CurrentAvMedPolicy N/A

OFEV (nintedanib) prior authorization

Prior authorization and step-edit request form and medical necessity criteria for coverage of OFEV (nintedanib) for IPF, chronic fibrosing ILD with progressive phenotype, and systemic sclerosis–associated ILD for AvMed members; applies to prescribers and pharmacists processing PA requests.

Policy Summary

PayerAvMed

PolicyOFEV (nintedanib) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must complete and sign the prior authorization form and submit required supporting documentation (PFTs, HRCT, chart notes) to AvMed Specialty Pharmacy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization duration

6 monthsReauthorization interval

≥50%IPF minimum FVC

≥45%Chronic ILD minimum FVC

≥40%SSc-ILD baseline %FVC

Coverage Criteria for OFEV (nintedanib)

Initial Therapy - IPF

Covered when ALL of the following are met for Idiopathic Pulmonary Fibrosis (IPF):

IPF diagnostic and prescriber requirements: Diagnosis of IPF; prescribed by or in consultation with a pulmonology specialist; diagnosis confirmed by HRCT showing idiopathic fibrosis or probable IPF; if not definitive, lung biopsy confirming IPF

Provide HRCT/PFT/biopsy reports

Pulmonary function thresholds for IPF initiation: FVC ≥ 50% predicted AND DLCO 30-79% predictedFVC >=50%; DLCO 30-79%

Provide PFT reports

Concomitant therapy restriction: No concomitant use of OFEV and Esbriet (pirfenidone)

Policy Summary

PayerAvMed

PolicyOFEV (nintedanib) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must complete and sign the prior authorization form and submit required supporting documentation (PFTs, HRCT, chart notes) to AvMed Specialty Pharmacy.

SourceLink

On This Page

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Initial Therapy - Chronic Fibrosing ILD

Covered when ALL of the following are met for Chronic Fibrosing Interstitial Lung Disease with Progressive Phenotype:

Diagnostic and prescriber requirements: Prescribed by or in consultation with a pulmonology specialist; diagnosis confirmed as chronic fibrosing ILD with progressive phenotype

Provide HRCT and clinical documentation

Radiologic and clinical progression: Fibrotic ILD involving at least 10% of the lungs on HRCT within the past 24 months AND clinical progression in the previous 24 months evidenced by either FVC decline >10% OR FVC decline ≥ 5% and <10% with worsening respiratory symptoms or increasing fibrosis on imagingHRCT >=10%; FVC decline >10% OR 5-9% with additional worsening

Provide serial HRCT and PFTs

Pulmonary function thresholds for initiation: FVC ≥ 45% predicted AND DLCO 30-80% predictedFVC >=45%; DLCO 30-80%

Provide PFT reports

Concomitant therapy restriction: No concomitant use of OFEV and Esbriet (pirfenidone)

Initial Therapy - Systemic Sclerosis–Associated ILD

Covered when ALL of the following are met for Systemic Sclerosis–Associated ILD:

Prescriber and diagnostic confirmation: Medication prescribed by or in consultation with a pulmonology specialist; diagnosis of systemic sclerosis confirmed with ACR/EULAR classification criteria score ≥ 9ACR/EULAR score >=9

Disease duration and prior therapy: Onset of disease (first non-Raynaud symptom) ≤ 5 years; disease worsening despite low-dose corticosteroids (eg, prednisone ≤ 10 mg/day) and stable immunosuppressant therapy<=5 years since onset

Provide chart notes and medication history

Baseline pulmonary function and imaging: Baseline %FVC ≥ 40% predicted AND %DLCO 30-89% predicted; HRCT showing pulmonary fibrosis involving at least 10% of the lungs%FVC >=40%; %DLCO 30-89%; HRCT >=10%

Provide PFT and HRCT reports

Prior biologic therapy failure: Member has tried and failed Actemra (tocilizumab), verified by chart notes or pharmacy paid claims (Actemra requires prior authorization)

Provide prior therapy documentation

Reauthorization / Continuation Therapy

Reauthorization criteria (all indications):

Continued diagnostic criteria: Continues to meet diagnostic criteria for the treated condition

Tolerability and safety: Not experiencing toxicity from drug treatment; ongoing liver monitoring; for female patients, periodic pregnancy testing as indicated; monitoring for GI events and arterial thromboembolic events

Provide labs and adverse event documentation

Clinical response: Disease state or symptomology determined to be stable with documentation of response by reduction in the rate of FVC decline compared to pre-treatment baseline

Provide comparative PFT data

Requests that fail to fully meet the policy’s required diagnostic confirmations, specialist involvement, pulmonary function and imaging thresholds, prior therapy requirements, or supporting documentation are not medically necessary. Examples include missing confirmation by HRCT or biopsy, absence of pulmonology prescriber or consult, baseline FVC/DLCO values below the stated initiation thresholds, lack of evidence of radiologic or clinical progression for chronic fibrosing ILD, failure to document prior Actemra use/failure when required for systemic sclerosis–associated ILD, or incomplete/illegible PA forms and missing PFT/HRCT/chart notes. Authorization may be delayed or denied if the request form is incomplete or required documentation (labs, diagnostics, chart notes, or pharmacy claims) is not provided.

