MHN golimumab coverage & prior auth updates

Coverage Criteria and Clinical Requirements

Initial Therapy: Ankylosing Spondylitis

Covered when ALL of the following are met

AS initial criteria: 1. Diagnosis of ankylosing spondylitis (AS). 2. Prescribed by or in consultation with a rheumatologist. 3. Age ≥ 18 years. 4. Failure of at least TWO NSAIDs at up to maximally indicated doses, each used ≥ 4 weeks, unless clinically significant adverse effects occur or all are contraindicated or member previously failed a biologic for AS. 5. Member meets ALL of the following, each used ≥ 3 consecutive months unless clinically significant adverse effects occur or contraindicated: a) Failure of one adalimumab product (preferred examples listed in policy) unless member has history of failure of two TNF blockers; b) Failure of Taltz (ixekizumab); c) If not responsive or intolerant to one or more TNF blockers, trial of Xeljanz/Xeljanz XR unless cardiovascular risk outweighs benefit. 6. No combination use with other biological DMARDs or Janus kinase inhibitors. 7. Dose does not exceed one of the following: a) Simponi 50 mg subcutaneously once monthly; or b) Simponi Aria 2 mg/kg IV at weeks 0 and 4, then 2 mg/kg every 8 weeks (see Appendix F for rounding).age >= 18; prior therapy durations as specified

Prior authorization may be required for comparator agents

Initial Therapy: Polyarticular Juvenile Idiopathic Arthritis

Covered when ALL of the following are met

pJIA initial criteria: 1. Diagnosis of polyarticular juvenile idiopathic arthritis (pJIA) with ≥ 5 joints with active arthritis. 2. Request is for Simponi Aria. 3. Prescribed by or in consultation with a rheumatologist. 4. Age ≥ 2 years. 5. Member meets one of the following unless previously failed a biologic for pJIA: a) Failure of ≥ 3 consecutive month trial of methotrexate (MTX) at up to maximally indicated doses; b) MTX intolerance/contraindication and failure of ≥ 3 consecutive month trial of sulfasalazine or leflunomide at up to maximally indicated doses; c) For sacroiliitis/axial involvement, failure of an NSAID trial ≥ 4 weeks at up to maximally indicated doses; d) Documentation of high disease activity. 6. Failure of ALL of the following, each used ≥ 3 consecutive months unless contraindicated: a) One adalimumab product (preferred examples listed) unless history of failure of two TNF blockers; b) Actemra (tocilizumab); c) If not responsive or intolerant to one or more TNF blockers, Xeljanz unless cardiovascular risk outweighs benefit. 7. No combination use with biological DMARDs or JAK inhibitors. 8. Dose does not exceed 80 mg/m2 IV at weeks 0 and 4, then 80 mg/m2 every 8 weeks (see Appendix F for rounding).age >= 2; pJIA joint count >=5

Prior authorization may be required for listed comparators

Initial Therapy: Psoriatic Arthritis

Covered when ALL of the following are met

PsA initial criteria: 1. Diagnosis of psoriatic arthritis (PsA). 2. Prescribed in consultation with a dermatologist or rheumatologist. 3. Member meets one of the following: a) Age ≥ 2 years and request is for Simponi Aria; or b) Age ≥ 18 years. 4. For members ≥ 18 years, failure of ALL of the following, each used ≥ 3 consecutive months unless contraindicated or intolerant: a) One adalimumab product (preferred examples listed) unless history of failure of two TNF blockers; b) Otezla (apremilast); c) Taltz (ixekizumab); d) One ustekinumab product (preferred examples listed); e) If not responsive or intolerant to one or more TNF blockers, Xeljanz/Xeljanz XR unless cardiovascular risk outweighs benefit. 5. For members 6–17 years, failure of ≥ 3 consecutive month trials of both Otezla and one ustekinumab product unless contraindicated. 6. No combination use with biological DMARDs or JAK inhibitors. 7. Dose limits: a) Simponi 50 mg SC once monthly; b) Simponi Aria adults: 2 mg/kg IV at weeks 0 and 4, then 2 mg/kg every 8 weeks; c) Simponi Aria pediatrics: 80 mg/m2 IV at weeks 0 and 4, then 80 mg/m2 every 8 weeks.prior therapy durations as specified

