Nintedanib
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This policy governs prior authorization and medical necessity criteria for coverage of nintedanib (Ofev and generics) for adults with idiopathic pulmonary fibrosis, progressive pulmonary fibrosis (chronic fibrosing ILDs with a progressive phenotype), and systemic sclerosis-associated interstitial lung disease for Cigna-administered benefit plans.
Updated policy name from 'Nintedanib' to 'Idiopathic Pulmonary Fibrosis and Related Lung Disease - Ofev.'
Changed requirement 'Forced vital capacity is ≥ 40% of the predicted value' to specify 'at baseline.'
Preferred Product Tables were added/updated for Individual and Family and Employer Plans, including criteria for generic nintedanib and Ofev.
Clarified that 'Initial therapy' refers to a patient who is not taking Ofev and that baseline is before starting antifibrotic therapies.
Progressive Pulmonary Fibrosis indication name replaced 'Interstitial Lung Diseases, Chronic Fibrosing with a Progressive Phenotype' and specialist requirement expanded to include rheumatologist.
Coverage Criteria for Nintedanib (Ofev)
Idiopathic Pulmonary Fibrosis (IPF) — FDA‑Approved Indication
Approve for 1 year if the patient meets ONE of the following (A or B):
Initial therapy refers to a patient who is not currently receiving nintedanib; baseline is before starting any antifibrotic therapy.
Examples of beneficial response include reduction in anticipated decline in FVC, six-minute walk distance, or in the number/severity of IPF exacerbations.
Progressive Pulmonary Fibrosis (PPF) / Chronic Fibrosing ILD with Progressive Phenotype — FDA‑Approved Indication
Approve for 1 year if the patient meets ONE of the following (A or B):
Examples of qualifying conditions include hypersensitivity pneumonitis, idiopathic NSIP, autoimmune ILD, exposure-related ILD, unclassifiable IIP.
Examples of beneficial response include reduction in anticipated decline in FVC, six-minute walk distance, or ILD-related exacerbations.
Systemic Sclerosis‑Associated Interstitial Lung Disease — FDA‑Approved Indication
Approve for 1 year if the patient meets ONE of the following (Initial Therapy or Currently Receiving):
HRCT should document fibrotic involvement per prescriber; initial therapy = patient not currently taking nintedanib.
Examples of beneficial response include reduction in anticipated decline in FVC, six-minute walk distance, or disease-related exacerbations.
Initial therapy coverage criteria
Covered when ALL of the following plan-specific conditions are met
Applies to Employer Plans per policy.
Applies to Individual and Family Plans per policy.
Initial therapy coverage criteria
Coverage applies when documented indication-specific criteria and documentation requirements are met.
Initial therapy defined as not currently taking Ofev; baseline is prior to antifibrotic therapy.
Prescriber-based statements accepted for extent of fibrosis and progression.
Continuation criteria and documentation requirements clarified in revisions.
Reimbursement is not allowed for services billed for conditions or diagnoses that are not covered under this Coverage Policy. When billing, providers must use the most appropriate diagnosis and procedure codes; claims submitted for services that are not accompanied by covered code(s) under this Coverage Policy will be denied as not covered.
The concomitant use of nintedanib together with pirfenidone (Esbriet or generic) is considered not medically necessary and is not covered. The effectiveness and safety of combining nintedanib with pirfenidone have not been established; clinical guidance does not recommend combined use and this combination will trigger a denial as not covered.
A detailed Conditions Not Covered / exclusions list appears elsewhere in this policy document. This section contains extensive numbered entries and cross-references that identify specific non‑covered uses, and providers should refer to that full exclusions section for comprehensive details.
Claims submitted without covered diagnosis or procedure codes under the applicable Coverage Policy will be denied as not covered. Providers must include the appropriate covered codes on claim submissions to be eligible for reimbursement under this policy.
The policy explicitly states that the concomitant use of nintedanib with pirfenidone is not medically necessary and will not be covered. Requests documenting combined therapy will be subject to denial based on this not medically necessary determination.
A formal Conditions Not Covered section is included in the policy and lists specific therapies and clinical scenarios that are excluded from coverage. While some entries are summarized elsewhere, the full exclusions section should be consulted for the complete list and reference details.
