London (Parliament Politics Magazine) – Britain’s health regulator has rejected a medication that can delay the progression of Alzheimer’s disease, stating its benefits are too small to explain the costs of the therapy and consolidated monitoring of patients for indications of “serious side effects”.
What Led to NICE’s Decision Against Funding Leqembi on the NHS?
The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK’s drugs regulator, showed the green light to the drug. However, the National Institute for Health and Care Excellence (NICE), the health regulator, simultaneously prohibited offering the drug on the NHS.
How Does the UK’s Stance on Leqembi Compare to the EU’s Position?
It comes weeks after the EU’s drugs regulator also disavowed the drug, stating the risk of serious brain node did not outweigh its small effect on slowing cognitive decline. It also expressed the effects of the drug on delaying cognitive decline were small.
What Are the Key Concerns Regarding the Costs and Side Effects of Leqembi?
The NICE finding is a further blow to the groups behind the drug, Eisai and Biogen, as the treatment encounters slow take-up in the US, where it commands about £20,000 per patient per year. It also lays bare the complexities linked to a new class of drugs that have aided early-stage patients but can cause serious side effects.
How Does Leqembi’s Approval in Other Countries Impact Its Availability in the UK?
The therapy, also comprehended as Leqembi, is authorised in the US, China, Hong Kong, Israel, Japan and South Korea. The green light from the MHRA suggests the UK has become the first nation in Europe to license a drug that can treat neurodegenerative disease rather than its signs.
What Evidence Did NICE Consider in Its Decision on Leqembi?
Dr Samantha Roberts, the chief executive of Nice, stated: “This is a new and rising field of medicine which will no doubt grow rapidly. “However, the reality is that the benefits this first treatment supplies are just too small to justify the considerable cost to the NHS. It is an intensive treatment to offer to patients involving a hospital visit every two weeks with professional staff needed to watch them for signs of serious side effects, plus the cost of purchasing the drug.
“Our independent panel has rigorously evaluated the available evidence, including the usefulness for carers, but Nice must only suggest treatments that offer good value to the taxpayer.”
According to Nice, clinical trials demonstrated lecanemab can delay cognitive decline by four to six months, but there was slight evidence of its long-term results. It estimates approximately 70,000 adults in England would have been qualified for treatment.