Breaking News: Lecanemab approved in UK but unavailable on NHS

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Eisai and Biogen’s new Alzheimer’s treatment, lecanemab, received a green light from UK regulators, marking a significant advance in treating early-stage Alzheimer’s disease.

Despite this, the drug, heralded as a breakthrough for its ability to slow cognitive decline, will not be available through the National Health Service (NHS) due to cost and safety concerns.

The Medicines and Healthcare products Regulatory Agency (MHRA) approved lecanemab on August 22, 2024. The drug works by targeting amyloid beta plaques in the brain, which are associated with Alzheimer’s progression. Clinical trials showed that lecanemab could reduce clinical decline in patients with mild cognitive impairment or mild dementia.

However, the drug's approval comes with notable limitations. Lecanemab is recommended only for patients in the early stages of Alzheimer’s who have one or no copies of the apolipoprotein E4 (ApoE4) gene, which is linked to an increased risk of developing Alzheimer’s. Patients with two copies of the gene (about 15% of Alzheimer’s patients) face higher risks of side effects, including brain swelling and bleeding, making the drug less suitable for them.

Lecanemab

Cost concerns are another significant factor in the NHS's decision. The high price tag associated with lecanemab, combined with the need for bi-weekly intravenous infusions, makes it a challenging addition to the NHS formulary. This has led to a situation where, although licensed, lecanemab will not be available to the majority of UK Alzheimer’s patients, sparking frustration among patient advocacy groups who view this as a missed opportunity to address the growing Alzheimer's crisis in the UK.

The drug's unavailability on the NHS raises broader questions about the accessibility of cutting-edge treatments and the role of cost-effective​.