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

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来源: FiercePharma

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

The Institute for Clinical and Economic Review (ICER) has issued an "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 monthly dose of the maintenance treatment, which is administered twice daily by a nebulizer. At an annual list price of $35,400, Ohtuvayre costs nearly three times more than the top of ICER’s valuation range for the product.

In its final evidence report, ICER 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 ability of 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.

“Unfortunately, the manufacturer chose a price for ensifentrine 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 promising new treatment.”

Verona did not respond immediately to a request for comment.

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 weeks ago, the European Union signed off on Dupixent to be used both in combination with other inhaled treatments and as a solo agent.

Evercore ISI has projected that a nod in COPD would boost annual sales of Dupixent by $3.5 billion annually. Meanwhile, Global Data has estimated that Ohtuvayre sales will reach $1.05 billion by 2029.

The new treatments could serve a massive population. In the U.S., 8.6 million patients are treated for chronic symptoms of COPD. More than 390 million people worldwide are living with COPD.

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