Written evidence submitted by Alzheimer’s Research UK (CBP0083)

 

About Alzheimer’s Research UK

  1. Alzheimer’s Research UK is the largest charitable funder of dementia research in Europe. Our focus on research means that we can channel our expertise and energy into catalysing scientific efforts in the UK and across the world. We are currently funding £39 million in world-class science at leading universities and research institutions and to date have funded £143 million in research projects.
  2. Alzheimer’s and other dementias are one of the UK’s leading causes of death and with no treatments to slow, stop or cure them, they are diseases that no-one has yet survived. However, we are committed to changing that. Backed by our passionate scientists and supporters, we are challenging the way people think about dementia, bringing together the people and organisations who can speed up progress, and investing in research to make these breakthroughs possible.
  3. Our mission is to bring about the first life-changing dementia treatment by 2025. Our research strategy is targeted to deliver research that offers the most potential for health benefit, including:
    1. Accelerating discovery science, including as a founding partner of the UK Dementia Research Institute, the country’s largest ever dementia research initiative.
    2. Driving international early-stage drug discovery to translate promising developments in the laboratory into transformational treatments.
    3. Co-ordinating global efforts to detect the diseases that cause dementia at their earliest stages when treatment is more likely to be successful.

About dementia diagnosis

  1. This submission focusses on the dementia diagnosis backlog caused by the pandemic. Earlier, more accurate diagnosis is key to unlocking research breakthroughs and realising the potential of new treatments. It also enables people with dementia to plan for the future, access care and support, and have the opportunity to participate in clinical trials.[1] For a dementia diagnosis to be effective it needs to be both early and accurate – able to identify the underlying disease(s) responsible for the dementia symptoms, known as dementia subtyping.
  2. Most people living with dementia are only diagnosed when they or a loved one notice the symptoms associated with it, such as memory loss. However, scientific evidence suggests that changes in the brain associated with dementia can happen as many as 10-15 years prior to the onset of visible clinical symptoms. Despite this realisation and advances in diagnostics, dementia is still diagnosed too late for too many people.
  3. There can be a perception that because we don’t yet have any disease-modifying treatments, there is little benefit to advocating for earlier diagnosis of dementia. However, it is the very lack of early and accurate diagnosis which makes it challenging to find suitable candidates for clinical trials, ultimately slowing progress towards a potential disease-modifying treatment.
  4. There is evidence that dementia is more likely to be treatable when it is at an early stage, and drug development is currently focussed on delivering a treatment that could slow progression for patients with the earlier stages of Alzheimer’s disease, the most common cause of dementia.
  5. Unless we transform dementia diagnosis, it will be too late for many patients to benefit from new treatments. This is more pressing than ever, as the first potential disease modifying treatment for Alzheimer’s has been approved by US regulators and is currently being reviewed in the UK and Europe. If it is approved, it will likely be available to patients in the UK in the next few years.

What is the anticipated size of the backlog and pent-up demand from patients for different healthcare services including, for example, elective surgery; mental health services; cancer services; GP services; and more widely across the healthcare system?

  1. The national ambition to diagnose two thirds of those estimated to be living with dementia has been consistently met since July 2016.[2] However, since March 2020, due to the impact of COVID-19 on access to services, the diagnosis rate for those 65 and over has dropped from 67% at the start of 2020 to 61% in February 2021.[3]
  2. Direct data on the backlog for dementia diagnoses is not available as data on referral waiting times is not routinely collected by memory services. We have therefore approximated the size of the backlog based on the number of missed dementia diagnoses during the pandemic, when compared to previous years. Based on these calculations, we estimate a backlog of at least 31,480 people waiting for a dementia diagnosis.[4]
  3. This is likely to be a considerable underestimate, as it does not include people under the age of 65 (those with young onset dementia) and does not account for the months since March 2021, even though the diagnosis rate has remained low and was still at 62% in July 2021.[5] Moreover, this figure does not include the third of people living with dementia who never receive a formal diagnosis, and who are not covered by the current target to diagnose two thirds of cases.
  4. The Department of Health and Social Care is currently drafting a new dementia strategy to 2024. It is vital that this looks beyond restoring services to pre-pandemic levels, and sets out an ambitious plan to transform dementia diagnosis and prepare the health system for the arrival of the first disease modifying treatments. Failure to do so would be a huge missed opportunity that will slow research progression and impact people affected by dementia for decades to come.

