CurrentCareSourcePolicy N/A

PHARMACY POLICY STATEMENT Akansas PASSE

Pharmacy benefit policy defining prior authorization and clinical criteria for coverage of Esbriet (pirfenidone), limited to specified diagnoses (primarily idiopathic pulmonary fibrosis), with initial and reauthorization requirements and dosing limits.

Policy Summary

PayerCareSource

PolicyPHARMACY POLICY STATEMENT Akansas PASSE

Policy CodePolicy N/A

Change TypeUpdated (no material change)

Effective DateJan 1, 2022

Next Review Date

Key ActionPrior authorization is required; submit HRCT or lung biopsy results for IPF confirmation and documentation of baseline FVC (>=50% predicted), attest non-smoking and document absence of severe hepatic impairment.

SourceLink

POLICY UPDATE CHANGES

New policy for Esbriet created; split off from combined IPF policy with Ofev.

Removed prescriber specialty requirement

1Covered Indication (IPF)

6 monthsInitial approval duration

12 monthsReauthorization duration

>=50% predictedFVC baseline threshold

Coverage Summary

Scope: Pharmacy benefit policy defining prior authorization and clinical criteria for coverage of Esbriet (pirfenidone) for Idiopathic Pulmonary Fibrosis (IPF). Coverage stance: Covered with criteria when prior authorization requirements and documentation are met, including submission of diagnostic confirmation (HRCT or lung biopsy), baseline FVC, and other clinical requirements; prior authorization is required.

Quick thresholds

Baseline FVC>= 50% predicted

Initial approval duration6 months

Reauthorization duration12 months

Maximum daily dose801 mg three times per day (2403 mg/day total)

Initial Therapy Criteria

Indications considered for coverage

Esbriet (pirfenidone) will only be considered for coverage under the pharmacy benefit when ALL of the following are met for the listed disease state:

Diagnosis confirmation: Member has diagnosis of Idiopathic Pulmonary Fibrosis (IPF) confirmed by high resolution computed tomography (HRCT) or lung biopsy; results must be submitted for review
Age: Member is 18 years old or older
Baseline FVC: Documentation of member's baseline forced vital capacity (FVC)>= 50% predicted
Smoking: Member is not a current smoker and provider attests the member will not smoke during treatment
Hepatic impairment: Member does not have severe hepatic impairment (Child Pugh Class C)
Dosing and titration: Dosage titration to a maximum of 801 mg three times per day (total 2403 mg/day)
Specific day-by-day titration schedule text in the source is incomplete/malformed; maximum total daily dose is specified

Initial authorization duration

Approval duration if initial criteria met:

Initial authorization duration: If member meets all initial requirements above, medication will be approved for 6 months

Continuation / Reauthorization Criteria

Reauthorization criteria

For continuation of therapy, ALL of the following must be met:

FVC response: Chart notes must demonstrate reduced rate of FVC decline
Smoking abstinence: Member continues to abstain from smoking
Reauthorization duration: If reauthorization requirements are met, medication will be approved for an additional 12 months

Not Medically Necessary / Exclusions

Not medically necessary

Excluded uses:

Not medically necessary: Esbriet is considered not medically necessary for treatment of diseases that are not listed in this document

Provider Actions / Prior Authorization

Prior Authorization

Prior authorization required

Prior authorization is required under the pharmacy benefit; submit HRCT or lung biopsy results for IPF confirmation and documentation of baseline FVC.

Pharmacy benefit (Non-Preferred Product)

Documentation Required

Diagnostic and baseline documentation

Provider must submit HRCT or lung biopsy results and baseline FVC value (>=50% predicted) and attest the member is not a current smoker and will not smoke during treatment.

Documentation Required

Hepatic impairment exclusion

Provider must document absence of severe hepatic impairment (Child Pugh Class C).

Documentation Required

Reauthorization documentation

For reauthorization, chart notes must demonstrate reduced rate of FVC decline and continued documentation of smoking abstinence.

Billing Rule

Use valid NDC

Claims must use a valid NDC code when billing under the pharmacy benefit.

Background

Esbriet (pirfenidone) is indicated as an antifibrotic medication for idiopathic pulmonary fibrosis (IPF). Diagnostic confirmation by high resolution computed tomography (HRCT) or lung biopsy is required and results must be submitted for review. Baseline pulmonary function must be documented with forced vital capacity (FVC) and baseline FVC must be >= 50% predicted to meet initial criteria.

For appropriate use and continuation, the member must be 18 years or older, not a current smoker with provider attestation of no smoking during treatment, and must not have severe hepatic impairment (Child Pugh Class C). Initial approval is for 6 months with reauthorization for an additional 12 months if reauthorization criteria (including chart notes demonstrating reduced rate of FVC decline and continued smoking abstinence) are met.

Dosing/titration: policy notes titration to a maximum total daily dose of 801 mg three times per day (2403 mg/day total) (day-by-day titration details referenced but incomplete in source).

Definitions

IPFIdiopathic Pulmonary Fibrosis

FVCForced Vital Capacity

Revision History

06/22/2020added

New policy for Esbriet created; split off from combined IPF policy with Ofev.

12/21/2021revised

Removed prescriber specialty requirement

2022-01-01effectiveLatest

Policy effective 2022-01-01

Policy Summary

PayerCareSource

PolicyPHARMACY POLICY STATEMENT Akansas PASSE

Policy CodePolicy N/A

Change TypeUpdated (no material change)

Effective DateJan 1, 2022

Next Review Date

SourceLink

On This Page

OpenPayer

PHARMACY POLICY STATEMENT Akansas PASSE

Coverage Summary

Initial Therapy Criteria

Continuation / Reauthorization Criteria

Not Medically Necessary / Exclusions

Applicable Codes

Provider Actions / Prior Authorization

Clinical Evidence & References

Background

Revision History