Cigna updated prior authorization and documentation requirements for Ofev (nintedanib) under IP0312, reaffirming that PA is required and approvals are typically time‑limited to one year. Coverage pathways for IPF, PPF, and SSc‑ILD are specified with separate initial and continuation criteria; prescribers must be specialists and baseline/diagnostic measures (e.g., FVC ≥40% predicted, HRCT or biopsy findings) are explicitly required and marked as [documentation required]. Continuation approvals require documented clinical benefit over the prior year or comparison to baseline if treated less than a year. Concomitant use of Ofev with pirfenidone (Esbriet) and any non‑listed indications are deemed not medically necessary.
March 15, 2026 Revision: Prior Authorization and Documentation Emphasis
This revision establishes the current criteria and administrative instructions for prior authorization of Ofev under Cigna's Coverage Policy IP0312. The policy explicitly states that prior authorization is required for benefit coverage and that approvals are time-limited (typically for 1 year) for the indications listed. It also reiterates that prescribing must be by or in consultation with a clinician who specializes in the treated condition (e.g., pulmonologist or rheumatologist) due to the specialized skills needed for evaluation and management.
The document adds explicit documentation requirements (marked as [documentation required]) for baseline measures such as forced vital capacity and diagnostic imaging or biopsy findings for certain indications, and clarifies that approvals for both initial therapy and continuation (patients currently receiving Ofev) are possible when the outlined criteria are met. This version highlights the preferred product criteria reference for Individual and Family Plans for idiopathic pulmonary fibrosis initial therapy.
Covered Indications and Approval Durations for `Ofev`
The policy covers three FDA-approved indications for Ofev with discrete approval pathways: Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis (PPF), and Interstitial Lung Disease Associated with Systemic Sclerosis (SSc-ILD). For each indication, approval is generally granted for 1 year when criteria are met. Criteria are structured as either or (continuation) with differing evidence requirements.
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