Preparing for a new chapter: disease modifying treatments for early Alzheimer’s disease

Easy read summary

  • Dementia is a general term that describes how someone can find it more difficult to remember things, think clearly, or make decisions. Alzheimer’s Disease is the most common cause of dementia and at the moment there is no medicine to stop it getting worse over time.
  • The NHS now has a team of experts who are looking into what would need to be in place to offer possible new treatments for some people with the early stages of Alzheimer’s Disease.  These new medicines could be made available as soon as next year.
  • None of these new treatments have yet been agreed for use in the NHS. However, the NHS wants to be ready to offer patients any new treatment that is proven to be safe, to work well and be affordable.
  • The NHS expert team is working with colleagues across England so that there are the right services in place to confirm whether a person is in the early stages of Alzheimer’s Disease and might be helped by the treatment, as well as the right staff, and equipment to provide the treatment, which is given through a drip in the arm.
  • None of the medicines are a cure for Alzheimer’s Disease, but it is hoped that they could slow down the rate at which someone’s dementia symptoms get worse.

Dementia is the leading cause of death in the UK, with the number of people living with the condition estimated to reach 1.7 million by 2040. Alzheimer’s disease is the most common cause of dementia, affecting an estimated 1 in 14 people over the age of 65 in the UK.

Potential new treatments for early Alzheimer’s disease

NHS England has been closely monitoring a pipeline of new disease modifying treatments (DMTs) in development for mild cognitive impairment associated with early or mild Alzheimer’s disease. One of these treatments, lecanemab, recently received regulatory approval in the US and Japan.

A second, donanemab, has also shown that it can slow the rate of progression of Alzheimer’s disease in trial data published earlier this year. Neither of these treatments represent a cure, and both come with some potential side effects (including risks of brain bleeds and swelling) which will need to be carefully weighed up by clinicians and patients. The treatments appear to slow (rather than stop or reverse) the rate of cognitive decline of people with early symptoms. While reported clinical benefits in published trials are relatively modest, these drugs do mark a real breakthrough in the way early Alzheimer’s disease might be treated in the future.

Recognising the significance of these medicines, this summer our Chief Executive Amanda Pritchard announced that NHS England had established a dedicated national programme team for early Alzheimer’s treatments. Working across the NHS, including with local health systems, industry partners, patient groups, research organisations, regulators and more, the team is working to prepare the health system for the potential arrival of treatments that receive the necessary UK regulatory approvals.

Challenges, opportunities, and learning from experience

Implementing these medicines will be one of the biggest challenges the NHS has faced in its 75-year history, with the team planning for the key challenges already identified, including:

  • Securing additional diagnostic capacity – implementation will require a significant expansion in MRI, lumbar puncture, PET-CT scanning and genetic testing capacity.
  • Delivering workforce solutions – additional capacity, further training and innovative workforce solutions will be required across the new diagnostic and treatment pathway.
  • Raising public awareness of the symptoms of early Alzheimer’s disease – as well as providing accessible information on eligibility for any approved treatment(s), and clear information on the potential benefits and harms, to enable informed treatment decisions.

In parallel to this preparatory work for potential new treatments for early Alzheimer’s disease, on 15 November NHS England announced that dementia diagnosis rates had reached their highest level in three years, following the decline seen during the pandemic when people were less likely to come forward for assessment. This positive development reflects the hard work of NHS and social care staff across the country.

Preparing in partnership

Harnessing the collective experience, expertise and enthusiasm across the Alzheimer’s community is vital in our work to prepare for new Alzheimer’s treatments. Crucially, it will be the 42 integrated care boards (ICBs) who will be the primary commissioners for most elements of the new referral and treatment pathway. ICB and regional colleagues are already embedded into the programme team, providing support, advice and challenge as we plan for both the national and local elements of implementation.  Building on other rapid service mobilisations, such as the roll out of COVID-19 vaccines and treatments, and our experience with challenging service transformations such as our pioneering ‘find and treat’ approach to hepatitis C elimination, rapid rollout of personalised ‘CAR-T’ cancer treatments at highly specialised NHS centres, and commissioning of cutting-edge gene therapies like Libmeldy®, we will be supporting ICBs in their rollout of approved treatments.

The National Institute for Health and Care Excellence (NICE), the organisation that assesses the clinical and cost-effectiveness of new medicines, has recently published an assessment of its readiness to appraise Alzheimer’s drugs. Its HTA Lab report identifies that while a number of challenges remain, such as a lack of published long-term outcome data that will require extensive assumptions to be made, NICE is ready to assess innovative Alzheimer’s treatments.

As we continue preparations for treatments already under review by the UK medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), further innovation is already in progress. Blood tests to help screen people for Alzheimer’s disease could, within a few years, be used as part of routine NHS care with welcome further research underway into the validity of these and digitally based tests for the Alzheimer’s in the future.

A recent film by Alzheimer’s Research UK, injecting urgency into greater and continuing research for new treatments, highlights the darkness currently faced by individuals and families living with Alzheimer’s. It is a powerful reminder, and the motivation behind our determination that NHS patients will be able to access effective treatments in the future.

Ann Jarvis is the Programme Director for NHS England’s Alzheimer’s Disease Modifying Treatments programme.