CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Pirfenidone

Defines prior authorization documentation and coverage criteria for pirfenidone (Esbriet) for treatment of idiopathic pulmonary fibrosis (IPF). Covers FDA-approved indication (IPF) when diagnostic and exclusion criteria are met; all other uses are considered experimental/investigational and not medically necessary. Authorizations are for 12 months.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPirfenidone

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit HRCT chest results and lung biopsy pathology report (if performed) and document exclusion of other causes of interstitial lung disease to initiate prior authorization review.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

1Covered Indications

1Non-covered (experimental) Indications

12 monthsAuthorization Duration

Coverage Summary

Defines prior authorization documentation and coverage criteria for pirfenidone (Esbriet) for treatment of idiopathic pulmonary fibrosis (IPF). Covered with criteria for the FDA-approved indication (IPF) when diagnostic criteria and exclusion of other causes are documented. Authorizations may be granted for 12 months. All other uses are considered experimental/investigational and not medically necessary.

Covered Indication: Idiopathic Pulmonary Fibrosis (IPF)

Authorization of 12 months may be granted when ALL of the following are met:

ALL of the following

Indication is idiopathic pulmonary fibrosis (IPF) (FDA-approved indication for Esbriet/pirfenidone).
Other known causes of interstitial lung disease have been excluded (e.g., domestic and occupational environmental exposures, connective tissue disease, drug toxicity).
Diagnostic evidence (ONE of)
- High-resolution computed tomography (HRCT) study of the chest or lung biopsy reveals a result consistent with the usual interstitial pneumonia (UIP) pattern.
- Alternative diagnostic pathway
  - HRCT study of the chest reveals a result other than the UIP pattern (e.g., probable UIP, indeterminate for UIP, alternative diagnosis).
  - Diagnosis is supported by a lung biopsy; OR if lung biopsy has not been previously conducted, diagnosis is supported by a multidisciplinary discussion between a radiologist and pulmonologist experienced in IPF.

Initial Therapy Criteria

Initial Therapy (Authorization of 12 months)

Initial therapy criteria

Indication is idiopathic pulmonary fibrosis (IPF) (FDA-approved indication for Esbriet/pirfenidone).
Other known causes of interstitial lung disease have been excluded (e.g., domestic and occupational environmental exposures, connective tissue disease, drug toxicity).
Diagnostic evidence (ONE of)
- High-resolution computed tomography (HRCT) study of the chest or a lung biopsy reveals a result consistent with the usual interstitial pneumonia (UIP) pattern.
- Alternative diagnostic pathway
  - HRCT study of the chest reveals a result other than the UIP pattern (e.g., probable UIP, indeterminate for UIP, alternative diagnosis).
  - Diagnosis is supported by a lung biopsy; OR if lung biopsy has not been previously conducted, diagnosis is supported by a multidisciplinary discussion between a radiologist and pulmonologist experienced in IPF.

Provider Actions

Prior Authorization

Prior authorization submission requirements

Submit HRCT chest results and lung biopsy pathology report (if performed) to initiate prior authorization review; these documents are required to demonstrate diagnostic criteria for IPF.

Documentation Required

Diagnostic work-up required

Document exclusion of other known causes of interstitial lung disease (e.g., domestic and occupational exposures, connective tissue disease, drug toxicity) and provide evidence per diagnostic pathways: HRCT consistent with UIP OR HRCT non-UIP plus lung biopsy OR HRCT non-UIP plus multidisciplinary discussion if biopsy not performed.

Documentation Required

Smoking counseling recommendation

If the member is a current smoker, document counseling on the harmful effects of smoking on pulmonary conditions and available smoking cessation options.

Clinical Evidence & References

References: Esbriet and pirfenidone package inserts (March 2023); Raghu et al., ATS/ERS/JRS/ALAT guideline (2022).

Background note: Pirfenidone (Esbriet) is FDA-approved for idiopathic pulmonary fibrosis (IPF).

Background

Pirfenidone (Esbriet) is FDA-approved for treatment of idiopathic pulmonary fibrosis (IPF). Coverage is limited to this indication when diagnostic criteria and exclusion of other known causes of interstitial lung disease are documented. Required diagnostic documentation includes HRCT chest and/or lung biopsy consistent with the usual interstitial pneumonia (UIP) pattern or alternative diagnostic pathway supported by biopsy or multidisciplinary discussion. References: Esbriet and pirfenidone package inserts (March 2023) and the 2022 ATS/ERS/JRS/ALAT guideline update on IPF.

UIP: Usual interstitial pneumonia pattern as determined by HRCT or lung biopsy consistent with IPF.