Coding Guidance and Clinical Thresholds
Prior Authorization, Documentation, and Step Therapy
Prior authorization required; specialist prescriber and typical 1‑year approvals
Prior authorization is required for benefit coverage of nintedanib. Approvals are provided for the duration noted in the policy (commonly 1 year) and the medication must be prescribed by or in consultation with a specialist (pulmonologist; rheumatologist included for some indications). Documentation is required where noted in the criteria.
- PA is required for coverage and approvals are generally for 1 year.
- Prescription must be by or in consultation with a specialist (pulmonologist; rheumatologist for some ILD indications).
- Documentation must be submitted where criteria indicate [documentation required].
PA may be required to document trial of pirfenidone before nintedanib
For some Individual and Family Plans, prior authorization may be required to document that the patient has tried pirfenidone (Esbriet) tablets (or equivalent formulations) and cannot take it before initiating nintedanib for IPF.
- The policy notes a pirfenidone trial "may require prior authorization."
- Trials of capsules or other pirfenidone tablet strengths or brand versions count toward the requirement.
Employer plan exception allows brand when generic bioequivalent not tolerated
Employer Plans permit coverage of the brand product (Ofev) when the patient has tried the bioequivalent generic nintedanib and cannot take it due to a formulation difference in inactive ingredients that would cause a significant allergy or serious adverse reaction.
- Applies to Employer Plans per the policy Employer Plans product criteria.
- Must document trial of the bioequivalent generic and the reason it cannot be tolerated (inactive ingredient difference).
PA must include indication, baseline FVC, and specialist involvement
Prior authorization requests must include documentation supporting the covered indication, baseline forced vital capacity (FVC) at baseline when required, and that the medication is prescribed by or in consultation with the appropriate specialist.
- Indication-specific documentation (e.g., IPF, PPF, systemic sclerosis‑ILD) as specified in the criteria.
- Baseline FVC ≥ 40% of predicted value at baseline where required [documentation required].
- Prescriber statement of specialist involvement (pulmonologist or rheumatologist as applicable).
Employer Plan formulary: brand requires trial of bioequivalent generic (unless contraindicated)
For Employer Plans, the preferred product rules require a trial of the bioequivalent generic nintedanib before approving brand Ofev unless the patient cannot take the generic because of inactive ingredient differences causing significant allergy or serious adverse reaction.
- Employer Plans: trial of bioequivalent generic required unless contraindicated or not tolerated.
- Documentation of intolerance due to inactive ingredient differences must be provided.
Step therapy for IPF in Individual & Family Plans: pirfenidone trial or already on nintedanib
For Individual and Family Plans, initiating nintedanib for IPF requires either documentation that the patient tried and cannot take pirfenidone (tablet formulations or equivalent) or that the patient is already on nintedanib therapy.
- If the patient tried Esbriet capsules or other pirfenidone tablet strengths, that trial satisfies the requirement.
- If the patient tried the brand version of a generic equivalent product, that trial counts toward the requirement.
Preferred product / step‑therapy: trials of brand or generic equivalents may satisfy requirements
Preferred product tables and step-therapy notes were added for plan types; prior trials of brand or generic equivalents may count toward step-therapy requirements per the policy.
- Policy notes that trials of the brand version of a generic equivalent product count toward requirements.
- Preferred product criteria are specified in tables for Employer and Individual/Family Plans.
Document baseline FVC and HRCT/biopsy evidence of UIP when required
Providers must supply documentation specified in the criteria such as baseline FVC (measured at baseline), HRCT findings or a surgical lung biopsy demonstrating usual interstitial pneumonia when requested.
- Baseline FVC must be documented when the criteria indicate "[documentation required]" (baseline defined as before antifibrotic therapy).
- HRCT findings indicating UIP or surgical lung biopsy demonstrating UIP must be documented where required.
Document trial and intolerance to pirfenidone when required
When a pirfenidone trial is required by the plan, providers must document that the patient has tried pirfenidone (tablet, capsule, or other accepted formulations) and cannot take it.
- Policy explicitly states trial of pirfenidone tablet (generic Esbriet tablet) may be required.
- Trials of capsules, different tablet strengths, or brand versions of a generic product count toward the requirement.
