Health Secretary urged to step in after Alzheimer’s drug blocked for use on NHS

A charity has urged the Health Secretary to step in after it emerged a drug that has been shown to slow the progression of Alzheimer’s disease may not be rolled out on the NHS due to costs.

Alzheimer’s Research UK described the announcements around lecanemab as “deeply disappointing” and warned it would only be available to those who could pay privately.

Lecanemab – made by Eisai and sold under the brand name Leqembi – was approved by the Medicines and Healthcare products Regulatory Agency (MHRA), which deemed it efficient at slowing Alzheimer’s disease.

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

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

The health service spending watchdog estimated that 70,000 patients would have benefited from the treatment.

Nice’s committee estimated that the administration costs, including the cost of giving the infusion, monitoring scans and outpatient reviews plus diagnostics, was £19,000 per patient per year.

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

Dr Samantha Roberts, Nice

Nice chief executive Dr Samantha Roberts 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.”

Hilary Evans-Newton, chief executive of Alzheimer’s Research UK, branded the announcement as bittersweet and said the charity had written to Wes Streeting urging him to act.

The letter said: “We know that right now, one in three people in England aren’t receiving a formal diagnosis and there are considerable waiting lists to receive a dementia diagnosis with people waiting up to a year.

“Action from government is essential to address these challenges.”

It added: “We recognise lecanemab’s benefits are modest, there are risks of side effects which need to be managed as well as a cost impact on the NHS.

“Nonetheless, the MHRA licence granted today reflects the great strides made in research over the last 20 years and moves us a step closer to a world free from the harm and heartbreak of dementia.

“On behalf of our supporters, Alzheimer’s Research UK are calling on you to help the NHS be fit for the future of dementia. Your leadership in bringing together key stakeholders is needed to help enable fast and equitable access to a new generation of treatments.”

The Government is committed to continuing to expand research and innovation in this area, with advanced clinical trials for other drugs under way. We will continue to work with NHS England and Nice to make treatments available as and when they’re ready

Department of Health and Social Care

A Department of Health and Social Care spokesperson said: “It is right that these decisions are taken independently based on an assessment of the available evidence on the relative costs and benefits of a treatment.

“The Government is committed to continuing to expand research and innovation in this area, with advanced clinical trials for other drugs under way. We will continue to work with NHS England and NICE to make treatments available as and when they’re ready.”

Lecanemab is a targeted antibody treatment that 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.

There are now more than 160 trials under way, testing over 125 experimental treatments for Alzheimer’s across the globe, including 30 in late-stage trials. Despite today’s frustrating news, it really is a matter of when, not if, new treatments become available

Hilary Evans-Newton, Alzheimer's Research UK

Ms Evans-Newton hailed the drug as a “sea change”.

“Lecanemab represents the beginning of a sea change in how diseases like Alzheimer’s will be treated in future,” she said.

“There are now more than 160 trials under way, testing over 125 experimental treatments for Alzheimer’s across the globe, including 30 in late-stage trials.

“Despite today’s frustrating news, it really is a matter of when, not if, new treatments become available.”

Julian Beach, interim executive director for healthcare quality and access at the 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.”

Fiona Carragher, chief policy and research officer at the Alzheimer’s Society, said the charity “respects” the regulatory decision, but added that Nice’s recommendation reflected the urgent challenges in how dementia was diagnosed and treated.

“While we welcome the MHRA approval, it is disappointing that Nice has not recommended approving lecanemab for use on the NHS at this stage,” she said.

“The news that lecanemab will be restricted to certain groups of patients will also lead to uncertainty for many people with Alzheimer’s disease and their loved ones.

“We respect the decisions regulators have made; however, we know these announcements will bring a mix of emotions for those who have been waiting a long time since the promising trial results were first announced.”

A public consultation on the Nice draft guidance is open until September 20.

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, 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.