CareSource Simponi Aria Prior Auth Coverage

Recommended Authorization Criteria

Ankylosing Spondylitis

Approve when ONE of the following is met

AS: Initial or continuation: A) Initial Therapy: Approve for 6 months if BOTH: i. Patient is > 18 years of age; AND ii. The medication is prescribed by or in consultation with a rheumatologist. OR B) Patient is Currently Receiving Simponi Aria or Subcutaneous: Approve for 1 year if BOTH: i. Patient has been established on therapy for at least 6 months; AND ii. Patient meets at least ONE of the following: a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples include ASDAS, ASQoL, BASDAI, BASFI, BAS-G, BASMI, DFI, HAQ-S, or serum markers such as CRP or ESR); OR b) Compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain or stiffness, improved function or activities of daily living).duration: 6 months (initial) or 1 year (continuation)

Objective measure examples listed in policy.

Juvenile Idiopathic Arthritis (JIA)

Approve when ONE of the following is met

JIA: Initial or continuation: A) Initial Therapy: Approve for 6 months if ALL: i. Patient is > 2 years of age; AND ii. Patient meets ONE of the following: a) Patient has tried one other medication for this condition (examples include methotrexate, sulfasalazine, leflunomide, or an NSAID) or a prior trial of a biologic other than the requested medication; OR b) Patient has aggressive disease as determined by the prescriber; AND iii. The medication is prescribed by or in consultation with a rheumatologist. OR B) Patient is Currently Receiving Simponi Aria or Subcutaneous: Approve for 1 year if BOTH: i. Patient has been established on therapy for at least 6 months; AND ii. Patient meets at least ONE of the following: a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples include MD global, PGA, PDA, JDAS, cJDAS, JSpADA, serum markers, or reduced corticosteroid dose); OR b) Compared with baseline, patient experienced improvement in at least one symptom (e.g., less joint pain, improved motion or function, decreased morning stiffness or fatigue).dosing up to 80 mg/m2 at Weeks 0 and 4 then not more frequently than every 8 weeks

Examples of other medications and objective measures provided in policy.

Psoriatic Arthritis

Approve when ONE of the following is met

PsA: Initial or continuation: A) Initial Therapy: Approve for 6 months if BOTH: i. Patient is > 2 years of age; AND ii. The medication is prescribed by or in consultation with a rheumatologist or dermatologist. OR B) Patient is Currently Receiving Simponi Aria or Subcutaneous: Approve for 1 year if BOTH: i. Patient has been established on therapy for at least 6 months; AND ii. Patient meets at least ONE of the following: a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples include DAPSA, CPDAI, PsA DAS, Grace Index, LEI, SPARCC, Leeds Dactylitis Instrument, MDA, PsAID-12, or serum markers such as CRP or ESR); OR b) Compared with baseline, patient experienced improvement in at least one symptom (e.g., less joint pain, reduced morning stiffness or fatigue, improved function, decreased soft tissue swelling).dosing: adults up to 2 mg/kg IV; pediatrics up to 80 mg/m2 IV at Weeks 0 and 4 then not more frequently than every 8 weeks

Rheumatoid Arthritis

Approve when ONE of the following is met

RA: Initial or continuation: A) Initial Therapy: Approve for 6 months if ALL: i. Patient is > 18 years of age; AND ii. Patient has tried ONE conventional synthetic DMARD for at least 3 months (examples include methotrexate, leflunomide, hydroxychloroquine, sulfasalazine). Exception: requirement may be waived if patient has already had a 3-month trial of at least one biologic other than the requested medication. AND iii. The medication is prescribed by or in consultation with a rheumatologist. OR B) Patient is Currently Receiving Simponi Aria or Subcutaneous: Approve for 1 year if BOTH: i. Patient has been established on therapy for at least 6 months; AND ii. Patient meets at least ONE of the following: a) Patient experienced a beneficial clinical response when assessed by at least one objective measure (examples include CDAI, DAS28-ESR/CRP, PAS-II, RAPID-3, SDAI); OR b) Patient experienced improvement in at least one symptom (e.g., decreased joint pain, morning stiffness, fatigue, improved function, or decreased soft tissue swelling).dosing up to 2 mg/kg IV at Weeks 0 and 4 then not more frequently than every 8 weeks

Requests for concurrent administration of Simponi Aria with another biologic or with a targeted synthetic oral small molecule used to treat an inflammatory condition are not recommended for approval. The policy states that combination therapy is generally discouraged because of a potentially higher rate of adverse events and a lack of controlled clinical data demonstrating additive efficacy.

Coverage of Simponi Aria is not recommended for indications or circumstances that are not included in the policy's Recommended Authorization Criteria. The policy explicitly calls out that criteria will be updated as new published data become available and that uses outside the listed criteria (for example, certain uses in ulcerative colitis with unclear IV dosing) are not recommended for coverage.

The appendix is provided for informational purposes and is not an all-inclusive list of indications. Reviewers and prescribers must refer to the respective product prescribing information for the complete set of FDA‑approved indications and formulation-specific details.

Administration of Simponi Aria in combination with another biologic or with targeted synthetic oral small molecule drugs is considered not recommended due to the documented concerns about increased adverse event risk and the absence of data supporting additive benefit. Conventional synthetic DMARDs (for example, methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine) are not excluded and may be used in combination per the policy.

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Recommended

Prior Authorization is recommended for medical benefit coverage of Simponi Aria. Approval is recommended only for members who meet the policy Criteria and Dosing for the listed indications. Initial approval requires the medication to be prescribed by or in consultation with a specialist who treats the condition (e.g., rheumatologist) because of the specialized skills and monitoring required. Extended approvals may be granted if the patient continues to meet Criteria and Dosing. Requests for doses outside the dosing documented in this policy will be reviewed case-by-case by a clinician (Medical Director or Pharmacist). All approvals are provided for the duration listed in the policy; when duration is expressed in months, 1 month = 30 days. Automation: None.

Prior authorization recommended for medical benefit coverage
Initial approval requires prescribing by or in consultation with a relevant specialist
Requests for nonstandard dosing reviewed case-by-case by clinician

Documentation Required

Required Prior Medication Trials

Key Definitions and Abbreviations

Simponi Aria — definition

DrugSimponi Aria (intravenous golimumab)

MechanismTumor necrosis factor inhibitor (TNFi)

Formulation & administrationIntravenous infusion administered by a healthcare professional

FDA‑approved indications (selected)Ankylosing spondylitis (adults), polyarticular juvenile idiopathic arthritis (≥2 years), psoriatic arthritis (≥2 years), rheumatoid arthritis (in combination with methotrexate in adults)

Efficacy noteEfficacy has not been established for patients switching between IV (Simponi Aria) and subcutaneous golimumab

Common abbreviations

Clinical and Drug Background

Simponi Aria is the intravenous formulation of golimumab, a tumor necrosis factor inhibitor (TNFi). It is indicated for inflammatory rheumatologic conditions including ankylosing spondylitis, polyarticular juvenile idiopathic arthritis (≥2 years), psoriatic arthritis (≥2 years), and rheumatoid arthritis (in adults, typically used in combination with methotrexate). Simponi Aria is administered by intravenous infusion and formulation-specific prescribing information should be consulted for dosing and administration details.

OpenPayer

Inflammatory Conditions - Simponi Aria Utilization Management Medical Policy

Recommended Authorization Criteria

Prior Authorization and Documentation Requirements

Key Definitions and Abbreviations

Clinical and Drug Background