UK’s Cost-Effectiveness Watchdog NICE rejects use of Alzheimer’s drug Leqembi

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

The Telegraph quoted from a NICE spokesperson who said “the costs of providing the treatment, including double hospitalization and intensive monitoring for side effects, combined with the small benefits it provides to patients means that it would not be considered good value for the payer. … Lecanemab offers an average of four to six months of progression from Alzheimer’s disease and mild to moderate, but this is not a good enough benefit to justify the additional costs to the NHS.”

The draft guidance issued by NICE will now be out for consultation until September 20, ahead of a final decision by the NHS.

Ms Evans-Newton of Alzheimer’s Research UK confirmed that “more than that [price] Discussions between NICE, drug maker Eisai and the NHS could provide a first step. “

There appears to be some similarity between the NICE assessment of Leqembi and that carried out by the US Institute for Clinical and Economic Review. Its independent review committee voted in 2023 that the evidence available at the time was insufficient to demonstrate a health benefit for lecanemab compared to supportive care. Using the data estimates, the ICER analyzes recommended that the Participant achieve average cost savings if the cost is between $8,900 and $21,500 per year of treatment. But Leqembi is currently priced at $26,500 per year.

NICE’s interim decision adds to the uncertainty surrounding the drug’s market success. The problems are not limited to the UK or Europe, where the European Medicines Agency rejected lecanemab for marketing approval in July on safety grounds.

Lecanemab works by removing the sticky protein, beta amyloid plaque from the brain. Such plaque accumulation is thought to be the cause of Alzheimer’s disease. Leqembi was granted accelerated and permanent approval by the US Food and Drug Administration in January and July 2023, respectively. Clinical data have shown less cognitive decline in patients with early Alzheimer’s disease. Therefore, medicine gives hope to patients. Therefore, there has been an increasing demand for this drug.

However, the Financial Times reported during the year that Leqembi is not going down the path it was planned to have a top position in America as the publicity has gone down. And this summer the manufacturer revealed $40 million in sales in the second quarter—compared to $19 million in the first quarter—and that about 5,000 patients are still on treatment. These numbers appear to be shy of what the company had hoped to achieve so far.

Issues preventing greater sales stem from a lack of consensus among neurologists about whether to recommend Leqembi to their patients. Others question whether the rate at which the drug slows cognitive decline is meaningful to patients.

There are also constant safety concerns. In clinical trials, lecanemab caused amyloid-related abnormalities characterized by edema in approximately 12% of participants. Most cases were asymptomatic, but sometimes there were severe reactions, including three deaths due to brain hemorrhage and inflammation. Two deaths related to the use of lecanemab have been reported since approval.

In general, the risk ratio may discourage physicians from increasing. And as the NICE review shows, the cost-effectiveness of this drug presents another challenge.