ModifiedCentenePolicy CP PHAR.286

Pirfenidone (Esbriet) coverage for idiopathic pulmonary fibrosis

Defines medical necessity criteria, prior authorization requirements, and continuation criteria for pirfenidone (Esbriet) for members with idiopathic pulmonary fibrosis (IPF) under Centene lines of business.

Policy Summary

PayerCentene

PolicyPirfenidone (Esbriet) coverage for idiopathic pulmonary fibrosis

Policy CodePolicy CP PHAR.286

Change TypeMaterial coverage updates (diagnostic confirmation, baseline thresholds, smoking restriction, concurrency prohibition)

Effective DateOct 1, 2016

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of IPF diagnosis, baseline FVC and DLCO, HRCT or pathologic confirmation, smoking status, and medication history showing no concurrent nintedanib.

SourceLink

POLICY UPDATE CHANGES

Requirement for HRCT UIP pattern and, when appropriate, biopsy/bronchoalveolar lavage or transbronchial cryobiopsy to confirm IPF diagnosis per ATS guidelines was added.

Baseline pulmonary function thresholds of FVC >= 50% predicted and DLCO >= 30% predicted were added.

Explicit prohibition of concurrent use of pirfenidone (Esbriet) with nintedanib (Ofev) was added.

Requirement that member is not an active smoker evidenced by a recent negative cotinine test was added.

Policy revised to include generic pirfenidone and to redirect brand requests to generic unless contraindicated or adverse events occur.

FVC ≥50%Baseline FVC

DLCO ≥30%Baseline DLCO

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

2,403 mg/dayMax dose

YesGeneric available

Coverage Criteria for Pirfenidone (Esbriet)

Initial Therapy

Covered when ALL of the following are met:

Initial Approval - IPF: Member has a diagnosis of idiopathic pulmonary fibrosis (IPF)

Prescriber: Prescribed by or in consultation with a pulmonologist

Age: Member is age >= 18 years

Radiologic / Pathologic confirmation: High-resolution computed tomography (HRCT) demonstrating pulmonary fibrosis with either a definite UIP pattern OR a probable/indeterminate UIP pattern with confirmatory surgical lung biopsy, transbronchial cryobiopsy, or cellular analysis of bronchoalveolar lavage fluid

ATS 2022 diagnostic guidance referenced

Exclude known causes: Known causes of pulmonary fibrosis have been ruled out per policy (see Appendix D)

Baseline pulmonary function - FVC: Baseline forced vital capacity (FVC) >= 50% of predicted

Baseline pulmonary function - DLCO: Baseline carbon monoxide diffusing capacity (DLCO) >= 30% of predicted

Smoking status: Member is not an active smoker as evidenced by a recent (within 30 days) negative cotinine (nicotine metabolite) test

Concurrent therapy restriction: Pirfenidone (Esbriet) is not prescribed concurrently with nintedanib (Ofev)

Dosing limits: Requested dose follows titration and does not exceed maximum dose (up to 2,403 mg per day; typical titration: Days 1–7, 801 mg/day; Days 8–14, 1,602 mg/day; Day 15 onward, 2,403 mg/day)

Formulation / step therapy: If requesting brand Esbriet, member must use generic pirfenidone first unless contraindicated or clinically significant adverse events experienced

Continuation Therapy

Covered when ALL of the following are met for continued therapy:

Enrollment or prior approval: Member is currently receiving pirfenidone via the Centene benefit or has previously met the initial approval criteria

Clinical response: Member is responding positively to therapy as documented by the provider

Concurrent therapy restriction: Pirfenidone is not prescribed concurrently with nintedanib (Ofev)

Formulation / step therapy: Brand requests follow generic redirection: member must use generic pirfenidone unless contraindicated or clinically significant adverse events are documented

Summary coverage criteria

Covered when ALL of the following are met (policy additions summarized):

Diagnosis confirmation: HRCT showing a UIP pattern OR pathologic confirmation via surgical lung biopsy, transbronchial lung cryobiopsy, or cellular analysis of bronchoalveolar lavage fluid per ATS guidelines

Added per 3Q2021 and 3Q2023 updates

Baseline pulmonary function: Baseline FVC and DLCO meeting pivotal trial inclusion thresholdssee policy for exact values (FVC >= 50% predicted; DLCO >= 30% predicted)

Added per 3Q2021 update

Concurrent therapy restriction: No concurrent use of nintedanib (Ofev)

Added per 3Q2021 update

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (e.g., CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, CP.PMN.53 for Medicaid) or other evidence of coverage documents.

