CurrentMass General Brigham Health PlanPolicy N/A

Targeted Immunomodulators — Simponi Aria (golimumab for infusion) coverage criteria

Policy governing prior authorization, coverage criteria, and quantity/step limits for Simponi Aria (intravenous golimumab) under Mass General Brigham Health Plan (MassHealth UPPL Plan and Commercial/Exchange), affecting prescribers and pharmacists when seeking medical-benefit coverage.

Policy Summary

PayerMass General Brigham Health Plan

PolicyTargeted Immunomodulators — Simponi Aria (golimumab for infusion) coverage criteria

Policy CodePolicy N/A

Change TypeRevised — material: moved higher-dose/frequency criteria

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, prior therapy failures or contraindications, appropriate dosing, and prescriber rationale for choosing Simponi Aria.

SourceLink

POLICY UPDATE CHANGES

Moved 'More Frequent or Higher Doses' criteria into the Coverage Guidelines section and updated formatting and references.

Updated formatting and references for the policy.

6 monthsInitial approval duration

12 monthsReauthorization duration

1 biologicPrior biologic failure (RA/pJIA)

2 NSAIDsNSAID failure (AS)

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Coverage and Medical Necessity Criteria

Initial Therapy — Rheumatoid Arthritis and pJIA

Covered when ALL of the following are met

RA/pJIA initial criteria: 1) Diagnosis of ONE of the following: a) Moderate to severe rheumatoid arthritis; b) Moderate to severe polyarticular juvenile idiopathic arthritis; 2) Inadequate response or adverse reaction to ONE or contraindication to ALL traditional DMARDs (see Appendix for examples); 3) Inadequate response or adverse reaction to ONE biologic DMARD that is FDA‑approved for the requested indication; 4) Appropriate dosing for the requested indication; 5) Prescriber provides clinical rationale for use of Simponi Aria instead of Enbrel and Humira.

Order and numbering reflect source policy; traditional DMARD examples listed in Appendix.

Initial Therapy — Psoriatic Arthritis

Covered when ALL of the following are met

Psoriatic Arthritis initial criteria: 1) Diagnosis of psoriatic arthritis; 2) Appropriate dosing for the requested indication; 3) Prescriber provides clinical rationale for use of Simponi Aria instead of Enbrel and Humira.

Numbering and wording follow source.

Initial Therapy — Ankylosing Spondylitis

Covered when ALL of the following are met

Ankylosing Spondylitis initial criteria: 1) Diagnosis of ankylosing spondylitis; 2) Inadequate response or adverse reaction to TWO NSAIDs or contraindication to ALL NSAIDs; 3) Appropriate dosing for the requested indication; 4) Prescriber provides clinical rationale for use of Simponi Aria instead of Enbrel and Humira.

Preserves source ordering and requirements.

More Frequent or Higher Doses

Requests for more frequent or higher doses may be approved if ALL of the following are provided

Higher dose/frequency criteria: 1) Severe disease; 2) Inadequate response or adverse reaction to ONE or contraindication to ALL other injectable biologics that are FDA‑approved for the requested indication; 3) Partial response to FDA‑approved dosing of current biologic therapy; 4) Specialist consult for the requested indication.

All four items are required per source.

Continuation of Therapy / Reauthorization

Reauthorization requires ALL of the following

Continuation of therapy: 1) Physician documentation of continuation of therapy; 2) Documentation of positive clinical response to therapy; 3) Ongoing FDA‑approved indication for treatment; 4) Appropriate dosing for the indication.

Initial approvals: 6 months; reauthorizations: 12 months (see Limitations).

Authorization exclusions: For members new to the plan who are currently receiving treatment with Simponi Aria, prior authorization review may be performed on a case-by-case basis, except when the product was obtained as samples or through the manufacturer’s patient assistance programs. Such members are excluded from routine case-by-case continuation review if the drug was provided as samples or via patient assistance.

Requests that do not meet the criteria outlined in this policy are considered not medically necessary. Examples include lack of documentation supporting the required diagnosis, required prior therapy failure or contraindication, appropriate dosing, or the prescriber rationale for choosing Simponi Aria over alternative agents. Note that new members currently stable on Simponi Aria may be approved without documentation of failed conventional therapies only when there is a documented history of hospitalization for one of the covered immune conditions; otherwise the standard criteria apply.

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Requirement

Authorization may be reviewed on a case-by-case basis for members new to the plan who are currently receiving treatment with Simponi Aria (golimumab for infusion). Authorization may be granted when ALL applicable clinical criteria are met and appropriate documentation is provided. Incomplete or missing documentation may result in denial or delay of the request.

Plan contact: All Plans Phone: 877-519-1908, Fax: 855-540-3693
Pharmacy contact (non-specialty): Phone: 800-711-4555, Fax: 844-403-1029
Simponi Aria may also be available through the pharmacy benefit; check the MassHealth Drug List for coverage and criteria.

