CurrentAvMedPolicy N/A

Pirfenidone (Esbriet) prior authorization and step-edit request

Form and clinical criteria that govern prior authorization and step-edit approval for pirfenidone (Esbriet) for AvMed members, affecting prescribers, specialty pharmacies, and member benefit adjudication.

Policy Summary

PayerAvMed

PolicyPirfenidone (Esbriet) prior authorization and step-edit request

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must complete and sign the prior authorization/step-edit request form and provide supporting clinical documentation including PFTs, HRCT or biopsy reports, and chart notes.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moinitial approval duration

6 moreauthorization duration

FVC 50-90%baseline FVC required

DLCO 30-90%baseline DLCO required

Prohibitedconcomitant OFEV

Coverage Criteria for Pirfenidone (Esbriet)

inv-01: Initial Therapy — Covered when ALL of the following are met for Initial Authorization

Covered when ALL of the following are met for Initial Authorization

Initial Authorization for Pirfenidone: Member has diagnosis of idiopathic pulmonary fibrosis (IPF); prescribed by or in consultation with a pulmonology specialist; diagnosis confirmed by excluding other causes of interstitial lung disease; HRCT consistent with idiopathic fibrosis or probable IPF; if HRCT not definitive then lung biopsy confirming IPF; baseline FVC 50-90% predicted; baseline DLCO 30-90% predicted; no concomitant use of OFEV (nintedanib).see child nodes

Supporting documentation (PFT reports, HRCT report, biopsy pathology, chart notes) must be provided

inv-02: Continuation/Reauthorization — Reauthorization covered when ALL of the following are met

Reauthorization covered when ALL of the following are met

Reauthorization for Pirfenidone:

Policy Summary

PayerAvMed

PolicyPirfenidone (Esbriet) prior authorization and step-edit request

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must complete and sign the prior authorization/step-edit request form and provide supporting clinical documentation including PFTs, HRCT or biopsy reports, and chart notes.

SourceLink

On This Page

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.

Coding and Clinical Measures

Diagnosis codes (to be provided by prescriber)ICD-10

ICD Code (if applicable) — blank on form; prescriber to supply

inv-05: Forced Vital Capacity (FVC) — baseline requirement 50-90% of predicted

Baseline FVC requirementForced Vital Capacity (FVC) measured at 50-90% of predicted value (supporting PFT report and/or chart notes required)

DocumentationProvide pulmonary function test (PFT) report and/or chart notes showing FVC result

Use for decisionsBaseline FVC used to determine eligibility for initiation of pirfenidone therapy

Reauthorization relevancePFTs will be used during reauthorization to document stability or response (change in %FVC vs baseline)

inv-06: Diffusing capacity for carbon monoxide (DLCO) — baseline requirement 30-90% of predicted

Baseline DLCO requirementDiffusing capacity for carbon monoxide (DLCO) measured at 30-90% of predicted value (supporting PFT report and/or chart notes required)

DocumentationProvide pulmonary function test (PFT) report and/or chart notes showing DLCO result

Use for decisionsBaseline DLCO used alongside FVC to assess severity prior to initiating pirfenidone

Reauthorization relevancePFTs including DLCO may be used to support continued coverage and assessment of disease stability

Initial Authorization Requirements

inv-13: Initial Authorization — detailed initial authorization criteria

Initial authorization — all criteria must be met and supported by documentation

Initiation: Member has a diagnosis of Idiopathic Pulmonary Fibrosis (IPF).

Diagnosis must be confirmed by excluding other causes of interstitial lung disease (environmental exposure, drug toxicity, connective tissue disease).

Specialist Involvement: Prescribed by or in consultation with a pulmonology specialist.

Diagnostic Confirmation: High-resolution computed tomography (HRCT) demonstrating idiopathic fibrosis or probable IPF; if HRCT is not definitive, lung biopsy confirming IPF is required.

Attach HRCT report or pathology report as applicable.

Pulmonary Function Testing - FVC: Baseline forced vital capacity (FVC) is 50-90% of predicted value.50-90% of predicted value

Provide supporting documentation including PFT report and/or chart notes.

Pulmonary Function Testing - DLCO: Baseline carbon monoxide (CO) diffusing capacity (DLCO) is 30-90% of predicted value.30-90% of predicted value

Provide supporting documentation including PFT report and/or chart notes.

