The National Institute for Health and Care Excellence (NICE) has rejected two breakthrough Alzheimer's drugs for NHS use, effectively denying access to over 70,000 eligible patients in England who cannot afford private treatment. The decision, expected to be finalized this week, marks a significant setback for the first medications proven to slow the progression of Alzheimer's disease.
Regulatory Decision Based on Cost-Effectiveness
NICE has refused to recommend lecanemab (Leqembi) manufactured by Eisai and donanemab (Kisunla) produced by Eli Lilly for NHS use, citing cost-effectiveness concerns. Helen Knight, director of medicines evaluation at NICE, stated that "donanemab could slow down cognitive decline by 4-7 months, but this is just not enough benefit to justify the additional cost to the NHS."
The cost-effectiveness estimate for donanemab is reportedly five to six times above what NICE normally considers an acceptable use of NHS resources. While the NHS was offered a lower price than the standard cost of £20,000 to £25,000, private treatment costs between £60,000-80,000 per year according to Alzheimer's Research UK.
Clinical Efficacy Demonstrated in Trials
Both drugs have demonstrated significant clinical benefits in treating early-stage Alzheimer's disease. Lecanemab removes build-ups of beta-amyloid protein from the brain and can slow the progression of Alzheimer's by 27% over 18 months when administered early in the disease course. The drug also reduced loss of quality of life by up to 56% according to the Alzheimer's Society.
Donanemab works by teaching the body's immune cells to recognize and remove amyloid protein, which builds up in the brains of people with Alzheimer's disease. These protein build-ups are considered toxic to brain cells, leading to the characteristic symptoms of the condition.
After positive drug trials in 2022, both medications were proven to clear toxic amyloid protein from the brain and slow the underlying cause of dementia. The drugs were shown in trials to slow the rate of decline for those with mild to moderate Alzheimer's by an average of four to seven months.
Safety Considerations
Both treatments carry notable safety risks. Lecanemab can cause swelling and bleeding in the brain. In trials for donanemab, a third of recipients experienced abnormalities in their brain scans caused by brain swelling and bleeding, according to NICE.
Industry and Patient Advocacy Response
The decision has drawn sharp criticism from leading dementia organizations. Hilary Evans-Newton, chief executive of Alzheimer's Research UK, described the decision as "deeply disappointing," warning it sends "a damaging signal to the life sciences sector - undermining confidence in the UK as a leader of dementia research, clinical trials and innovation, with knock-on effects for patients and the wider economy."
Evans-Newton acknowledged the treatments' limitations, stating: "These treatments are not perfect, and we recognise the challenges they pose around cost, delivery and safety. But scientific progress is incremental, and these drugs represent a vital foundation to build on."
Iain Hartnell, Research Communications Officer at Alzheimer's Society, had previously hailed the MHRA's approval as "a defining moment for people with early-stage Alzheimer's disease in the UK and a significant step towards a more hopeful future."
Market Access and Global Approval
Both drugs have received UK drug licenses from the Medicines and Healthcare products Regulatory Agency (MHRA), making them available for private purchase. Lecanemab has already received regulatory approval in the EU, US, China, Japan, Hong Kong, South Korea and Israel.
Without NICE's recommendation, an insider told The Times that "it is the end of the road for these drugs on the NHS," limiting access to patients who can afford private healthcare.
Disease Burden and Economic Impact
Alzheimer's represents a significant public health challenge in the UK. Approximately 982,000 people are currently estimated to be living with dementia in the UK, with this figure expected to reach 1.4 million by 2040. Alzheimer's Research UK analysis found 74,261 people died from dementia in 2022, compared to 69,178 the previous year, making it the country's biggest killer.
The Alzheimer's Society estimates the overall annual cost of dementia to the UK at £42 billion per year, with families bearing much of the burden. An aging population means these costs, which include lost earnings of unpaid carers, are projected to soar to £90 billion in the next 15 years.
NICE is scheduled to publish the final draft guidance about both drugs on Thursday, leaving opportunity for the decision to be challenged and sent to a review panel before final guidance is published.