 

What capacity is available within the NHS to deal with the current backlog? To what extent are the required resources in place, including the right number of staff with the right skills mix, to address the backlog?

  1. Even before the pandemic, there was a lack of capacity in the dementia diagnosis pathway. Most dementia diagnoses are made by memory clinics and the 2019 national memory service audit found huge variation between clinics. The average waiting time from referral to diagnosis was 13 weeks (with waiting times varying from 3 to 34 weeks), and only 26% of patients were diagnosed within the 6-week target.[6]
  2. The impact of COVID-19 on the health service clearly reduced capacity even further. While memory clinic referrals have increased steadily since the height of the pandemic (referrals in July 2021 surpassed the numbers seen a year before[7],[8]), this is yet to translate into significant improvements in the diagnosis rate.
  3. This is due to a range of factors, including fewer assessments happening at both GP and memory service level. Between October 2019 and July 2020, 165,000 assessments for dementia took place at a GP level and 30,000 at memory clinics; for the same period in 2020-21 this figure was 30,000 lower at GP practices and 10,000 lower for memory services. [9],[10] It’s clear that capacity issues are causing considerable delays in the dementia diagnostic pathway, but due to the limited data available we are unable to ascertain the full scale of this challenge.
  4. Another reason for the lagging dementia diagnosis rate is the limited access to diagnostics, particularly structural imaging capacity (CT and MRI scans). In June 2021, 18% of patients were waiting more than 6 weeks for a diagnostic MRI scan (for all conditions), while this was 15% for CT scans.[11] This has decreased compared to June 2020, but still indicates substantial challenges with diagnostic capacity in the face of growing activity.
  5. Looking at CT and MRI diagnostics specifically for dementia, there were already considerable waiting lists pre-pandemic. In the 2019 memory service audit, scan waiting times were highlighted as a key barrier to meeting the 6-week pathway. This was exacerbated by neuroimaging capacity, with 60% of memory services unable to view brain images from scans as they do not have access to the required imaging systems (PACS).[12]
  6. It’s possible there is even more of a backlog for neuroimaging services than covered by the estimated diagnosis backlog set out above. During the pandemic, memory services were advised that “if further investigations, e.g. neuroimaging, are required to establish the subtype but are not available then it would be acceptable to give a working diagnosis of unspecified dementia whilst awaiting further investigations.[13] Not only does this add to current bottleneck for neuroimaging services, but unspecified dementia diagnosis can directly affect the type of care and post-diagnostic support a patient receive e.g. in terms of accessing potentially important prescription medication.
  7. There is also a significant capacity issue with tests used for the more specific diagnosis of Alzheimer’s disease, rather than dementia more generally. A 2021 report from Alzheimer’s Research UK and the Royal College of Psychiatrists found that just 6% of psychiatry services are able to fully meet the current NICE guidelines regarding accessing further biomarker and diagnostic tests (FDG-PET and CSF) for Alzheimer’s disease.[14]
  8. As there was not enough capacity in dementia diagnosis even before the pandemic, both long-term structural solutions and more immediate interventions will be needed to address the backlog. The government and health system need to invest in the right workforce, infrastructure, and training for diagnosing dementia, including improving structural imaging capacity and access to FDG PET and CSF tests.

 

How much financial investment will be needed to tackle the backlog over the short, medium, and long-term; and how should such investment be distributed? To what extent is the financial investment received to date adequate to manage the backlog?

