CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Ofev (nintedanib) coverage for fibrosing ILDs including IPF and SSc-ILD

Defines coverage criteria for Ofev (nintedanib) for adults with idiopathic pulmonary fibrosis (IPF), chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype, and systemic sclerosis-associated ILD (SSc-ILD); includes documentation requirements, authorization duration, and continuation rules.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOfev (nintedanib) coverage for fibrosing ILDs including IPF and SSc-ILD

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionWhen requesting authorization, submit HRCT results; if performed, submit lung biopsy pathology report; include documentation that other known causes of ILD have been excluded and multidisciplinary discussion notes if biopsy not performed.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes noted in this brief.

3Covered Indications

12Authorization Duration (months)

>=10%HRCT fibrosis threshold

Coverage Summary & Indications

Scope: Defines coverage criteria for Ofev (nintedanib) for adults with idiopathic pulmonary fibrosis (IPF), chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype, and systemic sclerosis-associated ILD (SSc-ILD); includes documentation requirements, authorization duration, and continuation rules.

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Covered Indications and Per- indication Criteria

Ofev is covered for the FDA-approved indications below when ALL criteria are met and no exclusions to therapy exist:

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Prior Authorization & Documentation Requirements

Prior Authorization

Prior authorization required

Authorization review is required for Ofev. If approved, initial and continuation authorizations may be granted for up to 12 months per authorization.

Documentation Required

Submit diagnostic documentation

When requesting authorization, submit the result of a chest high-resolution computed tomography (HRCT) study. If a lung biopsy was performed, submit the associated pathology report. Include documentation that other known causes of interstitial lung disease have been excluded. If a biopsy was not performed, include multidisciplinary discussion notes between a radiologist and pulmonologist experienced in IPF.

HRCT results
Lung biopsy pathology report (if performed)
Documentation that other known causes of ILD were excluded
Multidisciplinary discussion notes if biopsy not performed

Documentation Required

Demonstrate progressive disease for chronic fibrosing ILD

Provide evidence of progressive disease for chronic fibrosing ILDs, such as a forced vital capacity (FVC) decline greater than or equal to 10% of predicted, worsening respiratory symptoms, or increased extent of fibrosis on HRCT.

FVC decline ≥ 10% predicted
Worsening respiratory symptoms
Increased extent of fibrosis on HRCT

Documentation Required

Confirm SSc-ILD diagnosis

Provide a high-resolution computed tomography (HRCT) study of the chest confirming systemic sclerosis-associated interstitial lung disease (SSc-ILD) for coverage.

Documentation Required

Exclude alternative causes for IPF

Document that other known causes of interstitial lung disease have been excluded, including domestic and occupational environmental exposures, connective tissue disease, and drug toxicity.

Environmental and occupational exposure history
Evaluation for connective tissue disease
Assessment for drug-induced ILD/toxicity

Clinical Evidence & Guidance Referenced

Key references: Raghu et al. 2022 ATS/ERS/JRS/ALAT guideline; Ofev [package insert], Boehringer Ingelheim, October 2022; Distler et al., N Engl J Med. 2019.

Background: Ofev (nintedanib) is indicated for adults with idiopathic pulmonary fibrosis (IPF), chronic fibrosing interstitial lung diseases with a progressive phenotype, and systemic sclerosis-associated interstitial lung disease (SSc-ILD) to slow the rate of decline in pulmonary function. The policy references FDA labeling and clinical guidelines for IPF and progressive pulmonary fibrosis and uses those indications and labeling as the basis for documentation and authorization requirements.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOfev (nintedanib) coverage for fibrosing ILDs including IPF and SSc-ILD

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

On This Page

OpenPayer

Ofev (nintedanib) coverage for fibrosing ILDs including IPF and SSc-ILD

Coverage Summary & Indications

Prior Authorization & Documentation Requirements

Applicable Codes

Clinical Evidence & Guidance Referenced

Definitions & Key Thresholds

Revision History