CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

pirfenidone (Esbriet) for idiopathic pulmonary fibrosis — Coverage Criteria

Policy governs coverage criteria for pirfenidone for treatment of idiopathic pulmonary fibrosis (IPF) for members of Neighborhood Health Plan of Rhode Island (Medicaid scope noted). It specifies initial and continuation authorization requirements, quantity limits, and exclusions of non‑FDA indications.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policypirfenidone (Esbriet) for idiopathic pulmonary fibrosis — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateDec 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization and document IPF diagnosis (ICD-10 J84.112) with HRCT or surgical lung biopsy evidence and baseline liver function tests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moinitial auth

12 mocontinuation auth

>=18min age

J84.112diagnosis code

801 mg / 267 mgquantity limits

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policypirfenidone (Esbriet) for idiopathic pulmonary fibrosis — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateDec 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization and document IPF diagnosis (ICD-10 J84.112) with HRCT or surgical lung biopsy evidence and baseline liver function tests.

SourceLink

On This Page

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Initial Therapy (6 months)

Covered when ALL of the following are met:

Initial Authorization Criteria: 1) Prescriber is a pulmonologist or prescribed in consultation with a pulmonologist; 2) Member is at least 18 years of age; 3) Documented diagnosis of IPF by all of the following: (a) exclusion of other known causes of interstitial lung disease (e.g., domestic and occupational environmental exposures, connective tissue disease, drug toxicity) documented; (b) ICD-10 code J84.112; AND (c) documentation of either: i) in patients without surgical lung biopsy, presence of a usual interstitial pneumonia (UIP) pattern on high-resolution computed tomography (HRCT) indicating IPF or probable IPF, OR ii) in patients with lung biopsy, both HRCT and surgical lung biopsy pattern reveal IPF or probable IPF; 4) Documentation that the member is not concurrently taking Ofev (nintedanib); 5) Documentation that baseline liver function tests have been performed.

Authorization may be granted for 6 months.

Continuation Therapy (12 months)

Covered for continuation when ALL of the following are met:

Continuation Authorization Criteria: 1) Documentation of a positive clinical response to pirfenidone; 2) Therapy is not being used in combination with Ofev (nintedanib); 3) Prescribed by a pulmonologist or prescribed in consultation with a pulmonologist.

Authorization may be granted for 12 months.

All indications other than the FDA‑approved indication for idiopathic pulmonary fibrosis (IPF) are considered experimental/investigational and are not a covered benefit.

Use of pirfenidone for non‑IPF indications is considered not medically necessary (experimental/investigational) and is not a covered benefit.

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required — Initial Authorization 6 months

Initial authorization for treatment of idiopathic pulmonary fibrosis (IPF) may be granted for 6 months when the clinical criteria are met. Prior authorization is required before initiation.

Prescriber is a pulmonologist or therapy is prescribed in consultation with a pulmonologist.
Member is ≥ 18 years of age.
Documentation must include diagnosis code J84.112 (Idiopathic pulmonary fibrosis).
Documentation of IPF must include either: (a) in patients without surgical lung biopsy — a usual interstitial pneumonia (UIP) pattern on HRCT consistent with IPF or probable IPF; OR (b) in patients with surgical lung biopsy — HRCT and surgical lung biopsy patterns consistent with IPF or probable IPF.
Baseline liver function tests performed prior to initiation.

Step Therapy

Combination Therapy Restriction

Nintedanib (Ofev) must not be used in combination with this therapy. Continuation authorization requires documentation of a positive clinical response and confirmation that the member is not receiving combination therapy with Ofev (nintedanib).

Combination use with Ofev (nintedanib) is contraindicated for coverage.
Continuation authorization (12 months) requires clinical improvement and absence of concurrent nintedanib use.

Denial Risk

Use for Non‑FDA Indications Not Covered

Use for any indication other than the FDA‑approved indication for treatment of IPF is considered experimental/investigational and is not a covered benefit.

Only the FDA‑approved indication (Treatment of IPF) is covered.
All other indications are not covered.

Documentation Required

Documentation Requirements

Providers must document the clinical rationale and supporting diagnostic evidence in the medical record to support authorization requests.

Include ICD-10 code J84.112 on request.
Provide HRCT report showing UIP pattern when no surgical lung biopsy was performed, or provide both HRCT and surgical lung biopsy reports when biopsy was performed.
Document exclusion of other known causes of interstitial lung disease (environmental exposures, connective tissue disease, drug toxicity).
Include baseline liver function test results.
For continuation requests, include documentation of positive clinical response and confirmation the member is not on nintedanib.

Definitions

Idiopathic pulmonary fibrosis (IPF) — diagnostic criteria

Required diagnosis codeICD-10: J84.112 (Idiopathic pulmonary fibrosis)

Imaging evidence (no biopsy)HRCT showing a usual interstitial pneumonia (UIP) pattern consistent with IPF or probable IPF

Biopsy evidenceWhen a surgical lung biopsy is performed, both HRCT and surgical lung biopsy pattern must reveal IPF or probable IPF

Exclusion of other causesDocumentation must show exclusion of other known causes of interstitial lung disease (e.g., environmental exposures, connective tissue disease, drug toxicity)

OpenPayer

pirfenidone (Esbriet) for idiopathic pulmonary fibrosis — Coverage Criteria

Coverage Criteria for pirfenidone (Esbriet)

Coding and Dosing

Provider Actions and Prior Authorization Requirements

Definitions

Background