  1. In March 2021, the Department of Health & Social Care announced a one-off investment of £17 million to “support recovery of the dementia diagnosis rate and tackle the backlog of appointments as a result of the pandemic”.[15] Specific details about how this money will be allocated are not yet clear, but it is understood it will be distributed across a number of priorities, including on workforce, referrals, ensuring a COVID safe environment (e.g. PPE and remote consultations) and post-diagnostic support. While this funding is welcome, it will not be sufficient to tackle the backlog.
  2. To understand how much investment might be required, we have calculated the cost for the estimated 31,480 undiagnosed patients to go through a memory assessment service over a period of 5 months which is our working estimate for average length of time a patient spends under the care of a memory assessment service. This gives an estimated cost of £292 million to tackle the dementia diagnosis backlog.[16] While this figure is a very rough approximation and there is significant heterogeneity in the set-up and capacity of memory services, it provides an indication of the scale of investment needed.
  3. Although the £17 million already allocated is clearly short of what’s needed, the Department of Health & Social Care must carefully and transparently monitor how it is implemented and its success in restoring the dementia diagnosis rate. In the likely situation that further funding is then required, this should be calculated based on patient need and provided without delay.
  4. Looking longer-term, towards the new dementia strategy and the spending review this autumn, there’s an urgent need for substantial further investment in dementia diagnosis that seeks to address existing structural barriers to improving diagnosis and looks at the transformation needed to prepare services for the first disease modifying treatments.

 

How might the organisation and work of the NHS and care services be reformed in order to effectively deal with the backlog, in the short-term, medium-term, and long-term?

  1. As set out above, it will not be possible to address the backlog without considering how short-term measures will feed into the longer-term picture. This is because the backlog in dementia diagnostic services has been exacerbated, not created, by the pandemic. This is coupled with the fact that dementia cases are rising due to our aging population and radical improvements will be needed in diagnosis to enable as many patients as possible to benefit from the first disease modifying treatments.
  2. What is needed is sustainable reform to tackle underlying issues, rather than short-term sticking plasters that are narrowly focussed on the immediate backlog. The areas that require investment and attention to deal with the backlog (such as workforce, diagnostic infrastructure, and pathway reform), are the same as those that need to be addressed if we are to improve dementia diagnosis in the longer-term and prepare the health system for the arrival of the first disease modifying treatments.
  3. Given the limited resources available, government and the NHS should consider how measures to address the backlog can also help shift the health system towards earlier and more accurate dementia diagnosis. This should be a key part of the forthcoming dementia strategy.
  4. In the short to medium-term (the next 1-3 years), the NHS should:
    1. Invest in improving structural imaging capacity, including picture archiving and communication system (PACS), so that memory clinics can offer access to scans in line with NICE guidelines. Limited access to structural imaging is foremost among the challenges contributing to diagnostic delays and a high level of unspecified dementia diagnoses.
    2. Invest in improving patient access to FDG PET and CSF tests for the diagnosis of Alzheimer’s disease, in line with NICE guidelines. Currently only 77% and 56% of memory services can refer patients for PET scans and CSF testing respectively. Moreover, it is likely that the services which can access these diagnostics are predominantly located near research centres, creating significant geographic inequality.
    3. Mandate a national audit of all specialist dementia diagnostic services, beginning with the National Memory Clinic Audit. The 2019 audit gave us ground-breaking insight into the performance of memory services and identified several vital improvement projects, such as expanding access to PACS. It concluded that there was “marked variation in almost every aspect of the memory service pathway”.[17] NHS England should repeat this audit to review the implementation of the proposed changed and mandate it be carried out at regular predefined intervals.

 

What can the Department of Health & Social Care, national bodies and local systems do to facilitate innovation as services evolve to meet emerging challenges?

