CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Simponi (golimumab) subcutaneous injection — Coverage Criteria

Policy governs prior authorization and coverage criteria for Simponi (golimumab) subcutaneous injection for adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis under the payer's Medicaid scope.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySimponi (golimumab) subcutaneous injection — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateFeb 1, 2022

Next Review DateN/A

Key ActionSubmit the member's chart or medical record documenting medical necessity based on the applicable indication criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthscoverage duration per authorization

≥18minimum patient age for approval

1 / 30dmaintenance dosing RA/PsA/AS

3 then 1 / moinduction → maintenance UC

Yesspecialist initiation required

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Coverage Criteria for Simponi (golimumab)

Rheumatoid arthritis

Covered when ALL of the following are met

Age and concomitant therapy: Patient is ≥18 years of age; Simponi will not be used concomitantly with another injectable biologic response modifier or specified oral non-biologic agents;

See policy for examples of excluded concomitant agents

Prescriber and diagnosis: Therapy must be initiated or recommended by a rheumatologist; patient has a diagnosis of moderate to severe active rheumatoid arthritis;

Biomarker requirement: Either positive test for rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) OR testing documented for RF, anti-CCP, and C-reactive protein (CRP) and/or erythrocyte sedimentation rate (ESR);

Prior therapy failure or contraindication to methotrexate: Either inadequate response to at least a 3-month trial of methotrexate despite adequate dosing (titrated to 20 mg/week) OR intolerance or contraindication to methotrexate (see Appendix A);

Appendix A lists examples of contraindications such as alcoholism, chronic liver disease, pregnancy, blood dyscrasias, elevated transaminases, pulmonary disease, renal impairment, significant drug interactions, or prior intolerance

Biologic failure requirement: Inadequate response, intolerance, or contraindication to at least a 3-month trial of adalimumab at maximum tolerated doses; AND patient is unable to tolerate the intravenous formulation of golimumab (Simponi Aria) with medical rationale provided;

Psoriatic arthritis

Covered when ALL of the following are met

Prescriber and diagnosis: Therapy must be initiated or recommended by a rheumatologist or dermatologist; patient has a documented diagnosis of psoriatic arthritis;

Disease phenotype prior therapy: If predominantly axial disease or active enthesitis/dactylitis: inadequate response or intolerance to at least two NSAIDs (unless contraindicated); OR if peripheral arthritis: inadequate response to at least a 3-month trial of one oral DMARD (e.g., methotrexate, azathioprine, sulfasalazine) unless intolerance;

Biologic failure requirement: Documentation of inadequate response, intolerance, or contraindication to at least a 3-month trial of adalimumab AND at least a 6-month trial of ustekinumab at maximum tolerated doses; AND patient is unable to tolerate the intravenous formulation of golimumab (Simponi Aria) with medical rationale provided;

Ankylosing spondylitis

Covered when ALL of the following are met

Prescriber and diagnosis: Therapy must be initiated or recommended by a rheumatologist; patient has a documented diagnosis of active ankylosing spondylitis;

Prior NSAID failure: Failure of, or contraindication to, TWO (2) NSAIDs;

Biologic failure requirement: Inadequate response, intolerance, or contraindication to a 3-month trial of adalimumab at maximum tolerated doses; AND patient is unable to tolerate the intravenous formulation of golimumab (Simponi Aria) with medical rationale provided;

Ulcerative colitis

Covered when ALL of the following are met

Prescriber and diagnosis: Therapy must be initiated or recommended by a gastroenterologist; patient has a diagnosis of ulcerative colitis;

Prior biologic failure: Documentation of inadequate response, intolerance, or contraindication to at least a 3-month trial of infliximab IV or adalimumab at maximum tolerated doses; AND inadequate response, intolerance, or contraindication to at least a 6-month trial of ustekinumab at maximum tolerated doses;

Continuation of therapy

Covered when ALL of the following are met

Diagnosis and prescriber: Patient has the indicated diagnosis and therapy is initiated or recommended by the appropriate specialist;

For RA/PsA/AS: rheumatologist or dermatologist as applicable; for UC: gastroenterologist

Clinical response: Patient has demonstrated a clinical response to therapy (e.g., improvement in physical function or pain, control of disease progression, decreased symptoms or hospitalizations, or for UC improvement in fistula occurrence/healing);

Concomitant use of Simponi (golimumab) with other injectable biologic response modifiers or certain oral non-biologic immunomodulatory agents is not permitted. Specifically, Simponi will not be used concomitantly with an injectable biologic response modifier (including other TNF inhibitors such as adalimumab, etanercept, infliximab, golimumab, and IL-inhibitors such as secukinumab, ustekinumab, guselkumab, tildrakizumab, risankizumab, bimekizumab, mirikizumab) or with specified oral non-biologic agents (for example, apremilast, tofacitinib, baricitinib, upadacitinib, etrasimod).

