Affordability Concerns Raised for Verona Pharma's Ohtuvayre

The eagerly awaited, first-in-class medication for chronic obstructive pulmonary disease (COPD), Ohtuvayre (ensifentrine), recently approved by Verona Pharma, has been the subject of a "access and affordability alert" from the Institute for Clinical and Economic Review (ICER).Verona said that it will charge $2,950 for a monthly dose of the maintenance treatment—which is delivered twice daily via a nebulizer—after receiving approval from the FDA three weeks ago. Ohtuvayre costs almost three times as much as the top of ICER's product value range, with an annual list price of $35,400.

ICER determined a health-benefit price benchmark of $7,500 to $12,700 year for Ohtuvayre in its final evidence report. The Boston-based nonprofit makes reasonable drug pricing recommendations after weighing the advantages and disadvantages of each medication and consulting with patients.

Ohtuvayre is a lifesaver for COPD exacerbations, and ICER acknowledges that it is meeting a need in the market. However, as chief medical officer David Rind, M.D. put it in a statement, "there are uncertainties about how much benefit it may add to unstudied combinations of inhaled treatments. Rind said, "Unfortunately, the manufacturer set the price for ensifentrine much higher than the value-based price." "This would prompt insurers to erect formulary barriers, which might restrict access for both patients and providers to this exciting new treatment.”