CurrentBlue Cross Blue Shield - IowaPolicy 05.01.118

Ofev (nintedanib) drug coverage

Defines prior authorization, documentation, and medical necessity criteria for coverage of Ofev (nintedanib) for IPF, SSc‑ILD, and chronic fibrosing ILDs with a progressive phenotype for Wellmark/Blue Cross Blue Shield members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyOfev (nintedanib) drug coverage

Policy CodePolicy 05.01.118

Change TypeNo material changes

Effective DateMay 29, 2020

Next Review Date

Key ActionSubmit prior authorization demonstrating diagnostic and progression criteria and include HRCT results (and biopsy report if performed).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moauthorization period

300 mg/daydaily quantity limit

>=10%minimum fibrosis extent

24 moprogression window

Coverage Criteria for Ofev (nintedanib)

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IPF initial criteria: 1) Other known causes of interstitial lung disease (e.g., domestic and occupational environmental exposures, connective tissue disease, drug toxicity) have been excluded; AND 2) The member has completed a high-resolution computed tomography (HRCT) study of the chest or a lung biopsy which reveals a result consistent with the usual interstitial pneumonia (UIP) pattern, OR has completed an HRCT study of the chest which reveals a result other than the UIP pattern (e.g., probable UIP, indeterminate for UIP) and the diagnosis is supported by a lung biopsy; if a lung biopsy has not been previously conducted, the diagnosis must be supported by a multidisciplinary discussion between a radiologist and pulmonologist experienced in IPF.

Authorization duration: 12 months

Chronic Fibrosing ILDs with a Progressive Phenotype — Initial Approval

Authorization of 12 months may be granted when ALL of the following are met:

Chronic fibrosing ILD criteria: 1) HRCT demonstrates fibrosing lung disease defined as reticular abnormality with traction bronchiectasis, with or without honeycombing, with fibrosis affecting more than 10% of the lungs; AND 2) HRCT does not show widespread consolidation or progressive massive fibrosis; AND 3) The member meets at least one of the following criteria for progression within the last 24 months despite standard treatment with an agent other than nintedanib (Ofev) or pirfenidone (Esbriet): a) Relative decline in FVC >=10% of predicted; OR b) Relative decline in FVC 5% to <10% of predicted PLUS either worsening respiratory symptoms OR increased extent of fibrosis on HRCT; OR c) Worsening respiratory symptoms AND increased extent of fibrotic changes on HRCT only.>10% fibrosis; progression within 24 months

Progression defined as: relative FVC decline >=10%; or relative FVC decline 5%-<10% plus worsening symptoms or increased fibrosis on HRCT; or worsening symptoms plus increased fibrosis on HRCT.

Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) — Initial Approval

Authorization of 12 months may be granted when ALL of the following are met:

SSc-ILD criteria: HRCT of the chest shows fibrosis affecting at least 10% of the lungs.>=10% fibrosis

Authorization duration: 12 months

Continuation of Therapy

All members (including new members) requesting continuation may be granted 12 months when the following is met:

Continuation criteria: Member is currently receiving treatment with Ofev; excludes members obtaining Ofev as samples or via manufacturer's patient assistance programs.

Authorization duration: 12 months

Members who are currently receiving Ofev as samples or through the manufacturer's patient assistance program are not exempt from the policy requirements. Such members must meet the initial approval criteria specified for Ofev, including submission of required diagnostic documentation (for example, chest HRCT and lung biopsy report if performed) to support the diagnosis and indication. This provision ensures members are treated equally regardless of whether their provider obtained medication samples or used patient assistance.

Key Diagnostic / Imaging Definitions and Coding Notes

inv-07: Fibrosis extent on HRCT — greater than 10% of the lungs.

ThresholdFibrosis affecting more than 10% of the lungs on HRCT

Where usedChronic fibrosing ILDs with a progressive phenotype initial approval criteria

Related requirementHRCT must not show widespread consolidation or progressive massive fibrosis (per policy)

inv-08: Progression look-back window — within the last 24 months.

