UnitedHealthcare Simponi prior auth policy update

Coverage Criteria by Indication

Initial Authorization — Rheumatoid Arthritis

Covered when ALL of the following are met

RA initial: Diagnosis of moderately to severely active rheumatoid arthritis

Chunk 2

Prior therapy for RA: Either: (a) history of failure to a 3-month trial of one non-biologic DMARD (e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) at maximally indicated doses unless contraindicated; OR (b) prior treatment with a targeted immunomodulator FDA‑approved for rheumatoid arthritis documented by claims history or medical records (document date and duration of therapy); OR (c) current Simponi user documented by claims/records

Chunk 2

Exclusions and prescriber: Patient is not receiving Simponi in combination with another targeted immunomodulator; prescribed by or in consultation with a rheumatologist; patients established on therapy via manufacturer-supplied sample or Janssen CarePath assistance must meet initial authorization criteria as if new to therapy

Chunk 4

Reauthorization — Rheumatoid Arthritis

Covered when ALL of the following are met

RA reauth: Documentation of positive clinical response to Simponi therapy

Chunk 5

Concomitant therapy exclusion: Patient is not receiving Simponi in combination with another targeted immunomodulator

Chunk 6

Initial Authorization — Psoriatic Arthritis

Covered when ALL of the following are met

PsA diagnosis: Diagnosis of active psoriatic arthritis

Chunk 7

Prior therapy for PsA: Either: (a) history of failure to a 3-month trial of methotrexate at maximally indicated dose unless contraindicated or adverse effects; OR (b) prior treatment with a targeted immunomodulator FDA‑approved for psoriatic arthritis documented by claims/records; OR (c) current Simponi user documented by claims/records

Chunks 8-9

Prescriber and exclusions: Prescribed by or in consultation with a rheumatologist or dermatologist; patient is not receiving Simponi in combination with another immunomodulator; patients established on therapy via manufacturer sample or Janssen CarePath assistance must meet initial authorization criteria as if new to therapy

Chunk 10

Reauthorization — Psoriatic Arthritis

Covered when ALL of the following are met

PsA reauth: Documentation of clinical response to Simponi and prior adequate trials of indicated doses when stated (document date and duration)

Chunk 11

Concomitant therapy exclusion: Patient is not receiving Simponi in combination with another immunomodulator

Chunk 12

Initial Authorization — Ankylosing Spondylitis

Covered when ALL of the following are met

AS diagnosis: Diagnosis of active ankylosing spondylitis

Chunk 13

Current therapy or exclusions: Patient is currently on Simponi therapy documented by claims/medical records (document date and duration); patient has not relied on manufacturer sample or Janssen CarePath assistance to establish current user status; patient is not receiving Simponi in combination with another targeted immunomodulator; prescribed by or in consultation with a rheumatologist

Chunk 14

Reauthorization — Ankylosing Spondylitis

Covered when ALL of the following are met

AS reauth options: Either: (a) documentation of positive clinical response to Simponi therapy; OR (b) prior treatment with a targeted immunomodulator FDA‑approved for ankylosing spondylitis documented by claims/medical records (document drug, date, and duration)

Chunks 15-16

Concomitant therapy exclusion: Patient is not receiving Simponi in combination with another targeted immunomodulator

Chunk 17

Initial Authorization — Ulcerative Colitis

Covered when ALL of the following are met

UC diagnosis: Diagnosis of moderately to severely active ulcerative colitis

Chunk 18

Prior therapy for UC: Either: (a) inadequate response to a therapeutic course of oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine; OR (b) prior treatment with a targeted immunomodulator FDA‑approved for ulcerative colitis documented by claims/medical records (document date and duration); OR (c) current Simponi user documented by claims/records (document date and duration)

Chunks 18-19

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial Authorization: Diagnosis of moderately to severely active ulcerative colitis

