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Ohtuvayre (ensifentrine) inhalation suspension 3 mg/2.5 mL — Blue Cross Blue Shield of Oklahoma

other FDA-labeled indication for Ohtuvayre

Initial criteria

  • 1. The patient has a diagnosis of COPD AND ALL of the following:
  • A. Diagnosis confirmed by spirometry with post-bronchodilator FEV1/FVC < 0.7
  • B. Post-bronchodilator FEV1 between 30% and 70% predicted
  • C. ONE of the following: modified Medical Research Council (mMRC) dyspnea score ≥ 2 OR COPD Assessment Test (CAT) score ≥ 10
  • D. ONE of the following: (1) currently treated with LABA + LAMA combination with or without ICS OR (2) has intolerance or hypersensitivity to LABA + LAMA combination OR (3) has an FDA-labeled contraindication to ALL LABA + LAMA combinations
  • OR 2. The patient has another FDA-labeled indication for the requested agent
  • AND if the patient has an FDA-labeled indication, ONE of the following: (A) the patient's age is within FDA labeling for indication OR (B) there is support for use in this age
  • AND if the patient has COPD, the patient will continue COPD control therapy (e.g., LABA, LAMA, ICS) in combination with Ohtuvayre
  • The prescriber is a specialist (e.g., allergist, immunologist, pulmonologist) or has consulted a specialist
  • The patient does not have any FDA-labeled contraindications to Ohtuvayre
  • Alternate approval pathway: the member resides in Ohio AND the plan is Fully Insured or HIM Shop (SG) AND BOTH of the following: (A) the patient has no FDA-labeled contraindications AND (B) ONE of the following: (1) another FDA-labeled indication OR (2) another indication supported in compendia (DrugDex level 1, 2A, 2B; AHFS-DI supportive text; NCCN 1 or 2A; Clinical Pharmacology supportive; LexiDrugs level A) OR (3) prescriber submits TWO peer-reviewed articles supporting use)

Reauthorization criteria

  • 1. The patient was previously approved for Ohtuvayre through plan’s PA process
  • 2. ONE of the following:
  • A. The patient has COPD AND BOTH of the following:
  • 1. Decrease in exacerbations and/or dyspnea with Ohtuvayre
  • 2. Will continue COPD control therapy (e.g., LABA, LAMA, ICS) in combination with Ohtuvayre
  • B. The patient has a diagnosis other than COPD AND has had clinical benefit with Ohtuvayre
  • 3. The prescriber is a specialist (e.g., allergist, immunologist, pulmonologist) or has consulted a specialist
  • 4. The patient does not have any FDA-labeled contraindications to Ohtuvayre

Approval duration

Initial 6 months (12 months for BCBSIL or Ohio scenario); Renewal 12 months