The National Institute for Health and Care Excellence (NICE) has issued a preliminary rejection of Eli Lilly's donanemab (Kisunla) for use within the National Health Service (NHS) in the UK. This decision follows the Medicines and Healthcare products Regulatory Agency's (MHRA) approval of the drug for patients with mild cognitive impairment (MCI) or mild Alzheimer’s disease (AD). The decision mirrors NICE's earlier stance on Eisai/Biogen’s lecanemab (Leqembi), creating uncertainty around access to disease-modifying therapies (DMTs) for Alzheimer's patients in the UK.
Concerns Over Cost-Effectiveness and Safety
The primary reasons cited by NICE for rejecting donanemab include concerns over its cost-effectiveness and potential safety issues. These concerns echo those raised regarding lecanemab. Both drugs, while representing a significant breakthrough as the first DMTs for AD, have demonstrated only modest efficacy. Clinicians remain uncertain whether the observed reduction in clinical decline is substantial enough to produce a noticeable difference in patients' cognitive function.
A significant safety concern associated with these anti-amyloid beta monoclonal antibodies is the development of amyloid-related imaging abnormalities (ARIAs). Monitoring for ARIAs requires magnetic resonance imaging (MRI) scans before treatment initiation, with further MRIs recommended prior to subsequent infusions, adding to the overall cost of therapy.
NICE Requests Further Evidence
NICE has requested additional evidence regarding the magnitude and duration of the drugs' effects and a comprehensive analysis of the overall costs. This is particularly relevant for donanemab, as its treatment regimen is not designed for indefinite use, potentially making its lifetime cost lower than that of lecanemab. Furthermore, the MHRA has planned a post-authorization safety study to evaluate the long-term effects of these drugs.
Market Impact and Future Prospects
Real-world evidence, especially from the US where both lecanemab and donanemab have been approved and are being prescribed, along with additional clinical trial data, will be critical for the future success of both drugs in the UK market. GlobalData forecasts that lecanemab and donanemab could generate sales of approximately $3.5 billion and $2.0 billion, respectively, in 2030 across the 8MM (US, France, Germany, Italy, Spain, UK, Japan, and China).