Look-back windowProgression must be demonstrated within the last 24 months

ContextApplied to chronic fibrosing ILDs with a progressive phenotype for initial authorization

Progression definitionsIncludes FVC relative decline >=10%; or FVC decline 5%-<10% plus worsening symptoms or increased fibrosis on HRCT; or worsening symptoms plus increased fibrosis on HRCT only

Prior Authorization & Provider Documentation Requirements

Prior Authorization

Prior authorization for Ofev

Prior authorization is required and may be granted for up to 12 months when the member meets the specified diagnostic and progression criteria for Ofev (nintedanib).

Authorization duration: 12 months
Applies to: Ofev (nintedanib)

Step Therapy

Step therapy / prior agents

For chronic fibrosing ILDs with a progressive phenotype, progression must have occurred despite standard treatment with an agent other than nintedanib (Ofev) or pirfenidone (Esbriet). Progression criteria include declines in FVC or worsening symptoms/HRCT changes within the last 24 months as specified in the policy.

Progression must have occurred despite standard treatment with an agent other than nintedanib or pirfenidone
Progression documented within the last 24 months

Documentation Required

PROVIDER ACTIONS – Imaging and Pathology Submission

Submit the result of a chest high-resolution computed tomography (HRCT) study of the chest as part of the prior authorization request. If a lung biopsy was performed, submit the associated pathology report.

Required: Chest HRCT report (describe extent of fibrosis; >10% for chronic fibrosing ILD or systemic sclerosis-associated ILD; presence of reticular abnormality with traction bronchiectasis; note if honeycombing present)
If performed: Lung biopsy pathology report

Denial Risk

Denial / Not Medically Necessary Conditions

Ofev is considered not medically necessary for members who do not meet the criteria set forth in the policy.

Members obtaining Ofev as samples or via manufacturer patient assistance programs must meet initial approval criteria for authorization
Counsel current smokers on smoking cessation as part of clinical care

Background on Nintedanib (Ofev)

Nintedanib (Ofev) is indicated to treat idiopathic pulmonary fibrosis, slow the decline in pulmonary function in systemic sclerosis‑associated interstitial lung disease, and to treat chronic fibrosing interstitial lung diseases with a progressive phenotype. The policy requires appropriate diagnostic evaluation (for example, HRCT and, when performed, lung biopsy) and adherence to the stated coverage criteria to determine medical necessity and authorization.

Definitions and Radiographic Patterns

inv-14: Fibrosing lung disease (HRCT definition) — Reticular abnormality with traction bronchiectasis, with or without honeycombing, with fibrosis affecting more than 10% of the lungs.

HRCT definitionReticular abnormality with traction bronchiectasis, with or without honeycombing, with fibrosis affecting more than 10% of the lungs

Clinical contextDefines fibrosing lung disease used to determine eligibility for chronic fibrosing ILD and SSc-ILD criteria

RequirementHRCT must not show widespread consolidation or progressive massive fibrosis when applying chronic fibrosing ILD criteria

inv-15: Usual interstitial pneumonia (UIP) pattern — HRCT or lung biopsy result consistent with the UIP pattern used to support diagnosis of IPF; probable/indeterminate HRCT results require ...

DefinitionHRCT or lung biopsy result consistent with the UIP pattern used to support diagnosis of IPF

Probable/indeterminate HRCTProbable or indeterminate HRCT results require lung biopsy or diagnosis supported by multidisciplinary discussion between an experienced radiologist and pulmonologist if biopsy not performed

Use caseOne of the diagnostic pathways required to meet IPF initial approval criteria

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyOfev (nintedanib) drug coverage

Policy CodePolicy 05.01.118

Change TypeNo material changes

Effective DateMay 29, 2020

Next Review Date

Key ActionSubmit prior authorization demonstrating diagnostic and progression criteria and include HRCT results (and biopsy report if performed).

SourceLink

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