CurrentMass General Brigham Health PlanPolicy N/A

Nintedanib (generic Ofev) — Prior Authorization for Select ILD Indications

Defines prior authorization requirements for commercial/exchange pharmacy benefit coverage of nintedanib (generic Ofev) for adults with IPF, chronic fibrosing ILD with a progressive phenotype, and SSc-ILD. Applies to Mass General Brigham Health Plan commercial/exchange members and contracted specialty pharmacies.

Policy Summary

PayerMass General Brigham Health Plan

PolicyNintedanib (generic Ofev) — Prior Authorization for Select ILD Indications

Policy CodePolicy N/A

Change TypeReauthorization criteria revisedquantity limits addednew-member documentation clarified

Effective DateJun 1, 2026

Next Review DateMar 11, 2026

Key ActionSubmit medical records documenting current treatment for members new to the plan (coverage effective date <= 90 days).

SourceLink

POLICY UPDATE CHANGES

Updated reauthorization criteria to require that the member has had a positive clinical response to therapy.

Added administrative language clarifying requirements for members new to the plan (<= 90 days) to submit medical records documenting current treatment when seeking authorization.

Added quantity limits specifying 2 capsules per day for nintedanib capsules.

12 monthsapproval duration for authorizations

2/dayquantity limit for nintedanib capsules

3FDA/indicated adult uses listed

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Coverage Criteria for Nintedanib (generic Ofev)

Idiopathic Pulmonary Fibrosis (Initial Therapy)

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

IPF diagnosis and exclusion: 1. Diagnosis of idiopathic pulmonary fibrosis (IPF). 2. Other known causes of interstitial lung disease (e.g., domestic and occupational environmental exposures, connective tissue disease, drug toxicity) have been excluded.

Diagnostic evidence for IPF: ONE of the following: a) Member has completed a high-resolution computed tomography (HRCT) study of the chest or a lung biopsy which reveals a result consistent with the usual interstitial pneumonia (UIP) pattern; OR b) BOTH of the following: i) HRCT shows a result other than the UIP pattern (e.g., probable UIP, indeterminate for UIP, alternative diagnosis); AND ii) ONE of the following: (1) diagnosis is supported by a lung biopsy, or (2) if no lung biopsy was previously conducted, diagnosis is supported by a multidisciplinary discussion between a radiologist and pulmonologist experienced in IPF.

Chronic Fibrosing ILD with Progressive Phenotype (Initial Therapy)

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

Diagnosis: 1. Diagnosis of chronic fibrosing interstitial lung disease (ILD) with a progressive phenotype.

Imaging: 2. Member has completed a high-resolution computed tomography (HRCT) study of the chest that shows fibrosis affecting at least 10% of the lungs.>= 10%

Progression evidence: 3. Member has progressive disease demonstrated by one or more of the following: FVC decline greater than or equal to 10% of predicted; worsening respiratory symptoms; or increased extent of fibrosis on HRCT.FVC decline >= 10%

Examples of progressive disease are provided in the policy.

Systemic Sclerosis-Associated ILD (Initial Therapy)

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

Diagnosis: 1. Diagnosis of systemic sclerosis-associated interstitial lung disease (SSc-ILD).

Imaging confirmation: 2. Diagnosis was confirmed by a high-resolution computed tomography (HRCT) study of the chest.

Continuation of Therapy (Reauthorization)

Requests for reauthorization may be approved when ALL of the following criteria are met:

Positive response: 1. Member demonstrates a positive clinical response to therapy.

Policy updated to require documented positive clinical response for reauthorization.

New-to-Plan Member Documentation

New-to-plan evidence: If member is new to the plan (coverage effective date <= 90 days), submit medical records documenting that the member is currently receiving treatment with the requested drug (excluding when the product is obtained as samples or via manufacturer's patient assistance programs).<= 90 days

Administrative pathway for continuity of therapy.

This policy applies to nintedanib dispensed under the pharmacy benefit and requires specialty dispensing at a contracted specialty pharmacy. Use of the drug billed to the medical benefit or dispensed through non-specialty (retail) pharmacies is not covered under this policy.

Use of nintedanib is not supported when the diagnostic criteria for the requested ILD indication are not met. Examples include absence of required confirmatory testing such as a high-resolution computed tomography (HRCT) or lung biopsy demonstrating the patterns specified for idiopathic pulmonary fibrosis, lack of HRCT evidence of ≥ 10% fibrosis and documentation of progression for chronic fibrosing ILD, or missing HRCT confirmation for systemic sclerosis-associated ILD.

Coding and Clinical Thresholds

Pharmacy codesNDC

NDC	Nintedanib (generic Ofev) — pharmacy benefit (no specific NDC provided in policy)

HRCT fibrosis extent

HRCT fibrosis extent>= 10% of the lungs

Measurement basisExtent measured on high-resolution computed tomography (HRCT) study of the chest

Indication contextRequired for chronic fibrosing ILD with a progressive phenotype initial therapy

FVC decline

FVC decline threshold>= 10% predicted

Clinical significanceRepresents evidence of disease progression for chronic fibrosing ILD

Acceptable documentation

Provider Actions, Documentation, and Denial Risk

Prior Authorization

Prior Authorization and Specialty Fill

Prior authorization required for nintedanib under the pharmacy benefit for Commercial/Exchange members. Specialty dispensing is required; the medication must be filled at a contracted specialty pharmacy.

Plan: Commercial/Exchange
Program Type: Prior Authorization
Benefit: Pharmacy Benefit
Specialty dispensing required: must be filled at a contracted specialty pharmacy

Step Therapy

No step therapy requirement specified for nintedanib in this policy.

Background on Nintedanib and Indications

Nintedanib is an oral tyrosine kinase inhibitor indicated to slow the decline in pulmonary function in adults with idiopathic pulmonary fibrosis (IPF), chronic fibrosing interstitial lung diseases with a progressive phenotype, and systemic sclerosis-associated interstitial lung disease (SSc-ILD). Clinical diagnosis typically relies on chest high-resolution computed tomography (HRCT) and, when needed, lung biopsy or multidisciplinary specialist discussion to establish characteristic patterns such as usual interstitial pneumonia (UIP). The drug’s role in these conditions is to reduce the rate of forced vital capacity (FVC) decline and thereby slow progression of fibrosis-related respiratory impairment.

Definitions and Diagnostic Criteria

High-resolution computed tomography (HRCT)

DefinitionHigh-resolution computed tomography (HRCT) is an imaging study of the chest used to support diagnoses of interstitial lung disease

Role in diagnosisDemonstrates usual interstitial pneumonia (UIP) pattern or non-UIP patterns and can substitute for or complement lung biopsy

QuantificationUsed to quantify extent of pulmonary fibrosis (e.g., ≥10% lung fibrosis for chronic fibrosing ILD with a progressive phenotype)

Usual interstitial pneumonia (UIP) pattern

DefinitionUsual interstitial pneumonia (UIP) pattern is an HRCT or lung biopsy pattern consistent with idiopathic pulmonary fibrosis (IPF)

Diagnostic rolePresence of UIP on HRCT or biopsy fulfills one diagnostic pathway for IPF

Policy Revision History

2026-06-01Effective dateLatest

Policy updates effective: administrative language clarified for new-to-plan members, quantity limits added, and reauthorization criteria revised to require documented positive clinical response to therapy.

2026-03-11Revision

Reviewed and updated at March P&T: administrative update clarifying new-to-plan documentation requirements and addition of quantity limits; reauthorization criteria updated to require that the member has had a positive clinical response to therapy (effective 06/01/2026).

2023-12-13