  1. As already outlined, the first disease modifying treatments for Alzheimer’s disease are expected to become available in the UK in the next 1-5 years. This will transform the way health services diagnose and treat dementia. The Department of Health and Social Care, NHS England and local systems all need to be planning for this now.
  2. The upcoming dementia strategy for 2022-24 will be essential in preparing the health system to deliver disease modifying treatments. The Department of Health and Social Care needs to ensure that this strategy sets a clear direction and is ambitious about what can be achieved in dementia diagnosis. The strategy must also be backed by significant long-term investment.
  3. In two recent reports[18],[19], Alzheimer’s Research UK set out specific recommendations for how the health service can meet the emerging challenges presented by the arrival of disease modifying treatments for Alzheimer’s disease. A summary of the recommendations that relate to delivering earlier diagnosis is provided below.
  4. NICE should develop national clinical guidelines on the diagnosis, treatment and follow-up of patients living with Mild cognitive impairment (MCI). We need to gradually transition from diagnosing in the dementia stage of Alzheimer’s disease to diagnosing in earlier stages, including MCI. We currently have NICE guidelines for the diagnosis, treatment and care of people living with dementia, but these guidelines do not apply to the stages before the established symptoms of dementia, such as MCI.
  5. MCI is already a widely used clinical diagnosis in England, with 17% of memory clinic patients aged 65 and over diagnosed with MCI.[20] However, there is widespread variation at a service level in the use of MCI as a diagnosis, amounting to between 0 and 47% of patients in memory clinics.[21] It is likely that this variation reflects differences in clinical attitudes and approaches to the use of MCI rather than significant underlying clinical differences in the presenting patients.
  6. The NHS should scope out short-term as well as long-term needs, and invest in infrastructure, resources and clinical workforce to build diagnostic capacity in preparation for the arrival of future disease-modifying treatments. In the event of a new disease-modifying treatment, there will be a considerable increase in demand for a diagnosis. This includes identifying those who are eligible for treatment based on the drug licensing, but also significant numbers of people who are likely to seek a diagnosis who had previously not done so. Given the existing system is already under strain, it is unlikely to have the capacity to cope with such an increase in demand. Considerable investment will be required in infrastructure and clinical capacity to both undertake molecular biomarker tests and interpret results.
  7. The health community should foster interdisciplinary collaboration between sites that already use molecular diagnostics, to increase relevant expertise across the country and develop a network of initial sites capable of delivering disease-modifying treatments in the short to medium term. When a disease-modifying treatment is licensed in the UK, there are likely to be a limited number of locations that have the diagnostic infrastructure, capacity, and skills available to be able to diagnose amyloid positivity. Regional collaboration will be needed between these centres, as well as between clinical academics who already employ biomarker testing in clinical and research settings. This will be needed to both inform the development of broader treatment pathways and improve equity of access.
  8. The health community should evaluate, and where appropriate, support the potential of innovative service models to offer a new diagnostic pathway. Brain health clinics have been proposed as one potential model of an integrated and multidisciplinary approach to care. They would identify and assess all those in the predementia stages and offer interventions to promote brain health, access to support services, and referral to research trials.
  9. Since brain health clinics were articulated in the Edinburgh Consensus, varying models are now in development in at least Edinburgh, Manchester, Oxford, and Bristol. A national programme in Scotland was also established in 2020. While these clinics are still at a proof-of-concept stage, their approach to early diagnosis and intervention could teach us a lot in the short term about how to design services in the long term. The successes of these programmes should be evaluated in due course to determine their longer-term viability and role in dementia patient pathways.

Sept 2021


[1] Roche (2020) Knowing: the debate on early detection and timely diagnosis in Alzheimer’s disease. Available at https://www.roche.co.uk/content/dam/rochexx/roche-co-uk/downloads/IN_Roche_Alzheimers_Knowing.pdf

[2] Department of Health and Social Care (2019) Dementia 2020 challenge: progress review. Available at https://www.gov.uk/government/publications/dementia-2020-challenge-progress-review

[3]NHS Digital (2021) Recorded Dementia Diagnoses February 2021. Available at https://digital.nhs.uk/data-and-information/publications/statistical/recorded-dementia-diagnoses/february-2021

[4] Calculations use 2019 as a baseline, when there was an average of 455,677 recorded dementia diagnoses in people ages 65 and over in England, with an average diagnosis rate of 68.4%. From April 2020 to March 2021, there was an average of 424,197 recorded dementia diagnoses and an average diagnosis rate of 62.9%.

