CurrentBlue Cross Blue Shield - NevadaPolicy N/A

Prior Authorization for Phosphodiesterase Inhibitors for Pulmonary-Related Disorders

Governs prior authorization requirements and required documentation for prescribing phosphodiesterase inhibitor drugs (e.g., roflumilast/Daliresp and ensifentrine/Ohtuvayre) for pulmonary-related disorders for members served by the plan; affects prescribing providers who must complete and submit the PA form and supporting clinical documentation.

Policy Summary

PayerBlue Cross Blue Shield - Nevada

PolicyPrior Authorization for Phosphodiesterase Inhibitors for Pulmonary-Related Disorders

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form with required clinical documentation, including PFTs and bronchodilator trial dates, and prescriber attestation that adjunct therapy will be continued.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2PDE products with PA

90Adjunct therapy trial (days)

18 mgMax dose check

>=45%FVC baseline threshold

Coverage Criteria

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Initial Therapy

Covered when ALL of the following are met for initial authorization:

Initial Authorization - pulmonary fibrosis: 1) Diagnosis of idiopathic pulmonary fibrosis confirmed by lung biopsy or HRCT demonstrating usual interstitial pneumonia (UIP) or probable UIP (documentation submitted) OR diagnosis of progressive pulmonary fibrosis confirmed by consistent decline in lung function supported by documentation (HRCT, PFTs); 2) Member is 18 years of age or older; 3) Baseline FVC ≥ 45% of predicted (documentation submitted); 4) DLCO (carbon monoxide diffusing capacity) ≥ 25% of predicted (documentation submitted); 5) Prescribed by or in consultation with a pulmonologist; 6) Requested dose does not exceed 18 mg twice daily.FVC ≥ 45% predicted; DLCO ≥ 25% predicted; dose ≤ 18 mg twice daily

All listed conditions must be met for initial approval

Continuation Therapy / Reauthorization

Covered when ALL of the following are met for reauthorization:

Reauthorization: 1) History of the requested agent for at least 90 days within the past 120 days, confirmed by claims history, chart documentation, or provider attestation including dates of trial; 2) Member demonstrates positive clinical response or stabilization to therapy (for example, improvement or stabilization in FVC with documentation showing trend from baseline); 3) Requested dose does not exceed 18 mg twice daily.history ≥ 90 days in past 120 days; dose ≤ 18 mg twice daily

All listed conditions must be met for reauthorization

COPD Initial Therapy

Covered when ALL of the following are met for COPD indications:

COPD agents (roflumilast, ensifentrine): 1) Diagnosis of COPD (for ensifentrine) or severe COPD with chronic bronchitis and history of exacerbations (for roflumilast) with documentation; 2) Provide most recent FEV1 % predicted (for roflumilast) or FEV1/FVC ratio and mMRC score (for ensifentrine) with dates and supporting documentation; 3) Member has used combination LABA/LAMA/ICS therapy for at least 90 of the past 120 days, or provider provides rationale for not using adjunct therapy; 4) Provide names and dates of bronchodilator/LABA/LAMA/ICS therapies trialed (including start/stop dates); 5) Prescriber attests that adjunct therapy will be continued while on the PDE inhibitor.LABA/LAMA/ICS trial ≥ 90 days in past 120 days; document FEV1% or FEV1/FVC and mMRC as applicable

All listed conditions must be met for COPD-related approvals

All sections of the prior authorization form must be fully completed and signed by the prescribing provider before the request can be processed. All sections must be completed or the request will be returned. If required fields or supporting documentation (for example, objective PFT values, HRCT or biopsy reports, bronchodilator trial dates, or prescriber attestation) are missing, the submission will be returned to the provider for completion and will not be reviewed for medical necessity until the form and documentation are complete.

