CurrentCignaPolicy N/A

Ofev (nintedanib) prior authorization — antifibrotic indications

Cigna prior authorization policy governing medical necessity and approval criteria for Ofev (nintedanib) for adults with idiopathic pulmonary fibrosis, progressive pulmonary fibrosis (PPF), and systemic sclerosis-associated interstitial lung disease. Applies to prescription benefit plans administered by Cigna companies.

Policy Summary

PayerCigna

PolicyOfev (nintedanib) prior authorization — antifibrotic indications

Policy CodePolicy N/A

Change TypeSpecialist requirement updatedclarifications to baseline and initial therapy

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization; approvals are provided for 1 year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

The specialist requirement was updated to include a rheumatologist in addition to a pulmonologist for certain indications.

Clarified that 'initial therapy' refers to patients not currently receiving Ofev and allowed concomitant use of Jascayd (neranimilast) in that context.

Clarified that the FVC ≥ 40% requirement is measured at baseline (before starting antifibrotic therapy) and defined which agents are examples of antifibrotic therapies.

The condition name was renamed to 'Progressive Pulmonary Fibrosis' and noted as used interchangeably with prior terminology.

3FDA-approved indications covered

1 yearTypical approval duration

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≥18Minimum age for approval

≥40%FVC threshold (most)

NMNConcomitant use with pirfenidone

Ofev Coverage Criteria

Idiopathic Pulmonary Fibrosis (IPF)

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

IPF - Initial or Ongoing

A) Initial Therapy
- Patient is ≥ 18 years of age
- Forced vital capacity is ≥ 40% of the predicted value at baseline
  Baseline is before a patient has started any antifibrotic therapies (examples: Ofev, Jascayd, pirfenidone).
- Diagnosis confirmed by ONE of: findings on high-resolution computed tomography indicate usual interstitial pneumonia OR a surgical lung biopsy demonstrates usual interstitial pneumonia
- The medication is prescribed by or in consultation with a pulmonologist
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 patients on therapy <1 year, response is from baseline prior to initiating Ofev; examples include reduction in anticipated decline in FVC, six-minute walk distance, and/or number or severity of IPF exacerbations.
- The medication is prescribed by or in consultation with a pulmonologist

threshold: see node text

Progressive Pulmonary Fibrosis (PPF)

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

PPF - Initial or Ongoing

A) Initial Therapy
- Patient is ≥ 18 years of age
- Forced vital capacity is ≥ 40% of the predicted value
- According to the prescriber, the patient has fibrosing lung disease impacting more than 10% of lung volume on high-resolution computed tomography
- According to the prescriber, the patient has clinical signs of progression
  Examples of clinical signs of progression include FVC decline ≥10% predicted OR FVC decline ≥5% to <10% with worsening symptoms and/or worsening imaging.

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

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

SSc-ILD - Initial or Ongoing

A) Initial Therapy
- Patient is ≥ 18 years of age
- Forced vital capacity is ≥ 40% of the predicted value
- Diagnosis is confirmed by high-resolution computed tomography
- The medication is prescribed by or in consultation with a pulmonologist or a rheumatologist
B) Patient is Currently Receiving Ofev

Concomitant use of Ofev (nintedanib) with pirfenidone (Esbriet or generic) is considered not medically necessary and is excluded from coverage. The policy states that the effectiveness and safety of combined therapy with Ofev and pirfenidone have not been established and therefore such combinations are not covered.

Use of Ofev in combination with pirfenidone is considered not medically necessary due to lack of established safety and effectiveness. The policy references guideline recommendations that do not support combined use and notes that available data are insufficient to demonstrate benefit for the combination.

Eligibility Thresholds and Key Clinical Measures

Age and pulmonary function thresholds

Minimum agePatient is ≥ 18 years for all covered indications

Baseline FVC requirement (most indications)Forced vital capacity ≥ 40% of predicted at baseline (before starting antifibrotic therapy)

PPF trial context thresholdsINBUILD trial required FVC ≥ 45% predicted and DLCO 30%–<80% of predicted (trial context)

Extent of fibrosis on HRCT (PPF)

Extent threshold for PPF>10% fibrotic features on HRCT as assessed/documented by the prescriber

Clinical contextUsed to define eligibility for Progressive Pulmonary Fibrosis (INBUILD criteria) when combined with clinical signs of progression

Prior Authorization, Prescriber Requirements, and Therapy Sequencing

Prior Authorization

Prior Authorization Required

Prior authorization is required for Ofev (nintedanib). Approvals are provided for 1 year when the documented criteria below are met. Because of the specialized skills required for evaluation and diagnosis of patients treated with Ofev, the medication must be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., pulmonologist or rheumatologist as applicable).

