Prior Authorization for Phosphodiesterase Inhibitors for Pulmonary-Related Disorders
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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.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Therapy
Covered when ALL of the following are met for initial authorization:
All listed conditions must be met for initial approval
Continuation Therapy / Reauthorization
Covered when ALL of the following are met for reauthorization:
All listed conditions must be met for reauthorization
COPD Initial Therapy
Covered when ALL of the following are met for COPD indications:
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
Provider Actions and Prior Authorization Requirements
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.
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).
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
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