British cost-effectiveness watchdog NICE says no to the drug against Alzheimer’s

The UK Medicines and Healthcare products Regulatory Agency late last month approved lecanemab (Leqembi) for patients with early-stage Alzheimer’s disease. But Britain’s cost-effectiveness watchdog, the National Institute for Health and Care Excellence, decided not to recommend that the National Health Service reimburse the drug.

The Telegraph quoted from a NICE spokesperson who said that the “cost of providing the treatment, including fortnightly infusions in hospital and intensive monitoring for side effects, combined with the relatively small benefits it brings to patients, means it is not considered good value for the taxpayer can be considered. … Lecanemab provides an average delay of four to six months in the progression of mild to moderate Alzheimer’s disease, but this is simply not enough benefit to justify the additional cost to the NHS.”

NICE’s draft guidelines will now be put out for consultation until September 20, ahead of a final decision by the NHS.

Ms Evans-Newton from Alzheimer’s Research UK claimed that “further [price] negotiations between NICE, drug manufacturer Eisai and the NHS could offer a way forward.â€

There appear to be certain parallels between NICE’s assessment of Leqembi and that of the US Institute for Clinical and Economic Review. The independent assessment committee voted in 2023 that the evidence available at the time was not sufficient to demonstrate a net health benefit for lecanemab compared to supportive care. Based on data estimates, ICER analyzes suggested that Leqembi would achieve common cost-effectiveness thresholds if the price were between $8,900 and $21,500 per treatment year. But Leqembi currently is priced at $26,500 on an annual basis.

The preliminary NICE decision increases the uncertainty surrounding the drug’s success on the market. The challenges are not limited to Britain or Europe, where the European Medicines Agency is located rejected Due to safety reasons, a marketing authorization for lecanemab was applied for in July.

Lecanemab works by removing a sticky protein called beta-amyloid plaque from the brain. Such plaque buildup is believed to be a cause of Alzheimer’s disease. Leqembi received accelerated and then regular approval from the US Food and Drug Administration in January and July 2023, respectively. Clinical data showed that a modest reduction in cognitive decline in patients with early-stage Alzheimer’s disease. As such, the drug offers hope to patients. Accordingly, there is a moderately increasing demand for the drug.

However, the Financial times reported this spring that Leqembi had done so fell short from its initially expected trajectory to blockbuster status in the US, now that the rollout has failed. And this summer, the manufacturer reported second-quarter sales of $40 million, following $19 million in first-quarter sales. 5,000 patients are under treatment. These figures seem far removed from what the company would have wanted to achieve.

Problems that hinder greater sales stem in part from: lack of consensus among neurologists about whether they should recommend Leqembi to their patients. Some wonder whether the extent to which the drug slows cognitive decline is clinically meaningful for patients.

There are also ongoing safety concerns. In clinical trials, lecanemab caused amyloid-related imaging abnormalities characterized by edema in approximately 12% of participants. Most cases were asymptomatic, but serious reactions occasionally occurred, including: three deaths against brain haemorrhages and swellings. There have been two deaths possibly related to the use of lecanemab reported since the drug’s regulatory approval.

In short, the benefit-risk balance may prevent the therapeutic agent from gaining momentum. And as NICE’s evaluation shows, the drug’s limited cost-effectiveness poses a further challenge.