OHTUVAYRE (ensifentrine)

OHTUVAYRE (ensifentrine)

Self-Administration - inhalation suspension

Diagnosis considered for coverage:

• Chronic Obstructive Pulmonary Disease (COPD): Indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.

Coverage Criteria:

For diagnosis of Chronic Obstructive Pulmonary Disease (COPD):

• Diagnosis of chronic obstructive pulmonary disease (COPD), AND 
• Both of the following: 
  • Post-bronchodilator forced expiratory volume [FEV1] / forced vital capacity [FVC] ratio less than 0.70 
  • Post-bronchodilator FEV1 % predicted greater than 30% and less than or equal to 70%; AND 
• Patient is symptomatic despite being on at least two therapies indicated for the treatment of COPD and will continue to be treated with the therapies (e.g. long acting muscarinic antagonists [e.g., tiotropium], long-acting beta agonist [e.g., formoterol]), unless there is a contraindication or intolerance; AND 
• Patient experiences dyspnea during everyday activities (e.g., short of breath when walking up a slight hill) 

Reauthorization Criteria:

For diagnosis of Chronic Obstructive Pulmonary Disease (COPD):

• Patient demonstrates a positive clinical response to therapy, AND 
• Patient continues to be treated with at least two therapies indicated for the treatment of COPD (e.g. long acting muscarinic antagonists [e.g., tiotropium], long-acting beta agonist [e.g., formoterol]), unless there is a contraindication or intolerance 

Coverage Duration: 

• Initial: 12 month
• Reauthorization: 12 month

Dosing: 

For diagnosis of Chronic Obstructive Pulmonary Disease (COPD):

• 3 mg (one unit-dose ampule) twice daily

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.
 

Additional Information: 

• Administered by oral inhalation using a standard jet nebulizer with a mouthpiece.

Policy Updates:

• 12/01/2024 (policy effective date) – New policy approved by WHA P&T Committee. (P&T, 11/20/2024) (P&T meeting date)  12/1/2024 (policy effective date)

References:

1. Ohtuvayre [prescribing information]. Raleigh, NC: Verona Pharma, Inc.; June 2024