Concurrent administration of pirfenidone with nintedanib (Ofev) is explicitly prohibited. Requests that indicate simultaneous use of both agents will not meet coverage criteria and should document that nintedanib is not being taken concomitantly.

Requests for therapy to treat indications that are not FDA‑approved and that are not discussed in this policy are considered not medically necessary unless the request includes adequate off‑label justification and supporting evidence per the referenced off‑label use policies.

Therapy is not medically necessary for members who are active smokers or for requests lacking required diagnostic confirmation or baseline pulmonary function measures. The policy requires that smoking status be documented (e.g., recent negative cotinine test) and that diagnostic confirmation (HRCT UIP pattern or pathologic confirmation such as surgical biopsy, bronchoalveolar lavage, or transbronchial lung cryobiopsy) and baseline FVC/DLCO values be provided per the coverage criteria; absence of these items may result in denial.

Coding and Key Thresholds

No billing/CPT/ICD/NDC codes listed in this sectionmixed

No codes listed

Drug formulations mentionedNDC

534 mg

new tablet strength (generic available from Laurus Generics)

Baseline FVC — numeric threshold required for coverage

Baseline FVC requirementFVC >= 50% of predicted

Source contextListed under Initial Approval Criteria as a required baseline measure for coverage

Related policy noteAdded per 3Q2021 annual review to align with pivotal trial inclusion criteria

Baseline DLCO — numeric threshold required for coverage

Baseline DLCO requirementDLCO >= 30% of predicted

Source contextListed under Initial Approval Criteria as a required baseline measure for coverage

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must obtain prior authorization for pirfenidone (generic) or Esbriet (brand) and ensure requests are prescribed by or in consultation with a pulmonologist.

Prescribed by or in consultation with a pulmonologist
Esbriet (brand) requests require prior use of generic pirfenidone or documentation of contraindication/clinically significant adverse event
Concurrent use with Ofev (nintedanib) is not permitted

Documentation Required

Required Documentation

Providers must submit supporting clinical documentation that the member meets all approval criteria. Missing or incomplete documentation is a common reason for denial.

Office chart notes describing diagnosis and pulmonologist involvement

Background on Idiopathic Pulmonary Fibrosis

Idiopathic pulmonary fibrosis (IPF) is a chronic fibrosing interstitial pneumonia characterized radiologically by a usual interstitial pneumonia (UIP) pattern on high‑resolution CT. A definite UIP pattern includes honeycombing; probable or indeterminate patterns may require pathologic confirmation with surgical lung biopsy, bronchoalveolar lavage, or transbronchial lung cryobiopsy per ATS guidance. Clinical trials of pirfenidone enrolled patients with mild to moderate impairment defined by pulmonary function thresholds, which the policy incorporates into baseline requirements.

Definitions and Abbreviations

UIP — usual interstitial pneumonia pattern definition

DefinitionUsual interstitial pneumonia (UIP) is the hallmark radiologic pattern of IPF

Radiologic featureHoneycombing is a distinguishing feature and must be present for a definite HRCT diagnosis of UIP

ContextATS 2022 guidelines build diagnostic criteria around HRCT findings and exclusion of known causes of interstitial lung disease

DLCO — carbon monoxide diffusing capacity

DefinitionDLCO = carbon monoxide diffusing capacity

AbbreviationListed in appendices as DLCO: carbon monoxide diffusing capacity

Policy Summary

PayerCentene

PolicyPirfenidone (Esbriet) coverage for idiopathic pulmonary fibrosis

Policy CodePolicy CP PHAR.286

Change TypeMaterial coverage updates (diagnostic confirmation, baseline thresholds, smoking restriction, concurrency prohibition)

Effective DateOct 1, 2016

Next Review DateN/A

SourceLink

On This Page

Dosing limits for continued therapy:

