Esbriet (pirfenidone) for idiopathic pulmonary fibrosis
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Defines prior authorization, documentation, and medical necessity criteria for Esbriet (pirfenidone) use in members with idiopathic pulmonary fibrosis (IPF) for Blue Cross Blue Shield - Iowa.
No material clinical or coverage changes in this revision.
Coverage Criteria for Esbriet (pirfenidone)
Initial Therapy — Idiopathic Pulmonary Fibrosis (IPF)
Covered when ALL of the following are met:
Supported by clinical evaluation and documentation.
Requires documentation of HRCT or pathology and multidisciplinary discussion.
Requires both biopsy confirmation and multidisciplinary discussion.
Continuation Therapy
Covered when ALL of the following are met:
This policy may not apply to the Federal Employee Program (FEP). Benefit determinations for FEP members are governed by the Federal Employee Program and should be verified with FEP-specific contract language.
Brand and generic Esbriet (pirfenidone) are considered not medically necessary for members who do not meet the approval criteria set forth in this policy.
Dosing, Quantity Limits, and Coding
Provider Actions and Prior Authorization Requirements
Prior authorization required; 12‑month authorizations
Prior authorization is required. Authorization of 12 months may be granted for treatment of idiopathic pulmonary fibrosis when the member has undergone a diagnostic work‑up which excludes other known causes of interstitial lung disease and diagnostic imaging/biopsy findings meet UIP or probable UIP criteria with multidisciplinary discussion between a radiologist and pulmonologist experienced in IPF.
Dosing and quantity limits per FDA‑recommended schedule
Approvals may be subject to dosing limits consistent with FDA labeling and specified quantity limits; dosing follows a 3‑step titration schedule with a maintenance dose of 801 mg three times daily (2403 mg/day).
- Days 1–7: 267 mg three times daily (801 mg/day)
- Days 8–14: 534 mg three times daily (1602 mg/day)
- Day 15 onward: 801 mg three times daily (2403 mg/day)
- Quantity limits: up to 9 of 267 mg tablets per day or 3 of 801 mg tablets per day
Required documentation for initial authorization
Submit supporting clinical documentation with the initial authorization request: chest high‑resolution computed tomography (HRCT) results and pathology reports when biopsy/TBLC was performed.
- Chart notes or medical record documentation of chest HRCT results
- Pathology report of lung biopsy, if performed
- Pathology report of transbronchial lung cryobiopsy (TBLC), if performed
Denial risk if coverage criteria not met
Brand and generic Esbriet (pirfenidone) will be denied as not medically necessary when the member does not meet the specified approval criteria for IPF (including required diagnostic work‑up and imaging/biopsy criteria).
Background
Pirfenidone (Esbriet) is approved for treatment of idiopathic pulmonary fibrosis (IPF). Continuation of therapy may be authorized for up to 12 months for members currently receiving the medication; authorization requires that the member’s treatment corresponds to an indication listed in the coverage criteria.
Definitions
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