British Medicines Agency approves Alzheimer's drug

The United Kingdom has approved the Alzheimer's drug Leqembi, saying it is the first medicine to show some effect in slowing the progression of the neurodegenerative disease.

But the UK government is unlikely to cover the cost after an independent agency issued separate draft guidance concluding that the benefits of Leqembi “cannot be considered to represent good value for money for the taxpayer”.

Aside from the cost of the drug, providing Leqembi requires patients to be hospitalized every two weeks and carefully monitored for side effects.

Experts also pointed to the lack of data on the long-term effectiveness of Leqembi, made by Japanese drugmaker Eisai.

“The reality is that the benefit of this first treatment is simply too small to justify the significant cost,” said Dr Samantha Robers, chief executive of the National Institute for Health and Care Excellence (NICE).

The draft guidance issued by NICE will be open for public consultation and all responses will be considered at a second meeting in late 2024 before a final recommendation is issued.

The agency estimated that around 70,000 people in the UK could benefit from Leqembi.

The drug can still be prescribed if patients pay for it themselves.

In the United States, the cost per patient per year is approximately $26,000 ($39,000 Australian dollars).

Some experts said that while they understood that patients and their families were disappointed by the news, there was hope that better drugs could be developed soon.

Hilary Evans-Newton, chief executive of Alzheimer's Research UK, said Leqembi “represents the beginning of a fundamental change in the future treatment of diseases like Alzheimer's”.

She said there are currently more than 160 trials underway worldwide testing more than 125 experimental treatments for Alzheimer's.

“Despite today's frustrating news, it is really just a question of when, not if, new treatments will become available,” she said in a statement.

The U.S. Food and Drug Administration approved Leqembi in July 2023, paving the way for Medicare and other insurance plans to cover the treatment.

In July, the European Medicines Agency recommended that Leqembi not be approved across the EU. The agency justified this by saying that the drug's effectiveness in slowing cognitive decline did not outweigh the serious side effects, such as swelling and possible brain bleeding.