CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Pirfenidone (Esbriet) for Idiopathic Pulmonary Fibrosis — Coverage Criteria

Covers use of pirfenidone for treatment of idiopathic pulmonary fibrosis (IPF) when approval criteria and documentation requirements are met; applies to members of Neighborhood Health Plan of Rhode Island subject to benefit exclusions.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPirfenidone (Esbriet) for Idiopathic Pulmonary Fibrosis — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit HRCT chest results (and lung biopsy pathology if performed) to document exclusion of other causes and diagnostic evidence of IPF.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration for initial and continuation therapy

FDA-approvedindication limited to idiopathic pulmonary fibrosis

Other usesclassified as experimental/investigational and not medically necessary

HRCT or biopsydiagnostic documentation to support IPF diagnosis

Smoking counselingadvice recommended for current smokers

Coverage Criteria for Pirfenidone (Esbriet)

Initial therapy

Covered when ALL of the following are met:

FDA indication: Medication is prescribed for idiopathic pulmonary fibrosis (IPF).

From FDA‑approved indication; other indications are experimental/investigational and not medically necessary.

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

Diagnostic evidence: Either (1) chest high-resolution CT (HRCT) consistent with usual interstitial pneumonia (UIP) pattern; OR (2) HRCT not UIP but lung biopsy supportive of diagnosis; OR (3) HRCT not UIP and diagnosis supported by multidisciplinary discussion if biopsy not performed.

Diagnostic work-up must include HRCT; if biopsy performed submit pathology report.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPirfenidone (Esbriet) for Idiopathic Pulmonary Fibrosis — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit HRCT chest results (and lung biopsy pathology if performed) to document exclusion of other causes and diagnostic evidence of IPF.

SourceLink

On This Page

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Provider Actions, Authorization & Documentation Requirements

Prior Authorization

Prior authorization duration

Authorization of 12 months may be granted for treatment of idiopathic pulmonary fibrosis when the member has undergone a diagnostic work-up which includes the required documentation.

Step Therapy

Continuation therapy requirement

Authorization of 12 months may be granted for members currently receiving the requested medication; this does not apply when the medication was obtained solely as samples or via manufacturer patient assistance programs.

Member must be currently receiving the requested medication.
Therapy obtained only as samples or through manufacturer patient assistance programs is excluded from continuation authorization.

Documentation Required

Required diagnostic documentation

Submit results of a high-resolution chest CT (HRCT); if a lung biopsy was performed, submit the associated pathology report. Documentation must demonstrate exclusion of other known causes of interstitial lung disease and either HRCT consistent with UIP, HRCT plus supportive biopsy, or multidisciplinary discussion if biopsy not performed.

HRCT chest study results are required.
If a lung biopsy was conducted, include the pathology report.
Documentation must show exclusion of other known causes of interstitial lung disease and diagnostic support for UIP (by HRCT, biopsy, or multidisciplinary discussion).

Denial Risk

Non‑FDA indications not covered

Requests for pirfenidone for indications other than idiopathic pulmonary fibrosis are considered experimental/investigational and not medically necessary and may be denied.

Definitions

UIP — Definition and diagnostic evidence

DefinitionUsual interstitial pneumonia (UIP) pattern on high-resolution CT (HRCT) or lung biopsy findings that support a diagnosis of idiopathic pulmonary fibrosis (IPF).

Acceptable diagnostic evidenceHRCT chest demonstrating UIP pattern, OR HRCT not UIP but lung biopsy supportive of UIP, OR HRCT not UIP with diagnosis supported by multidisciplinary discussion when biopsy not performed.

Required diagnostic work-upHRCT chest is required; submit lung biopsy pathology if biopsy performed. Multidisciplinary discussion (radiologist and pulmonologist experienced in IPF) may substitute if biopsy not done.

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

Authorization implicationDocumentation of UIP on HRCT or biopsy (or supported via multidisciplinary discussion) is needed to meet criteria for prior authorization for IPF treatment.

OpenPayer

Pirfenidone (Esbriet) for Idiopathic Pulmonary Fibrosis — Coverage Criteria

Coverage Criteria for Pirfenidone (Esbriet)

Provider Actions, Authorization & Documentation Requirements

Background

Definitions