<p>To be made routinely available to National Health Service patients in England, new medicines must receive a marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) and a positive recommendation from the National Institute for Health and Care Excellence (NICE) to demonstrate clinical and cost effectiveness.</p><p>A number of potential new disease modifying treatments for Alzheimer’s disease are in development and MHRA, NICE, NHS England and the Department are working closely to ensure that arrangements are in place to support the adoption of any new licensed and NICE recommended treatment for Alzheimer’s disease as soon as possible.</p><p>NICE’s appraisal of lecanemab for treating early Alzheimer's disease is currently underway and, subject to licensing and the company engaging in the process, NICE expects to publish final guidance in July 2024 as close to licence as possible. NICE is also due to begin its appraisal of donanemab for treating early Alzheimer’s disease later this year.</p><p>To prepare for these appraisals, and the expected pipeline of further disease modifying dementia treatments, the NICE Health Technology Assessment Innovation Laboratory has already started working on identifying potential challenges that might face the evaluation of these medicines and ways of addressing them.</p>