(Press-News.org)
Luxembourg, 9 January 2024 – In a new position paper, and following engagement with its national members and the European Working Group of People with Dementia (EWGPWD), Alzheimer Europe calls for concrete actions to enable timely, safe and equitable access to anti-amyloid drugs, for patients who are most likely to benefit from these innovative new treatments for Alzheimer’s disease (AD).
The growing prevalence and impact of AD has catalysed huge investments in research on its causes, diagnosis, treatment and care. After many high-profile failures, recent clinical trials of anti-amyloid drugs have marked a turning point for the field, leading to the approval of the first disease-modifying therapies for AD in the US. European regulators are currently evaluating whether there is sufficient evidence to approve these drugs for patients with mild cognitive impairment (MCI) or mild dementia due to AD.
Anti-amyloid drugs represent a new hope for people with AD. Classed as disease-modifying therapies, drugs such as lecanemab and donanemab can slow the progressive, clinical decline associated with AD, with the potential to give patients more time in the less symptomatic stages of the disease. However, the benefits and risks of initiating treatment with anti-amyloid drugs are multifaceted and complex, as are the patterns of evidence and effectiveness from clinical trials.
Access to anti-amyloid drugs hinges entirely on a timely and accurate diagnosis of AD, in the MCI or mild dementia stages, with biomarker confirmation of AD pathology. However, diagnosing AD remains challenging in clinical practice, excluding many from accessing patient-centred support, care and treatments. Currently, European healthcare systems are inadequately resourced to provide a timely diagnosis, let alone equitable access to anti-amyloid drugs, for all people with early AD who could benefit from treatment.
The Alzheimer Europe position paper addresses questions of anti-amyloid drug efficacy, safety and cost, highlighting three priority areas to ensure equitable access to these innovative treatments: effective communication of risks and benefits; an accurate, timely diagnosis; and healthcare systems preparedness. To address these challenges, Alzheimer Europe calls for concrete actions from industry, regulators, payers, healthcare systems and governments. These include:
Accessible, inclusive communication of the benefits and risks of anti-amyloid drugs, so patients can weigh the potential slowing of clinical decline against the side effects, financial costs and logistical burdens of treatment;
The adoption of realistic, sustainable pricing policies for anti-amyloid drugs, coupled with clear reimbursement frameworks that reflect the true value of treatment for patients and society, without impacting the coverage of existing therapies that are hugely valued by people with dementia and their carers/supporters;
Development of patient registries for long-term collection of real-world evidence on the efficacy and safety of anti-amyloid drugs, including data on outcomes that are meaningful for patients and their carers/supporters;
Investment in infrastructures for diagnosis and treatment, with expansion of workforce capacity and capability supported by clear guidance on drug eligibility, and parameters for treatment initiation, safety monitoring and discontinuation;
Implementation of biomarker-guided clinical pathways which support the diagnosis and treatment of AD in the early stages of disease, integrated alongside existing pathways focused on managing the symptoms of later-stage dementia;
Continued investment in the development of diagnostics and treatments for other causes and stages of dementia, as well as support and care services that can help people live well with dementia at all stages.
Commenting on the position paper, Alzheimer Europe’s Executive Director, Jean Georges, stated:
“If anti-amyloid drugs are approved by European regulators, these innovative treatments should be accessible for patients most likely to benefit, with clear protocols to exclude those most likely to suffer serious side effects. Fair pricing policies are crucial, to support broad coverage and reimbursement. The development of disease-modifying therapies for early AD marks a turning point in the fight against the disease. However, the needs of people with more advanced AD, or less common forms of dementia, must not be overlooked. Research into other treatment options is essential, including symptomatic treatment for people with more advanced dementia, and preventative approaches throughout the lifecourse."
Our full position paper can be accessed on the Alzheimer Europe website:
https://www.alzheimer-europe.org/policy/positions/alzheimer-europe-position-anti-amyloid-therapies
For further information, contact:
Jean Georges, Executive Director of Alzheimer Europe, 14, rue Dicks, L-1417 Luxembourg, Tel.: +352-29 79 70, Fax: +352-29 79 72, jean.georges@alzheimer-europe.org www.alzheimer-europe.org
Notes to editors:
Alzheimer Europe is the umbrella organisation of national Alzheimer associations and currently has 42 member organisations in 37 European countries. Our mission is to change perceptions, policy and practice in order to improve the lives of people affected by dementia.
The European Working Group of People with Dementia was launched by Alzheimer Europe and its member associations in 2012. The group is composed entirely of people with dementia, who are nominated by their national Alzheimer associations. They work to ensure that the activities, projects and meetings of Alzheimer Europe duly reflect the priorities and views of people living with dementia. The Chairperson is also an ex-officio member on the Board of Alzheimer Europe with full voting rights.
END
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