CurrentMass General Brigham Health PlanPolicy N/A

Ofev (nintedanib) coverage

Defines prior authorization, quantity limit, specialty pharmacy, and coverage criteria for Ofev (nintedanib) under the Mass General Brigham Health Plan pharmacy benefit for applicable commercial/exchange members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyOfev (nintedanib) coverage

Policy CodePolicy N/A

Change TypeSwitched to customeffective date updated

Effective DateJan 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization and dispense through a contracted specialty pharmacy with applicable quantity limits.

SourceLink

POLICY UPDATE CHANGES

Policy was switched from SGM to Custom and became effective 1/1/2024 following review on 12/13/2023.

12 monthsapproval duration

specialtyfill at contracted specialty pharmacy

commercial/exchangeapplicable plan

pharmacybenefit type

PA + qty limitprogram types applied

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Coverage Criteria for Ofev (nintedanib)

Initial Therapy — IPF

Covered when ALL of the following are met for Idiopathic Pulmonary Fibrosis (IPF):

IPF initial therapy criteria

Exclude other causes: Other known causes of interstitial lung disease (e.g., domestic and occupational environmental exposures, connective tissue disease, drug toxicity) have been excluded
Diagnostic imaging/biopsy: One of: (1) HRCT or lung biopsy consistent with UIP pattern; OR (2) HRCT not UIP but lung biopsy supports diagnosis; OR (3) HRCT not UIP and diagnosis supported by multidisciplinary discussion between experienced radiologist and pulmonologist if biopsy not done

Initial Therapy — Chronic Fibrosing ILD with Progressive Phenotype

Covered when ALL of the following are met for Chronic Fibrosing ILDs with a Progressive Phenotype:

Progressive fibrosing ILD criteria: HRCT demonstrates fibrosis affecting at least 10% of the lungs AND member has evidence of progressive disease as shown by one or more of: FVC decline ≥10% of predicted, worsening respiratory symptoms, or increased extent of fibrosis on HRCT

Progression may be demonstrated by any of the listed findings

Initial Therapy — SSc-ILD

Covered when ALL of the following are met for Systemic Sclerosis–Associated ILD (SSc-ILD):

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

Continuation Therapy

Continuation of therapy:

Continuation criteria: Member is currently receiving treatment with Ofev (nintedanib), including members who are new to the plan and currently on therapy

Authorization may be granted based on documentation of ongoing treatment

Not Medically Necessary

Not covered:

Experimental/Not Medically Necessary: Use of Ofev for indications other than idiopathic pulmonary fibrosis (IPF), chronic fibrosing ILDs with a progressive phenotype, or systemic sclerosis–associated ILD (SSc-ILD)

These indications are considered experimental/investigational and not medically necessary

All uses of Ofev (nintedanib) for indications other than the three FDA‑approved indications listed in this policy — Idiopathic Pulmonary Fibrosis (IPF), chronic fibrosing interstitial lung diseases with a progressive phenotype, and systemic sclerosis-associated interstitial lung disease (SSc‑ILD) — are excluded as experimental/investigational and are not medically necessary.

Use of Ofev for any diagnosis not included in the FDA‑approved indications above (IPF, chronic fibrosing ILDs with a progressive phenotype, or SSc‑ILD) is considered experimental/investigational and therefore not medically necessary for coverage decisions.

Coding, Clinical Thresholds, and Definitions

Extent of fibrosis on HRCT — key threshold

Extent of fibrosis on HRCT>= 10 percent of the lungs

Imaging modalityHigh-resolution computed tomography (HRCT) of the chest

Applies toChronic fibrosing ILDs with a progressive phenotype eligibility criterion

FVC decline threshold — key clinical threshold

FVC decline threshold>= 10% of predicted value

MeasureForced vital capacity (FVC) percent predicted

Context

Provider Actions, Documentation, and Operational Notes

Prior Authorization

Prior Authorization Required

Prior authorization is required for Ofev under the pharmacy benefit. Specialty pharmacy dispensing is required and quantity limits apply.

Pharmacy benefit prior authorization required
Specialty pharmacy dispensing required
Quantity limits apply

Step Therapy

No step therapy requirements are specified for Ofev in this policy.

Documentation Required

Background on Nintedanib (Ofev)

Nintedanib (Ofev) is an FDA‑approved antifibrotic therapy indicated to slow the rate of decline in pulmonary function 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). The policy scope is limited to these indications; requests for other uses are considered experimental/investigational and not medically necessary.