Chunk 18

Initial Authorization - prior therapy: One of the following: (a) inadequate response to a therapeutic course of oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine; OR (b) prior treatment with a targeted immunomodulator FDA‑approved for ulcerative colitis documented by claims history or medical records (document date and duration); OR (c) current Simponi user documented by claims/records (document date and duration)

Chunk 19

Prescriber and combination therapy: Prescribed by or in consultation with a gastroenterologist; patient must not be receiving Simponi in combination with another targeted immunomodulator (examples listed)

Chunk 20

Initial Therapy — Initial authorization criteria by indication

Covered when ALL of the following are met

Initial RA: Diagnosis of the condition per indication and meet indication-specific prior therapy requirements (see respective indication criteria)

Chunks 2,7,13,18

Step therapy requirement: Prior adequate trial/failure of specified conventional DMARDs or other indicated agents as stated for each indication (commonly a 3-month trial where specified)

Chunks 2,7,18

Combination therapy exclusion: Patient is not receiving Simponi in combination with another targeted immunomodulator

Chunk 4

Prescriber requirement: Prescribed by or in consultation with an appropriate specialist for the indication (e.g., rheumatologist, dermatologist, gastroenterologist)

Simponi (golimumab) must not be used concurrently with another targeted immunomodulator. Examples of prohibited concomitant agents include Enbrel (etanercept), Cimzia (certolizumab), Orencia (abatacept), adalimumab, Xeljanz (tofacitinib), Olumiant (baricitinib), and Rinvoq (upadacitinib). This restriction applies to initial authorization and continuation unless otherwise specified in the policy.

Use of Simponi in combination with another targeted immunomodulator is specifically excluded. Examples listed in the policy include adalimumab, ustekinumab (Stelara), tofacitinib (Xeljanz), upadacitinib (Rinvoq), baricitinib (Olumiant), and risankizumab (Skyrizi); prescribers should not request authorization for concurrent use of these agents with Simponi.

Per the authorization criteria, the use of Simponi in combination with another targeted immunomodulator is considered not allowable. Requests for authorization when the member is receiving a second targeted immunomodulator (for example, those listed in the policy) will not meet coverage criteria and are subject to denial.

Concurrent administration of Simponi with other targeted immunomodulators is not allowed under this policy. Representative agents cited as incompatible with Simponi include Enbrel (etanercept), Cimzia (certolizumab), Orencia (abatacept), adalimumab, Xeljanz (tofacitinib), Olumiant (baricitinib), Rinvoq (upadacitinib), Stelara (ustekinumab), and Skyrizi (risankizumab). Authorization will not be approved when such combination therapy is documented.

Initial Therapy and Indication-Specific Criteria

Initial Therapy — Initial authorization criteria by indication

Initial authorization criteria by indication

Initial RA: Rheumatoid arthritis: diagnosis of moderately to severely active disease AND prior failure of a 3-month trial of a non-biologic DMARD at maximally indicated doses unless contraindicated, OR prior targeted immunomodulator therapy documented by claims/records, OR current Simponi user documented by claims/records

Chunk 2

Initial PsA: Psoriatic arthritis: diagnosis of active disease AND prior failure of a 3-month trial of methotrexate at maximally indicated dose unless contraindicated, OR prior targeted immunomodulator therapy documented by claims/records, OR current Simponi user documented by claims/records

Chunks 7-8

Initial AS: Ankylosing spondylitis: diagnosis of active disease AND current Simponi user documented by claims/records or prior targeted immunomodulator therapy per policy; patients established via manufacturer sample/CarePath assistance must meet initial criteria as new to therapy

Reauthorization / Continuation Requirements

Continuation (Reauthorization) — Reauthorization requirements across indications

Reauthorization requirements across indications

Continuation requirement: Documentation of positive clinical response to Simponi therapy

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Continuation Therapy — Reauthorization conditions

