CurrentCignaPolicy N/A

Idiopathic Pulmonary Fibrosis and Related Lung Disease - Authorization Policy

Defines prior authorization requirements and medical necessity criteria for coverage of Ofev for IPF, chronic fibrosing interstitial lung diseases with a progressive phenotype, and systemic sclerosis-associated interstitial lung disease for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyIdiopathic Pulmonary Fibrosis and Related Lung Disease - Authorization Policy

Policy CodePolicy N/A

Change TypeAnnual revision — no criteria changes

Effective DateN/A

Next Review DateJul 16, 2025

Key ActionObtain prior authorization and document diagnosis, age, FVC percent predicted, diagnostic confirmation, and that prescribing is by or in consultation with an appropriate specialist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3FDA‑approved indications listed

1 yrtypical approval duration

≥18minimum patient age

FVC ≥40%baseline FVC requirement

No changesAnnual revisions

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Coverage and Medical Necessity Criteria

Idiopathic Pulmonary Fibrosis (IPF)

Covered when ONE of the following is met for Idiopathic Pulmonary Fibrosis (approve for 1 year):

IPF: Initial therapy OR current therapy: A) Initial Therapy: ALL of (i) patient is ≥ 18 years of age; (ii) forced vital capacity (FVC) is ≥ 40% of predicted; (iii) diagnosis confirmed by ONE of: (a) HRCT findings indicate usual interstitial pneumonia (UIP) OR (b) surgical lung biopsy demonstrates UIP; (iv) medication is prescribed by or in consultation with a pulmonologist. OR B) Patient is Currently Receiving Ofev: ALL of (i) patient is ≥ 18 years of age; (ii) patient has experienced a beneficial response to therapy over the last year while receiving Ofev (for patients on therapy <1 year, response is assessed from baseline prior to initiating Ofev; examples include reduced anticipated decline in FVC, improved 6‑minute walk distance, or fewer/severe IPF exacerbations); (iii) medication is prescribed by or in consultation with a pulmonologist.see node text

Approve duration: 1 year.

Chronic Fibrosing ILD with Progressive Phenotype

Covered when ONE of the following is met for Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype (approve for 1 year):

Progressive fibrosing ILD: Initial therapy OR current therapy: A) Initial Therapy: ALL of (i) patient is ≥ 18 years of age; (ii) forced vital capacity (FVC) is ≥ 40% of predicted; (iii) prescriber states fibrosing lung disease impacts >10% of lung volume on HRCT; (iv) prescriber states clinical signs of progression (examples: FVC decline ≥10% OR FVC decline ≥5% to <10% with worsening symptoms and/or imaging); (v) medication is prescribed by or in consultation with a pulmonologist. OR B) Patient is Currently Receiving Ofev: ALL of (i) patient is ≥ 18 years of age; (ii) patient has experienced a beneficial response to therapy over the last year while receiving Ofev (for patients on therapy <1 year, response is assessed from baseline; examples include reduced anticipated decline in FVC, improved 6‑minute walk distance, or fewer/severe ILD‑related exacerbations); (iii) medication is prescribed by or in consultation with a pulmonologist.see node text

Approve duration: 1 year.

Systemic Sclerosis‑Associated ILD

Covered when ONE of the following is met for Interstitial Lung Disease Associated with Systemic Sclerosis (approve for 1 year):

Systemic sclerosis-associated ILD: Initial therapy OR current therapy: A) Initial Therapy: ALL of (i) patient is ≥ 18 years of age; (ii) forced vital capacity (FVC) is ≥ 40% of predicted; (iii) diagnosis confirmed by high‑resolution computed tomography (HRCT); (iv) medication is prescribed by or in consultation with a pulmonologist or rheumatologist. OR B) Patient is Currently Receiving Ofev: ALL of (i) patient is ≥ 18 years of age; (ii) patient has experienced a beneficial response to therapy over the last year while receiving Ofev (for patients on therapy <1 year, response is assessed from baseline; examples include reduced anticipated decline in FVC, improved 6‑minute walk distance, or fewer/severe disease‑related exacerbations); (iii) medication is prescribed by or in consultation with a pulmonologist or rheumatologist.see node text

Approve duration: 1 year.

