Health System Readiness for Disease-Modifying Therapies for Alzheimer Disease

What Is the Issue? Alzheimer disease (AD) is a chronic neurological degenerative disease and one of the most common causes of dementia. It affected an estimated 368,200 people in Canada in 2020. Mild cognitive impairment (MCI) is a clinical condition involving memory loss that can progress to dementia and is often due to underlying AD. It was estimated to affect around 917,000 people in Canada aged 60 and older in 2020. Disease-modifying therapies (DMTs) are being developed that target underlying pathologic processes of AD to slow disease progression, unlike contemporary treatments that focus on managing symptoms. A prominent target of these therapies is amyloid-beta, a protein known to contribute to amyloid plaques. Many of the anti–amyloid-beta DMTs are intended for people with early-stage AD, which includes MCI and mild dementia due to AD. At least 7 countries have approved a therapy from this treatment class, and, at the time of writing, 2 therapies are undergoing regulatory review by Health Canada and reimbursement review by Canada's Drug Agency (CDA-AMC). DMTs demand more frequent health care visits and higher use of medical imaging for safe treatment and monitoring. This would greatly impact current care pathways for early-stage AD, necessitating an examination of health system readiness in Canada. What Did CDA-AMC Do? CDA-AMC sought to examine health system readiness in Canada and care pathways for early-stage patients with AD in preparation for the potential use of these anti–amyloid-beta DMTs in Canada. CDA-AMC reviewed publicly available data and literature about health systems and AD treatment pathways for improving dementia care to prepare for the possible introduction of DMTs in health systems in Canada. What Did CDA-AMC Find? CDA-AMC found that, if DMTs were approved by Health Canada and provincial and territorial drug plans, a new model of care for AD in Canada would be necessary. The new care pathway would require: earlier screening and diagnosis, at the MCI or mild dementia stages of AD guidance for optimal use of diagnostic imaging and biomarker-based tests, as well as an increase in equitable access to PET-CT units for amyloid PET exams or cerebrospinal fluid (CSF) testing to assess treatment eligibility increased capacity to administer IV infusions guidance for optimal use of MRI to avoid overuse and increase equitable access to MRI to monitor individuals through treatment a combination of reliable and validated methods and tools for evaluating cognitive decline in diverse populations, including Indigenous Peoples and racialized groups, presenting with cognitive symptoms or undergoing treatment clear criteria for discontinuing treatment. CDA-AMC found that assessment and diagnosis of early-stage AD and timely access to DMTs could be delayed due to: a lack of education and awareness of symptoms of early-stage AD among the general public and care providers, as well as cultural barriers, including a fear of stigma or cultural perceptions of the condition staffing shortages in care providers capable of assessing and treating dementia and other supporting staff, including primary care providers (PCPs), dementia specialists, nurses, imaging staff, and social care providers limited capacity of medical imaging (e.g., PET-CT and MRI) and laboratory services (i.e., CSF analysis) to confirm early-stage AD and treatment eligibility and to monitor drug response and disease progression. A variety of new technologies are in development, including new AD biomarker testing methods, that may alleviate some capacity concerns in dementia detection, treatment eligibility screening, treatment administration, and patient monitoring. Alternative DMTs that target other AD pathologic processes are also in development. What Does This Mean? There may be challenges in providing equitable and timely access to DMTs for AD, given the geographic distribution of the population (especially in rural and remote locations), cultural barriers, and lack of awareness of the condition in the population in Canada. Not all individuals with mild dementia due to early-stage AD or MCI who are eligible for treatment may have timely access to screening and diagnosis, which could prevent them from receiving DMTs. Additionally, an increased number of individuals — some of whom may not be eligible for DMTs — may be motivated to seek screening, leading to higher demand and potential delays in the screening process. Health system decision-makers may want to consider system-wide adaptations to enhance screening and care for individuals with suspected early-stage AD, given the projected rise in AD prevalence, which is expected to exceed 1.1 million people by 2050. This may include: adding more health and social care staff providing enhanced training to effectively assess and diagnose early-stage AD improving access to diagnostic imaging to screen and monitor patients using anti–amyloid-beta DMTs.

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