Document intolerance to bioequivalent generic due to inactive ingredient differences
If coverage depends on failure of the bioequivalent generic, providers must document that the patient tried the generic and could not take it due to a formulation difference in inactive ingredients causing a significant allergy or serious adverse reaction.
- Specify the inactive ingredient difference (e.g., dyes, fillers, preservatives) and the adverse reaction observed.
- This documentation supports Employer Plan exceptions to allow brand Ofev.
Required clinical documentation: indication, initial‑therapy status, and baseline assessments
Providers must document the indication, confirm the patient is not currently taking Ofev for initial‑therapy requests, and provide baseline assessments before starting antifibrotic therapy as specified throughout the policy.
- Document that initial therapy patients are not currently taking Ofev (baseline defined prior to antifibrotic therapy).
- Provide baseline FVC and other assessments as required by the indication-specific criteria.
Coding-based denials: include covered diagnosis/procedure codes or claim will be denied
Claims submitted without covered diagnosis or procedure codes under this Coverage Policy will be denied as not covered when billed for conditions or diagnoses not covered.
- When billing, providers must use the most appropriate codes as of the effective date; claims lacking covered codes will be denied.
Prior authorization required — noncompliant requests risk denial
Prior authorization is required for benefit coverage of nintedanib; requests that do not meet the PA requirements (including documentation and specialist involvement) risk denial.
- PA must show the patient meets indication-specific criteria and required documentation.
- Lack of required documentation or specialist prescription/consultation can lead to denial.
Concomitant use with pirfenidone is not medically necessary and will be denied
Use of nintedanib concomitantly with pirfenidone (Esbriet or generic) is listed as not medically necessary; concomitant use would be denied.
- Policy states the effectiveness and safety of concomitant use have not been established and lists this as a condition not covered.
Denial risk if documentation or criteria (including baseline FVC) are not satisfied
Denials may occur if documentation requirements and indication-specific criteria are not met, including failure to document baseline FVC (at baseline) or other required clinical evidence.
- Examples of required documentation include baseline FVC, HRCT findings, surgical biopsy results, and prescriber statements about extent of disease and progression.
- Continuation approvals require documentation of beneficial response as specified.
Background and Clinical Context
Idiopathic pulmonary fibrosis (IPF) is a chronic interstitial pneumonia characterized by the usual interstitial pneumonia (UIP) pattern on HRCT or surgical lung biopsy, primarily affecting older adults and presenting with progressive dyspnea and cough. Nintedanib is an antifibrotic tyrosine kinase inhibitor approved for IPF; clinical trials have shown it reduces the annual rate of decline in forced vital capacity (FVC) compared with placebo. Policy coverage for nintedanib is limited to FDA‑approved indications and is contingent on documented diagnostic criteria, baseline assessments (for example, baseline FVC prior to antifibrotic therapy), and prior authorization requirements.
Definitions and Terminology
Policy Revision History
Policy name updated from 'Nintedanib' to 'Idiopathic Pulmonary Fibrosis and Related Lung Disease - Ofev' and IPF initial therapy criteria revised (removed certain HRCT examples and biopsy pairing requirement).
Further policy name update and additional clarifications to IPF initial therapy criteria (continuation of prior revisions).
Added documentation requirements throughout the policy and clarified that 'Initial therapy' refers to a patient who is not taking Ofev; added notes about beneficial response measurement for patients with <1 year of therapy.
Clarified that forced vital capacity (FVC) eligibility requirement applies at baseline (prior to antifibrotic therapy) and added Preferred Product Table note that trials of brand versions of a generic equivalent count toward step requirements.
Changed 'Interstitial Lung Diseases, Chronic Fibrosing with a Progressive Phenotype' to 'Progressive Pulmonary Fibrosis' and expanded specialist prescriber requirement to include rheumatologists in addition to pulmonologists.
Policy title changed (multiple prior titles consolidated) and continued harmonization of indication terminology and specialist list expansions.
Policy title updated again as part of ongoing revisions to the policy header/name conventions.
Added Preferred Products Table for Individual and Family Plans with criteria for generic nintedanib (generic Ofev).
Another update to the policy title recorded in revision history as part of iterative naming changes.
Policy effective date recorded and Preferred Product Tables added/updated for Individual and Family and Employer Plans, including criteria for generic nintedanib and Ofev; this entry corresponds to the current effective policy in force.
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