CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

pirfenidone (Esbriet) for idiopathic pulmonary fibrosis

Covers use of pirfenidone for treatment of idiopathic pulmonary fibrosis (IPF) for members when approval criteria are met; applies to Medicaid scope at Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policypirfenidone (Esbriet) for idiopathic pulmonary fibrosis

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateDec 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization for up to 12 months when initial criteria are met and ensure prescription is by or in consultation with a pulmonologist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

>=18minimum age

6/dayqty limit (267mg)

3/dayqty limit (801mg)

No nintedanibcombination exclusion

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Initial Therapy

Covered when ALL of the following are met:

Prescriber: Requested drug is prescribed by or in consultation with a pulmonologist.

Age: Member is at least 18 years of age.>=18 years

Diagnosis: Documented diagnosis of idiopathic pulmonary fibrosis (IPF) with other known causes of interstitial lung disease excluded.

Specify exclusion of domestic/occupational exposures, connective tissue disease, and drug toxicity where applicable.

Diagnostic evidence: Either (1) HRCT or lung biopsy showing a usual interstitial pneumonia (UIP) pattern OR (2) HRCT not showing UIP pattern but diagnosis supported by lung biopsy or, if no biopsy performed, by multidisciplinary discussion between an experienced radiologist and pulmonologist.

Baseline tests: Documentation of baseline forced vital capacity (FVC) and baseline liver function tests.

Combination therapy exclusion: Member is not concurrently taking nintedanib (Ofev).

Concurrent use with nintedanib is not allowed.

Continuation Therapy

Covered for continuation when ALL of the following are met:

Clinical response: Member has documentation of a positive clinical response to the medication (e.g., reduction in anticipated decline in forced vital capacity, improvement or stability in six-minute walk distance, and/or reduction in number or severity of exacerbations).

Combination therapy exclusion: Medication is not being used in combination with nintedanib (Ofev).

Concurrent use with nintedanib is not allowed.

Prescriber: Prescribed by a pulmonologist or in consultation with a pulmonologist.

All indications other than the FDA-approved use for idiopathic pulmonary fibrosis (IPF) are considered experimental/investigational and are not covered under this policy.

Use of pirfenidone for any indication other than treatment of IPF is considered not medically necessary/experimental and will not be covered.

Coding, Age, and Dosage Limits

Covered NDC/Dose optionsNDC | mixedCovered

pirfenidone 267mg	dose/formulation referenced for quantity limit
pirfenidone 801mg	dose/formulation referenced for quantity limit

Covered ProductmixedCovered

pirfenidone (generic Esbriet)

listed covered agent

Eligibility age and related thresholds

Minimum age for coverageMember must be at least 18 years of age.

Authorization durationPrior authorization may be granted for up to 12 months when initial criteria are met.

Prescriber requirementRequested drug must be prescribed by or in consultation with a pulmonologist.

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

An authorization may be granted for up to 12 months when initial criteria are met. Prior authorization is required for pirfenidone (generic Esbriet).

Prior authorization duration: up to 12 months when initial criteria are satisfied.
Covered product: pirfenidone (Esbriet, generic).

Note

(Provider Action)

Provider-action placeholder: ensure submission of all required documentation and include consultant pulmonologist information when applicable.

Documentation Required

Required Clinical Documentation

Submit documentation supporting the diagnosis of idiopathic pulmonary fibrosis (IPF).

Diagnosis of IPF required.
Exclude other known causes of interstitial lung disease (e.g., environmental exposures, connective tissue disease, drug toxicity).
Support diagnosis with HRCT and/or lung biopsy results consistent with UIP or with HRCT plus lung biopsy or multidisciplinary discussion if biopsy not done.

Documentation Required

Prescriber Requirement

The drug must be prescribed by or in consultation with a pulmonologist.

Prescription must be written by a pulmonologist or with documented consultation from a pulmonologist.

Denial Risk

Non‑FDA Indications Not Covered

Use of pirfenidone for indications other than the FDA‑approved treatment of IPF is considered experimental/investigational and is not covered.

Denial Risk

Concurrent Therapy Exclusion

Concurrent use with nintedanib (Ofev) is not allowed and may result in denial of the request.

Document that the member is not concurrently receiving nintedanib (Ofev).

Background

Idiopathic pulmonary fibrosis (IPF) is a progressive fibrosing interstitial lung disease for which antifibrotic therapy can slow decline in lung function and reduce disease progression. Antifibrotic treatment with pirfenidone (Esbriet) is indicated for IPF and is the FDA‑approved use addressed by this policy; therapies or uses outside this indication are considered experimental/investigational and not a covered benefit.

Definitions

Usual interstitial pneumonia (UIP) — definition and diagnostic requirements

Definition (radiologic or histologic)Usual interstitial pneumonia (UIP) pattern = HRCT of the chest or lung biopsy showing results consistent with UIP.

Alternate diagnostic pathwayIf HRCT does not show UIP (e.g., probable UIP or indeterminate), diagnosis must be supported by lung biopsy or multidisciplinary discussion between an experienced radiologist and pulmonologist.

Exclusion of other causesDiagnosis of IPF with UIP pattern requires exclusion of other known causes of interstitial lung disease (e.g., environmental exposures, connective tissue disease, drug toxicity).