CurrentNeighborhood Health Plan of Rhode IslandPolicy 1882-A

Ofev (nintedanib) — coverage for pulmonary fibrosing diseases

Policy governs prior authorization, coverage criteria, and continuation for nintedanib (Ofev) for adults with IPF, chronic fibrosing ILDs with a progressive phenotype, and systemic sclerosis-associated ILD for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOfev (nintedanib) — coverage for pulmonary fibrosing diseases

Policy CodePolicy 1882-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit chest HRCT results and lung biopsy pathology report (if performed) to initiate prior authorization review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

>=10%HRCT fibrosis threshold

>=10%progression FVC decline

3 indicationscovered uses

Coverage Criteria for Ofev (nintedanib)

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IPF diagnostic work-up: Other known causes of interstitial lung disease (e.g., domestic and occupational environmental exposures, connective tissue disease, drug toxicity) have been excluded

Diagnostic confirmation for IPF: Either (i) HRCT or lung biopsy consistent with the usual interstitial pneumonia (UIP) pattern OR (ii) HRCT not showing UIP (e.g., probable UIP, indeterminate for UIP) with diagnosis supported by lung biopsy or, if biopsy not performed, by multidisciplinary discussion between an experienced radiologist and pulmonologist

If biopsy not done, multidisciplinary discussion required for non-UIP HRCT patterns

Chronic Fibrosing ILD with Progressive Phenotype (PPF)

Covered when ALL of the following are met

HRCT fibrosis extent: HRCT shows fibrosis affecting at least 10% of the lungs>=10%

Evidence of progression: Member has progressive disease demonstrated by one or more of: forced vital capacity (FVC) decline greater than or equal to 10% of predicted, worsening respiratory symptoms, or increased extent of fibrosis on HRCTFVC decline >=10%

Examples of progressive disease provided in policy

Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)

Covered when ALL of the following are met

Diagnostic confirmation for SSc-ILD: Diagnosis of systemic sclerosis-associated interstitial lung disease confirmed by high-resolution computed tomography (HRCT) of the chest

Authorization of 12 months may be granted when HRCT confirms diagnosis

Continuation of Therapy

Covered when ALL of the following are met

Continuation of therapy: Member is currently receiving treatment with Ofev (nintedanib)

Authorization of 12 months may be granted for continuation, including for new members transferring care

Coding and Key Diagnostic Thresholds

Policy Referencemixed

1882-A

Reference/policy number for Ofev (nintedanib)

inv-08: HRCT fibrosis extent threshold

HRCT fibrosis extent threshold>= 10% of lungs on HRCT

ContextRequired for diagnosis of progressive pulmonary fibrosis (PPF) to qualify for authorization

Source requirementMust be measured on a completed high-resolution computed tomography (HRCT) study of the chest

inv-09: FVC decline indicative of progression

FVC decline indicative of progression>= 10% of predicted (absolute decline)

Clinical examplesFVC decline >=10% may be used alone to demonstrate progressive disease for coverage consideration

DocumentationReported percent predicted FVC should be included in prior authorization materials

Prior Authorization & Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization for 12 months is required when approval criteria specific to the indication are met. Authorization of 12 months may be granted for covered indications (IPF, chronic fibrosing ILD with a progressive phenotype, and SSc-ILD) when the member meets the applicable diagnostic and documentation criteria.

Authorization duration: 12 months when criteria are met
Covered indications: IPF; chronic fibrosing ILDs with a progressive phenotype (PPF); systemic sclerosis-associated ILD (SSc-ILD)

Note

Continuation and Other Considerations

Continuation authorizations of 12 months may be granted for current members who are currently receiving treatment with Ofev. If the member is a current smoker, counsel on smoking cessation and the harmful effects of smoking on pulmonary conditions.

Continuation authorization: 12 months for members currently receiving treatment
Counsel current smokers on cessation and harms

Documentation Required

Required Documentation for Prior Authorization

Submit the following documentation to initiate the prior authorization review where applicable.

Result of a chest high-resolution computed tomography (HRCT) study
Pathology report of lung biopsy (if performed)

Denial Risk

Other Indications

All indications other than the FDA-approved indications listed (IPF; chronic fibrosing ILDs with a progressive phenotype; SSc-ILD) are considered experimental/investigational and not medically necessary.

Non‑FDA or non‑specified indications: Experimental/investigational — Not medically necessary

Background

Nintedanib (Ofev) is FDA-approved for three adult indications: (1) treatment of idiopathic pulmonary fibrosis (IPF); (2) treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype; and (3) slowing the rate of decline in pulmonary function in systemic sclerosis-associated interstitial lung disease (SSc-ILD). Documentation and authorization requirements in this policy align with these labeled indications.

Definitions

inv-15: Usual Interstitial Pneumonia (UIP) pattern

DefinitionHRCT or lung biopsy result consistent with the usual interstitial pneumonia (UIP) pattern used to support diagnosis of idiopathic pulmonary fibrosis (IPF)

Diagnostic pathwayUIP on HRCT or lung biopsy supports IPF diagnosis; if HRCT is non‑UIP, a supporting lung biopsy or multidisciplinary discussion is required

Required testingHigh-resolution computed tomography (HRCT) of the chest or lung biopsy results must be submitted for prior authorization

inv-16: Progressive pulmonary fibrosis (PPF)

Definition of PPF for coverageChronic fibrosing ILD with fibrosis affecting >=10% of the lungs on HRCT plus clinical progression (e.g., FVC decline >=10% predicted, worsening respiratory symptoms, or increased extent of fibrosis on HRCT)

Imaging requirementHRCT showing fibrosis in at least 10% of the lungs is required to meet the PPF criterion

Progression criteria examplesProgression may be demonstrated by FVC decline >=10% predicted, worsening respiratory symptoms, or increased fibrosis extent on follow‑up HRCT

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOfev (nintedanib) — coverage for pulmonary fibrosing diseases

Policy CodePolicy 1882-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit chest HRCT results and lung biopsy pathology report (if performed) to initiate prior authorization review.

SourceLink

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