CurrentMass General Brigham Health PlanPolicy N/A

Pirfenidone (Esbriet) — Coverage Criteria for Idiopathic Pulmonary Fibrosis

This policy governs prior authorization, quantity limits, specialty handling, and coverage criteria for Esbriet (pirfenidone) under Mass General Brigham Health Plan pharmacy and medical benefits for members requiring treatment of idiopathic pulmonary fibrosis (IPF).

Policy Summary

PayerMass General Brigham Health Plan

PolicyPirfenidone (Esbriet) — Coverage Criteria for IPF

Policy CodePolicy N/A

Change TypeOperational revision

Effective DateJan 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization and submit HRCT or lung biopsy results (or multidisciplinary discussion documentation) to support a diagnosis of IPF.

SourceLink

POLICY UPDATE CHANGES

Policy was switched from SGM to Custom effective 01/01/2024 following review 12/13/2023.

12 monthsauthorization approval duration

Prior Authorizationrequirement for coverage

Specialty pharmacyspecialty fill

IPF onlyindication limit

Coverage Criteria for Pirfenidone (Esbriet)

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Initial Therapy

Covered for idiopathic pulmonary fibrosis when ALL of the following are met:

Diagnosis and indication: Member has a diagnosis of idiopathic pulmonary fibrosis (IPF); pirfenidone is FDA-approved for IPF and other indications are considered experimental/investigational and not medically necessary.

supported by chunk 1

Radiographic/Pathologic evidence: Either (1) HRCT chest or lung biopsy reveals a pattern consistent with usual interstitial pneumonia (UIP), OR (2) HRCT reveals a non-UIP pattern (probable UIP, indeterminate for UIP, or alternative) supported by lung biopsy showing UIP. If no lung biopsy performed, diagnosis must be supported by multidisciplinary discussion between a radiologist and pulmonologist experienced in IPF.

supported by chunk 3

Exclusion of other causes: Other known causes of interstitial lung disease (domestic/occupational environmental exposures, connective tissue disease, drug toxicity) have been excluded.

supported by chunk 3

Continuation Therapy

Covered for continuation when ALL of the following are met:

Currently receiving therapy: Member is currently receiving treatment with the requested medication (including new members transferring into plan).

supported by chunk 4

All indications for pirfenidone other than idiopathic pulmonary fibrosis (IPF) are considered experimental/investigational and not medically necessary.

Use of pirfenidone (Esbriet) for any indication other than idiopathic pulmonary fibrosis (IPF) is not medically necessary.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for new members currently receiving pirfenidone and for initiation of therapy for idiopathic pulmonary fibrosis (IPF).

Affected product: Esbriet (pirfenidone) / pirfenidone (generic)
Contact for specialty medications: Phone 877-519-1908; Fax 855-540-3693
Non-specialty contact: Phone 800-711-4555

Step Therapy

No step therapy requirements are specified for pirfenidone.

Documentation Required

Required Diagnostic Documentation

Authorization may be granted when diagnostic work-up supports IPF. Required documentation includes HRCT chest results and, if performed, lung biopsy consistent with usual interstitial pneumonia (UIP). If biopsy was not performed, documentation of a multidisciplinary discussion between radiology and pulmonology experienced in IPF is required. Other known causes of interstitial lung disease must be excluded.

Required: HRCT chest showing UIP or lung biopsy consistent with UIP
If HRCT is non‑UIP (e.g., probable UIP, indeterminate, alternative diagnosis) a lung biopsy supporting the diagnosis is required
If no biopsy performed: documentation of multidisciplinary discussion between an experienced radiologist and pulmonologist
Documentation that other causes (environmental exposures, connective tissue disease, drug toxicity) have been excluded

Documentation Required

Continuation Documentation Required

For members already receiving pirfenidone, authorization for continuation may be granted when documentation shows the member is currently receiving the requested medication. This includes new members who transfer coverage and are actively on therapy; authorizations will not be granted for medications obtained only as samples or through manufacturer patient assistance programs.

Provide evidence of current treatment (e.g., recent fill history, medical chart note)
New-to-plan members must show active treatment with the requested product; exclusions apply for sample or PAP-supplied medication

Denial Risk

Indication Limits — Experimental/Not Covered

Requests for pirfenidone for indications other than idiopathic pulmonary fibrosis (IPF) are considered experimental/investigational and not covered.

Definitions

Idiopathic Pulmonary Fibrosis (IPF) — definition and diagnostic criteria (HRCT and/or lung biopsy consistent with usual interstitial pneumonia patterns)

DefinitionIdiopathic Pulmonary Fibrosis (IPF): a chronic, progressive fibrosing interstitial pneumonia of unknown cause diagnosed when HRCT and/or lung biopsy are consistent with a usual interstitial pneumonia (UIP) pattern and other known causes of interstitial lung disease have been excluded.

Required radiographic/pathologic evidenceHRCT chest or lung biopsy showing a pattern consistent with usual interstitial pneumonia (UIP).

Alternative diagnostic pathwayIf HRCT shows a non‑UIP pattern (probable UIP, indeterminate for UIP, or alternative diagnosis), diagnosis must be supported by lung biopsy demonstrating UIP; if no lung biopsy was performed, a multidisciplinary discussion between an experienced radiologist and pulmonologist must support the diagnosis.

Exclusion of other causesOther known causes of interstitial lung disease (eg, domestic/occupational environmental exposures, connective tissue disease, drug toxicity) must be excluded.

FDA‑approved indicationPirfenidone (Esbriet) is indicated for the treatment of IPF; all other indications are considered experimental/investigational and not medically necessary.