A new Alzheimer’s drug, donanemab, has been rejected for widespread use in the NHS in England after the health spending watchdog ruled it “does not currently demonstrate value for the NHS”. The National Institute for Health and Care Excellence (NICE) has made the decision to not approve the drug for use in England’s health services.
Alzheimer’s UK expressed concerns about this decision, labeling it a “frustrating setback” for people with the disease. They warned that this move could potentially leave patients in the UK behind and signal that the country is no longer a favourable place to launch new treatments. The decision by NICE comes after the drug was licensed for use in the UK by the Medicines and Healthcare products Agency (MHRA), making it the second Alzheimer’s drug to be rejected by NICE in recent months.
Donanemab, also known as Kisunla, is manufactured by pharmaceutical company Eli Lilly and is a targeted antibody drug that aims to slow the early stages of Alzheimer’s. Along with another new treatment named lecanemab, these drugs are considered a significant advancement in research as they target a known cause of the disease rather than just treating the symptoms.
NICE’s director of medicines evaluation, Helen Knight, explained that for a medicine to be approved for NHS use, it must provide additional benefits to patients and represent a good use of NHS resources. Despite evidence showing that donanemab could slow down cognitive decline by four to seven months, the cost-effectiveness estimate for the drug is deemed to be too high, around five to six times above the acceptable use of NHS resources.
Lecanemab, another Alzheimer’s drug approved by the MHRA, was also rejected for widespread use in the NHS by NICE earlier. Both donanemab and lecanemab target amyloid, a protein that accumulates in the brains of individuals with Alzheimer’s, to help clear the build-up and slow down cognitive decline. It is believed that these drugs are most effective when administered at an early stage of the disease.
Clinical trials have shown promising results for donanemab, indicating a significant slowing in the rate at which memory and thinking abilities decline, along with a reduction in everyday activity decline. Despite the benefits, the drug does come with potential serious side effects such as brain swelling and micro brain bleeds.
While both drugs have been approved for use in the US, the European medicines regulator rejected lecanemab earlier this year. Alzheimer’s Research UK expressed disappointment in the decision, highlighting that these drugs are the first to slow down the decline in memory and thinking skills associated with Alzheimer’s, rather than just treating symptoms.
The charity has called upon the health secretary to ensure that UK Alzheimer’s patients are not left behind and that the country remains a welcoming place for the launch of new dementia treatments. Manufacturer Lilly remains confident in the value that donanemab can bring to patients and the NHS, despite the rejection for widespread use in England.
**Insights:**
The rejection of donanemab for NHS use due to cost-effectiveness raises important questions about access to innovative treatments for Alzheimer’s patients. The decision by NICE underscores the challenges of balancing treatment benefits with the financial implications for healthcare systems. It also highlights the need for ongoing research and development in the field of Alzheimer’s to find more effective and affordable solutions for patients. The concerns raised by Alzheimer’s UK and other stakeholders reflect the growing urgency to address the unmet needs of individuals living with this debilitating disease.