What we think about system preparedness for disease-modifying treatments for Alzheimer’s disease

What do we mean by system preparedness?

System preparedness means the NHS being ready to deliver new disease-modifying treatments – with the necessary processes and resources in place to do this.

What we think

Recent research breakthroughs mean there are now disease-modifying treatments (DMTs) that appear to slow the progression of early-stage Alzheimer’s disease. Three such drugs are currently being assessed by regulators in the UK, and with over 100 Alzheimer’s disease drugs in clinical trials this year, we are likely to see more drugs emerging soon. 

Thousands of people in the UK could potentially benefit from these new drugs if they’re approved for use, but the healthcare system is not yet ready to deliver them. This is why Alzheimer’s Society is calling on the NHS in England and Wales and HSC (health and social care) system in Northern Ireland to publish plans on how they intend to deliver new treatments. These plans must include investment in specialist diagnostic tests and the workforce required to ensure everyone with suspected Alzheimer’s disease can access a test that can confirm eligibility for treatment at an early stage in their disease progression. 

Background

DMTs are treatments that are able to slow the progression of a disease by targeting the root causes, rather than just addressing symptoms of the disease. Recent research breakthroughs mean there are now DMTs that appear to slow the progression of early-stage Alzheimer’s disease. Three such drugs, lecanemab, donanemab, and hydromethylthionine mesylate (HMTM), are currently being assessed by regulators in the UK, and with over 100 Alzheimer’s disease drugs in clinical trials this year, we are likely to see more drugs making applications to UK regulators in the near future. For a treatment to become available on the NHS, it would need to be approved by both the MHRA (Medicines and Healthcare products Regulatory Agency, who assess the drug for efficacy and safety), and NICE (National Institute for Health and Care Excellence, who assess the drug for clinical and cost effectiveness).

One published journal paper has estimated that around 30,000 people in the UK could be eligible to start treatment each year. NHSE have estimated that the number of patients that might be eligible for DMTs ranges from 50,000 to 280,000. This wide range of estimates is because there are a lot of unknowns which make it challenging to produce accurate estimates. 

The challenges

If DMTs were approved tomorrow, there would be significant barriers to access:

• Access to these drugs would rely on early and accurate diagnosis. Yet currently more than one third of people with dementia don’t have a diagnosis. For those who do, research has found that on average people have symptoms for 3.5 years before they get a diagnosis. 
• Access to these drugs would also require a specialist diagnostic test that confirms that a person has Alzheimer’s disease. Currently this means a PET scan or a cerebrospinal fluid (CSF) test via a lumbar puncture, yet only 2.1% of patients seen at memory services receive specialist tests such as these. There is currently ongoing research seeking to determine if blood tests – which are cheaper and easier to administer than PET and CSF - could be used in the diagnosis process for accessing DMTs in the future.

What change do we want to see?  

• We need UK healthcare systems to publish plans for how they intend to deliver DMTs. These plans must include investment in specialist diagnostic tests and investment in the workforce required to support the DMTs pathway – including carrying out and analysing results of diagnostic tests, administering the drugs, and monitoring during treatment. 
• This must be supported by at-pace expansion of diagnostic capacity so that people with Alzheimer’s disease are able to receive a diagnosis at an early stage of disease progression, without facing long waiting times. 
• Improved access to an early and accurate diagnosis, including information on the type of dementia a person has, is beneficial for everyone – not just those who may be eligible for DMTs. A diagnosis brings benefits of access to information, care, support, and the opportunity to plan ahead. We must capitalise on this moment as a catalyst for improving dementia diagnosis for everyone.
   

What Alzheimer’s Society is doing 

• We have submitted evidence to NICE for their appraisals of DMTs lecanemab, donanemab and hydromethylthionine mesylate (HMTM).
• We are engaging with people with dementia, including through interviews, focus groups and surveys, to understand their views in relation to DMTs, and using this to inform our policy development and submission to NICE appraisals of new drugs. 
• We are continually engaging with experts including leading researchers and clinicians, through meetings and attending conferences such as the Alzheimer’s Association International Conference (AAIC), to stay up-to-date on the latest developments and to use new insight to adapt our policy position and approach where required. 
• We are working with national and local healthcare systems leaders across the three nations to discuss the challenges and to identify solutions.