CurrentColorado Rocky Mountain Health PlansPolicy 2025 P 2203-9

Prior Authorization/Medical Necessity - Simponi (golimumab) (subcutaneous)

Prior authorization and medical necessity criteria for subcutaneous golimumab (Simponi) covering initial authorization and reauthorization across indications (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis), prescriber requirements, combination therapy exclusions, and program operational notes. Effective for the subcutaneous formulation; IV formulation (Simponi Aria) handled separately under medical benefit.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyPrior Authorization/Medical Necessity - Simponi (golimumab) (subcutaneous)

Policy CodePolicy 2025 P 2203-9

Change TypeAnnual review / background updates (most recent 11/2025)

Effective DateJan 17, 2026

Next Review Date

Key ActionProviders must obtain prior authorization and document diagnosis, prior medication trials (drug, date, duration) or claims history/medical records to meet initial authorization criteria; reauthorization requires documentation of positive clinical response.

POLICY UPDATE CHANGES

Annual review. Updated combination examples and language with no change to clinical intent. Updated background and criteria to address new pediatric indication for UC. Updated reference.

Annual review with no change to coverage criteria; updated state mandate footnote.

Updated not receiving in combination language to 'targeted immunomodulator' and updated examples.

Added targeted synthetic DMARD to bypass criteria for AS and added Rinvoq and Xeljanz as JAK inhibitor examples; added Mississippi to state mandate language.

Added coverage criteria for patients previously treated with a biologic DMARD and clarified that submission of medical records is required when claim history not available.

Program created (new prior authorization/medical necessity program for Simponi).

4Indications with explicit criteria (RA, PsA, AS, UC)

Coverage Summary

Scope: Prior authorization and medical necessity criteria apply to the subcutaneous formulation of golimumab (Simponi) covering initial authorization and reauthorization across rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), and ulcerative colitis (UC). The policy is effective 2026-01-17 with last review 2025-11. Coverage stance: covered with criteria/prior authorization for the subcutaneous formulation. The intravenous formulation (Simponi Aria) is billed and managed separately under the medical benefit and a separate UnitedHealthcare drug policy.

Key thresholds and scope

DMARD trial duration (RA)History of failure to a 3 month trial of one non-biologic DMARD at maximally indicated doses (document drug, date, duration)

Methotrexate trial (PsA)History of failure to a 3 month trial of methotrexate at maximally indicated dose (document date, duration)

NSAID trials (AS)Failure to two NSAIDs at maximally indicated doses, each used for at least 4 weeks (document drug, date, duration)

Authorization durationAuthorization/reauthorization issued for 12 months where specified (e.g., PsA, UC, other reauthorization notes)

Effective datePolicy effective date: 2026-01-17

Last reviewLast review: 2025-11

Policy numberProgram / Policy number: 2025 P 2203-9

Initial Authorization Criteria (by indication)

Reauthorization / Continuation Criteria (by indication)

Combination Therapy & Exclusions

Recurring exclusion: Across indications and in both initial authorization and reauthorization criteria, the patient must not receive Simponi in combination with another systemic targeted immunomodulator for the treatment of the same indication. The policy lists examples of systemic targeted immunomodulators (e.g., adalimumab, certolizumab, etanercept, JAK inhibitors, and others) in each indication section. Patients who were established on therapy solely via manufacturer samples or Janssen CarePath assistance are treated as new to therapy and must meet initial criteria (document sample/CarePath assistance when submitting). Provider documentation actions require prior authorization and submission of claims history or medical records to support prior therapy or current use.

Applicable Codes / Examples

Noted example drugs (policy examples, not billing codes)mixed

adalimumab	example systemic targeted immunomodulator
certolizumab (Cimzia)	example systemic targeted immunomodulator
etanercept (Enbrel)	example systemic targeted immunomodulator
baricitinib (Olumiant)	example systemic targeted immunomodulator
abatacept (Orencia)	example systemic targeted immunomodulator
upadacitinib (Rinvoq)	example JAK inhibitor
tofacitinib (Xeljanz/XR)	example JAK inhibitor
bimekizumab (Bimzelx)	psoriatic arthritis example
secukinumab (Cosentyx)	psoriatic arthritis example
apremilast (Otezla)	psoriatic arthritis example

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Provider Actions & Operational Notes

Prior Authorization

Prior authorization required for subcutaneous Simponi

Prior authorization is required for the subcutaneous Simponi formulation. To support initial authorization, document the diagnosis and prior medication trials including drug name, dates, and duration, or provide claims history/medical records. Reauthorization requires documentation of positive clinical response.

Documentation Required

Documentation of prior therapy and claims history

When bypassing non-biologic therapy requirements based on prior biologic or targeted therapy, submit claims history or medical records documenting the drug, date, and duration of therapy. Note that UnitedHealthcare may approve initial or reauthorization solely based on prior claim/medication history, diagnosis codes, and/or claim logic, and automated approvals may occur where applicable.

Clinical Evidence & References

Oct 2025Package insert: Simponi (golimumab)

ACR/AGAGuideline refs: 2015 ACR (RA) and 2020 AGA (UC)

Evidence: Package insert — Simponi [package insert]; October 2025. Guideline references include the 2015 American College of Rheumatology (ACR) guideline for RA and the AGA clinical practice guideline on management of moderate to severe ulcerative colitis (2020).

Background

Background: Simponi (golimumab) is a tumor necrosis factor (TNF) blocker indicated for adult patients with moderately to severely active rheumatoid arthritis in combination with methotrexate; for active psoriatic arthritis (alone or with methotrexate); for active ankylosing spondylitis; and for moderate to severely active ulcerative colitis in adult and pediatric patients weighing at least 15 kg. The intravenous formulation, Simponi Aria, has separate indications and is typically covered under the medical benefit.

Definitions

Current user bypassAllows initial authorization without prior step therapy if patient is currently on Simponi documented by claims/medical records and was not established solely via manufacturer samples or Janssen CarePath assistance

Systemic targeted immunomodulatorIncludes biologic DMARDs and targeted synthetic DMARDs/JAK inhibitors as listed in policy examples (e.g., adalimumab, certolizumab, etanercept, baricitinib, abatacept, upadacitinib, tofacitinib and others)

Revision History

2020-05material_change

Program created (new prior authorization/medical necessity program for Simponi).

2021-06material_change

Added coverage criteria for patients previously treated with a biologic DMARD and clarified that submission of medical records is required when claim history not available.

2022-05revised

Added targeted synthetic DMARD to bypass criteria for ankylosing spondylitis and added Rinvoq and Xeljanz as JAK inhibitor examples; added Mississippi to state mandate language.