CurrentCignaPolicy IP0312

Pulmonary - Antifibrotics - Ofev

Defines Cigna prior authorization and medical necessity criteria for Ofev (nintedanib capsules) for FDA-approved indications: idiopathic pulmonary fibrosis (IPF), progressive pulmonary fibrosis (chronic fibrosing ILDs with a progressive phenotype), and interstitial lung disease associated with systemic sclerosis. Includes age, baseline FVC thresholds, diagnostic documentation requirements, prescriber specialty requirements, duration of approval, individual/family plan preferred product step, and exclusions.

Policy Summary

PayerCigna

PolicyPulmonary - Antifibrotics - Ofev

Policy CodePolicy IP0312

Change TypeAnnual revision (title and criteria updates)

Effective DateMar 15, 2026

Next Review Date

Key ActionObtain prior authorization for Ofev and ensure prescribing is by or in consultation with a specialist (pulmonologist or rheumatologist) and required documentation is provided.

SourceLink

POLICY UPDATE CHANGES

Policy name updated from 'Nintedanib' to 'Idiopathic Pulmonary Fibrosis and Related Lung Disease - Ofev'.

Simplified diagnostic confirmation options for IPF initial therapy.

Diagnostic exclusion criterion removed.

Replaced prior documentation wording with prescriber-attestation language.

Applies to continuation criteria for current Ofev recipients.

Previously only pulmonologist was listed.

Multiple documentation-required flags added to baseline FVC and diagnostic items.

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Coverage summary

Defines Cigna prior authorization and medical necessity criteria for Ofev (nintedanib) for FDA-approved indications: idiopathic pulmonary fibrosis (IPF), progressive pulmonary fibrosis (chronic fibrosing ILDs with a progressive phenotype), and interstitial lung disease associated with systemic sclerosis. Approvals are issued for 1 year. Policy requires patients to be at least 18 years of age and have a baseline forced vital capacity (FVC) of at least 40% of predicted (documentation required). Diagnostic confirmation and documentation requirements apply per indication, and the medication must be prescribed by or in consultation with an appropriate specialist (pulmonologist; pulmonologist or rheumatologist where specified). For Individual & Family Plans initial IPF therapy, a step requirement is applied (trial of pirfenidone/Esbriet or prior start on Ofev as specified).

Ofev for any other use is considered not medically necessary (exclusions include, for example, concomitant use with Esbriet/pirfenidone per the Exclusion section).

Idiopathic Pulmonary Fibrosis (IPF) — Initial and Continuation Therapy

Idiopathic Pulmonary Fibrosis (IPF) - FDA-Approved Indication

Approve for 1 year if the patient meets ONE of the following (A or B):

A) Initial Therapy

Patient is ≥ 18 years of age
Forced vital capacity is ≥ 40% of the predicted value≥ 40%
[documentation required]
Diagnosis confirmation (ONE of)
- Findings on high-resolution computed tomography indicate usual interstitial pneumonia
  [documentation required]
- A surgical lung biopsy demonstrates usual interstitial pneumonia
  [documentation required]
Medication is prescribed by or in consultation with a pulmonologist
Preferred product criteria is met for the product as listed in the Individual and Family Plans - Idiopathic Pulmonary Fibrosis - Initial Therapy table

Progressive Pulmonary Fibrosis (Chronic Fibrosing ILDs with Progressive Phenotype) — Initial and Continuation Therapy

Progressive Pulmonary Fibrosis (Chronic Fibrosing ILDs with Progressive Phenotype) - FDA-Approved Indication

Approve for 1 year if the patient meets ONE of the following (A or B):

A) Initial Therapy

Patient is ≥ 18 years of age
Forced vital capacity is ≥ 40% of the predicted value≥ 40%
[documentation required] (baseline)
According to the prescriber, the patient has fibrosing lung disease impacting more than 10% of lung volume on high-resolution computed tomography> 10%

Interstitial Lung Disease Associated with Systemic Sclerosis — Initial and Continuation Therapy

Interstitial Lung Disease Associated with Systemic Sclerosis - FDA-Approved Indication

Approve for 1 year if the patient meets ONE of the following (1 or 2):

1. Initial Therapy

Patient is ≥ 18 years of age
Forced vital capacity is ≥ 40% of the predicted value≥ 40%
[documentation required]
Diagnosis is confirmed by high-resolution computed tomography
[documentation required]

Individual & Family Plans — IPF Initial Therapy Preferred Product Requirement

Individual and Family Plans - Idiopathic Pulmonary Fibrosis - Initial Therapy (Preferred Product Table requirement)

Patient meets ONE of the following (1 or 2):

ANY of the following

Patient has tried and cannot take pirfenidone tablet (generic Esbriet tablet)
[may require prior authorization]
Patient has already been started on therapy with Ofev.