Initial Authorization Rules

Initial authorization

Initial authorization is for 6 months when criteria for the specific indication are met.

Form completion: Prescriber must complete and sign the prior authorization form with all required fields and legible contact information; submit per form instructions

Fax to AvMed Specialty Pharmacy; incomplete requests may be delayed or denied

Indication-specific criteria: Member meets the full set of diagnostic, imaging, PFT thresholds, specialist involvement, and prior therapy requirements for the selected indication (IPF, chronic fibrosing ILD with progressive phenotype, or SSc-ILD)

See indication-specific initial therapy criteria and provide supporting documentation

Reauthorization and Continuation

Reauthorization

Diagnostic stability: Continues to meet diagnostic criteria and is not experiencing drug-related toxicity

Provide documentation

Monitoring: Regular liver toxicity monitoring and, for females, periodic pregnancy testing; monitor for GI and thromboembolic events

Provide labs and monitoring notes

Clinical benefit: Documentation of stability or reduction in rate of FVC decline compared to pre-treatment baseline

Provide serial PFT data

Clinical Thresholds and Diagnostic Parameters

inv-07: IPF - Forced Vital Capacity (FVC) — ≥ 50% predicted

ThresholdFVC ≥ 50% predicted

Documentation requiredProvide supporting pulmonary function test (PFT) report and/or chart notes showing FVC

Indication contextApplies to initiating OFEV for Idiopathic Pulmonary Fibrosis (IPF) when diagnosis confirmed by HRCT or lung biopsy

inv-08: IPF - DLCO — 30 - 79% predicted

ThresholdDLCO 30 - 79% predicted

Documentation requiredProvide supporting pulmonary function test (PFT) report and/or chart notes showing DLCO

Indication contextRequired baseline DLCO for initiation of OFEV in IPF

inv-09: Chronic fibrosing ILD - lung involvement on HRCT — ≥ 10% of lungs within past 24 months

ThresholdHRCT showing fibrotic ILD involving ≥ 10% of the lungs within the past 24 months

Documentation requiredSubmit HRCT imaging reports demonstrating extent of fibrosis and timing within 24 months

Role in criteriaOne radiologic requirement for chronic fibrosing ILD with progressive phenotype

inv-10: Chronic fibrosing ILD - FVC for initiation — ≥ 45% predicted

ThresholdFVC ≥ 45% predicted

Documentation requiredProvide supporting pulmonary function test (PFT) report and/or chart notes showing FVC

Indication contextBaseline FVC requirement to initiate OFEV for chronic fibrosing ILD with progressive phenotype

inv-11: Chronic fibrosing ILD - DLCO — 30 - 80% predicted

ThresholdDLCO 30 - 80% predicted

Documentation requiredProvide supporting pulmonary function test (PFT) report and/or chart notes showing DLCO

Indication contextBaseline DLCO requirement to initiate OFEV for chronic fibrosing ILD with progressive phenotype

inv-12: Systemic sclerosis - baseline %FVC — ≥ 40% predicted

ThresholdBaseline %FVC ≥ 40% predicted

Documentation requiredProvide baseline %FVC from PFT report and/or chart notes

Indication contextApplies to systemic sclerosis–associated ILD (SSc-ILD) initiation criteria

inv-13: Systemic sclerosis - %DLCO — 30 - 89% predicted

Threshold%DLCO 30 - 89% predicted

Documentation requiredProvide baseline %DLCO (corrected for hemoglobin) from PFT report and/or chart notes

Indication contextApplies to systemic sclerosis–associated ILD (SSc-ILD) initiation criteria

Provider Requirements and Submission Instructions

Prior Authorization

Prior Authorization Required

Prior authorization required. The prescribing physician must sign and clearly print their name on the prior authorization (PA) request form (preprinted stamps are not valid). Complete the PA form and submit via fax to AvMed Specialty Pharmacy per form instructions (fax: 1-305-671-0200). Incomplete, incorrect, or illegible information can delay the authorization process.

Prescriber signature and printed name required (no stamps).
Fax completed PA to AvMed Specialty Pharmacy per form instructions (1-305-671-0200).

Note

Specialty Pharmacy and Samples

Medication is dispensed through the designated specialty pharmacy (Proprium Rx). Samples do not meet step-edit or prior authorization criteria and cannot be used to satisfy PA or step requirements.

