Following the news that the National Institute for Health and Care Excellence (NICE) is not recommending Eli Lilly’s anti-amyloid beta (Aβ) monoclonal antibody (mAb) Kisunla (donanemab) on the NHS following its approval by the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of patients with mild cognitive impairment (MCI) or mild Alzheimer’s disease (AD);
Philippa Salter, Managing Neurology Analyst at GlobalData, offers her view:
“While disappointing for the many patients with AD in the UK, the decision from NICE was not unexpected. This is the second time in 2024 that on the same day that the MHRA has approved a new disease-modifying therapy (DMT) for AD, the initial recommendation from NICE was to not cover the drug on the NHS.
“In August 2024, Eisai/Biogen’s anti-Aβ mAb Leqembi (lecanemab) became the first DMT to be approved for AD in the UK, but is currently not recommended by NICE due to a lack of cost-effectiveness and concerns with safety. Without approval from NICE, symptomatic treatments remain the only drugs available on the NHS for AD.
“Although Leqembi and Kisunla represent a major breakthrough in the AD market as the first DMTs, their efficacy is modest, and uncertainty remains among physician whether the reduction in clinical decline is big enough for patients to notice a real difference in their cognition.
“Further, a known side effect of these drugs, the development of amyloid-related imaging abnormalities (ARIAs), remains a significant concern. To monitor this, a magnetic resonance imaging (MRI) scan is required before treatment, with further MRIs recommended prior to subsequent infusions, adding to the overall cost of therapy.
“Importantly, the decision from NICE for both drugs are not final. NICE had requested further evidence regarding the magnitude and benefit of the effects of the drugs and what the overall costs would be. This is particularly important to understand for Kisunla, as this drug is not designed to be taken indefinitely, which means that its total lifetime cost of therapy could be significantly cheaper than Leqembi. Further, there is a post-authorisation safety study planned by the MHRA to evaluate long-term effects of the drugs.
“Further real-world evidence, particularly from the US, where both Leqembi and Kisunla have been approved and are prescribed, and clinical trial data will be vital for the success of both drugs. GlobalData forecasts that in the 8MM (US, France, Germany, Italy, Spain, UK, Japan, and China) Leqembi and Kisunla could generate sales of approximately $3.5 billion and $2.0 billion in 2030, respectively.”