First drug to slow Alzheimer’s too costly for NHS

The first drug that can slow down the progression of early-stage Alzheimer’s disease, known as lecanemab, will not be available on the NHS in England. This decision comes from NICE, the health assessment body, which stated that the benefits of the drug are too minimal to justify its high costs. Lecanemab has received approval for use in Great Britain from the medicines regulator, the MHRA, which means it can be prescribed privately. Clinical trials have shown that the drug can slow cognitive decline by approximately 25% in patients with early Alzheimer’s over an 18-month period. However, NICE pointed out that the treatment incurs significant costs, including the need for intensive monitoring for side effects and the requirement for patients to visit the hospital every two weeks. David Thomas, head of policy at Alzheimer’s Research UK, described the approval of lecanemab as a 'bittersweet moment. ' He expressed disappointment over NICE's decision not to approve it for the NHS, stating, 'The approval of lecanemab is a milestone moment, but the decision by NICE is deeply disappointing. ' Dr. Samantha Roberts, the chief executive of NICE, explained that the organization conducted a thorough evaluation of the available evidence, including the benefits for caregivers, but could only recommend treatments that provide good value for taxpayers. Helen Knight, director of medicines evaluation at NICE, noted that lecanemab offers an average of four to six months of slowing in the progression from mild to moderate Alzheimer’s disease, which is not sufficient to justify the additional costs to the NHS. A final decision from NICE is expected towards the end of the year after a public consultation. Approximately 70,000 adults in England would have qualified for treatment with lecanemab. Wales and Northern Ireland typically follow the medical guidance set in England, while the organization that assesses newly licensed medicines in Scotland has yet to make a decision regarding the drug's value. NHS England has stated that a dedicated team is currently reviewing 27 other Alzheimer’s drugs that are in advanced trials and could potentially be approved in the near future. Lecanemab works by eliminating a harmful protein called amyloid that accumulates in the brains of Alzheimer’s patients. The drug is administered as an intravenous infusion every two weeks. Researchers in the field of Alzheimer’s hailed the trial results as historic, as no previous drug had convincingly demonstrated the ability to slow the underlying mechanism of the disease. However, concerns have been raised regarding the frequent occurrence of amyloid-related imaging abnormalities (ARIA), which can be detected in MRI scans, including small brain bleeds and temporary swelling. While most of these occurrences in trials were mild or asymptomatic, some participants required hospitalization. The price of the drug has not been publicly disclosed in the UK, but it is estimated to cost around £20,000 per patient per year in the US. Fiona Carragher from the Alzheimer’s Society expressed to BBC News that this decision would lead to uncertainty and confusion for nearly one million individuals living with dementia. Although the MHRA has approved the drug in Great Britain, it has set restrictions on which patients can receive it due to the risk of side effects. For instance, individuals who carry two copies of the apolipoprotein E4 gene (ApoE4), which affects about 15% of those diagnosed with Alzheimer’s, will not be eligible for treatment, nor will those on blood thinners. Mavis Guinn, a 90-year-old woman, is one of the few individuals in the UK receiving lecanemab as part of a clinical trial. Her husband, Rodney, shared that the drug has allowed Mavis to maintain her personality. He expressed gratitude for the drug, stating, 'We've had some wonderful years since you came on this drug and some great times. ' Mavis receives the drug every two weeks through infusion, but her short-term memory remains significantly impacted. The benefits of lecanemab are modest, and some argue they are barely noticeable. Additionally, there are potential side effects to consider. Nevertheless, many experts view this as a pivotal moment, indicating that Alzheimer’s disease is not an unstoppable condition. Alzheimer’s is the most prevalent form of dementia and is the leading cause of death in the UK. The BBC’s Panorama program followed patients on lecanemab and another new drug, donanemab. In a broadcast earlier this year, Professor Cath Mummery, a consultant neurologist and head of clinical trials at the Dementia Research Centre, University College London, remarked that while the benefits of these drugs are small, they signify a turning point. 'For the first time, we've got drugs that show that you can alter the course of Alzheimer’s disease, and that's an extraordinary thing,' she stated.