Approval duration: 1 year when criteria met.
Prescriber requirement: Prescribed by or in consultation with a specialist (pulmonologist and/or rheumatologist as applicable).

Documentation Required

Initial Therapy Requirements (Documentation Expectations)

For initial therapy requests (patient not currently receiving Ofev), approve when ALL of the following are documented: patient is ≥ 18 years of age; baseline forced vital capacity (FVC) ≥ 40% of predicted; diagnosis confirmed by either high-resolution computed tomography showing usual interstitial pneumonia (UIP) pattern or surgical lung biopsy demonstrating UIP; and the medication is prescribed by or in consultation with a pulmonologist (or rheumatologist for non‑IPF indications where specified). Baseline FVC refers to measurement before initiating any antifibrotic therapy. Examples of antifibrotic therapies include Ofev, Jascayd (neramandi.../nerandomilast) and pirfenidone (Esbriet, generic).

Key Definitions

Progressive Pulmonary Fibrosis (PPF) — definition & diagnostic features

DefinitionChronic fibrosing interstitial lung diseases with a progressive phenotype characterized by fibrosing lung disease and clinical progression

Fibrosis extent criterion>10% fibrotic features on HRCT (prescriber assessment) required for PPF enrollment in trials and for policy initial-therapy criteria

Examples of clinical progressionFVC decline ≥10% OR FVC decline ≥5% to <10% with worsening symptoms and/or worsening imaging

Idiopathic Pulmonary Fibrosis (IPF) — definition

DefinitionChronic interstitial pneumonia with a usual interstitial pneumonia (UIP) pattern on HRCT or surgical lung biopsy

Typical clinical featuresProgressive dyspnea, dry cough, and reduced survival; mean survival often 3–5 years after symptom onset

Background on Ofev (nintedanib)

Ofev (nintedanib) is an oral tyrosine kinase inhibitor approved to slow decline in pulmonary function for adults with idiopathic pulmonary fibrosis (IPF), chronic fibrosing interstitial lung diseases with a progressive phenotype (referred to as progressive pulmonary fibrosis, PPF), and systemic sclerosis-associated interstitial lung disease (SSc-ILD). Clinical trials demonstrated reduced annual decline in forced vital capacity (FVC). Prior authorization is required for Ofev and approvals are typically provided for 1 year when coverage criteria are met.

Policy Summary

PayerCigna

PolicyOfev (nintedanib) prior authorization — antifibrotic indications

Policy CodePolicy N/A

Change TypeSpecialist requirement updatedclarifications to baseline and initial therapy

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization; approvals are provided for 1 year when criteria are met.

SourceLink

On This Page

The 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 patients on therapy <1 year, response is from baseline prior to initiating Ofev; examples include reduction in anticipated decline in FVC, six-minute walk distance, and/or number or severity of ILD-related exacerbations.
The medication is prescribed by or in consultation with a pulmonologist or a rheumatologist

threshold: see node text

PPF terminology is used interchangeably with chronic fibrosing ILDs with a progressive phenotype.

Patient is ≥ 18 years of age

Patient has experienced a beneficial response to therapy over the last year while receiving Ofev

For patients on therapy <1 year, response is from baseline prior to initiating Ofev; examples include reduction in anticipated decline in FVC, six-minute walk distance, and/or number or severity of disease-related exacerbations.

The medication is prescribed by or in consultation with a pulmonologist or a rheumatologist

threshold: see node text

SENSCIS trial context required ≥10% fibrosis on HRCT and FVC ≥40% (trial context).

Trial requirement noteINBUILD enrolled patients with >10% fibrosis and required additional evidence of progression (e.g., FVC decline)

Initial therapy = patient not currently receiving Ofev.
Baseline FVC = before starting any antifibrotic therapy.

Step Therapy

Therapy Sequencing and Contraindicated Combinations

Therapy must follow guideline-based sequencing and established contraindications. Concomitant use of Ofev with pirfenidone is considered not medically necessary and will be denied. Requests for combination Ofev + pirfenidone lack established evidence of safety and effectiveness and are listed under conditions not covered. If a patient is intolerant of, or has failed, an alternative indicated therapy, document the specific intolerance or reason for failure and clinical rationale for use of Ofev as applicable.

Concomitant Ofev + pirfenidone: not medically necessary — deny.
If prior therapies were tried and failed or were not tolerated, include documented evidence of failure/intolerance and rationale for sequencing to Ofev.

Diagnostic confirmation for coverageDiagnosis must be confirmed by HRCT showing UIP pattern or by surgical lung biopsy demonstrating UIP (per policy initial-therapy criteria)