Prior authorization may be required for listed comparators

Initial Therapy: Rheumatoid Arthritis

Covered when ALL of the following are met

RA initial criteria: 1. Diagnosis of rheumatoid arthritis (RA) per ACR criteria. 2. Prescribed by or in consultation with a rheumatologist. 3. Age ≥ 18 years. 4. Member meets one of the following unless previously failed a biologic for RA: a) Failure of a ≥ 3 consecutive month trial of methotrexate at up to maximally indicated doses; b) MTX intolerance/contraindication and failure of a ≥ 3 consecutive month trial of at least one conventional DMARD (e.g., sulfasalazine, leflunomide, hydroxychloroquine). 5. Failure of ALL of the following, each used ≥ 3 consecutive months unless contraindicated: a) One adalimumab product (preferred examples listed) unless history of failure of two TNF blockers; b) Actemra (tocilizumab); c) If not responsive or intolerant to one or more TNF blockers, Xeljanz/Xeljanz XR unless cardiovascular risk outweighs benefit. 6. Prescribed concomitantly with MTX or another DMARD if MTX is intolerant/contraindicated. 7. Documentation of baseline disease activity using CDAI or RAPID3. 8. No combination use with biological DMARDs or JAK inhibitors. 9. Dose does not exceed: a) Simponi 50 mg SC once monthly; or b) Simponi Aria 2 mg/kg IV at weeks 0 and 4, then 2 mg/kg every 8 weeks.age >= 18; prior therapy durations >=3 months

Prior authorization may be required for listed comparators

Initial Therapy: Ulcerative Colitis

Covered when ALL of the following are met

UC initial criteria: 1. Diagnosis of ulcerative colitis (UC). 2. Request is for Simponi (subcutaneous formulation). 3. Prescribed by or in consultation with a gastroenterologist. 4. If member < 18 years, weight ≥ 15 kg. 5. Documentation of disease activity: Mayo Score ≥ 6, modified Mayo Score ≥ 5, or Mayo Endoscopic Score ≥ 2. 6. Failure of an 8‑week trial of systemic corticosteroids unless contraindicated or previously failed a biologic for UC. 7. For adults, failure of one of the following used for ≥ 3 consecutive months unless contraindicated: a) One adalimumab product (preferred examples listed) unless history of failure of two TNF blockers; b) One ustekinumab product (preferred examples listed). 8. No combination use with biological DMARDs or JAK inhibitors. 9. Dose does not exceed one of the following weight‑based regimens: a) Weight ≥ 15 kg to < 40 kg: 100 mg Week 0, 50 mg Week 2, then 50 mg every 4 weeks; b) Weight ≥ 40 kg: 200 mg Week 0, 100 mg Week 2, then 100 mg every 4 weeks.Mayo scores as specified; weight-based dosing

Prior authorization may be required for listed comparators

Initial Therapy: Other/Off‑label routing

Covered when ONE of the following is met

Other indications: 1. If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy, follow the applicable no-coverage or non‑formulary policy for the line of business (e.g., CP.PMN.255 or CP.PMN.16 for Medicaid). 2. If the requested use is not specifically listed in Section I and criterion 1 does not apply, route the request per the off‑label use policy (CP.PMN.53).recent label change within 6 months

Administrative routing guidance

Continued Therapy

Covered when ALL of the following are met

Continued therapy general criteria: 1. Member is currently receiving the medication via the Centene benefit or previously met initial approval criteria, or continuity of care applies. 2. Member is responding to therapy: a) For RA, evidenced by decrease in CDAI or RAPID3 from baseline or justified inability to perform CDAI with submission of RAPID3 showing comparable/improved disease severity; b) For all other indications, documentation that member is responding positively to therapy. 3. No combination use with biological DMARDs or JAK inhibitors. 4. If dose increase requested, new dose must not exceed indication‑based maximums: a) AS/PsA/RA (Simponi): 50 mg SC once monthly; b) AS/PsA/RA (Simponi Aria) adults: 2 mg/kg IV every 8 weeks; c) UC (Simponi) weight‑based SC regimens per initial criteria; d) PJIA/PsA (Simponi Aria) pediatrics: 80 mg/m2 IV every 8 weeks. Approval duration: 12 months.evidence of clinical response; dose ceilings apply

