Pharmacy Prior Authorization Criteria

Ohtuvayre (ensifentrine) - PA, NF

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

Ohtuvayre

Non Formulary (Initial Authorization)

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

• Submission of medical records (e.g., chart notes) confirming diagnosis of chronic obstructive pulmonary disease (COPD)
AND
• Submission of medical records (e.g., chart notes) confirming post-bronchodilator forced expiratory volume [FEV1] / forced vital capacity [FVC] ratio less than 0.70
AND
• Submission of medical records (e.g., chart notes) confirming 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
• Submission of medical records (e.g., chart notes) confirming patient experiences dyspnea during everyday activities (e.g., short of breath when walking up a slight hill) [A]

Ohtuvayre

Non Formulary (Reauthorization)

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

• Submission of medical records (e.g., chart notes) confirming patient demonstrates a positive clinical response to therapy
AND
• Submission of medical records (e.g., chart notes) or paid claims confirming 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

2025-02-05, 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

• 2025-02-05: Addition of non-formulary criteria.
• 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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