UK Reconsiders Alzheimer’s Drug Coverage After Appeals | Kisunla & Leqembi Review

LONDON — U.K. Health officials have reopened a review of two recently authorized Alzheimer’s therapies, Kisunla (donanemab) from Eli Lilly and Leqembi (lecanemab) developed by Eisai and Biogen, after initially determining they did not offer sufficient therapeutic value relative to their cost. The move follows appeals from the pharmaceutical companies behind the drugs, challenging the earlier assessments made by the National Institute for Health and Care Excellence (NICE), the body responsible for advising the National Health Service (NHS) on the adoption of new treatments.

Both Kisunla and Leqembi received regulatory approval in the U.K. In 2024, representing a significant step forward in the treatment of Alzheimer’s disease. Yet, NICE initially found that the price of the medications, coupled with the logistical costs of administering them – including the need for frequent intravenous infusions and monitoring for potential side effects – outweighed the limited clinical benefits they offered to patients. NICE reaffirmed this position in a subsequent review last year, prompting the manufacturers to appeal.

Understanding the New Alzheimer’s Therapies

Leqembi and Kisunla represent a novel approach to Alzheimer’s treatment. Unlike earlier medications that primarily addressed the symptoms of the disease, these therapies aim to modify its underlying course by targeting and removing amyloid plaques, abnormal protein deposits that accumulate in the brain and are believed to contribute to neuronal damage. Lecanemab (Leqembi) is an antibody administered via intravenous infusion, designed to clear beta-amyloid from the brain. Clinical trials have shown that it can slow cognitive and functional decline in individuals with early-stage Alzheimer’s disease, including those with mild cognitive impairment (MCI) or mild dementia, who have confirmed elevated amyloid levels. Similarly, Kisunla utilizes a monoclonal antibody to target amyloid plaques.

The approval of these drugs marked a turning point, as just three years prior, there were no FDA-approved treatments that targeted the underlying causes of Alzheimer’s—only medications that modified symptoms. BrightFocus highlights this shift in the landscape of Alzheimer’s treatment.

The Cost-Effectiveness Debate

The core of the dispute lies in the concept of “cost-effectiveness.” NICE employs a rigorous methodology to assess whether the benefits of a new treatment justify its price, considering not only clinical outcomes but also the broader economic impact on the NHS. This involves calculating the Incremental Cost-Effectiveness Ratio (ICER), which compares the additional cost of a new treatment to the additional health benefits it provides, typically measured in Quality-Adjusted Life Years (QALYs). A treatment is generally considered cost-effective if its ICER falls below a certain threshold, set by NICE based on societal willingness to pay for health gains.

In the case of Leqembi and Kisunla, NICE determined that the high cost of the drugs, combined with the substantial resources required for patient selection (including amyloid PET scans to confirm eligibility), infusion administration, and monitoring for adverse events like amyloid-related imaging abnormalities (ARIA) – brain swelling or bleeding – resulted in an ICER that exceeded the acceptable threshold. This doesn’t necessarily mean the drugs are ineffective, but rather that their benefits do not justify their price given the constraints of the NHS budget.

Who is Affected by This Reconsideration?

The NICE review directly impacts individuals in the U.K. Living with early-stage Alzheimer’s disease. Currently, access to these potentially disease-modifying therapies is limited, as the NHS is not routinely commissioning them due to the cost-effectiveness concerns. A positive outcome from the renewed review could open access to these treatments for eligible patients, offering them the possibility of slowing the progression of their disease and maintaining cognitive function for a longer period. However, it’s important to note that these drugs are not a cure, and their benefits are most pronounced in the early stages of the disease.

What to Expect During the Review Process

The reopening of the review process will involve a thorough reassessment of the clinical and economic evidence supporting the use of Kisunla and Leqembi. NICE will likely consider any new data that has emerged since the initial assessments, including real-world evidence from countries where the drugs are already available. The pharmaceutical companies will have the opportunity to present additional information and arguments in support of their products. NICE will also consult with clinical experts, patient advocacy groups, and other stakeholders to gather diverse perspectives. The timeline for the review is not yet clear, but a decision is expected in the coming months.

The Broader Implications for Alzheimer’s Treatment

This case highlights the ongoing challenges of balancing innovation with affordability in healthcare. The development of disease-modifying therapies for Alzheimer’s disease represents a major scientific achievement, but the high cost of these treatments raises demanding questions about access and equity. The outcome of the NICE review will likely have implications beyond the U.K., potentially influencing pricing and reimbursement decisions in other countries as well. It also underscores the need for continued research to develop more affordable and effective treatments for Alzheimer’s disease, as well as improved diagnostic tools to identify individuals who are most likely to benefit from these therapies. Icahn School of Medicine notes that both Leqembi and Kisunla are monoclonal antibody treatments designed to reduce amyloid beta plaques in the brain.

Further updates on the NICE review and any subsequent guidance will be closely watched by patients, clinicians, and the pharmaceutical industry alike. Individuals with concerns about Alzheimer’s disease should consult with their healthcare providers to discuss the latest treatment options and develop a personalized care plan.