Specialty pharmacy: Proprium Rx.
Samples do not satisfy PA / step-edit requirements.

Documentation Required

Incomplete Documentation Risk

Authorization can be delayed or denied if the PA form is incomplete, incorrect, or illegible, or if required supporting documentation (see below) is not provided. Ensure phone/fax numbers and all requested fields are accurate.

Incomplete/incorrect/illegible requests may be delayed or denied.
Ensure contact information on the form is complete and accurate.

Denial Risk

Failure to Meet Clinical Criteria

Requests will be denied if the clinical criteria for the specific diagnosis are not fully met. Confirm that all diagnosis-specific requirements (IPF, chronic fibrosing ILD, or systemic sclerosis–associated ILD) are satisfied before submission.

Denial risk if diagnostic criteria for the requested indication are not met.
No concomitant use with Esbriet for indicated diagnoses where contraindicated.

Documentation Required

Required Supporting Documentation

Provide all required supporting documentation with the PA request to avoid delays: pulmonary function test (PFT) reports showing FVC and DLCO/%DLCO, HRCT imaging reports documenting extent of fibrosis (including percent lung involvement where applicable), relevant chart notes, and any prior therapy documentation (e.g., pharmacy claims or chart notes verifying prior treatments).

PFT reports with FVC and DLCO/%DLCO values.
HRCT imaging report showing extent of disease (e.g., ≥10% lung involvement when required).
Relevant chart notes, including specialist consultation notes and documentation of progression or stability.
Pharmacy paid claims or chart notes documenting prior therapies.

Step Therapy

Step Requirement for Systemic Sclerosis

For systemic sclerosis–associated ILD indication, member must have tried and failed Actemra prior to approval; Actemra itself requires prior authorization. Verify failure of Actemra via chart notes or pharmacy paid claims and include that documentation with the PA request.

Step requirement: prior failure of Actemra (document with chart notes or pharmacy claims).
Note: Actemra requires its own prior authorization.

Step	Requirement
1	Document prior Actemra (tocilizumab) use and failure via chart notes or pharmacy paid claims (Actemra also requires prior authorization).

Definitions and Diagnostic Criteria

inv-21: Idiopathic Pulmonary Fibrosis (IPF) — Diagnosis requiring pulmonology involvement and confirmation by HRCT or lung biopsy; baseline FVC ≥ 50% predicted and DLCO 30–79% predicted.

Diagnosis confirmationDiagnosis of IPF requiring pulmonology involvement and confirmation by HRCT or lung biopsy

Baseline pulmonary functionBaseline FVC ≥ 50% predicted and DLCO 30–79% predicted

Concomitant therapy restrictionNo concomitant use of OFEV and Esbriet (pirfenidone)

inv-22: Chronic fibrosing interstitial lung disease with progressive phenotype — Fibrotic ILD with progression over 24 months including ≥10% lung involvement on HRCT and clinical progression demonstrated by FVC decline.

Radiologic progressionFibrotic ILD with ≥ 10% lung involvement on HRCT within past 24 months

Clinical progressionEvidence of progression over 24 months: FVC decline >10% OR FVC decline 5–9% with worsening symptoms or increased fibrosis on imaging

Baseline pulmonary functionBaseline FVC ≥ 45% predicted required for initiation

inv-23: Systemic sclerosis–associated ILD (SSc-ILD) — SSc-ILD meeting ACR/EULAR classification score ≥9, disease onset ≤5 years, worsening despite low-dose steroids and stable immunosuppressive therapy.

Classification and diagnosisSSc-ILD confirmed with ACR/EULAR classification score ≥ 9

Disease duration and prior therapyOnset ≤ 5 years and worsening despite low-dose corticosteroids and stable immunosuppressive therapy; member has tried and failed Actemra (tocilizumab)

Baseline pulmonary function and imagingBaseline %FVC ≥ 40% predicted and %DLCO 30–89% predicted; HRCT showing pulmonary fibrosis involving at least 10% of lungs

Background

OFEV (nintedanib) is an antifibrotic tyrosine kinase inhibitor indicated for idiopathic pulmonary fibrosis (IPF), chronic fibrosing interstitial lung disease with a progressive phenotype, and systemic sclerosis–associated interstitial lung disease (SSc-ILD). Initial authorizations are for 6 months; reauthorization is also for 6 months and requires documentation of continued diagnostic criteria, tolerability (including regular liver monitoring and pregnancy testing when applicable), and clinical benefit (stability or reduction in the rate of FVC decline compared to pre-treatment baseline). Medication is dispensed via the designated specialty pharmacy (Proprium Rx).

OpenPayer