As the number of Alzheimer’s treatments seeking regulatory approval rises, ADI continues to provide technical and patient-centred guidance to regulators. In this blog, ADI highlights some of our ongoing engagement in this area, based on our guiding principles:
Context:
ADI strongly believes that people living with dementia have the right to choose whether or not to incorporate disease modifying therapies into their treatment pathway and have the right to be fully aware of treatment options, benefits and risks. Access should be equitable and not reliant on income, background or geographic location. Regulators should note the broad range of opinion of people living with dementia within their assessments, and consider the merits of new treatments pragmatically and fairly, noting that early and innovative treatments are rarely perfect and draw comparisons from designations such as oncology. Governments have an obligation to ensure that health systems are prepared for new treatments. Finally, while acknowledging the significant costs involved in research and development, it is essential that industry ensures new treatments are priced fairly and sustainably. If treatments are priced beyond the capacity of healthcare systems, they risk being inaccessible to the very people they are intended to benefit.
Global
Through its policy and advocacy work, ADI has consistently highlighted the need for health system readiness for a new era of treatments. Globally, shortages of specialists, health care practitioners and equipment, particularly MRI and PET scanners, mean that accessing a timely diagnosis or confirmatory diagnosis for concerned individuals is challenging and put limits on the ability for treatment monitoring. Through the adoption of National Dementia Plans (NDP), ADI has advocated and provided feedback on legislation to enable governments and health systems to improve diagnosis rates and to put in place robust post-diagnostic support. This is echoed by many of our member associations around the world advocating to governments to develop NDPs and working alongside their health systems, in an advisory capacity, on education, training and practice.
ADI also routinely engages with the media, providing a patient perspective to ongoing discussions on regulatory decisions and translating these complex decisions for lay audiences. Recently, for example, ADI has highlighted the risk of health tourism, where there are disparities in regulatory decision across countries in close proximity, alongside the health inequity this risks.
United States
Much of the global attention over the last few years has been on the United States. In 2022, ADI challenged the Centers for Medicare & Medicaid Services (CMS) decision to limit reimbursement of aducanumab to those in CMS approved trials. This decision risked inequitable access, particularly for groups which are underrepresented in clinical trials. While noting the CMSs rational based on the significant cost and burden of these treatments on health care systems, ADI raised concerns about placing restrictions on the whole class of anti-amyloid treatments, including those in development, potentially stifling the ongoing development of new disease modifying therapies in this sector. ADI also highlighted the inconsistencies with previous rulings in other disease areas and the misalignment with the purpose and spirit of the accelerated approval pathway.
Europe
ADI continues to maintain communication with the European Medicines Agency (EMA), engaging with the agency on their assessment and re-assessment of lecanumab for the treatment of early Alzheimer’s disease. Through our communication with the regulator, we have continued to articulate the necessity of a choice for people living with dementia and have highlighted the potential of health tourism and health inequity across the region; a growing concern in light of the UK regulators decision to approve the medication. From the patient perspective, it is essential that the regulatory process consults widely and captures the voice of lived experience and patient advocates, especially those that have participated in clinical trials. ADI is continuing to engage with the agency and has applied to join the body in an official capacity to provide insights and recommendations on new therapeutics as and when they are assessed.
United Kingdom
ADI provided formal feedback during the consultation process for the National Institute for Health and Care Excellence recommendations on lecanemab. In the UK, the regulator, Medicines and Healthcare products Regulatory Agency (MHRA) approved the use of lecanemab, however the payer (NICE) recommended against reimbursement. This approach has recently been replicated for donanemab. ADI highlighted the need for those living with dementia to be able to access disease modifying therapies, and the risk of health inequity that exists if only those who can afford the treatments can access them. ADI also challenged the exclusion of informal carer costs from the economic modelling, highlighting that up to 50% of the estimated global costs for dementia result from informal care.
Canada
Alongside ADI member, Alzheimer Society of Canada (ASC), ADI provided feedback on a report by the Canada Drug Agency (CDA) on ‘Health System Readiness for Disease-Modifying Therapies for Alzheimer’s Disease’. ADI queried a number of technical assumptions made in the report, such as the number of people who are likely to incorporate disease modifying therapies into their treatment plan and the estimates relating to imaging demand.
ADI will continue to work with regulatory agencies, supporting the activities of our member associations as we enter this new age of innovation in treatments and diagnostic breakthroughs.
In December 2025, ADI hosted an end of year webinar on translating the ‘Alzheimer’s Treatment Revolution into Real World Solutions’ to further help demystify and inform the public on what these new treatments means for them.
