ModifiedCignaPolicy N/A

Pulmonary - Antifibrotics - Nintedanib Prior Authorization Policy

Defines Cigna's prior authorization requirements and medical necessity criteria for nintedanib (Ofev) for IPF, progressive pulmonary fibrosis (chronic fibrosing ILD with progressive phenotype), and systemic sclerosis-associated ILD for affected benefit plans administered by Cigna companies.

Policy Summary

PayerCigna

PolicyPulmonary - Antifibrotics - Nintedanib Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMaterial coverage and criteria updates (specialist expansiongeneric addedFVC baseline clarified)

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with documentation of specialist involvement, baseline FVC ≥40% prior to antifibrotic therapy, diagnostic confirmation or progression, and indicate initial therapy status if not currently receiving Ofev.

SourceLink

POLICY UPDATE CHANGES

Generic nintedanib was added, where relevant, throughout the policy.

The specialist requirement was updated to include a rheumatologist (previously only pulmonologist).

The requirement regarding forced vital capacity ≥ 40% was clarified to state at baseline and baseline was defined as before a patient has started antifibrotic therapies.

A Note was added clarifying that initial therapy patients may be taking concomitant Jascayd (nerandomilast tablets) and examples of antifibrotic therapies were added (Ofev, Jascayd, pirfenidone capsules and film-coated tablets).

3FDA-approved indications listed

≥40% FVCMinimum baseline FVC

10% fibrosisImaging threshold (HRCT)

Policy Summary

PayerCigna

PolicyPulmonary - Antifibrotics - Nintedanib Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMaterial coverage and criteria updates (specialist expansiongeneric addedFVC baseline clarified)

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Coverage Criteria for Nintedanib (Ofev)

Idiopathic Pulmonary Fibrosis (IPF)

Covered when ONE of the following for Idiopathic Pulmonary Fibrosis is met:

IPF approval: A) Initial Therapy: Approve if ALL of (i) patient is ≥ 18 years; (ii) baseline forced vital capacity (FVC) is ≥ 40% of predicted; (iii) diagnosis confirmed by ONE of: HRCT showing usual interstitial pneumonia (UIP) OR surgical lung biopsy demonstrating UIP; (iv) medication is prescribed by or in consultation with a pulmonologistFVC ≥ 40% at baseline

Initial therapy refers to a patient who is not currently receiving nintedanib; patient may be taking concomitant Jascayd (nerandomilast tablets).

IPF continuation: B) Patient is Currently Receiving Nintedanib: Approve if ALL of (i) patient is ≥ 18 years; (ii) patient has experienced a beneficial response to therapy over the last year while receiving nintedanib (for <1 year, response is from baseline prior to initiating nintedanib); (iii) medication is prescribed by or in consultation with a pulmonologist

Examples of beneficial response include reduction in anticipated decline in FVC, six-minute walk distance, and/or number or severity of IPF exacerbations.

Progressive Pulmonary Fibrosis (Chronic fibrosing ILD with progressive phenotype)

Covered when ONE of the following for Progressive Pulmonary Fibrosis (PPF) is met:

PPF initial: A) Initial Therapy: Approve if ALL of (i) patient is ≥ 18 years; (ii) forced vital capacity (FVC) is ≥ 40% of predicted; (iii) prescriber documents fibrosing lung disease impacting > 10% of lung volume on high-resolution computed tomography (HRCT); (iv) prescriber documents clinical signs of progression (e.g., FVC decline ≥ 10% OR FVC decline ≥ 5% to <10% with worsening symptoms and/or imaging); (v) medication is prescribed by or in consultation with a pulmonologist or a rheumatologistFVC ≥ 40%

Examples of clinical signs of progression are provided in policy.

PPF continuation: B) Patient is Currently Receiving Nintedanib: Approve if ALL of (i) patient is ≥ 18 years; (ii) patient has experienced a beneficial response to therapy over the last year while receiving nintedanib (for <1 year, response is from baseline prior to initiating nintedanib); (iii) medication is prescribed by or in consultation with a pulmonologist or a rheumatologist

Examples of beneficial response include reduction in anticipated decline in FVC, six-minute walk distance, and/or interstitial lung disease-related exacerbations.

Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)

Covered when ONE of the following for Interstitial Lung Disease Associated with Systemic Sclerosis is met:

SSc-ILD initial: A) Initial Therapy: Approve if ALL of (i) patient is ≥ 18 years; (ii) forced vital capacity (FVC) is ≥ 40% of predicted; (iii) diagnosis is confirmed by high-resolution computed tomography (HRCT); (iv) medication is prescribed by or in consultation with a pulmonologist or a rheumatologistFVC ≥ 40%

HRCT must confirm diagnosis.

SSc-ILD continuation: B) Patient is Currently Receiving Nintedanib: Approve if ALL of (i) patient is ≥ 18 years; (ii) patient has experienced a beneficial response to therapy over the last year while receiving nintedanib (for <1 year, response is from baseline prior to initiating nintedanib); (iii) medication is prescribed by or in consultation with a pulmonologist or a rheumatologist

Examples of beneficial response include reduced decline in FVC, six-minute walk distance, or disease-related exacerbations.