Unproven / Not Medically Necessary Uses

Exclusion - Not Medically Necessary Uses

Ofev for any other use is considered not medically necessary, including:

Concomitant use of Ofev with Esbriet (pirfenidone capsules) is not covered

Effectiveness and safety of concomitant use have not been established; guideline does not recommend combination

Provider actions and documentation requirements

Prior Authorization

Prior authorization required

Prior Authorization is required for benefit coverage of Ofev. All approvals are provided for 1 year. Medication must be prescribed by or in consultation with a specialist (pulmonologist or, where specified, rheumatologist).

Documentation Required

Documentation requirements

Documentation is required for specified criteria and must include patient-specific identifying information. Required documentation items include: baseline forced vital capacity (FVC); HRCT findings or surgical lung biopsy demonstrating usual interstitial pneumonia (where applicable); extent of fibrosing disease (e.g., >10% lung volume for progressive PF per prescriber); and clinical signs of progression (examples: FVC decline ≥10% predicted, or FVC decline ≥5% to <10% with worsening symptoms and/or imaging). Acceptable forms of documentation include chart notes, laboratory tests, claims records, and/or other information. All documentation must include patient identifiers.

Applicable codes

NDC / DrugNDC

No codes listed

Clinical evidence summary

INPULSIS: n=1,231INPULSIS Phase III IPF trials (Ofev reduced annual FVC decline vs placebo)

INBUILD: n=663INBUILD Phase III trial (reduced rate of FVC decline in chronic fibrosing ILDs with progression)

SENSCIS: n=576SENSCIS Phase III trial (reduced annual FVC decline in systemic sclerosis–associated ILD)

Clinical trials demonstrated efficacy of Ofev in reducing the annual rate of decline in forced vital capacity (FVC): the INPULSIS Phase III IPF program (n=1,231) showed reduced annual FVC decline versus placebo; the INBUILD trial (n=663) showed reduced rate of FVC decline in chronic fibrosing ILDs with a progressive phenotype; and the SENSCIS trial (n=576) demonstrated reduced annual FVC decline versus placebo in systemic sclerosis-associated ILD.

The safety and effectiveness of Ofev in pediatric patients have not been established.

Background and definitions

Ofev is an FDA-approved antifibrotic kinase inhibitor indicated for: idiopathic pulmonary fibrosis (IPF), interstitial lung diseases, chronic fibrosing with a progressive phenotype (progressive pulmonary fibrosis), and interstitial lung disease associated with systemic sclerosis.

Key trials supporting approvals include the INPULSIS program for IPF, the INBUILD trial for chronic fibrosing ILDs with progression, and the SENSCIS trial for systemic sclerosis-associated ILD; these trials evaluated Ofev 150 mg twice daily vs placebo with primary endpoints focused on the annual rate of decline in FVC.

The policy notes that the safety and effectiveness of Ofev in pediatric patients have not been established.

Term	Definition
{"text":"Baseline","status":""},{"text":"Measurement before a patient has started any antifibrotic therapies.","status":""}
{"text":"Clinical signs of progression","status":""},{"text":"Examples include FVC decline ≥ 10% predicted, or FVC decline ≥ 5% to < 10% with worsening symptoms and/or worsening imaging.","status":""}

Revision history

10/15/2024title_change

Policy name updated from 'Nintedanib' to 'Idiopathic Pulmonary Fibrosis and Related Lung Disease - Ofev'.

10/15/2024diagnostic_simplification (material)

Simplified diagnostic confirmation for IPF initial therapy: removed examples of HRCT findings that indicate usual interstitial pneumonia and removed the requirement that both HRCT and biopsy pattern indicate 'probable' UIP.

10/15/2024diagnostic_exclusion_removed (material)

Removed the diagnostic exclusion criterion to exclude other potential causes of interstitial lung disease (e.g., medication use, environmental exposures).

Step Therapy

Preferred product / step requirement for Individual & Family Plans

For Individual and Family Plans (IPF initial therapy), the member must have tried and cannot take pirfenidone (Esbriet) OR have already been started on Ofev. A trial of pirfenidone in any listed form (Esbriet capsules, pirfenidone tablets, or the brand version of a generic equivalent) counts toward the requirement. Prior authorization may be required for exceptions to the Esbriet trial.

Trial of Esbriet (pirfenidone) in any acceptable form counts (capsules, tablets, or brand of generic equivalent)
Prior authorization may be required for exceptions to the Esbriet trial requirement

Documentation Required

Specialist consultation requirement

Ofev must be prescribed by or in consultation with a physician who specializes in the condition being treated. Specialist requirements: pulmonologist for idiopathic pulmonary fibrosis (IPF); pulmonologist or rheumatologist for progressive pulmonary fibrosis and systemic sclerosis–associated ILD. Prescription may be by the specialist or by another prescriber in consultation with the specialist.

Pulmonologist required for IPF
Pulmonologist or rheumatologist required for progressive PF and SSc-ILD
Prescription may be by or in consultation with the specialist