Ofev (nintedanib) is considered not medically necessary for any uses not expressly listed as covered. The policy specifically states that off‑label or other uses outside the covered indications are not covered and that the conditions‑not‑covered list may be updated as new published data become available.

No additional explicit exclusions are listed in this portion of the document beyond the conditions‑not‑covered section; the history notes that annual reviews occurred with no criteria changes during the documented review dates.

Concurrent use of Ofev with Esbriet (pirfenidone) is listed as not medically necessary. The policy explains that the effectiveness and safety of the combination have not been established and cites guideline recommendations that do not support combined use.

No additional not medically necessary statements are present on these pages of the policy; the document records routine annual revisions with no criteria changes at the listed review dates.

Clinical Thresholds and Diagnostic Parameters

inv-08: Forced vital capacity (FVC) percent predicted — Thresholds

Routine baseline requirementForced vital capacity (FVC) percent predicted generally must be ≥ 40% for covered indications; used as an inclusion/approval threshold.

INBUILD trial requirement (chronic fibrosing ILD)INBUILD required FVC ≥ 45% predicted for trial enrollment; referenced as a higher threshold in trial context.

Approval duration tied to FVC criteriaApprovals (initial or renewal) are provided for 1 year when the patient meets the FVC threshold as part of the indication-specific criteria.

inv-09: Extent of fibrosis on HRCT — Imaging thresholds

Primary imaging threshold> 10% lung volume of fibrotic features on high-resolution computed tomography (HRCT) as stated by the prescriber for chronic fibrosing ILD with a progressive phenotype.

Prior Authorization, Documentation, and Denial Risk

Prior Authorization

Prior Authorization Required

Prior authorization required — Prior authorization is recommended for Ofev. Approvals are generally for 1 year and require that Ofev be prescribed by or in consultation with a specialist (e.g., pulmonologist or rheumatologist where indicated).

Approvals typically granted for 1 year
Prescriber must be a specialist or consult with one

Documentation Required

Required Documentation

Required documentation — Providers should document the diagnosis, patient age, forced vital capacity (FVC) percent predicted, diagnostic confirmation (HRCT or surgical lung biopsy when required by indication), and evidence of clinical progression or beneficial response when applicable.

Diagnosis and supporting imaging/biopsy (HRCT or surgical lung biopsy)
Patient age (≥ 18 years)

Clinical Background

Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive fibrosing interstitial pneumonia characterized by a usual interstitial pneumonia (UIP) pattern on high‑resolution CT or surgical lung biopsy. It primarily affects older adults and is associated with progressive dyspnea, declining pulmonary function (notably forced vital capacity), and a poor prognosis. Ofev (nintedanib) is a tyrosine kinase inhibitor approved to slow the decline in FVC in IPF and related fibrosing interstitial lung diseases; when covered by this policy, approvals are generally provided for 1 year with criteria that require diagnostic confirmation and specialist involvement.

Key Definitions

inv-19: IPF definition

Core definitionIdiopathic pulmonary fibrosis (IPF) is a chronic interstitial lung pneumonia associated with the usual interstitial pneumonia (UIP) histologic pattern on HRCT or surgical lung biopsy.

Clinical featuresIPF typically presents with progressive exertional dyspnea and a chronic dry cough and primarily affects older adults.

Diagnostic confirmationDiagnosis is confirmed by HRCT showing UIP pattern or by surgical lung biopsy demonstrating UIP, as required in the policy's coverage criteria.

inv-20: Progressive fibrosing ILD

Working definitionProgressive fibrosing interstitial lung disease (PF-ILD) is a chronic fibrosing ILD with a progressive phenotype characterized by fibrotic features affecting >10% of lung volume on HRCT plus clinical progression.

Examples of clinical progression

Policy Revision History

2025-07-16Annual revisionLatest

Annual revision completed; no coverage criteria changes documented.

2024-07-10Annual revision

Annual revision completed; no coverage criteria changes documented.

2023-06-28Annual revision

Annual revision completed; no coverage criteria changes documented.