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Ohtuvayre (ensifentrine) — Blue Cross Blue Shield of Alabama

Chronic obstructive pulmonary disease (COPD)

Initial criteria

  • ONE of the following:
  • • The requested agent is eligible for continuation of therapy AND ONE of the following:
  • – The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
  • – The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed
  • OR BOTH of the following apply:
  • • Diagnosis criteria:
  • – The patient has a diagnosis of chronic obstructive pulmonary disease (COPD) AND ALL of the following:
  • ○ Diagnosis confirmed by spirometry with post-bronchodilator FEV1/FVC < 0.7
  • ○ Post-bronchodilator FEV1 between 30% and 70% predicted
  • ○ ONE of the following: Medical Research Council dyspnea score ≥ 2 OR COPD Assessment Test (CAT) score ≥ 10
  • • Treatment criteria:
  • – ONE of the following:
  • ○ The patient is currently being treated with a LABA + LAMA combination with or without an inhaled corticosteroid (ICS)
  • ○ The patient has an intolerance or hypersensitivity to a LABA + LAMA combination
  • ○ The patient has an FDA labeled contraindication to ALL LABA + LAMA combinations
  • ○ The patient has another FDA labeled indication for the requested agent
  • • Age criteria: If the patient has an FDA labeled indication, the patient's age is within FDA labeling or there is support for use for the patient's age
  • • Ongoing therapy: If the patient has COPD, will continue COPD control therapy (e.g., LABA, LAMA, ICS) in combination with the requested agent
  • • Specialist requirement: The prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist, immunologist, pulmonologist) or has consulted with such a specialist
  • • The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

  • The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
  • AND ONE of the following:
  • • The patient has a diagnosis of COPD AND BOTH of the following:
  • – Has had a decrease in exacerbations and/or dyspnea with the requested agent
  • – Will continue COPD control therapy (e.g., LABA, LAMA, ICS) in combination with the requested agent
  • OR
  • • The patient has a diagnosis other than COPD AND has had clinical benefit with the requested agent
  • AND
  • • The prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist, immunologist, pulmonologist) or has consulted with a specialist
  • • The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

initial 6 months; renewal 12 months