CurrentCignaPolicy IP0312

Pulmonary - Antifibrotics - Ofev

Policy Summary

PayerCigna

PolicyPulmonary - Antifibrotics - Ofev

Policy CodePolicy IP0312

Change TypeRevisions and clarifications

Effective DateMar 15, 2026

Next Review Date

Key ActionPrior Authorization is required for Ofev and document baseline FVC, HRCT or biopsy findings when applicable, and prescriber specialty consultation.

SourceLink

POLICY UPDATE CHANGES

Policy name updated and several criteria clarified/modified across indications (e.g., removed some HRCT example findings; changed requirements for documentation and prescriber specialty).

Added note that for patients who received less than 1 year of therapy, beneficial response is assessed from baseline prior to initiating Ofev for all indications.

Updated specialist requirement to include rheumatologist for this indication.

Added documentation requirements throughout the policy.

3Covered Indications (FDA-approved)

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Auth duration (typical)

1Not covered: concomitant with pirfenidone

Coverage Summary

Defines Cigna prior authorization and medical necessity criteria for coverage of Ofev (nintedanib) for Idiopathic Pulmonary Fibrosis, Progressive Pulmonary Fibrosis (chronic fibrosing ILDs with a progressive phenotype), and Systemic Sclerosis-associated Interstitial Lung Disease for members of Cigna-administered health benefit plans. Coverage requires prior authorization and specialist prescribing/consultation (pulmonologist; pulmonologist or rheumatologist for PPF and systemic sclerosis-associated ILD).

Coverage stance: covered_with_criteria. Typical authorization duration: 1 year.

Effective date: 2026-03-15. Last review date: 2025-10-15.

Key thresholds

Age≥ 18 years

Forced Vital Capacity (FVC)≥ 40% of predicted (baseline) for IPF, PPF, and SSc‑ILD; documentation required

Fibrosis extent on HRCT> 10% of lung volume on HRCT (per prescriber) for Progressive Pulmonary Fibrosis; documentation required for SSc‑ILD (≥ 10%)

Typical authorization duration1 year

FDA-Approved Indications - Idiopathic Pulmonary Fibrosis (IPF)

Approve for 1 year if the patient meets ONE of the following (A or B):

ANY of the following

A) Initial Therapy
- Patient is ≥ 18 years of age
- Forced vital capacity is ≥ 40% of the predicted value [documentation required]≥ 40% of predicted (baseline)
  Baseline is before a patient has started any antifibrotic therapies
- Diagnosis confirmation (ONE of)

FDA-Approved Indications - Progressive Pulmonary Fibrosis (PPF)

Approve for 1 year if the patient meets ONE of the following (A or B):

ANY of the following

A) Initial Therapy
- Patient is ≥ 18 years of age
- Forced vital capacity is ≥ 40% of the predicted value [documentation required]≥ 40% of predicted (baseline)
  Baseline is before a patient has started any antifibrotic therapies
- According to the prescriber, the patient has fibrosing lung disease impacting more than 10% of lung volume on high-resolution computed tomography

FDA-Approved Indications - Interstitial Lung Disease Associated with Systemic Sclerosis

Approve for 1 year if the patient meets ONE of the following (1 or 2):

ANY of the following

1) Initial Therapy
- Patient is ≥ 18 years of age
- Forced vital capacity is ≥ 40% of the predicted value [documentation required]≥ 40% of predicted (baseline)
- Diagnosis is confirmed by high-resolution computed tomography [documentation required]

Individual and Family Plans - Preferred Product Requirement

Individual and Family Plans - Preferred Product Requirement for IPF Initial Therapy

Patient must meet ONE of the following (1 or 2):

ANY of the following

Patient has tried and cannot take pirfenidone tablet (generic Esbriet tablet) [may require prior authorization]
If the patient has tried Esbriet capsules or pirfenidone tablets, this satisfies the criterion. If the patient tried the brand version of a generic equivalent product, that trial counts.
Patient has already been started on therapy with Ofev

Exclusions - Not Medically Necessary Uses

Ofev for any other use is considered not medically necessary, including the following:

Concomitant use of Ofev with Esbriet (pirfenidone capsules) is considered not medically necessary

Effectiveness and safety of concomitant use have not been established; guideline does not recommend combination therapy.

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Prior Authorization is required for benefit coverage of Ofev; approvals provided for duration noted (typically 1 year).

Documentation Required

Documentation required for baseline measures and diagnosis

Documentation is required where noted (chart notes, labs, claims, imaging). Specifically document baseline FVC percent predicted, HRCT findings or surgical lung biopsy when applicable, and prescriber specialty consultation.

Applicable Codes & Product Names

NDC / Drug identifierNDC

No codes listed

Relevant product names referencedmixed

Ofev	nintedanib capsules (Boehringer Ingelheim)
Esbriet	pirfenidone capsules and film-coated tablets (pirfenidone)
Jascayd	nerandomilast tablets (concomitant use noted)

Clinical Evidence

n = 1,231INPULSIS (IPF) - pooled Phase II/III trials

n = 663INBUILD (PPF) - Phase III trial

n = 576SENSCIS (SSc‑ILD) - Phase III trial

INPULSIS/Phase III IPF trials: n = 1,231; Ofev 150 mg BID showed statistically significant reduction in annual rate of decline of FVC vs placebo.

