CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Pirfenidone (Esbriet) for idiopathic pulmonary fibrosis

Covers prior authorization, documentation, and continuation criteria for Esbriet (pirfenidone) to treat idiopathic pulmonary fibrosis (IPF) for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPirfenidone (Esbriet) for idiopathic pulmonary fibrosis

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit HRCT results and any lung biopsy pathology report when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

FDA-approvedindication status for IPF

HRCT or biopsydiagnostic documentation

smoking counselingother member counseling

Coverage Criteria for Pirfenidone (Esbriet)

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FDA indication: Medication is being prescribed for idiopathic pulmonary fibrosis (IPF), the FDA-approved indication.

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

Diagnostic evidence: Either: (A) HRCT chest showing a result consistent with usual interstitial pneumonia (UIP) pattern; OR (B) HRCT chest showing a non‑UIP pattern supported by lung biopsy; OR (C) HRCT non‑UIP pattern with diagnosis supported by multidisciplinary discussion between an experienced radiologist and pulmonologist if no biopsy was performed.

Documentation submission: Submit HRCT chest results and, if a lung biopsy was performed, the associated pathology report to initiate prior authorization review.

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required. Authorization may be granted for up to 12 months when approval criteria and documentation requirements are met.

Authorization duration: up to 12 months when criteria met
Prior authorization required for initiation and continuation of therapy

Documentation Required

Submit required diagnostic and clinical documentation with the prior authorization request. If a lung biopsy was performed, include the pathology report.

Submit HRCT chest results showing UIP pattern or other pattern with supporting lung biopsy, OR HRCT plus multidisciplinary discussion between experienced radiologist and pulmonologist when biopsy not performed
If lung biopsy performed, submit pathology report
Exclude other known causes of interstitial lung disease (e.g., environmental exposures, connective tissue disease, drug toxicity)
Provide documentation that diagnostic work‑up supports diagnosis of idiopathic pulmonary fibrosis (IPF)

Denial Risk

Indication Limits

Use is limited to the FDA‑approved indication of idiopathic pulmonary fibrosis (IPF). Use for any other indication is considered experimental/investigational and may be denied.

Covered indication: IPF only
All other indications are experimental/investigational and not medically necessary

Note

Provider Actions / Required Clinical Evidence

Providers must ensure clinical records demonstrate exclusion of other known causes of interstitial lung disease and that the diagnostic evaluation (HRCT and/or lung biopsy and multidisciplinary discussion when applicable) supports IPF prior to request submission.

Confirm exclusion of other causes (environmental/occupational exposures, connective tissue disease, drug toxicity)
If HRCT is non‑UIP, include supporting lung biopsy or multidisciplinary discussion documentation

Background

Pirfenidone (Esbriet) is FDA-approved for the treatment of idiopathic pulmonary fibrosis (IPF). Diagnosis of IPF requires exclusion of other known causes of interstitial lung disease and appropriate imaging and/or histopathology consistent with a usual interstitial pneumonia (UIP) pattern or multidisciplinary confirmation prior to therapy initiation.

Definitions

Usual interstitial pneumonia (UIP) pattern

DefinitionUsual interstitial pneumonia (UIP) pattern as demonstrated on HRCT chest or lung biopsy consistent with UIP.

Diagnostic alternativesHRCT showing non‑UIP pattern (probable UIP, indeterminate for UIP, or alternative diagnosis) may be accepted only if diagnosis is supported by lung biopsy.

Multidisciplinary confirmationIf no lung biopsy was performed, a diagnosis for HRCT non‑UIP patterns must be supported by multidisciplinary discussion between an experienced radiologist and pulmonologist.

Exclusion requirementOther known causes of interstitial lung disease (eg, domestic/occupational exposures, connective tissue disease, drug toxicity) must be excluded when asserting UIP/IPF.