Use of Simponi in combination with the agents listed above would render the request inconsistent with the policy's approval criteria. Prior authorization requires documentation that the member is ≥18 years of age and that Simponi will not be administered concomitantly with other injectable biologic response modifiers or the specified oral non-biologic agents.

Product Coding & Prior Trial Details

Covered product dosing (by syringe strength)NDC | mixedCovered

50mg/0.5mL	One (1) 50mg/0.5mL syringe per 30 days (RA, PsA, AS)
100mg/1mL	One (1) 100mg/1mL syringe per 30 days (maintenance for UC); initial UC: Three (3) 100mg/1mL syringes for the first month

Prior trial durations

Methotrexate (RA, PsA - peripheral)Typically a ≥3-month trial at adequate dosing (titrated to 20 mg/week) is required unless intolerance or contraindication documented

Adalimumab (RA, PsA, AS, UC)Typically a ≥3-month trial at maximum tolerated doses is required prior to approval for RA and AS; for PsA and UC, adalimumab is included among required prior biologic trials

Ustekinumab (PsA, UC)Typically a ≥6-month trial at maximum tolerated doses is required for psoriatic arthritis and ulcerative colitis prior to approval

NSAIDs (AS, PsA axial/enthesitis/dactylitis)Failure or contraindication to TWO NSAIDs is required for ankylosing spondylitis; for PsA with axial disease or active enthesitis/dactylitis, failure/intolerance to ≥2 NSAIDs is acceptable

Prior Authorization, Step Therapy, and Documentation Requirements

Prior Authorization

Prior authorization requirements

Prior authorization is required. The patient must be ≥18 years of age; Simponi must not be used concomitantly with an injectable biologic response modifier (including TNF‑inhibitors and IL‑inhibitors) or specified oral non‑biologic agents; therapy must be initiated or recommended by the appropriate specialist for the indication (rheumatologist, dermatologist, or gastroenterologist as applicable); and indication‑specific prior treatment trials must be documented.

Minimum age: ≥18 years (all indications).
No concomitant use with other injectable biologic response modifiers (e.g., adalimumab, etanercept, infliximab, golimumab) or IL‑inhibitors or certain oral non‑biologic agents (e.g., apremilast, tofacitinib, baricitinib, upadacitinib).
Prescriber requirement: therapy must be initiated or recommended by the appropriate specialist (RA/AS: rheumatologist; PsA: rheumatologist or dermatologist; UC: gastroenterologist).
Document prior treatment trials per indication (see step therapy requirements).

Step Therapy

Step therapy requirements

Background

Golimumab (Simponi) is a tumor necrosis factor (TNF) inhibitor indicated for several inflammatory conditions. Policy requirements for Simponi coverage include that therapy be initiated or recommended by the appropriate specialist and that concomitant use with other injectable biologic response modifiers or certain oral non-biologic immunomodulators is avoided. The policy therefore restricts simultaneous administration of Simponi with other TNF inhibitors, interleukin inhibitors, and listed oral agents to prevent overlapping immunosuppression and to align with approval criteria.

Definitions and Contraindications

Examples of contraindications to methotrexate

Alcoholic or chronic liver diseaseAlcoholism, alcoholic liver disease, or other chronic liver disease listed as contraindications to methotrexate

Breastfeeding and pregnancyBreastfeeding, pregnancy, or planning pregnancy are listed as contraindications

Hematologic abnormalitiesBlood dyscrasias (eg, thrombocytopenia, leukopenia, significant anemia) or myelodysplasia are contraindications

Pulmonary and renal conditionsInterstitial pneumonitis/clinically significant pulmonary fibrosis and renal impairment listed as contraindications

Laboratory abnormalities and intolerancesElevated liver transaminases, significant drug interactions, hypersensitivity, or history of intolerance/adverse event to methotrexate are contraindications