CurrentNeighborhood Health Plan of Rhode IslandPolicy Ofev 1882-A SGM P2024

Ofev (nintedanib) coverage for fibrosing interstitial lung diseases

Defines medical necessity and prior authorization requirements for Ofev (nintedanib) for adults with IPF, chronic fibrosing ILDs with a progressive phenotype (PPF), and systemic sclerosis-associated ILD (SSc-ILD) for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOfev (nintedanib) coverage for fibrosing interstitial lung diseases

Policy CodePolicy Ofev 1882-A SGM P2024

Change TypeNo material change noted

Effective Date

Next Review Date

Key ActionSubmit HRCT chest 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 period granted for approved indications

>=10%min HRCT fibrosis for PPF

>=10%FVC decline threshold indicating progression

3FDA‑approved indication categories listed

Coverage Criteria for Ofev (nintedanib)

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Idiopathic Pulmonary Fibrosis (IPF) — Initial authorization

Authorization of 12 months may be granted for treatment of IPF when ALL of the following are met:

IPF diagnostic workup: Other known causes of interstitial lung disease have been excluded

Examples: domestic and occupational environmental exposures, connective tissue disease, drug toxicity

Diagnostic evidence supporting IPF: Either HRCT or lung biopsy shows a result consistent with the usual interstitial pneumonia (UIP) pattern, OR HRCT non‑UIP supported by lung biopsy or multidisciplinary discussion

If no lung biopsy, multidisciplinary discussion between an experienced radiologist and pulmonologist required to support diagnosis

Chronic Fibrosing ILDs with Progressive Phenotype (PPF) — Initial authorization

Authorization of 12 months may be granted when ALL of the following are met:

Imaging criterion: HRCT shows fibrosis affecting at least 10% of the lungs>=10% lung involvement on HRCT

Evidence of progression: Progressive disease demonstrated by >=10% predicted FVC decline, worsening respiratory symptoms, or increased extent of fibrosis on HRCTFVC decline >=10%

Examples of progression listed are not exhaustive

Systemic Sclerosis-Associated ILD (SSc-ILD) — Initial authorization

Authorization of 12 months may be granted when the following is met:

Diagnostic confirmation: Diagnosis of systemic sclerosis‑associated interstitial lung disease confirmed by HRCT of the chest

Continuation of Therapy

All members (including new members) requesting continuation of therapy for an indicated condition may be granted 12 months when currently receiving Ofev:

Current therapy: Member is currently receiving treatment with Ofev

Authorization period for continuation is 12 months

Use of Ofev (nintedanib) is limited to the FDA‑approved and compendial indications listed in this policy. All other indications are considered experimental/investigational and not medically necessary. This exclusion complements the specific coverage criteria for idiopathic pulmonary fibrosis (IPF), chronic fibrosing ILDs with a progressive phenotype (PPF), and systemic sclerosis‑associated ILD (SSc‑ILD); requests for use outside those indications should be denied as not medically necessary.

Specifically, use of Ofev for any condition other than IPF, chronic fibrosing ILDs with a progressive phenotype (PPF), or SSc‑ILD is not medically necessary and is considered experimental/investigational. Prior authorization will not be approved for indications outside those three categories.

Coding and Measurement Thresholds

Medication referencedmixedCovered

Ofev (nintedanib)

Brand name medication referenced for coverage

Fibrosis extent on HRCT

Minimum HRCT fibrosis extentFibrosis affecting at least 10% of the lungs on high-resolution CT (HRCT)

Applies toChronic fibrosing ILDs with a progressive phenotype (PPF)

PurposeImaging inclusion criterion for initial authorization of Ofev for PPF (authorization may be granted for 12 months when met)

FVC decline indicating progression

FVC decline thresholdForced vital capacity (FVC) decline greater than or equal to 10% of the predicted value

Context of useExample metric demonstrating progressive disease in PPF used to meet authorization criteria

Other evidence of progressionWorsening respiratory symptoms or increased extent of fibrosis on HRCT may also indicate progression

Provider Actions, Documentation, and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Ofev. Authorizations may be granted for up to 12 months for approved indications (IPF, chronic fibrosing ILD with progressive phenotype/PPF, and SSc-ILD). Approval is contingent on meeting the specific diagnostic and documentation criteria for the requested indication.

Authorization period: 12 months for initial and continuation requests
Affected policy: Ofev 1882-A SGM P2024

Step Therapy

No step therapy requirements apply for Ofev under this policy. Providers do not need to try alternative antifibrotic agents prior to requesting prior authorization.

Documentation Required

Documentation Required for PA Review

Submit the following documentation with the prior authorization request to support medical necessity: HRCT chest report for all indications; pathology report of lung biopsy when a biopsy was performed.

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

Denial Risk

Non‑approved Indications

Uses of Ofev outside the listed FDA-approved and compendial indications (IPF, chronic fibrosing ILDs with progressive phenotype/PPF, SSc-ILD) are considered experimental/investigational and not medically necessary.

Key Definitions

Progressive pulmonary fibrosis (PPF)

DefinitionProgressive pulmonary fibrosis (PPF): chronic fibrosing ILDs with progression, including fibrosis affecting >=10% of the lungs on HRCT and evidence of progression.

Key imaging requirementHRCT showing fibrosis affecting at least 10% of the lungs

Progression criteriaProgressive disease demonstrated by >=10% predicted FVC decline, worsening respiratory symptoms, or increased extent of fibrosis on HRCT

Authorization implicationWhen these criteria are met, prior authorization for Ofev may be granted for 12 months

Usual interstitial pneumonia (UIP) pattern

DefinitionUsual interstitial pneumonia (UIP) pattern: HRCT or lung biopsy result consistent with the UIP pattern used to support a diagnosis of idiopathic pulmonary fibrosis (IPF).

Diagnostic roleUIP pattern on HRCT or lung biopsy satisfies diagnostic evidence for IPF initial authorization

Alternate pathwayIf HRCT does not show UIP, diagnosis may be supported by lung biopsy or multidisciplinary discussion between experienced radiologist and pulmonologist

OpenPayer

Ofev (nintedanib) coverage for fibrosing interstitial lung diseases

Coverage Criteria for Ofev (nintedanib)

Coding and Measurement Thresholds

Provider Actions, Documentation, and Authorization

Key Definitions

Background