CurrentMass General Brigham Health PlanPolicy N/A

Pirfenidone (Esbriet) — Coverage Criteria

Covers prior authorization, quantity limits, and specialty pharmacy requirements for Esbriet (pirfenidone) under the Mass General Brigham Health Plan pharmacy benefit for Commercial/Exchange members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyPirfenidone (Esbriet) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization and required diagnostic documentation (HRCT or biopsy or multidisciplinary discussion) to support IPF diagnosis.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Commercial/Exchangeplan population listed

12 monthsmaximum approval duration

PA + QLprogram types applied

Specialty pharmacyspecialty limitation requirement

Coverage Criteria

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Member new to plan on current therapy: Member is new to the plan and is currently receiving treatment with the requested medication.

Excludes product obtained as samples or via manufacturer's patient assistance programs.

Diagnostic-confirmed idiopathic pulmonary fibrosis (IPF): Member has undergone a diagnostic work-up with BOTH: (A) exclusion of other known causes of interstitial lung disease (e.g., domestic and occupational environmental exposures, connective tissue disease, drug toxicity) AND (B) chest HRCT or lung biopsy showing a UIP pattern OR HRCT not showing UIP with diagnosis supported by lung biopsy OR HRCT not showing UIP and no biopsy performed but diagnosis supported by multidisciplinary discussion between an experienced radiologist and pulmonologist.

Multidisciplinary discussion substitutes for biopsy when biopsy not performed.

Provider Actions & Requirements

Prior Authorization

Prior Authorization and specialty fill

Prior authorization is required for Esbriet/pirfenidone under the pharmacy benefit for Commercial/Exchange members and the medication is designated specialty and must be filled at a contracted specialty pharmacy.

Program Type: Prior Authorization; Quantity Limit
Benefit: Pharmacy Benefit
Specialty fill required: contracted specialty pharmacy
Contact (Pharmacy Benefit): Phone 800-711-4555, Fax 844-403-1029

Step Therapy

Step therapy

No step therapy requirement is specified for this medication.

Documentation Required

Diagnostic documentation required

Documentation that other known causes of interstitial lung disease have been excluded AND diagnostic evidence consistent with usual interstitial pneumonia (UIP) is required. Acceptable documentation: HRCT results consistent with UIP, OR HRCT plus lung biopsy showing UIP, OR HRCT showing probable/indeterminate/alternative diagnosis supported by lung biopsy. If no lung biopsy, a multidisciplinary discussion between an experienced radiologist and pulmonologist supporting the diagnosis is required.

Required: Exclusion of other known causes (environmental exposures, connective tissue disease, drug toxicity, etc.)
Acceptable diagnostic studies: HRCT and/or lung biopsy
If no biopsy: documentation of multidisciplinary discussion between experienced radiologist and pulmonologist

Documentation Required

Current treatment documentation

If the member is new to the plan and currently receiving treatment with the requested medication, authorization may be granted when documentation of current treatment is provided. Requests for members receiving product as samples or via manufacturer patient assistance programs are excluded from this allowance.

Documentation must show current treatment with Esbriet/pirfenidone
Authorization for continuation may be granted for members currently receiving treatment (including new members)
Exclusion: samples or manufacturer patient assistance program supplies are not eligible

Denial Risk

Indication not approved

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

FDA-approved indication: treatment of idiopathic pulmonary fibrosis (IPF)
All other indications = not medically necessary / experimental or investigational

Background

Pirfenidone (Esbriet) is an antifibrotic medication with an FDA-approved indication for the treatment of idiopathic pulmonary fibrosis (IPF). Diagnostic confirmation of IPF requires exclusion of other known causes of interstitial lung disease and demonstration of a pattern consistent with usual interstitial pneumonia (UIP) on high-resolution CT or lung biopsy; when biopsy is not performed, multidisciplinary discussion between experienced clinicians may support the diagnosis.

Definitions

Idiopathic Pulmonary Fibrosis (IPF) — definition and diagnostic criteria

DefinitionA chronic, progressive fibrosing interstitial pneumonia of unknown cause characterized by a usual interstitial pneumonia (UIP) pattern on high-resolution CT or lung biopsy; pirfenidone (Esbriet) is FDA‑approved for this indication.

Required diagnostic exclusionOther known causes of interstitial lung disease (e.g., domestic/occupational exposures, connective tissue disease, drug toxicity) must be excluded.

Imaging or histology to support diagnosisHRCT of the chest or lung biopsy demonstrating a result consistent with UIP is required to support authorization.

Alternative diagnostic pathwaysIf HRCT does not show UIP, a lung biopsy supporting the diagnosis qualifies; if no biopsy performed, a multidisciplinary discussion between an experienced radiologist and pulmonologist may substitute.

Coverage limitationOnly the FDA‑approved indication (IPF) is covered; all other indications are considered experimental/investigational and not medically necessary.

Usual Interstitial Pneumonia (UIP) pattern — radiographic or histologic definition

DefinitionA radiographic or histologic pattern consistent with usual interstitial pneumonia (UIP) identified on high‑resolution CT or lung biopsy that supports a diagnosis of IPF.

HRCT result consistent with UIPHigh‑resolution CT of the chest demonstrating features consistent with the UIP pattern qualifies to support authorization.

Lung biopsy confirmationLung biopsy showing histologic UIP pattern supports the diagnosis when HRCT is non‑diagnostic or to confirm imaging findings.

When HRCT is non‑UIPIf HRCT shows probable UIP, indeterminate for UIP, or an alternative diagnosis, a lung biopsy supporting UIP is required; if no biopsy, multidisciplinary discussion between an experienced radiologist and pulmonologist may substitute.