INBUILD trial: n = 663; Ofev 150 mg BID reduced annual rate of FVC decline in chronic fibrosing ILDs with progressive phenotype.

SENSCIS trial: n = 576; Ofev reduced annual rate of FVC decline in systemic sclerosis-associated ILD.

Background

Ofev (nintedanib) is a kinase inhibitor FDA-approved for idiopathic pulmonary fibrosis (IPF), chronic fibrosing interstitial lung diseases with a progressive phenotype (progressive pulmonary fibrosis), and interstitial lung disease associated with systemic sclerosis.

Key trials: INPULSIS (Phase III IPF program, n=1,231), INBUILD (PPF, n=663), and SENSCIS (systemic sclerosis-associated ILD, n=576); these trials demonstrated slowed decline in FVC.

Safety/effectiveness in pediatric patients has not been established.

Definitions

BaselineMeasurement before a patient has started any antifibrotic therapies.

Progressive Pulmonary Fibrosis (PPF)Term used interchangeably with 'chronic fibrosing interstitial lung diseases with a progressive phenotype'; includes conditions such as hypersensitivity pneumonitis, idiopathic NSIP, unclassifiable IIP, autoimmune ILD, exposure-related ILD, and mixed connective tissue disease ILD.

Beneficial responseReduction in anticipated decline in FVC, improvement or stabilization in six‑minute walk distance, and/or reduction in number or severity of disease‑related exacerbations.

Revision History

2026-03-15revisedLatest

Policy name updated and several criteria clarified/modified across indications (e.g., removed some HRCT example findings; changed requirements for documentation and prescriber specialty).

2026-02-01addedLatest

Added note that for patients who received less than 1 year of therapy, beneficial response is assessed from baseline prior to initiating Ofev for all indications.

2025-10-15

Policy Summary

PayerCigna

PolicyPulmonary - Antifibrotics - Ofev

Policy CodePolicy IP0312

Change TypeRevisions and clarifications

Effective DateMar 15, 2026

Next Review Date

Key ActionPrior Authorization is required for Ofev and document baseline FVC, HRCT or biopsy findings when applicable, and prescriber specialty consultation.

SourceLink

On This Page

Findings on high-resolution computed tomography indicate usual interstitial pneumonia [documentation required]

A surgical lung biopsy demonstrates usual interstitial pneumonia [documentation required]

Medication is prescribed by or in consultation with a pulmonologist

Preferred product criteria is met for the product as listed in the Individual and Family Plans Idiopathic Pulmonary Fibrosis - Initial Therapy table

B) Patient is Currently Receiving Ofev

Patient is ≥ 18 years of age
Patient has experienced a beneficial response to therapy over the last year while receiving Ofev
For a patient who has received less than 1 year of therapy, response is from baseline prior to initiating Ofev
Medication is prescribed by or in consultation with a pulmonologist

> 10% of lung volume (per prescriber)

According to the prescriber, the patient has clinical signs of progression

Examples include FVC decline ≥ 10% predicted, or FVC decline ≥ 5% to < 10% with worsening symptoms and/or worsening imaging

Medication is prescribed by or in consultation with a pulmonologist or a rheumatologist

B) Patient is Currently Receiving Ofev

Patient is ≥ 18 years of age
Patient has experienced a beneficial response to therapy over the last year while receiving Ofev
For a patient who has received less than 1 year of therapy, response is from baseline prior to initiating Ofev
Medication is prescribed by or in consultation with a pulmonologist or a rheumatologist

Medication is prescribed by or in consultation with a pulmonologist or a rheumatologist

2) Patient is Currently Receiving Ofev

Patient is ≥ 18 years of age
Patient has experienced a beneficial response to therapy over the last year while receiving Ofev
For a patient who has received less than 1 year of therapy, response is from baseline prior to initiating Ofev
Medication is prescribed by or in consultation with a pulmonologist or a rheumatologist

Documentation Required

Specialist prescribing requirement

Ofev must be prescribed by or in consultation with a physician who specializes in the condition: pulmonologist is required for IPF; a pulmonologist or rheumatologist is required for Progressive Pulmonary Fibrosis and Systemic Sclerosis-associated ILD.

Billing Rule

Coverage limited to FDA-approved indications (per policy)

Coverage is limited to the FDA‑approved indications listed in the policy (IPF, Progressive Pulmonary Fibrosis/chronic fibrosing ILDs with a progressive phenotype, and systemic sclerosis-associated ILD). Claims submitted for diagnoses not covered under this policy will be denied as not covered.

Prior Authorization

Preferred product trial requirement (Individual and Family Plans)

For Individual and Family Plans (IPF initial therapy), the patient must have tried and been unable to take pirfenidone (Esbriet or generic pirfenidone tablet) or already be started on Ofev; prior trial of the brand version of a generic equivalent product counts toward this requirement.

Added documentation requirements throughout the policy.

2024-10-15added

Annual revision: removed examples of HRCT findings indicating UIP, removed requirement for both HRCT and biopsy pattern to indicate 'probable' UIP, removed criterion to exclude other potential causes of ILD, and clarified baseline FVC requirement.