Definitions and Key Terms

Progressive phenotype — definition and ways to demonstrate progression

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

Objective measureFVC percent predicted decline (>=10%) from baseline

Imaging evidenceIncreased extent of fibrosis on serial HRCT examinations

Symptom evidenceWorsening respiratory symptoms such as increased dyspnea or cough documented in clinical notes

Usual interstitial pneumonia (UIP) pattern — imaging and histologic features

UIP pattern definitionHRCT or lung biopsy demonstrating imaging or histologic features consistent with UIP

Policy Revision History

2024-01-01operational_changeLatest

Policy became effective as a Custom policy replacing the SGM version (operational change following December 13, 2023 review).

2023-12-13review

Policy reviewed at the December P&T meeting and decision made to switch from SGM to Custom effective 01/01/2024.

Policy Summary

PayerMass General Brigham Health Plan

PolicyOfev (nintedanib) coverage

Policy CodePolicy N/A

Change TypeSwitched to customeffective date updated

Effective DateJan 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization and dispense through a contracted specialty pharmacy with applicable quantity limits.

SourceLink

On This Page

Used to demonstrate progressive disease in chronic fibrosing ILDs

Progressive phenotype — Demonstration of progression

Progression criteria (any one)FVC decline >=10% predicted, worsening respiratory symptoms, or increased extent of fibrosis on HRCT

Documentation requiredHRCT showing fibrosis >=10% of lungs plus one of the progression findings

Example measureAbsolute or relative decline in FVC documented by pulmonary function testing

Usual interstitial pneumonia (UIP) pattern — diagnostic guidance

UIP diagnostic modalitiesHRCT or lung biopsy demonstrating imaging or histologic features consistent with UIP

When HRCT non-definitiveIf HRCT is not UIP pattern, diagnosis should be supported by lung biopsy

Alternative when biopsy not doneMultidisciplinary discussion between experienced radiologist and pulmonologist may support diagnosis

IPF diagnostic documentation

Documentation for idiopathic pulmonary fibrosis (IPF) must include: exclusion of other known causes of interstitial lung disease (e.g., domestic and occupational environmental exposures, connective tissue disease, drug toxicity) AND either: HRCT showing a usual interstitial pneumonia (UIP) pattern, OR HRCT showing a non‑UIP pattern supported by lung biopsy. If no prior lung biopsy, the diagnosis must be supported by a multidisciplinary discussion between a radiologist and pulmonologist experienced in IPF.

Exclude other known causes of ILD (environmental/occupational exposures, connective tissue disease, drug toxicity)
HRCT demonstrating UIP pattern OR HRCT (probable/indeterminate for UIP) plus lung biopsy
If no lung biopsy, multidisciplinary confirmation (radiologist + pulmonologist experienced in IPF)

Documentation Required

Progressive fibrosing ILD documentation

Documentation for chronic fibrosing interstitial lung diseases with a progressive phenotype must include an HRCT showing fibrosis affecting ≥10% of the lungs and evidence of progression, such as FVC decline ≥10% predicted, worsening respiratory symptoms, or increased extent of fibrosis on HRCT.

HRCT showing fibrosis ≥10% of lungs
Evidence of progression (e.g., FVC decline ≥10% predicted, worsening symptoms, increased fibrosis on imaging)

Documentation Required

SSc‑ILD diagnostic documentation

Documentation for systemic sclerosis‑associated interstitial lung disease (SSc‑ILD) must include a confirming HRCT of the chest demonstrating the diagnosis.

HRCT confirming SSc‑ILD diagnosis

Documentation Required

Continuation / new‑to‑plan documentation

If a member is new to the plan and is currently receiving Ofev, authorization may be granted when documentation shows the member is actively receiving treatment with the requested medication. This does not apply to product obtained only as samples or through manufacturer patient assistance programs.

New‑to‑plan members currently receiving Ofev may be eligible for continuation authorization
Excludes therapy obtained solely as samples or via manufacturer patient assistance programs

Denial Risk

Indication and documentation denial risk

Requests for use of Ofev for indications other than IPF, chronic fibrosing ILDs with a progressive phenotype, or SSc‑ILD are considered experimental/investigational and not medically necessary. Requests lacking required diagnostic documentation (HRCT, lung biopsy or multidisciplinary confirmation, exclusion of other causes, or evidence of progression where applicable) may be denied.

Non‑approved indications are experimental/investigational
Insufficient diagnostic evidence may result in denial (missing HRCT, lung biopsy/multidisciplinary confirmation, exclusion of other causes, or progression evidence)

Support when HRCT non-definitiveRequire lung biopsy to support diagnosis

Multidisciplinary alternativeIf biopsy not performed, multidisciplinary discussion between experienced radiologist and pulmonologist may support UIP diagnosis

Use caseRequired for confirming IPF diagnosis as part of authorization documentation