
The Institute for Clinical and Economic Review (ICER) has released its Final Evidence Report assessing the effectiveness and value of ensifentrine for the treatment of COPD. The drug was recently approved by the FDA as a treatment for adults with COPD.
The report said that, while current evidence is adequate to demonstrate a net health benefit for ensifentrine as an addition to maintenance treatment for COPD, there are some concerns over the cost of the drug.
Shortly after FDA approval, the drug’s manufacturer, Verona Pharma, set its price at $35,400 per year. ICER wrote in its report that, “approximately 0.5% of the roughly 9.1 million U.S. patients with moderate to severe COPD could be treated within five years without crossing the Institute for Clinical and Economic Review potential budget impact threshold of $735 million per year.”
Due to the low number of patients below that threshold, ICER has issued an access and affordability alert for ensifentrine. The purpose of the alert, ICER stated, is to “signal to stakeholders and policymakers that the amount of added health care costs associated with a new service may be difficult for the health care system to absorb over the short term without displacing other needed services, creating pressure on payers to sharply restrict access, causing rapid growth in health care costs that would threaten sustainable access to high-value care for all patients.”
ICER’s roundtable of experts — including clinical experts, patient advocates and representatives for U.S. payers — recommended that manufacturers set prices that allow access and affordability for all patients.
“For ensifentrine, the manufacturer has priced far above this level and therefore missed an opportunity to provide broad access and increased uptake of the drug,” ICER said in a statement.