Reauthorization conditions

Continuation: Documentation of positive clinical response to Simponi; patient is not receiving Simponi in combination with another targeted immunomodulator; authorization will be issued for 12 months (state mandates may apply; CT/KY/MS have a 30-day trial requirement)

Chunks 21,23

Prior Trials and Step Therapy Rules

Requirement	Details
Prior trials required	For rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, approval requires prior adequate trial(s) of specified conventional non-biologic DMARDs (for example: methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) — commonly a 3-month trial at maximally indicated doses unless contraindicated or clinically significant adverse effects occur. Document dates and duration of trial.
Alternative prior targeted therapy	Approval may also be granted if the patient has been previously treated with a targeted immunomodulator FDA‑approved for the specific indication, as documented by claims history or medical records (document date and duration of therapy).
Current Simponi use	Current use of Simponi documented by claims history or medical records (document date and duration) can satisfy prior therapy requirement when applicable.

Bypass option	Documentation and examples
Bypass of non‑biologic step therapy	The policy permits bypassing required prior non‑biologic therapies when there is documentation of prior treatment with a targeted immunomodulator; submission of claims history or medical records is required (include drug name, dates, and duration).
Examples of targeted immunomodulators	Examples listed in the policy include adalimumab, ustekinumab (Stelara), tofacitinib (Xeljanz), and upadacitinib (Rinvoq). Use the policy examples to document prior targeted agents.

What the Provider Must Do

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial and reauthorization of subcutaneous golimumab (Simponi). Include indication-specific documentation and meet the criteria below before submitting a request.

Policy number: 2024 P 2203-8
Effective date: 1/1/2025

Documentation Required

Initial Authorization — Ulcerative Colitis

For initial authorization for ulcerative colitis, provide documentation that all of the following are met: diagnosis of moderately to severely active ulcerative colitis; AND either (a) an inadequate response to a therapeutic course of oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine (document dates and duration), OR (b) prior treatment with an FDA‑approved targeted immunomodulator for ulcerative colitis as documented by claims history or medical records (include drug name, dates, and duration). If the patient is currently on Simponi, submit claims history or medical records documenting current use (date and duration). Prescriptions should be by or in consultation with a gastroenterologist.

Definitions and Product

Simponi — definition and key attributes

DrugSimponi (golimumab) — subcutaneous formulation

Drug classTumor necrosis factor (TNF) blocker / Anti‑TNF biologic

Indications (adult)Moderately to severely active rheumatoid arthritis; active psoriatic arthritis; active ankylosing spondylitis; moderately to severely active ulcerative colitis (inducing and maintaining response)

Ulcerative colitis specificsFor UC: indicated for patients with corticosteroid dependence or inadequate response to or intolerance of oral aminosalicylates, oral corticosteroids, azathioprine, or 6‑mercaptopurine

Related formulationIntravenous formulation available as Simponi Aria (refer to medical benefit policy)

Simponi (golimumab), a TNF inhibitor — quick facts

Background

Golimumab (Simponi) is a subcutaneous tumor necrosis factor (TNF) blocker indicated for adult patients with moderately to severely active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and for inducing and maintaining response in moderately to severely active ulcerative colitis. An intravenous formulation (Simponi Aria) is also available for certain indications; the policy covers the subcutaneous formulation with indication‑specific prior authorization criteria.

Site of Care and Benefit Coverage

Note

Simponi Aria (IV) — medical benefit / infusion center

The intravenous infusion formulation (Simponi Aria) is typically covered under the medical benefit; refer to the UnitedHealthcare Drug Policy for Simponi Aria and facility/infusion center billing rules.

OpenPayer

Simponi (golimumab) subcutaneous — Prior Authorization and Medical Necessity

Coverage Criteria by Indication

Initial Therapy and Indication-Specific Criteria

Reauthorization / Continuation Requirements

Prior Trials and Step Therapy Rules

What the Provider Must Do

Definitions and Product

Background

Site of Care and Benefit Coverage