CurrentNeighborhood Health Plan of Rhode IslandPolicy 1882-A

Ofev (nintedanib) coverage for fibrosing interstitial lung diseases

Defines medical necessity and authorization requirements for Ofev (nintedanib) for adults with idiopathic pulmonary fibrosis, chronic fibrosing interstitial lung diseases with a progressive phenotype, and systemic sclerosis-associated interstitial lung disease for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOfev (nintedanib) coverage for fibrosing interstitial lung diseases

Policy CodePolicy 1882-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit HRCT results (and lung biopsy pathology if performed) to initiate authorization review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

>=10%minimum HRCT fibrosis extent

>=10% FVCprogression threshold (FVC)

adultsindicated population

Coverage Criteria for Ofev (nintedanib)

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Idiopathic Pulmonary Fibrosis (IPF)

Covered for idiopathic pulmonary fibrosis when ALL of the following are met

IPF diagnostic criteria: Other known causes of interstitial lung disease (e.g., domestic and occupational environmental exposures, connective tissue disease, drug toxicity) have been excluded AND the member has undergone diagnostic work-up including either: HRCT consistent with a usual interstitial pneumonia (UIP) pattern OR HRCT not UIP (e.g., probable UIP or indeterminate for UIP) supported by lung biopsy; if no lung biopsy, diagnosis must be supported by multidisciplinary discussion between an experienced radiologist and pulmonologist.

Authorization of 12 months may be granted.

Chronic Fibrosing ILD with Progressive Phenotype

Covered for chronic fibrosing interstitial lung diseases with a progressive phenotype when ALL of the following are met

Chronic fibrosing ILD progression criteria: HRCT shows fibrosis affecting at least 10 percent of the lungs AND the member has progressive disease defined by: >=10% absolute decline in FVC percent predicted OR worsening respiratory symptoms OR increased extent of fibrosis on HRCT.fibrosis >=10%; FVC decline >=10%

Authorization of 12 months may be granted.

Systemic Sclerosis-Associated ILD (SSc-ILD)

Covered for systemic sclerosis-associated interstitial lung disease when ALL of the following are met

SSc-ILD diagnostic criteria: Diagnosis confirmed by high-resolution computed tomography (HRCT) study of the chest demonstrating interstitial lung disease.

Authorization of 12 months may be granted.

Continuation of Therapy

Continuation therapy

Continuation: Members currently receiving Ofev for an indication listed in this policy (including new members already on therapy) may be granted authorization for 12 months.

Authorization of 12 months may be granted.

All indications for Ofev (nintedanib) that are not among the FDA‑approved or compendial uses listed in this policy are considered experimental/investigational and are not covered. This includes any use beyond treatment of idiopathic pulmonary fibrosis (IPF), chronic fibrosing interstitial lung diseases with a progressive phenotype, or systemic sclerosis‑associated interstitial lung disease (SSc‑ILD).

Use of Ofev for indications not listed in this policy (i.e., uses other than for IPF, chronic fibrosing ILD with a progressive phenotype, or SSc‑ILD) is not medically necessary and will not be authorized.

Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Ofev (nintedanib). Authorization of up to 12 months may be granted when clinical criteria for the specific indication are met.

Authorization may be granted for up to 12 months for: IPF; chronic fibrosing ILD with a progressive phenotype; and systemic sclerosis-associated ILD (SSc-ILD).
All members (including new members) currently receiving Ofev for a listed indication may be granted a 12-month continuation authorization.

Documentation Required

Required Clinical Documentation

Submit required clinical documentation to initiate the prior authorization review.

Result of chest high-resolution computed tomography (HRCT).
If a lung biopsy was performed, submit the associated pathology report.

Denial Risk

Non-covered Indications

Ofev 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). Use for any other indication is considered experimental/investigational and is not medically necessary.

Non-covered indications: any diagnosis other than IPF, chronic fibrosing ILD with progressive phenotype, or SSc-ILD.

Note

Provider actions to support authorization review and avoid delays.

Ensure other known causes of interstitial lung disease are excluded when diagnosing IPF (eg, environmental exposures, connective tissue disease, drug toxicity).
For IPF diagnosis, provide HRCT consistent with UIP pattern OR HRCT showing probable/indeterminate UIP supported by lung biopsy; if no biopsy, include documentation of multidisciplinary discussion between experienced radiologist and pulmonologist.
For SSc-ILD, provide HRCT confirming diagnosis.
Confirm member meets the specific clinical criteria for the requested indication prior to submission.

Definitions and Diagnostic Patterns

Progressive phenotype

Definition of progressive phenotypeEvidence of progression such as FVC decline >=10% predicted, worsening respiratory symptoms, or radiographic progression (increased extent of fibrosis on HRCT)

Supported documentationSerial pulmonary function tests, clinical notes documenting symptom worsening, and interval HRCT comparisons

Relevance to authorizationProgressive phenotype required for coverage of chronic fibrosing ILD; may support approval for up to 12 months

UIP pattern

UIP pattern definitionUsual interstitial pneumonia (UIP) pattern on HRCT or lung biopsy supports diagnosis of idiopathic pulmonary fibrosis

Diagnostic optionsHRCT showing UIP OR HRCT non-UIP supported by lung biopsy; if no biopsy, multidisciplinary discussion between experienced radiologist and pulmonologist may support diagnosis

Role in coveragePresence of UIP pattern is part of diagnostic work-up supporting authorization for IPF treatment

OpenPayer

Ofev (nintedanib) coverage for fibrosing interstitial lung diseases

Coverage Criteria for Ofev (nintedanib)

Key Coding & Imaging Thresholds

Authorization, Documentation, and Provider Requirements

Background

Definitions and Diagnostic Patterns