If request is for a dose increase, the new dose does not exceed the maximum dosing limits (up to 2,403 mg/day; e.g., 9 capsules or 3 tablets per day)

Approval duration: Authorization duration: 12 months

Member is not an active smoker

Evidence of negative cotinine test within 30 days required; added per 3Q2021 update

Formulation / generic redirection: Brand or generic pirfenidone covered; policy applies redirection to generic tablet or capsule formulations as specified

Revised 2022–2025 to include generic formulations and redirection rules

Related policy noteAdded per 3Q2021 annual review to align with pivotal trial inclusion criteria

Baseline pulmonary function — FVC and DLCO per pivotal trial inclusion criteria

Pivotal trial thresholdsBaseline FVC >= 50% predicted and DLCO >= 30% predicted must be met

Clinical contextClinical trials enrolled patients with mild-to-moderate impairment per FVC and DLCO

Policy additionBaseline pulmonary function thresholds were added in the 3Q2021 update to match trial inclusion criteria

Baseline pulmonary function tests: FVC >= 50% predicted and DLCO >= 30% predicted

Recent nicotine metabolite (cotinine) test within 30 days showing negative result

Evidence that known causes of pulmonary fibrosis have been ruled out

Documentation Required

Diagnosis Confirmation (HRCT / Pathology)

Imaging and pathology to confirm diagnosis must be provided. Lack of HRCT or pathologic confirmation may result in denial.

High-resolution CT (HRCT) showing UIP pattern, probable UIP, or indeterminate UIP
If HRCT is probable/indeterminate UIP, provide surgical biopsy, transbronchial cryobiopsy, or bronchoalveolar lavage (cellular analysis) confirming IPF
Pathology or biopsy reports when applicable

Prior Authorization

Generic-First Redirection for Esbriet

Requests for brand Esbriet will be redirected to generic pirfenidone unless there is documentation of a contraindication or a clinically significant adverse event to the generic product.

Generic-first redirection applies to tablet or capsule formulations (brand requests must document why generic cannot be used)
Template updated to allow either tablet or capsule generic formulation

Denial Risk

Denial Triggers / Risk

Denials may be issued when key approval criteria or required supporting documentation are missing.

No documentation confirming IPF diagnosis (HRCT or pathology/biopsy/BAL/cryobiopsy)
Missing baseline FVC or DLCO values or values below required thresholds
Failure to show pulmonologist involvement or consultation
Active smoking evidenced by a positive cotinine test within 30 days
Concurrent prescription with Ofev (nintedanib)

Note

Provider Action — Submit Complete Clinical Package

Provider action highlight: ensure all required charts, labs, imaging, and pathology/BAL/cryobiopsy reports are submitted at time of prior authorization to avoid processing delays.

Submit office chart notes, PFT reports (FVC, DLCO), HRCT images/reports, pathology or cryobiopsy reports, and recent cotinine test results
Document prior use of generic pirfenidone or reasons for brand Esbriet request

Required baseline DLCO value specified for coverage decisions

FVC — forced vital capacity

DefinitionFVC = forced vital capacity

AbbreviationListed in appendices as FVC: forced vital capacity

Use in policyRequired baseline FVC value specified for coverage decisions

UIP pattern on HRCT — definition/requirement

HRCT UIP pattern requirementHRCT demonstrating pulmonary fibrosis with a definite UIP pattern or a probable/indeterminate UIP pattern with confirmatory pathology is required

HoneycombingHoneycombing must be present for a definite HRCT diagnosis of UIP per ATS 2022

When biopsy is neededProbable or indeterminate UIP patterns require surgical lung biopsy, transbronchial cryobiopsy, or BAL cellular analysis to confirm diagnosis

Diagnostic confirmation — biopsy options including surgical biopsy, transbronchial lung cryobiopsy, or BAL per ATS guidelines

Acceptable diagnostic confirmation methodsSurgical (surgical lung) biopsy, transbronchial lung cryobiopsy, or cellular analysis of bronchoalveolar lavage (BAL)

Guideline basisOptions reflect recommendations in the 2022 ATS IPF diagnostic guidelines

Policy applicationBiopsy/cryobiopsy/BAL confirmation is required for probable or indeterminate UIP patterns per policy and must be documented for prior authorization