CurrentCignaPolicy N/A

Idiopathic Pulmonary Fibrosis and Related Lung Disease - Pirfenidone Preferred Specialty Management Policy

Defines Cigna's preferred specialty management and prior authorization expectations for pirfenidone products used to treat idiopathic pulmonary fibrosis, including preferred vs non-preferred products and exception criteria for non-preferred formulations. Applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyPirfenidone Preferred Specialty Management (Idiopathic Pulmonary Fibrosis and Related Lung Disease)

Policy CodePolicy N/A

Change TypeRevised exception criteria

Effective DateN/A

Next Review DateJul 16, 2025

Key ActionObtain prior authorization and document prior trial of generic pirfenidone or prescriber justification of formulation-related allergy to support non-preferred product exceptions.

SourceLink

POLICY UPDATE CHANGES

The requirement that a patient cannot take generic pirfenidone was updated to specify that the reason must be a formulation difference in inactive ingredients (e.g., dyes, fillers, preservatives) that the prescriber says would result in a significant allergy or serious adverse reaction.

1 yearauthorization duration for approvals

6preferred products

Exception requirednon-preferred condition

Requireddocumentation

Coverage and Exception Criteria

Non-Preferred Product Exception Criteria

Approve for 1 year if the patient meets BOTH of the following (A and B):

A: Patient meets the standard Idiopathic Pulmonary Fibrosis and Related Lung Disease - Pirfenidone Prior Authorization Policy criteria.

i: Patient has tried generic pirfenidone.
Documentation required
ii: Patient cannot take generic pirfenidone due to a formulation difference in the inactive ingredient(s) (e.g., difference in dyes, fillers, preservatives) which, per the prescriber, would result in a significant allergy or serious adverse reaction.
Documentation required

Policy Summary

PayerCigna

PolicyPirfenidone Preferred Specialty Management (Idiopathic Pulmonary Fibrosis and Related Lung Disease)

Policy CodePolicy N/A

Change TypeRevised exception criteria

Effective DateN/A

Next Review DateJul 16, 2025

Key ActionObtain prior authorization and document prior trial of generic pirfenidone or prescriber justification of formulation-related allergy to support non-preferred product exceptions.

SourceLink

On This Page

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Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

All medications (Preferred and Non-Preferred) require meeting the standard Idiopathic Pulmonary Fibrosis and Related Lung Disease - Pirfenidone prior authorization criteria. Requests for Non-Preferred products will be reviewed using the exception criteria. Approvals for Preferred and Non-Preferred products are provided for 1 year.

Prior authorization required for all products — approval contingent on meeting the applicable Pirfenidone prior authorization policy criteria.
Approvals (Preferred and Non-Preferred) are authorized for 1 year.

Step Therapy

Step therapy (try preferred first)

Patients are required to try Preferred Products (generic pirfenidone) before Non-Preferred products will be approved unless exception criteria are met. If the patient meets the standard prior authorization criteria but has not tried the generic Preferred product, approval for the generic Preferred product will be authorized.

Step therapy: trial of generic pirfenidone required prior to approval of branded or other Non-Preferred pirfenidone products.
Exceptions to step therapy are considered under the Non-Preferred Product Exception Criteria when documented reasons are provided.

Documentation Required

Required documentation

Documentation is required where noted in the criteria as [documentation required]. Documentation may include, but is not limited to, chart notes, prescription claims records, and other pertinent clinical information to support prior authorization requests and exceptions.

Provide chart notes, prescription claims records, and prescriber documentation when requested.
For exception requests (e.g., inability to tolerate generic formulation), include documentation supporting the clinical rationale (allergy or serious adverse reaction) and evidence the preferred product was tried.

Denial Risk

Coding and billing denial risk

Claims submitted for services that are not accompanied by covered diagnosis or procedure codes under the applicable coverage policy will be denied as not covered. When billing, providers must use the most appropriate codes as of the effective date of submission.

Coding and billing denial risk: submit covered diagnosis/procedure codes that match the applicable coverage policy.
Claims lacking covered codes for the service or drug will be denied.

OpenPayer

Idiopathic Pulmonary Fibrosis and Related Lung Disease - Pirfenidone Preferred Specialty Management Policy

Coverage and Exception Criteria

Coding Guidance

Provider Actions and Requirements

Background

Definitions