The UK health regulator rejected a new Alzheimer’s drug despite it having passed an examination by the Medicines and Healthcare products Regulatory Agency. The National Institute for Health and Care Excellence announced that it was too expensive and had too little benefit to gain usage on the NHS against the backdrop of its success in slowing Alzheimer’s in trials.

The UK’s health regulator has surprisingly refused to allow a new Alzheimer’s drug, lecanemab, to be used on the NHS. This goes against the Medicines and Healthcare Products Regulatory Agency—the other key agency—which gave the drug a clean bill of health.

What’s the Big Deal About Lecanemab?

Lecanemab is a drug designed to slow Alzheimer’s disease, which is a condition affecting memory and thinking. It works by removing sticky clumps of protein in the brain called amyloid beta, associated with this disease. The drug is not an upfront cure but can slow the progress of the disease. It helped patients at an early stage of Alzheimer’s improve their cognitive abilities by 27 percent compared to those who received a placebo, a harmless dummy treatment, in tests.

Despite being cleared by the MHRA, Nice has ruled that lecanemab will not be available on the NHS. Nice had admitted to finding the benefit of this drug to patients against the high cost and regular monitoring of patients required to be too small.

Why Did Nice Say No?

Nice’s blow comes as yet another setback for the companies that developed lecanemab: Eisai and Biogen. They had been hoping that the drug would be licensed for use in the UK following licensing in places like the US, China, and Japan. On second thought, Nice is reported to have an opinion that the cost of this drug, presently positioned at around £20,000 per patient per year, is too costly. Further treatment requires patients to visit the hospital every two weeks for monitoring, which ramps up the overall costs associated with the treatment.

Nice also highlighted that while lecanemab can reduce cognitive decline by four to six months, very little evidence is available about how well it works in the long term. They estimate that there could be around 70,000 people in England who may have benefited from the drug but think it’s too pricey.

What Do Experts Think?

Hilary Evans-Newton, of Alzheimer’s Research UK, said that on the one hand, it is exciting to have a first licensed drug able to slow Alzheimer’s, but on the other, it is disappointing not to have NHS coverage, feeling that this only goes to prove how our health system is just not ready for these new kinds of treatments.

Dr. Samantha Roberts, of Nice, said that the benefit from lecanemab has to be balanced against consideration of the high cost of treatment and the need for careful monitoring. She said it involves regular hospital visits and skilled staff watching for serious side effects—something too expensive to be handled by the NHS.

Side Effects and Future Outlook

The arrival of a new drug is considered the biggest step in treating Alzheimer’s, but it is not free from problems. Experts, including Prof Tara Spires-Jones of the UK Dementia Research Institute, say lecanemab does offer some progress but serious side effects as well. People taking the drug reported cases of brain swelling and bleeding, which further caused some deaths.

The MHRA will continue to monitor carefully the safety and effectiveness of the licensed medicinal product. Further research will be conducted to prove that the benefits brought about by the drug overpower the risks in real-world use.

What’s Next?

A public consultation on Nice’s decision will be open until September 20th, allowing people to share their views. Although lecanemab won’t be available on the NHS right now, it’s still approved in other countries, and that may yet become more widely available.

In the meantime, the drug will be available to those who are in a position to afford it privately, hence it shall only be available to people who have the money to pay for it.

Basically, lecanemab gives hope for slowing Alzheimer’s disease but at too high a cost and serious side effects to be an option in most people in the UK.