Approval duration 12 months

Dosing-based coverage (per product labeling)

Covered when dosing and indication match product labeling and payer rules (document contains dosing regimens by indication and age/weight):

Simponi SC adults (AS, PsA, RA): 50 mg subcutaneously once monthly; maximum maintenance 50 mg/month.

per product labeling

Simponi SC ulcerative colitis (adults and pediatric ≥40 kg): Initial: 200 mg SC at Week 0 then 100 mg SC at Week 2; Maintenance: 100 mg SC every 4 weeks; maximum maintenance 100 mg every 4 weeks.

per product labeling

Simponi SC pediatric UC 15–<40 kg: Initial: 100 mg SC at Week 0 then 50 mg SC at Week 2; Maintenance: 50 mg SC every 4 weeks.

per product labeling

Simponi Aria IV adults (AS, PsA, RA):

Covered with criteria (general)

Policy coverage is conditional and includes step therapy/redirection, preferred agent requirements, and severity documentation.

General coverage logic: Coverage requires meeting disease‑specific criteria and step‑therapy/redirection requirements, including use of specified preferred agents or biosimilars where indicated, and submission of appropriate disease severity documentation (e.g., modified Mayo Score ≥ 5 or Mayo Endoscopic Score > 2 for UC). Bypass allowances apply for prior biologic failure or specific contraindications per policy updates. Detailed per‑indication logic and preferred agent lists are in the respective sections of the policy.see thresholds

Step therapy, redirection, and preferred agent rules updated in recent document revisions

Requests for golimumab in combination with other biological disease‑modifying antirheumatic drugs (bDMARDs) or potent immunosuppressants are not authorized. The policy explicitly lists classes and representative agents excluded from combination use, including tumor necrosis factor antagonists (for example, adalimumab and other TNF blockers), interleukin inhibitors (such as Actemra, Taltz, Stelara and biosimilars), Janus kinase inhibitors (e.g., Xeljanz/Xeljanz XR), anti‑CD20 agents (e.g., Rituxan), integrin antagonists (e.g., Entyvio), tyrosine kinase 2 inhibitors, and S1P modulators due to additive immunosuppression and elevated infection risk.

Non‑FDA approved (off‑label) indications that are not specifically addressed in this policy are not covered unless the provider supplies sufficient evidence of efficacy and safety per the plan’s off‑label use procedures (see referenced off‑label policy). Providers should route such requests through the off‑label/no‑coverage pathways described in the policy.

Golimumab carries boxed warnings for serious infections and malignancy. Although the policy lists no absolute contraindications, providers must consider these boxed warnings when assessing suitability for therapy and must document risk considerations and any relevant safety monitoring in the prior authorization request.

Failure to acknowledge or address these safety concerns in submitted documentation may trigger denial or additional safety review; clinicians should ensure that the member’s infection history, concurrent immunosuppressive therapies, and cancer risk factors are documented when requesting approval.

HCPCS and other billing codes referenced in this policy are provided for informational purposes only. Inclusion or omission of a code in the policy does not, by itself, determine coverage.

Coverage decisions require that the submitted codes be accompanied by appropriate clinical documentation demonstrating that the member meets the policy’s indication‑specific medical necessity criteria.

Use of golimumab in combination with the specified agents (including but not limited to the listed bDMARDs, JAK inhibitors, anti‑CD20 agents, interleukin antagonists, integrin antagonists, tyrosine kinase 2 inhibitors, and S1P modulators) is expressly prohibited or considered not authorized due to the risk of additive immunosuppression and related adverse events.

When a provider requests combination therapy, the request will be evaluated against these exclusions and may be denied unless there is exceptional, documented justification aligned with the plan’s off‑label review processes.

