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

Initial criteria

• The patient has a diagnosis of chronic obstructive pulmonary disease (COPD) AND ALL of the following:
• • Diagnosis confirmed by spirometry with a post-bronchodilator FEV1/FVC ratio < 0.7
• • Post-bronchodilator FEV1 between 30% and 70% predicted
• • ONE of the following: (a) modified MRC dyspnea score ≥ 2 OR (b) COPD Assessment Test (CAT) score ≥ 10
• • ONE of the following: (a) currently treated with LABA + LAMA combination with or without ICS OR (b) intolerance or hypersensitivity to a LABA + LAMA combination OR (c) FDA labeled contraindication to ALL LABA + LAMA combinations
• If the patient has another FDA labeled indication for the requested agent, ONE of the following must apply: (a) age is within FDA labeling OR (b) there is support for using the agent for the patient’s age for the indication
• If the patient has COPD, the patient will continue COPD control therapy (e.g., LABA, LAMA, ICS) in combination with the requested agent
• 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
• For Ohio Fully Insured or HIM Shop (SG) plans, approval also requires:
• • Member resides in Ohio
• • Plan is Fully Insured or HIM Shop (SG)
• • No FDA labeled contraindications
• • ONE of the following: (a) has another FDA labeled indication and route of administration OR (b) indication supported in compendia (Non-oncology: DrugDex levels 1, 2A, 2B; AHFS-DI supportive text; Oncology: NCCN 1 or 2A; AHFS-DI, DrugDex 1/2A/2B, Clinical Pharmacology, LexiDrugs level A) OR (c) prescriber has submitted TWO peer-reviewed journal articles supporting proposed use

Reauthorization criteria

• The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• ONE of the following:
• • For COPD: BOTH (a) patient has had a decrease in exacerbations and/or dyspnea with therapy AND (b) patient will continue COPD control therapy (e.g., LABA, LAMA, ICS) in combination with the requested agent
• • For other indications: patient has had clinical benefit with the requested agent
• 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

Approval duration

Initial: 6 months (BCBSIL 12 months); Renewal: 12 months