Initial therapy / General approval conditions

Criteria and approvals reference idiopathic pulmonary fibrosis and progressive pulmonary fibrosis; specific coverage requires meeting baseline and other conditions:

General approval conditions (summary): Approval requires: diagnosis of idiopathic pulmonary fibrosis, progressive pulmonary fibrosis, or systemic sclerosis-associated ILD as specified; baseline forced vital capacity (FVC) ≥ 40% of predicted prior to initiation of antifibrotic therapy; specialist involvement (pulmonologist for IPF; pulmonologist or rheumatologist for PPF and SSc-ILD); and for initial therapy requests, the patient must not currently be receiving Ofev (nintedanib).FVC ≥ 40% at baseline

Baseline is defined as before a patient has started any antifibrotic therapies. Examples of antifibrotic therapies include Ofev (nintedanib), Jascayd (nerandomilast tablets), and pirfenidone (Esbriet, generic). Concomitant use of nintedanib with pirfenidone is considered not medically necessary.

Use of nintedanib concomitantly with pirfenidone (Esbriet, generic) is considered not medically necessary. The policy states that the effectiveness and safety of combining nintedanib with pirfenidone have not been established and references guideline recommendations that do not support combined use.

No explicit exclusion list is provided in the excerpt of this policy beyond the specific not medically necessary statements identified elsewhere; the history and revisions note changes to indications and specialist requirements but do not add a separate exclusion list in this excerpt.

Any use of nintedanib outside the specified FDA‑approved indications and the supported uses described in this policy is considered not medically necessary. The policy specifically indicates that requests for uses not supported by the policy (including concomitant pirfenidone) will be denied.

Within the provided excerpt there are no additional explicit statements labeled as 'not medically necessary' beyond the identified contraindicated combinations and the general restriction to FDA‑approved and policy‑supported uses.

Coding and Measurement Thresholds

No specific billing codes providedmixed

No codes listed

Baseline Forced Vital Capacity (FVC)

ThresholdForced vital capacity (FVC) ≥ 40% of predicted for most indications

ContextPolicy clarifies this is measured at baseline (before any antifibrotic therapy)

Trial noteINBUILD trial for PPF required FVC ≥ 45% but policy uses ≥ 40% for coverage decisions

Extent of fibrosis on HRCT

Imaging threshold> 10% fibrosis of lung volume on HRCT (prescriber-reported)

Clinical correlationRequired documentation of clinical signs of progression (e.g., FVC decline ≥10% or FVC decline ≥5% to <10% with worsening symptoms or imaging)

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is recommended for prescription benefit coverage of nintedanib (Ofev and generic nintedanib). Approvals are provided for the durations noted in the policy (typically 1 year). Because evaluation and diagnosis require specialized skills, nintedanib must be prescribed by or in consultation with a physician who specializes in the condition being treated.

Prior authorization recommended for Ofev (nintedanib) and generic nintedanib for IPF, PPF, and SSc-ILD.
All approvals are typically for 1 year.
Medication must be prescribed by or in consultation with a specialist (pulmonologist; pulmonologist or rheumatologist for PPF and SSc-ILD).

Documentation Required

Required Clinical Documentation

Documentation must support specialist involvement and baseline clinical measures prior to initiating antifibrotic therapy. For initial therapy, baseline forced vital capacity (FVC) must be recorded (baseline defined as before starting any antifibrotic therapies). Prescribers should document the diagnosis method and extent of disease where applicable.

Background on Nintedanib and Indications

Nintedanib is a tyrosine kinase inhibitor indicated for treatment of idiopathic pulmonary fibrosis (IPF), chronic fibrosing interstitial lung diseases with a progressive phenotype (progressive pulmonary fibrosis, PPF), and systemic sclerosis–associated interstitial lung disease (SSc‑ILD). Clinical trial evidence demonstrates that nintedanib reduces the annual rate of decline in forced vital capacity (FVC); trials generally enrolled adults with moderate impairment and the policy aligns coverage with these FDA‑approved indications.

Definitions and Terminology

Progressive pulmonary fibrosis (PPF) / chronic fibrosing ILD with progressive phenotype

DefinitionInterstitial lung diseases with >10% fibrosis on HRCT and evidence of progression (e.g., FVC decline ≥10%, or FVC decline ≥5% to <10% with worsening symptoms or imaging)

Alternate termPolicy uses the terms 'chronic fibrosing ILD with a progressive phenotype' and 'progressive pulmonary fibrosis' interchangeably

Clinical trial basisINBUILD enrolled patients with >10% fibrotic features and required evidence of progression

Idiopathic pulmonary fibrosis (IPF)

DefinitionA chronic interstitial pneumonia with a usual interstitial pneumonia (UIP) pattern on HRCT or surgical lung biopsy, with progressive dyspnea and cough

Typical course