Skip to content
The Policy VaultThe Policy Vault

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

Chronic obstructive pulmonary disease (COPD)

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