The approval of Lecanemab (Biogen/Eisai) represents a landmark moment in the treatment of Alzheimer’s disease (AD), as it is the first drug proven to slow the progression of AD to be authorised in the UK. With nearly a million people in the UK living with dementia, the majority of whom have Alzheimer’s, the implications of this approval are significant. However, Lecanemab faces a major obstacle: it has not been recommended by the National Institute for Health and Care Excellence (NICE) for use on the NHS.
Lecanemab’s approval is based on compelling data from the Clarity Alzheimer’s disease trial, where the drug demonstrated a 27% reduction in clinical decline compared to a placebo over 18 months. Administered bi-weekly via intravenous infusion, Lecanemab targets amyloid beta plaques in the brain—one of the hallmarks of Alzheimer’s—thereby slowing cognitive decline in patients with mild cognitive impairment or mild dementia.
Despite these clinical outcomes, NICE cites the small benefits relative to the high costs as a barrier to recommending the drug for NHS use. The treatment involves not only the drug costs but also the infrastructure needed for regular hospital infusions and the intensive monitoring required to manage potential side effects.
The public consultation on the draft NICE guidance is due on 20 September 2024, with final recommendations expected following a second committee meeting later this year.
NICE’s decision underscores a critical issue: balancing the promise of innovative therapies with the economic challenges of the healthcare system. It is not only necessary to demonstrate clinical efficacy, but also to provide a compelling cost-effectiveness argument. How can companies continue developing advanced therapies if they are deemed not cost-effective? This situation raises important questions about the sustainability of current reimbursement models. There is an imminent need to explore innovative mechanisms for reimbursement. Without them, patients may be left without access to potentially life-changing therapies.
To conclude:
Lecanemab serves as a case study for the industry, highlighting the value of an integrated market access approach that ensures early dialogue with health technology assessment agencies and anticipates risks and challenges in bringing treatments to patients.
Sources: