methotrexate for RA, NSAIDs for AS, conventional UC agents) and requires submission of medical records demonstrating clinical response for reauthorization.

Evidence: Referenced source is the Simponi (golimumab) Prescribing Information (Janssen Biotech Inc; October 2025). The full prescribing information is the primary referenced evidence source.

Definitions

New to the plan: Member with coverage effective date less than or equal to 90 days. For such members, submission of medical records documenting current receipt of the requested drug (excluding samples or manufacturer patient assistance programs) is required.

Revision History

2026-05-01clarifiedLatest

Administrative update changed reauthorization verbiage to 'submission of medical records (e.g., chart notes...)' and updated language for members new to the Plan.

2026-03-01revised

Updated ulcerative colitis criteria to remove corticosteroid dependence as an approvable condition to align with labeling.

2026-01-01revised

Minor verbiage updates to trial language for ankylosing spondylitis; intent remains the same.