The United Kingdom’s Medicines and Healthcare products Regulatory Agency approved lecanemab (Leqembi) late last month for patients with early stage Alzheimer’s disease. But the British cost-effectiveness watchdog, the National Institute for Health and Care Excellence, decided not to recommend that the National Health Service reimburse the medicine.
The Telegraph quoted from a spokesperson for NICE who said that the “costs of providing the treatment, including fortnightly infusions in hospital and intensive monitoring for side effects, combined with the relatively small benefits it provides to patients means it cannot be considered good value for the taxpayer. … Lecanemab provides on average four to six months slowing in the rate of progression from mild to moderate Alzheimer’s disease, but this is just not enough benefit to justify the additional cost to the NHS.”
The draft guidance issued by NICE will now go out for consultation until September 20th, ahead of a final decision by the NHS.
Ms Evans-Newton of Alzheimer’s Research UK asserted that “further [price] negotiations between NICE, drug manufacturer Eisai and the NHS might offer a way forward.”
There appear to be certain parallels between NICE’s assessment of Leqembi and the one carried out by the U.S. Institute for Clinical and Economic Review. Its independent appraisal committee voted in 2023 that the then available evidence wasn’t adequate to show a net health benefit for lecanemab when compared to supportive care. Using data estimates, ICER analyses suggested Leqembi would achieve common cost-effectiveness thresholds if priced between $8,900 and $21,500 per year of treatment. But Leqembi is currently priced at $26,500 on an annual basis.
The provisional NICE decision adds to the uncertainty surrounding the drug’s market success. Challenges aren’t confined to the U.K. or Europe, where the European Medicines Agency rejected lecanemab for marketing authorization in July owing to safety concerns.
Lecanemab works by removing a sticky protein, beta amyloid plaque, from the brain. Such plaque build-up is hypothesized to be a cause of Alzheimer’s disease. Leqembi was granted accelerated and then regular approval by the U.S. Food and Drug Administration in January and July 2023, respectively. Clinical data demonstrated a modest lessening of cognitive decline in patients with early stage Alzheimer’s disease. As such, the medication offers hope to patients. Accordingly, there’s been moderately rising demand for the drug.
However, the Financial Times reported this spring that Leqembi has fallen short of its initially projected path towards blockbuster status in the U.S. as the rollout has stumbled. And this summer the manufacturer disclosed $40 million in sales in the second quarter—following $19 million in revenue in the first quarter—and that approximately 5,000 patients are on treatment. These numbers appear far shy of what the company had aspired to achieving by now.
Issues impeding larger sales stem in part from a lack of consensus among neurologists on whether to recommend Leqembi to their patients. Some question whether the degree to which the drug slows cognitive deterioration is clinically meaningful to patients.
There are also persistent safety worries. In clinical trials, lecanemab triggered amyloid-related images abnormalities characterized by edema in about 12% of participants. Most cases were asymptomatic, but occasional severe reactions occurred, including three deaths from brain bleeding and swelling. Two deaths possibly linked to the use of lecanemab have been reported since the drug’s regulatory approval.
In sum, the benefit-risk ratio may be inhibiting the therapeutic from gaining greater momentum. And as NICE’s evaluation demonstrates, the drug’s limited cost-effectiveness presents a further challenge.
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