[5] NHS Digital (2021) Recorded Dementia Diagnoses July 2021. Available at https://digital.nhs.uk/data-and-information/publications/statistical/recorded-dementia-diagnoses/july-2021

[6] NHS England (2020) The 2019 national memory service audit. Available at https://www.england.nhs.uk/london/wp-content/uploads/sites/8/2020/04/The-2019-national-memory-service-audit.pdf

[7] NHS Digital (2021) Recorded Dementia Diagnoses July 2020. Available at https://digital.nhs.uk/data-and-information/publications/statistical/recorded-dementia-diagnoses/july-2020

[8] NHS Digital (2021) Recorded Dementia Diagnoses July 2021. Available at https://digital.nhs.uk/data-and-information/publications/statistical/recorded-dementia-diagnoses/july-2021

[9] NHS Digital (2021) Recorded Dementia Diagnoses July 2020. Available at https://digital.nhs.uk/data-and-information/publications/statistical/recorded-dementia-diagnoses/july-2020

[10] NHS Digital (2021) Recorded Dementia Diagnoses July 2021. Available at https://digital.nhs.uk/data-and-information/publications/statistical/recorded-dementia-diagnoses/july-2021

[11] NHS England (2021) NHS Diagnostic Waiting Times and Activity Data, June 2021. Available at https://www.england.nhs.uk/statistics/wp-content/uploads/sites/2/2021/08/DWTA-Report-June-2021_K70GO.pdf

[12] NHS England (2020) The 2019 national memory service audit. Available at https://www.england.nhs.uk/london/wp-content/uploads/sites/8/2020/04/The-2019-national-memory-service-audit.pdf

[13] Yorkshire and the Humber Clinical Networks (2020) Memory Service Assessments: A New Way of Working. Available at http://www.yhscn.nhs.uk/media/PDFs/mhdn/Dementia/Covid%2019/MAS/MSA%20-%20A%20New%20Way%20of%20Working%20revised%20Dec%202020.pdf

[14] Alzheimer's Research UK (2021) Are we ready to deliver disease modifying treatments? Available at https://www.alzheimersresearchuk.org/wp-content/uploads/2021/05/ARUK-Are-we-ready-to-deliver-disease-modifying-treatments_25May21.pdf

[15] Department of Health and Social Care press release (2021). Available at https://www.gov.uk/government/news/mental-health-recovery-plan-backed-by-500-million

[16] Based on a monthly mean cost per patient to go through a Memory Assessment Service of £1,855, from Pennington et al. (2016) The cost of diagnosis and early support in patients with cognitive decline. International Journal of Geriatric Psychiatry. Available at http://eprints.lse.ac.uk/69002/1/Knapp_The%20cost%20of%20diagnosis%20and%20early%20support%20in%20patients_author_2017%20LSERO.pdf

[17] NHS England (2020) The 2019 national memory service audit. Available at https://www.england.nhs.uk/london/wp-content/uploads/sites/8/2020/04/The-2019-national-memory-service-audit.pdf

[18]Alzheimer's Research UK (2021) The Right to Know: Accurate and Earlier Diagnosis of Dementia. Available at https://www.alzheimersresearchuk.org/wp-content/uploads/2021/05/ARUK-The-Right-to-Know_Accurate-and-Earlier-Diagnosis-of-Dementia_25May21.pdf

[19] Alzheimer's Research UK (2021) Are we ready to deliver disease modifying treatments? Available at https://www.alzheimersresearchuk.org/wp-content/uploads/2021/05/ARUK-Are-we-ready-to-deliver-disease-modifying-treatments_25May21.pdf

[20] NHS England (2020) The 2019 national memory service audit. Available at https://www.england.nhs.uk/london/wp-content/uploads/sites/8/2020/04/The-2019-national-memory-service-audit.pdf

[21] ibid