Ensifentrine (Ohtuvayre) — Coverage Criteria for Maintenance Treatment of COPD
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Prior authorization and coverage criteria for ensifentrine (Ohtuvayre) as maintenance treatment for adult patients with COPD under AllCare Advantage.
No material clinical or coverage changes in this revision.
Coverage Criteria for Ensifentrine (Ohtuvayre)
Initial Therapy
Covered when ALL of the following are met for initial authorization:
Initial Authorization
- Age: Member is ≥18 years old
Refer chunk 4
- Diagnosis: Documentation supports a diagnosis of chronic obstructive pulmonary disease (COPD)
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- Prescriber: Therapy is prescribed by or in consultation with a pulmonologist
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- Use: Ensifentrine will be used as maintenance treatment
Refer chunk 4
- Eosinophils: Blood eosinophil level ≥100 cells/microliter≥100 cells/microliter
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- Prior therapy: Patient had an adequate trial of, and will continue on, or has a contraindication/failure to, a LAMA/LABA/ICS combination therapy (e.g., Trelegy Ellipta, Breztri)
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- Exacerbation management: For continued frequent exacerbations, documentation of a one-year trial of azithromycin or roflumilast without improvement is required
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Renewal Therapy
Renewal approval requires meeting initial criteria and clinical response:
Renewal Authorization
- Met initial criteria: Member met the initial criteria for ensifentrine
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- Clinical response: Member has shown clinical response evidenced by ONE of: reduction in COPD exacerbations from baseline OR reduction in severity or frequency of COPD-related symptoms
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Use of ensifentrine (Ohtuvayre) is excluded for patients younger than 18 years. Members must be ≥18 years old to meet the coverage criteria; requests for patients with age <18 fail criteria and should not be approved.
Initial Therapy Requirements
Initial Therapy Requirements
Initial therapy criteria summary:
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Continuation / Renewal Criteria
Continuation/Renewal
Renewal requirements for continuation of therapy:
Continuation
- Initial met: Member met initial criteria
Refer chunk 5
- Demonstrated response: Reduction in COPD exacerbations from baseline OR reduction in severity/frequency of COPD symptoms
Refer chunk 6
Provider Actions, Prior Authorization, and Documentation
Obtain prior authorization with required clinical elements
Prior authorization is required and must document that the member is ≥18 years old, has a diagnosis of COPD, the therapy is prescribed by or in consultation with a pulmonologist, ensifentrine will be used as maintenance treatment, the patient’s blood eosinophil level is ≥100 cells/µL, and prior trial/failure/contraindication to LAMA/LABA/ICS combination therapy (and azithromycin or roflumilast trial if frequent exacerbations persist) when applicable.
- Member age ≥18 years
- Documentation supports diagnosis of COPD
- Prescribed by or in consultation with a pulmonologist
- Intended use as maintenance treatment
- Blood eosinophil level ≥100 cells/microliter
- Prior adequate trial of (and will continue on), or contraindication/failure to, LAMA/LABA/ICS combination therapy
- If frequent exacerbations persist, documentation of a one‑year trial of azithromycin or roflumilast without improvement
Step therapy: trial of LAMA/LABA/ICS required
Before approval, confirm the patient had an adequate trial of a LAMA/LABA/ICS combination product (e.g., Trelegy Ellipta, Breztri) and will continue it, or document a contraindication, intolerance, or failure to that combination therapy.
- Examples of combination therapy: Trelegy Ellipta, Breztri
- Document trial duration, response, or reason for discontinuation
Provide required clinical documentation with PA
Submit documentation that supports the COPD diagnosis, shows the prescriber is a pulmonologist or consulted one, indicates ensifentrine will be used as maintenance therapy, reports the most recent blood eosinophil level (≥100 cells/µL), and includes prior trials/failures/contraindications to required therapies; renewals must include evidence of clinical response.
- COPD diagnosis documentation (clinical record, testing as applicable)
- Prescriber specialty or pulmonology consultation note
- Statement that ensifentrine is for maintenance treatment
- Most recent blood eosinophil level (report value and date)
- Records of prior trials or documented contraindications/failures to LAMA/LABA/ICS combination therapy
- For frequent exacerbations: one‑year trial documentation of azithromycin or roflumilast without improvement
- For renewals: documentation of clinical response (reduced exacerbations or reduced severity/frequency of symptoms)
Denial triggers — documentation and eligibility failures
The request will be denied if documentation does not support COPD, the prescriber is not a pulmonologist (and no consultation is documented), ensifentrine is not intended as maintenance therapy, the member is <18 years old, or the blood eosinophil level is <100 cells/µL.
- No documentation of COPD diagnosis → Deny
- Prescriber not a pulmonologist and no pulmonology consultation → Deny
- Use not for maintenance treatment → Deny
- Member age <18 years → Deny
- Blood eosinophils <100 cells/µL → Deny
Step Therapy Requirements
| Step | Requirement | Example(s) |
|---|---|---|
| 1 | ||
| Patient must have had an adequate trial of, and will continue on, or have a documented contraindication, failure, or intolerance to LAMA/LABA/ICS combination therapy | ||
| Trelegy Ellipta; Breztri |
Coding and Clinical Thresholds
Quantity Limits
Background
Ensifentrine (Ohtuvayre) is a first-in-class, inhaled dual phosphodiesterase (PDE) 3 and PDE4 inhibitor approved for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. It is positioned as an additional maintenance option for patients with COPD who require further bronchodilator and anti-inflammatory benefit despite standard inhaled therapies.
Definitions
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