Step Therapy

Step Therapy Requirements

Step therapy requirements apply for Rheumatoid Arthritis (RA), Polyarticular Juvenile Idiopathic Arthritis (pJIA), Psoriatic Arthritis (PsA), and Ankylosing Spondylitis (AS). The prescriber must document prior treatment failures or contraindications as specified below before authorization will be approved.

Key Definitions and Drug Classes

Traditional DMARD examples

AzathioprineListed as an example traditional disease-modifying antirheumatic drug (DMARD)

CyclosporineListed as an example traditional DMARD

HydroxychloroquineListed as an example traditional DMARD

LeflunomideListed as an example traditional DMARD

MethotrexateListed as an example traditional DMARD

SulfasalazineListed as an example traditional DMARD

ThalidomideListed as an example traditional DMARD

Clinical Background

Simponi Aria (golimumab for infusion) is an intravenous tumor necrosis factor (TNF) blocker indicated for treatment of moderately to severely active rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and moderate to severe polyarticular juvenile idiopathic arthritis. It is used when patients have an inadequate response to other disease‑modifying therapies or have contraindications to them.

Per policy operational guidance, initial approvals for Simponi Aria are for 6 months, and reauthorizations are for 12 months. The policy lists required prior therapy steps by indication (for example, prior traditional DMARDs and biologic failures for RA/pJIA, or ≥2 NSAID trials for ankylosing spondylitis) and requires documentation of appropriate dosing and prescriber rationale when selecting Simponi Aria over other TNF inhibitors such as Enbrel or Humira.

Policy Revision History

2025-06-01Effective dateLatest

Policy formatting and references updated; 'More Frequent or Higher Doses' criteria moved into Coverage Guidelines; effective date set.

2025-05-15Review

Reviewed and updated for P&T; formatting and references updated and criteria reorganized.

2023-03-01Effective date

Policy Summary

PayerMass General Brigham Health Plan

PolicyTargeted Immunomodulators — Simponi Aria (golimumab for infusion) coverage criteria

Policy CodePolicy N/A

Change TypeRevised — material: moved higher-dose/frequency criteria

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, prior therapy failures or contraindications, appropriate dosing, and prescriber rationale for choosing Simponi Aria.

SourceLink

On This Page

RA and pJIA: Inadequate response or adverse reaction to ONE traditional DMARD (see Appendix) AND inadequate response or adverse reaction to ONE biologic DMARD that is FDA‑approved for the requested indication.

Psoriatic Arthritis: Prescriber must provide clinical rationale for use of Simponi Aria instead of Enbrel and Humira; appropriate dosing required.

Ankylosing Spondylitis: Inadequate response or adverse reaction to TWO NSAIDs or contraindication to ALL NSAIDs; prescriber must provide clinical rationale if electing Simponi Aria over Enbrel and Humira; appropriate dosing required.

Documentation Required

Required Documentation

Provide complete clinical documentation with the initial and reauthorization requests. Failure to submit required documentation may result in denial or delay.

Diagnoses: Specify the member's diagnosis (e.g., moderate to severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis).
Treatment history: Document prior therapies, dates, responses, and reasons for discontinuation (including inadequate response, intolerance, or contraindication). Include documentation of failure of required DMARDs, biologic DMARDs, or NSAIDs per indication.
Prescriber rationale: For requests seeking Simponi Aria instead of Enbrel or Humira, include a clear clinical rationale explaining why those agents are not appropriate.
Dosing: Document recommended dosing and that dosing is appropriate for the FDA‑approved indication.
Continuation/reauthorization: Provide physician documentation of positive response to therapy, ongoing need, FDA‑approved indication, and continued appropriate dosing.

Denial Risk

Denial Risk for Incomplete Criteria

Denials are likely if required criteria or documentation are incomplete, missing, or do not demonstrate prior therapy failures/contraindications per the step therapy requirements.

Requests lacking documentation of prior DMARDs, biologic DMARDs, or NSAID trials (as applicable) may be denied.
Requests without a prescriber rationale when required (e.g., choosing Simponi Aria over Enbrel or Humira) may be denied.
Continuation requests without documentation of clinical benefit and appropriate dosing may be denied.

Revisions from 01/11/2023 review (added specific indications, stability language for new members, examples of traditional DMARDs and higher dosing criteria in appendix) took effect.

2021-06-01Effective date

Added moderate to severe polyarticular juvenile idiopathic arthritis (pJIA) to criteria; effective date set.

2020-10-21Review and update

Reviewed and updated; separated Commercial/Exchange vs MassHealth and matched MassHealth Preferred Unified Formulary for implementation 01/01/2021.

2014-01-13Reviewed and revised

Reviewed and revised for Simponi Aria update and applied weight-based quantity limit decision (filed 08/26/2013).