The UK's healthcare cost watchdog has doubled down on its decision to deny National Health Service (NHS) coverage for two newly approved Alzheimer's treatments, highlighting the growing tension between breakthrough therapies and healthcare affordability.
The National Institute for Health and Care Excellence (NICE) has reaffirmed its position against recommending both donanemab and lecanemab for NHS use, even after reviewing additional evidence from the manufacturers. The independent appraisal committee maintained that while these treatments show promise, their clinical benefits do not justify their substantial costs to the healthcare system.
Regulatory Approval vs. Cost-Effectiveness
Despite receiving approval from the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) - Eli Lilly's Kisunla (donanemab) in October and Biogen's Leqembi (lecanemab) in August - both drugs face significant hurdles in gaining NHS coverage. NICE's assessment focused on the balance between clinical benefit and economic impact, concluding that neither treatment currently represents good value for British taxpayers.
"The benefits of these new Alzheimer's drugs are too small to justify the costs," NICE stated in its guidance draft, emphasizing the need for either improved clinical evidence or more favorable pricing structures.
Impact on Patient Access
The decision significantly impacts access to these innovative treatments for Alzheimer's patients in the UK. While both medications have shown promise in clinical trials, the gap between their therapeutic value and cost continues to present a substantial barrier to widespread adoption within the NHS framework.
Next Steps and Stakeholder Engagement
NICE has opened a consultation period running through March 27, 2025, during which stakeholders can provide additional input and perspectives. The agency has scheduled a third committee meeting to review all responses and conduct additional analyses before issuing final recommendations.
This development underscores the broader challenge facing healthcare systems worldwide: balancing access to innovative treatments with sustainable healthcare spending. The outcome of this process could set important precedents for how other healthcare systems approach the funding of expensive breakthrough therapies.