Concomitant Therapy Exclusion: No concomitant use of OFEV (nintedanib) with pirfenidone.

Documentation Requirement: Supporting documentation (PFTs, HRCT report, biopsy pathology, and chart notes) must be provided to substantiate each criterion checked.

Requests may be denied if documentation is not provided.

Reauthorization / Continuation Criteria

inv-14: Reauthorization — reauthorization criteria for continued coverage

Reauthorization — all criteria must be met and supported by documentation

Continued Diagnostic Criteria: Member continues to meet the diagnostic criteria for IPF (per initial confirmation).

Absence of Significant Toxicity: Member is not experiencing liver toxicity, significant GI adverse events (including diarrhea, nausea, vomiting, perforation), arterial thromboembolic events, or signs of photosensitivity.

For female patients, periodic pregnancy testing must be performed.

Clinical Response or Stability: Documentation demonstrates current disease state is stable or has responded, specifically a reduction in the rate of decline in percent predicted FVC compared to the pre-treatment baseline.documentation of stability or response required

Provide PFTs and chart notes to support response/stability.

Authorization Period: Reauthorization approvals are granted for 6 months when all reauthorization criteria are met.

Provider Responsibilities and Submission Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. The prescribing physician must complete, sign (handwritten signature; preprinted stamps not acceptable), and clearly print their name on the PA/step-edit request form. Fax the completed form and all supporting clinical documentation to 1-305-671-0200. Incomplete, incorrect, or illegible forms (including missing phone/fax numbers) or missing supporting documentation may delay or result in denial of authorization.

Fax number: 1-305-671-0200
Prescriber signature and printed name required (preprinted stamps not valid)
Handwritten date required

Step Therapy

Step-Edit / Samples

Samples do not satisfy step-edit or prior authorization requirements. If therapy was initiated with a sample, the member must still meet step-edit/PA criteria and provide documentation of prior therapies through pharmacy paid claims or submitted chart notes.

Use of samples to initiate therapy does not meet step edit/preauthorization criteria
Previous therapies will be verified through pharmacy paid claims or submitted chart notes

Documentation Required

Required Documentation and Form Completion

Required documentation must accompany the PA form. The prescriber must provide member and prescriber identifiers, drug name/formulation/strength, dosing schedule, length of therapy requested, diagnosis (with ICD code if applicable), weight, and date. Clinical documentation supporting each checked clinical criterion (lab results, PFT reports, HRCT, biopsy reports, chart notes) must be supplied.

Member name and AvMed ID
Member date of birth
Prescriber name, DEA or NPI number, office contact, phone and fax
Drug requested (name, form/strength), dosing schedule, length of therapy
Diagnosis and ICD code (if applicable)
Weight and date
Supporting clinical documentation: PFT reports (including FVC and DLCO), HRCT, biopsy reports, lab results, chart notes

Denial Risk

Incomplete or Missing Documentation

Incomplete, illegible, or missing information on the PA form (including missing prescriber signature, missing contact numbers, or absent supporting clinical documentation) may delay the review or lead to denial. Ensure all fields are accurate and legible before faxing.

Authorization may be delayed or denied for incomplete/incorrect/illegible forms
Ensure phone and fax numbers are provided and legible
Provide all requested supporting documentation to avoid delays

Requirement	Details
Documentation of prior therapies may be required
Use of samples to initiate therapy does not meet step edit/preauthorization criteria; previous therapies will be verified through pharmacy paid claims or submitted chart notes.

Background Information

Pirfenidone (Esbriet) is an antifibrotic agent indicated for the treatment of idiopathic pulmonary fibrosis (IPF). Clinical assessment for IPF typically includes exclusion of other causes of interstitial lung disease, high-resolution CT imaging consistent with idiopathic fibrosis (or lung biopsy if imaging is not definitive), and pulmonary function testing to establish baseline disease severity prior to initiating therapy. Baseline testing required for initiation includes forced vital capacity (FVC) 50–90% of predicted and diffusing capacity for carbon monoxide (DLCO) 30–90% of predicted; supporting documentation (PFT reports, HRCT report, biopsy pathology, and chart notes) must be provided with the prior authorization request.

OpenPayer