Required Clinical Thresholds and Measurements

Required clinical thresholds

Adjunct bronchodilator/LABA-LAMA-ICS trialMember must have used combination LABA/LAMA/ICS therapy for at least 90 of the past 120 days (or provide rationale and dates of trials)

FEV1 % predictedMost recent FEV1 % predicted must be provided with documentation (required for roflumilast)

FEV1/FVC ratioMost recent FEV1/FVC ratio must be provided with documentation (required for ensifentrine)

FVC baseline thresholdBaseline FVC greater than or equal to 45% of predicted (documentation submitted)

DLCO thresholdCarbon monoxide diffusing capacity (DLCO) greater than or equal to 25% of predicted (documentation submitted)

Maximum requested doseRequested dose must not exceed 18 mg twice daily

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for the listed phosphodiesterase (PDE) inhibitors and inhaled COPD agents. A completed prior authorization form and all required supporting documentation must be submitted; incomplete forms or missing required sections will result in the request being returned.

Affected products include DALIRESP (roflumilast) and OHTUVAYRE (ensifentrine).
Completed PA form must be faxed to the Prior Authorization of Benefits Center (see form for fax numbers).
All required supporting documentation (diagnosis confirmation, PFTs, FEV-1/FVC, mMRC scores, HRCT reports, bronchodilator trial dates, etc.) must be included.

Documentation Required

COPD Agents — LABA/LAMA/ICS Use Required

For COPD-targeted agents (roflumilast and ensifentrine), the prescriber must document use of combination long-acting bronchodilator and inhaled corticosteroid therapy: the member must have used LABA/LAMA/ICS therapy for at least 90 days within the past 120 days, with names and dates of prior bronchodilator trials provided. If adjunct therapy will not be used, the prescriber must provide a rationale and attest to ongoing therapy when applicable.

Document last FEV-1 % predicted (roflumilast) or FEV-1/FVC ratio (ensifentrine) with dates.
Provide last mMRC score (ensifentrine) where applicable.
List medication names, start and stop dates for bronchodilator therapies trialed.
Prescriber attestation that member will continue adjunct LABA/LAMA/ICS therapy while on therapy (signature required).

Denial Risk

Form Completion and Submission Requirements

All prior authorization requests must include a fully completed PA form plus supporting clinical documentation. If the form is incomplete or required sections are missing, the request will be returned and processing delayed.

Required documentation includes diagnosis confirmation (eg, HRCT, lung biopsy for fibrosis; PFTs for COPD), recent pulmonary function test results, exacerbation history, and any other requested clinical notes.
Ensure prescriber name, license/NPI, signature, contact/fax number, and dates of service (if retroactive request) are completed on the form.
Retroactive PA requests must be submitted separately with dates of service prior to 30 calendar days of submission per form instructions.

Background

Roflumilast (Daliresp) and ensifentrine (Ohtuvayre) are phosphodiesterase-related agents used in the management of chronic pulmonary disorders, most commonly chronic obstructive pulmonary disease (COPD) and certain progressive fibrotic lung diseases. The prior authorization form for these agents requests objective pulmonary function data (for example, FEV1 % predicted, FEV1/FVC ratio, FVC % predicted, and DLCO), documentation of prior bronchodilator or combination LABA/LAMA/ICS therapy (including dates), and exacerbation history when applicable to establish medical necessity.

For COPD indications, the policy requires documentation that the member has used combination LABA/LAMA/ICS therapy for at least 90 days within the past 120 days (or a documented rationale for why adjunct therapy was not used), plus the relevant spirometric measures (FEV1 or FEV1/FVC and symptom scores). For initial use in idiopathic or progressive pulmonary fibrosis, the policy requires confirmation of diagnosis by lung biopsy or high-resolution CT (UIP or probable UIP), age ≥18, and baseline thresholds such as FVC ≥ 45% predicted and DLCO ≥ 25% predicted, and limits requested doses to not exceed 18 mg twice daily.

Definitions and Specific Authorization Thresholds

Initial authorization (pulmonary fibrosis)

Diagnosis confirmation (HRCT or lung biopsy)Diagnosis of idiopathic pulmonary fibrosis confirmed by lung biopsy or HRCT demonstrating UIP or probable UIP (documentation must be submitted)

Age requirementMember is 18 years of age or older

Baseline FVCMember has a forced vital capacity (FVC) greater than or equal to 45% of predicted (documentation submitted)

Baseline DLCOMember has a carbon monoxide diffusing capacity greater than or equal to 25% of predicted (documentation submitted)

Prescriber specialtyPrescribed by, or in consultation with, a pulmonologist

Dose limitRequested dose does not exceed 18 mg twice daily