The UK's National Institute for Health and Care Excellence (NICE) has announced plans to reconvene for a third committee meeting in May to reassess two groundbreaking Alzheimer's treatments, signaling potential hope for thousands of patients currently unable to access the medications through the NHS.
The drugs in question, lecanemab and donanemab, previously received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) but were initially rejected by NICE due to concerns over their estimated £1 billion annual implementation cost. Currently, these treatments are only accessible to patients who can afford the approximate £60,000 yearly private treatment cost.
Clinical Efficacy and Mechanism of Action
Both medications have demonstrated significant promise in clinical trials. Lecanemab has shown the ability to slow disease progression by 27 percent, while donanemab has demonstrated even more impressive results, with up to 35 percent reduction in disease progression. These monthly intravenous treatments work by stimulating the immune system to clear amyloid protein buildup in the brains of early-stage Alzheimer's patients.
Safety Considerations and Expert Perspectives
However, safety concerns remain a significant consideration. Professor Rob Howard from University College London notes that approximately 40 percent of patients treated with this class of drugs develop brain swelling and bleeding. While most cases are not severe, about 1 percent of patients may experience serious complications, including strokes and potentially fatal outcomes.
The European Medicines Authority has specifically highlighted concerns regarding rare but serious side effects, particularly focusing on brain swelling and potential bleeding complications. These side effects, known as amyloid-related imaging abnormalities (ARIA), can manifest as headaches, confusion, dizziness, vision changes, and other neurological symptoms.
Market Access and Global Context
Lecanemab has already received regulatory approval in multiple jurisdictions, including the EU, US, China, Japan, Hong Kong, South Korea, and Israel. Nick Burgin, Eisai's European-area president, called NICE's decision to reconvene "encouraging" while acknowledging that substantial changes are needed in Alzheimer's disease management.
Disease Burden and Economic Impact
The reassessment comes against the backdrop of growing pressure to address the mounting burden of Alzheimer's disease in the UK. Recent analysis by the Alzheimer's Society estimates the annual cost of dementia to the UK at £42 billion, with projections suggesting this could rise to £90 billion within 15 years.
Approximately 944,000 people in the UK are living with dementia, and recent data from Alzheimer's Research UK indicates that dementia has become the country's leading cause of death, with 74,261 deaths recorded in 2022, up from 69,178 the previous year.
Next Steps
NICE has launched a second public consultation period, ending this month, to gather additional input on their previous decision to reject the drugs. The outcome of these deliberations could potentially benefit an estimated 70,000 adults in England who might be eligible for these treatments if approved for NHS use.
