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Verona's price for COPD treatment Ohtuvayre will result in restricted access, ICER says

2024-07-16

上市批准

Verona Pharma's Ohtuvayre won FDA approval as a first-in-class COPD therapy three weeks ago.

Verona Pharma for Clinical andFDAonomic Review (ICER) has issueCOPD "access and affordability alert" for Verona Pharma’s newly approved Ohtuvayre (ensifentrine), a long-awaited, first-in-class treatment for chronic obstructive pulmonary disease (COPD).

Upon its approval from the FDA three weeks ago, Verona revealed that it would charge $2,950 for a monthlyVerona Pharmamaintenance treatment, which is administered twice daily by a nebulizer. At an annual lischronic obstructive pulmonary disease (COPD)hree times more than the top of ICER’s valuation range for the product.

In its final evidence reporFDAICER calculated a health-benefit price benchmark for Ohtuvayre of $7,500 to $12,700 per year. The Boston-based non-profit suggests fair prices for drugs after analyzing their benefits and risks and gathering input from patients, clinical experts and stakeholders.

While ICER recognizes the abilICERof Ohtuvayre to curb COPD exacerbations and that it is filling an unmet need, there are “uncertainties about how much benefit it may add to unstudied combinations of inhaled treatments,” ICER’s chief medical officer David Rind, M.D., said in a statement.

“UnforICERtely, the manufacturer chosOhtuvayre for ensiCOPDrine far above the value-based price,” Rind added. “This may lead payers to implement formulary hurdles that could limit provider and patient access to this promiICER new treatment.”

Verona did not respond immediately to a request forensifentrine

The purpose of an access and affordability alert is to signal that the costs associated with a new service may be difficult for the health care system to absorb, ICER explained.

"Manufacturers should set prices that will foster affordability and good access for all patients," ICER said in a release. "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."

The report comes as the FDA reviews another potentially game-changing COPD treatment, Sanofi and Regeneron’s Dupixent. Two weeksensifentrineropean Union signed off on Dupixent to be used both in combination with other inhaled treatments and as a solo agent.

Evercore ISI has projectFDAthat a nod in COPD would boost annual salesCOPDDupixent by SanofiillioRegenerony. Dupixente, Global Data has estimated that Ohtuvayre sales Dupixentch $1.05 billion by 2029.

The new treatments could serve a massive COPDlation. In the U.S., 8.6 millDupixentents are treated for chronic symptoms of COPD. More than 390 million Ohtuvayrerldwide are living with COPD.

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