New Alzheimer’s drug should not be rolled out on NHS, says spending watchdog

The NHS spending watchdog has recommended that a drug shown to slow the progression of Alzheimer’s disease should not be rolled out on the health service, despite the UK medicines regulator saying it is safe and effective for use.

The National Institute for Health and Care Excellence (Nice) said the benefits of lecanemab are “just too small to justify the significant cost to the NHS”.

A charity said it is “deeply disappointing” that patients with early stage Alzheimer’s will not have access to the drug on the health service “and it will only be available to those who can pay privately”.

The Medicines and Healthcare products Regulatory Agency (MHRA) has deemed lecanemab, developed by pharmaceutical company Eisai and sold under the brand name Leqembi, efficient at slowing Alzheimer’s disease.

The reality is that the benefits this first treatment provides are just too small to justify the significant cost to the NHS

The targeted antibody treatment binds to amyloid, a protein which builds up in the brains of people living with the condition.

It is designed to help clear the build-up and slow down cognitive decline and is given to patients through an intravenous drip fortnightly.

The drug is the first treatment of its kind to be licensed for use in Great Britain.

However, Nice has recommended lecanemab is not rolled out on the NHS in England in draft guidance due to the cost to the taxpayer.

Dr Samantha Roberts, chief executive of Nice, said: “This is a new and emerging field of medicine which will no doubt develop rapidly.

“However, the reality is that the benefits this first treatment provides are just too small to justify the significant cost to the NHS.

“It is an intensive treatment to give to patients involving a hospital visit every two weeks with skilled staff needed to monitor them for signs of serious side-effects, plus the cost of purchasing the drug.

“Our independent committee has rigorously evaluated the available evidence, including the benefit for carers, but Nice must only recommend treatments that offer good value to the taxpayer.”

According to Nice, clinical trials showed lecanemab can slow cognitive decline by four to six months, however there is little evidence on its long-term effects.

It estimates about 70,000 adults in England would have been eligible for treatment.

A public consultation on Nice’s draft guidance will close on September 20.

Julian Beach, interim executive director for healthcare quality and access at MHRA, said: “Licensing medicines which meet acceptable standards of safety, quality and efficacy is a key priority for us.

“We’re assured that, together with the conditions of the licence approval, the appropriate regulatory standards for this medicine have been met.

“As with all medical products, we will keep its safety under close review, and with a controlled post-authorisation safety study to be undertaken, we will ensure that the benefit risk of lecanemab in clinical use is closely followed up.”

Reacting to the decisions by MHRA and Nice, Professor Sir Stephen Powis , national medical director at NHS England, said: “The NHS now awaits a final decision from the National Institute for Health and Care Excellence that will look at the clinical benefits and cost-effectiveness of lecanemab and determine if it should be routinely offered by the NHS in England.

“Lecanemab is the first disease modifying treatment for Alzheimer’s disease with a market approval in the UK, and to ensure the health system is prepared for future advances in treatments, a dedicated NHS team is also looking ahead to 27 other drugs which are currently in advanced clinical trials that could be potentially approved by 2030.”

Hilary Evans-Newton, chief executive of Alzheimer’s Research UK, said: “Today’s news is bittersweet for people affected by Alzheimer’s disease.

“It’s a remarkable achievement that science is now delivering licensed treatments that can slow down the devastating effects of Alzheimer’s, rather than just alleviating its symptoms.

“However, it’s clear our health system isn’t ready to embrace this new wave of Alzheimer’s drugs. It means that, as things stand, people in the early stages of the disease will be denied access to lecanemab through the NHS, and it will only be available to those who can pay privately. This is deeply disappointing.”

It is understood that manufacturer Eisai is working with Nice, the Scottish Medicines Consortium and the NHS to make the drug available.

Lecanemab is already licensed in the US, where it costs about £20,000 per patient per year, although it was rejected by the European Medicines Agency (EMA) in late July.

The EMA said the benefits of lecanemab did not counterbalance the risk of people suffering serious side-effects such as bleeding and swelling in the brain.

It also said the effects of the drug on delaying cognitive decline were small.

A similar drug called donanemab, which is developed by Eli Lilly, is also being assessed for approval in the UK by medicine regulators.

NHS England estimates between 50,000 and 280,000 patients might be eligible for the new treatments.

Prior to being given the drugs, they will need to have a baseline MRI scan and then either a Pet-CT scan or lumbar puncture to confirm Alzheimer’s.