Pharmacy Prior Authorization Criteria

Ohtuvayre (ensifentrine)

Indications for Prior Authorization

Ohtuvayre (ensifentrine)

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

Criteria

Ohtuvayre

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Chronic Obstructive Pulmonary Disease (COPD

• Diagnosis of chronic obstructive pulmonary disease (COPD)
AND
• Post-bronchodilator forced expiratory volume [FEV1] / forced vital capacity [FVC] ratio less than 0.70
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) [A]

Ohtuvayre

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
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

P & T Revisions

2024-09-16, 2024-08-22, 2024-08-09

References

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

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Revision History

• 2024-09-16: Removal of criterion requiring: Post-bronchodilator FEV1 % predicted greater than 30% and less than or equal to 70%.
• 2024-08-22: Removal of prescriber requirement, in line with P&T approved criteria.
• 2024-08-09: New Program.

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