Alzheimer Europe position on anti-amyloid therapies

Background

The growing prevalence and burden of Alzheimer’s disease 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 Alzheimer’s disease by the FDA. It is now up to European regulators to determine whether there is sufficient evidence to approve these drugs for patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease.

Overview

Here, we outline Alzheimer Europe’s position on anti-amyloid therapies for Alzheimer’s disease, which was adopted by the Board of Alzheimer Europe following consultations with our member associations and with the European Working Group of People with Dementia. Beyond questions of drug efficacy, safety and cost, we highlight important issues that must be addressed by industry, regulators, payers, healthcare systems and governments, to ensure that patients have timely, appropriate and equitable access to innovative treatments, regardless of their socio-economic background, insurance status, or place of residence. We also call for continued investment in research on treatments that might benefit people with more advanced Alzheimer’s disease – as well as support and care services that can help people live well with dementia at all stages of the disease.

Alzheimer Europe emphasises its commitment to a human rights-based approach to dementia, and its firm belief that people with Alzheimer’s disease and other forms of dementia have the right to receive an accurate, timely diagnosis, as well as access to patient-centred support, treatment and care.

We call on Industry to:

  • Alzheimer Europe emphasises its commitment to a human rights-based approach to dementia, and its firm belief that people with Alzheimer’s disease and other forms of dementia have the right to receive an accurate, timely diagnosis, as well as access to patient-centred support, treatment and care
  • Adopt realistic, sustainable pricing policies for anti-amyloid drugs, reflecting the true value of treatment for patients and society, and ensuring affordability for mid- and low-income countries
  • Ensure transparent, timely and accurate communication of results from clinical trials, to trial participants as well as the wider AD community
  • Clearly present the benefits and risks of anti-amyloid drugs in an accessible, inclusive way, providing culturally appropriate information for minority ethnic and other marginalised groups
  • Continue investing in the development of diagnostics and treatments for other causes and stages of dementia, including both symptomatic and disease-modifying therapies.

We call on regulators, HTA and payers to:

  • Grant a marketing authorisation for anti-amyloid treatments whose risk-benefit ratio has been shown to be positive
  • Ensure that the label for these medicines, as well as any communications and recommendations, clearly address drug eligibility, risk/benefit ratios, and detection, monitoring and management of side effects from anti-amyloid drugs
  • Support the 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 caregivers
  • Develop clear reimbursement frameworks to ensure equitable coverage for anti-amyloid drugs, as well as the biomarker tests, diagnostics and scans that will be required to identify, treat and monitor eligible patients
  • Ensure that reimbursement of anti-amyloid drugs does not impact the coverage of symptomatic and non-pharmacological treatments that are hugely valued by people with dementia and their carers.

We call on governments and healthcare systems to:

  • Commit funding and resources so patients can access to diagnosis and treatment in the early stages of Alzheimer’s disease, when they are most likely to benefit from treatment with anti-amyloid drugs
  • Invest in infrastructures for diagnosis, drug therapy and side effect monitoring, including tools for biomarker assessment, brain imaging facilities and infusion centres
  • Expand workforce capacity and capability, increasing recruitment and training of dementia specialists, primary care doctors, and other healthcare practitioners to ensure broad access to a timely diagnosis, treatment and care
  • Develop biomarker-guided clinical pathways which support the diagnosis and treatment of Alzheimer’s in the early stages of disease, integrated alongside existing pathways focused on managing the symptoms of later-stage dementia
  • Develop clear guidelines on how to identify patients who are most likely to benefit from anti-amyloid drugs, as well as guidance and training on detection, monitoring and management of side effects
  • Ensure that investments in diagnostic tools and infrastructures to support access and delivery of anti-amyloid drugs also benefit the wider dementia community, not just those with Alzheimer’s disease
  • Invest in tangible measures to reduce geographic and socioeconomic disparities in access to diagnosis and treatment, to avoid exacerbating existing health inequalities
  • Adopt dementia strategies and health policies that incorporate specific objectives to enable a timely diagnosis and equitable access to anti-amyloid drugs for patients across Europe.