GSK gets once-rejected asthma med Nucala past England's cost watchdogs

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Patients in the U.K. are set to have access to GSK's Nucala following a positive recommendation by NICE.

After an initial rejection, Glaxo’s first-in-class severe asthma treatment Nucala has passed the tough examination of England’s cost watchdogs, winning a recommendation contingent on a confidential discount.

Severe asthma patients in the U.K. are set to gain access to the anti-IL-5 asthma treatment with NICE’s recommendation for coverage, announced Thursday. Nucala was first approved in the EU late last year.

The decision follows an earlier "no" for the med on cost effectiveness concerns. GSK came back with “further analyses,” the institute reported, and pledged “an additional price reduction.” Nucala ran at 840 pounds per dose before the undisclosed discount.

Since Nucala's launch, NICE hasn’t been alone in criticizing the med's price. Last December, self-appointed U.S. price watchdog ICER said the drug was more than two times more expensive than it should be due to uncertainties about its long-term benefits.

Nonetheless, the news marks a win for GSK, as many companies have had mixed success at England’s cost gatekeepers in recent months. NICE centre for health technology evaluation director Carole Longson said in a statement that the decision will give U.K. patients “an extra option” where there aren’t many.

The decision also positions the London-based company favorably in the severe asthma field. Teva’s Cinqaero is still under review at the agency, which has asked that the company come back with more cost-effectiveness data on its drug.

However, some analysts believe AstraZeneca’s benralizumab, which was beat to the market by its competition, could be the strongest med in its class, at least based on dosing regimen. That candidate posted data in September showing a four-week regimen was no better than an eight-week course, potentially supporting less frequent dosing. GSK holds the first-to-market advantage.

About 100,000 people in the U.K. have severe asthma, Longson said. Nucala won backing as an add-on treatment for patients with eosinophilic asthma who’ve had four or more attacks in a year. It’s also recommended for patients who are taking maintenance oral corticosteroids.