WHA

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., needs to stop for breath when walking on level ground) [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., needs to stop for breath when walking on level ground) [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

  • Guideline ID
    GL-391210

  • Formulary
    Premium

  • Effective date
    Dec 1, 2025

  • P&T approval date
    Aug 15, 2024

P & T Revisions

2025-09-25, 2025-02-05, 2024-09-16, 2024-08-22, 2024-08-09

  1. Ohtuvayre [prescribing information]. Raleigh, NC: Verona Pharma, Inc.; July 2025.
  2. Anzueto A, Barjaktarevic IZ, Siler TM, Rheault T, Bengtsson T, et al. Ensifentrine, a Novel Phosphodiesterase 3 and 4 Inhibitor for the Treatment of Chronic Obstructive Pulmonary Disease: Randomized, Double-Blind, Placebo-controlled, Multicenter Phase III Trials (the ENHANCE Trials). Am J Respir Crit Care Med. 2023 Aug 15;208(4):406-416. doi: 10.1164/rccm.202306-0944OC.
  3. Modified Medical Research Council (mMRC) dyspnea scale | https://www.uptodate.com/contents/image?imageKey=PULM/86426
  1. In the ENHANCE trials, the inclusion criteria included a grade of greater than or equal to 2 on the Medical Research Council (MRC) Dyspnea Scale [2, 3]
  • 2025-09-25: 2025 Annual Review. Example of dyspnea during everyday activities in initial criteria updated to reflect the description of breathlessness for Medical Research Council (MRC) Dyspnea Scale grade of greater than or equal to 2. Added endnote [A] In the ENHANCE trials, the inclusion criteria included a grade of greater than or equal to 2 on the Medical Research Council (MRC) Dyspnea Scale [2,3]. Update references.
  • 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.