CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

nintedanib (Ofev) — coverage criteria for IPF, chronic fibrosing ILDs with progressive phenotype, and SSc-ILD

Policy governs prior authorization, coverage criteria, and quantity limits for nintedanib (Ofev/generic) for treatment of idiopathic pulmonary fibrosis (IPF), chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype, and systemic sclerosis-associated ILD (SSc-ILD) for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policynintedanib (Ofev) — coverage criteria for IPF, chronic fibrosing ILDs with progressive phenotype, and SSc-ILD

Policy CodePolicy N/A

Change TypeNo material changes noted

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with indication-specific documentation, baseline FVC and LFTs, and pulmonologist involvement; approvals are for 6 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsauthorization duration

>=18 yrsminimum age

60/30 daysquantity limit

HRCT requiredimaging requirement

Coverage Criteria for Nintedanib (Ofev)

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Initial therapy — IPF

Covered when ALL of the following are met:

IPF initial criteria: 1) The requested drug is prescribed by or in consultation with a pulmonologist; 2) Member is at least 18 years of age; 3) Documented diagnosis of IPF: (a) other known causes of interstitial lung disease have been excluded; AND (b) either (i) HRCT or lung biopsy consistent with the usual interstitial pneumonia (UIP) pattern OR (ii) HRCT not UIP (e.g., probable UIP or indeterminate) supported by lung biopsy or, if biopsy not performed, by multidisciplinary discussion between an experienced radiologist and pulmonologist; 4) Documentation of baseline forced vital capacity (FVC); 5) Documentation of baseline liver function tests; 6) Not being used concurrently with pirfenidone (generic Esbriet).

Authorization may be granted for 6 months.

Initial therapy — chronic fibrosing ILDs with progressive phenotype

Covered when ALL of the following are met:

Chronic fibrosing ILD initial criteria: 1) The requested drug is prescribed by or in consultation with a pulmonologist; 2) Member is at least 18 years of age; 3) Documented diagnosis of chronic fibrosing ILD with a progressive phenotype: (a) HRCT showing fibrosis affecting at least 10% of the lungs; AND (b) progressive disease defined as FVC decline ≥10% predicted OR FVC decline ≥5% and <10% with worsening respiratory symptoms or imaging OR worsening respiratory symptoms and imaging with increased extent of fibrosis on HRCT; 4) Documentation of baseline forced vital capacity (FVC); 5) Documentation of baseline liver function tests; 6) Not being used concurrently with pirfenidone (generic Esbriet).>= 10% fibrosis on HRCT; progression defined per FVC thresholds

Authorization may be granted for 6 months.

Initial therapy — SSc-ILD

Covered when ALL of the following are met:

SSc-ILD initial criteria: 1) The requested drug is prescribed by or in consultation with a pulmonologist; 2) Member is at least 18 years of age; 3) Documented diagnosis of systemic sclerosis-associated interstitial lung disease (SSc-ILD) confirmed by HRCT; 4) Documentation of baseline forced vital capacity (FVC); 5) Documentation of baseline liver function tests; 6) Not being used concurrently with pirfenidone (generic Esbriet).

Authorization may be granted for 6 months.

Continuation of therapy — Covered when ALL of the following are met.

Covered when ALL of the following are met:

Continuation criteria: 1) Documentation of a positive clinical response to the medication (for example, reduction in the anticipated decline in FVC, improvement or stabilization in six‑minute walk distance, and/or reduction in number or severity of exacerbations); 2) Not being used in combination with pirfenidone (generic Esbriet); 3) The medication is prescribed by or in consultation with a pulmonologist.

Authorization of 6 months may be granted.

Coverage for nintedanib is limited to the FDA‑approved indications: idiopathic pulmonary fibrosis (IPF), chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype, and systemic sclerosis‑associated ILD (SSc‑ILD). All other indications are considered experimental/investigational and are not a covered benefit.

Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for nintedanib. Requests must include indication-specific documentation, baseline FVC and liver function tests (LFTs), and evidence the drug is prescribed by or in consultation with a pulmonologist. Requests for uses other than the FDA‑approved indications listed are considered experimental and are not covered.

Authorization may be granted for up to 6 months when criteria are met.
Documentation must show the drug is not being used concurrently with pirfenidone (Esbriet).

Step Therapy

No step therapy requirements are specified for nintedanib.

Documentation Required

IPF Documentation Requirements

For initial requests for idiopathic pulmonary fibrosis (IPF), include documentation of all of the following: confirmation the request was prescribed by or in consultation with a pulmonologist; member is ≥18 years of age; exclusion of other known causes of interstitial lung disease; diagnostic support via HRCT showing UIP pattern or HRCT plus lung biopsy / multidisciplinary discussion per policy; baseline forced vital capacity (FVC); baseline liver function tests (LFTs); and confirmation the member is not taking pirfenidone concurrently.

HRCT chest results and/or lung biopsy report supporting UIP or alternative pattern with supporting biopsy or multidisciplinary discussion.
Baseline FVC measurement.
Baseline liver function test results.
Documentation excluding other known causes of ILD.

Documentation Required

SSc-ILD Documentation Requirements

For systemic sclerosis–associated ILD (SSc-ILD), include documentation of all of the following: prescribed by or in consultation with a pulmonologist; member is ≥18 years of age; HRCT-confirmed diagnosis of SSc-ILD; baseline FVC; baseline LFTs; and confirmation the member is not taking pirfenidone concurrently.

HRCT chest report confirming SSc-ILD.
Baseline FVC measurement.
Baseline liver function test results.

Documentation Required

Continuation Documentation

Authorization renewal (continuation of therapy) may be granted for 6 months when documentation shows clinical benefit or stabilization (for example, reduction in the anticipated decline in FVC, improved or stable six-minute walk distance, and/or fewer or less severe exacerbations), the member is not receiving pirfenidone concurrently, and the treatment remains prescribed by or in consultation with a pulmonologist.

Evidence of positive clinical response or disease stabilization (objective measures or clinician assessment).
Confirmation of no concurrent pirfenidone use.
Documentation of ongoing pulmonologist involvement.

Denial Risk

Non‑covered Indications

Use of nintedanib for indications other than the FDA‑approved ones listed (IPF, chronic fibrosing ILDs with a progressive phenotype, SSc-ILD) is considered experimental/investigational and is not a covered benefit.

Definitions and Diagnostic Patterns

Progressive disease (chronic fibrosing ILDs)

Definition AProgressive disease defined as FVC decline >= 10% of predicted.

Definition BFVC decline >= 5% and <10% with worsening respiratory symptoms or imaging.

Definition CWorsening respiratory symptoms and imaging with increased extent of fibrosis on HRCT.

Usual Interstitial Pneumonia (UIP) pattern

DefinitionUsual Interstitial Pneumonia (UIP) pattern is a radiographic or histopathologic result on HRCT or lung biopsy consistent with UIP used to support a diagnosis of IPF.

Alternate pathwaysIf HRCT is non‑UIP, diagnosis may be supported by lung biopsy or multidisciplinary discussion between an experienced radiologist and pulmonologist.

Role in coveragePresence of UIP on HRCT or biopsy is an element of documented IPF required for authorization.

OpenPayer

nintedanib (Ofev) — coverage criteria for IPF, chronic fibrosing ILDs with progressive phenotype, and SSc-ILD

Coverage Criteria for Nintedanib (Ofev)

Quantity Limits and Coding Details

Authorization, Documentation, and Provider Requirements

Definitions and Diagnostic Patterns

Background on Nintedanib