OpenPayer

This revision (Policy 2026D0051S) establishes and reiterates detailed coverage criteria for Simponi Aria (golimumab) intravenous infusion specifically for psoriatic arthritis (PsA). The policy organizes criteria into clear blocks for both initial therapy and continuation/reauthorization, and it specifies that initial and reauthorization approvals are for no more than 12 months. The document also reiterates that dosing must follow the US Food and Drug Administration (FDA) labeled dosing for PsA and that the medication should not be used in combination with other systemic targeted immunomodulators for the same indication.

The policy additionally includes clinical trial evidence supporting efficacy and safety of golimumab in PsA (a randomized, placebo-controlled trial of 480 adults), and ties coverage determinations to both treatment history (e.g., methotrexate trial or prior targeted immunomodulator) and prescriber specialty for certain pathways. These structured requirements and the explicit 12-month authorization limits are the prominent points presented in this revision.

The policy defines the covered population as adults with a documented diagnosis of active psoriatic arthritis (PsA) and separates requirements for initial therapy and continuation of therapy. For initial therapy, the policy requires diagnosis of active PsA and that Simponi Aria be started and titrated per FDA-labeled dosing. Continuation criteria require prior receipt of the IV infusion formulation, documentation of a positive clinical response, and adherence to FDA dosing.

Both initial and continuation pathways include an explicit prohibition on concomitant use of Simponi Aria with other systemic targeted immunomodulators for the same indication. Examples of such agents are listed (e.g., adalimumab, etanercept, secukinumab, upadacitinib, ustekinumab, among others), indicating combination therapy for the same indication is not covered.

For initial medical necessity determination, the policy requires one of three pathways in addition to active PsA diagnosis: (1) documented failure of a 3-month trial of methotrexate at the maximally indicated dose unless contraindicated or not tolerated; (2) prior treatment with a systemic targeted immunomodulator FDA‑approved for PsA (a list of examples is provided); or (3) the patient is currently on Simponi Aria.

The policy also states that when pursuing the pathway involving prior or current treatment, Simponi Aria must still be initiated and titrated per FDA labeling and that initial authorization duration is limited to no more than 12 months. This ties coverage to documented prior therapy or intolerance to conventional DMARD therapy.

The policy requires that, in at least one articulated path for initial therapy, Simponi Aria be prescribed by or in consultation with a Rheumatologist or Dermatologist. For continuation of therapy, the policy requires documentation of a positive clinical response to the medication and confirms dosing must remain consistent with FDA labeling.

Both initial and continuation authorizations are explicitly capped at a maximum duration of 12 months, and reauthorization similarly requires the patient not to be receiving concomitant systemic targeted immunomodulators for the same indication.

The policy includes a summary of the pivotal clinical trial supporting efficacy and safety of golimumab in PsA: a multicenter, randomized, double-blind, placebo-controlled trial of 480 adults with active PsA despite NSAID or DMARD therapy. Key trial features cited include randomization to golimumab 2 mg/kg IV versus placebo with dosing at Weeks 0, 4, 12, and 20 (and subsequent dosing through Week 52), enrollment criteria requiring ≥5 swollen and ≥5 tender joints and CRP ≥0.6 mg/dL, and allowance for stable doses of MTX, NSAIDs, and low-dose corticosteroids.

Efficacy outcomes highlighted in the policy include statistically significant improvement in ACR 20 response at Week 14 for golimumab versus placebo, greater improvement in enthesitis (Leeds Enthesitis Index) and dactylitis scores, inhibition of structural progression (72% with no progression at Week 24 vs 43% for placebo), and meaningful functional improvement on HAQ-DI and quality-of-life gains on SF-36.