The policy’s list of codes (e.g., HCPCS entries) is intended to assist billing and prior authorization workflows but is not a substitute for clinical criteria. Absence of a specific code or absence of explicit criteria for a requested code may render the request not medically necessary under plan adjudication.

Providers must supply supporting clinical documentation (diagnosis, prior therapy history, disease activity scores, and specialist consultation) to substantiate medical necessity irrespective of the codes used on the claim.

Billing and Scoring Codes

HCPCS codes referencedHCPCS

J1602	Injection, golimumab, 1 mg, for intravenous use.
J3590	Unclassified drugs or biologicals (subcutaneous golimumab).
C9399	Unclassified drugs or biologicals (subcutaneous golimumab) - listed in same HCPCS line.

Mayo Score thresholds

Mayo Score (total)Mayo Score ≥ 6

Modified Mayo ScoreModified Mayo Score ≥ 5

Mayo Endoscopic ScoreMayo Endoscopic Score ≥ 2

Treatment durations for prior therapies

Standard prior therapy durationMost required prior therapy trials: ≥ 3 consecutive months

NSAID trial durationNSAIDs typically required for ≥ 4 weeks (e.g., AS sacroiliitis/axial spine involvement)

Corticosteroid trial in UC

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization required — Provider must document that the member meets indication‑specific criteria (diagnosis, specialist involvement, age, and dosing) before golimumab (Simponi / Simponi Aria) will be approved.

Prior authorization may also be required for comparator biologics and JAK inhibitors referenced in criteria (e.g., adalimumab products, ustekinumab products, Actemra, Xeljanz/Xeljanz XR).

Prior Authorization

Prior authorization: indication, prior therapy, and dosing

Prior authorization requests must document the indication, prior therapy trials (including duration and outcomes), and the planned dosing/route. For UC, include pediatric weight when applicable and the specified induction and maintenance dosing.

Document indication-specific prior therapies and durations (e.g., ≥3 months for MTX or other DMARDs, ≥4 weeks for NSAIDs where specified, 8-week systemic corticosteroid trial for UC).
Specify formulation and dosing requested (Simponi SC vs Simponi Aria IV) and ensure dose does not exceed policy maximums (see Dosage and Administration).

Therapeutic Background and Product Information

Golimumab is a tumor necrosis factor (TNF) blocker available as subcutaneous Simponi and intravenous Simponi Aria. It is indicated for multiple immune‑mediated conditions including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and certain juvenile indications depending on formulation.

Simponi is provided as a prefilled subcutaneous product and Simponi Aria as an individual‑use intravenous formulation; dosing and indication‑specific regimens (including pediatric weight‑based dosing for some indications) are specified in the policy and must be followed to meet coverage requirements.

Scales, Indexes, and Reference Sources

CDAI

CDAICDAI: clinical disease activity index — baseline assessment score used to document response in RA (decrease from baseline used for continued therapy)

Use in continued therapyFor RA continued therapy, a decrease in CDAI from baseline is accepted evidence of response

Appendix referenceCDAI defined in Appendix A and detailed in Appendix H

RAPID3

RAPID3RAPID3: routine assessment of patient index data 3 — an RA assessment tool used when CDAI cannot be performed

Continued therapy useIf CDAI re-assessment is not possible, submission of RAPID3 associated with similar or improved disease severity may justify continued therapy

Policy Revision Timeline

2022-10-11template_update

Template changes applied to other diagnoses/indications and continued therapy section; references reviewed and updated; 2Q 2023 annual review added TNFi bypass for history of failure of two TNF blockers.

2023-07-25policy_change

July SDC: removed certain prior redirection requirements (Cimzia and Enbrel) for AS/other indications and added requirement to use one adalimumab product with specified preferred examples; for UC added Zeposia use after adalimumab failure and updated Appendix B therapeutic alternatives.

2023-12-06update

OpenPayer

Golimumab (Simponi, Simponi Aria) coverage

Coverage Criteria and Clinical Requirements

Billing and Scoring Codes

Prior Authorization, Documentation, and Step Therapy

Therapeutic Background and Product Information

Scales, Indexes, and Reference Sources

Policy Revision Timeline