- Given the number of MCI cases that would require screening, diagnosis, and then treatment as quickly as possible to prevent the progression to full-blown Alzheimer's dementia, how prepared are the health care systems in France, Germany, Italy, Spain, Sweden, and the United Kingdom to ensure timely diagnosis and treatment of patients if a disease-modifying therapy for Alzheimer's becomes available?
No disease-modifying therapy is currently available for Alzheimer's disease, but therapies are in development, and one may become available in the near future. Based on results from early-stage clinical trials, therapeutic development has focused on the hypothesis that Alzheimer's dementia must be prevented rather than cured, because candidate treatments have not been able to reverse the course of dementia. Thus, current trials target patients with early-stage Alzheimer's disease. Were a therapy to become available, patients could undergo first screening for signs of early-stage memory loss or mild cognitive impairment (MCI), testing for the Alzheimer's disease pathology, and then treatment with the aim of halting or slowing progression to Alzheimer's dementia. An important health systems challenge will arise if this new treatment paradigm bears out in late-stage clinical trials. In the 28 European Union countries, we estimate that approximately 20 million individuals over age 55 have MCI, although most people have not been tested for disease pathology. Thus, when a therapy first becomes available, there would be a substantial number of existing (or prevalent) MCI patients who would require screening, diagnosis, and then treatment as quickly as possible to prevent the progression to full-blown Alzheimer's dementia. This research analyzes the preparedness of the health care systems in six European countries — France, Germany, Italy, Spain, Sweden, and the United Kingdom — to ensure timely diagnosis and treatment of patients if a disease-modifying therapy for Alzheimer's becomes available.
- The burden of Alzheimer's disease in high-income countries is expected to approximately double between 2015 and 2050. Recent clinical trial results give hope that a disease-modifying therapy might become available in the near future. The therapy is expected to treat early-stage patients to prevent or delay the progression to dementia.
- This preventive treatment paradigm implies the need to screen, diagnose, and treat a large population of patients with mild cognitive impairment. There would be many undiagnosed prevalent cases that would need to be addressed initially, and then the longer-term capacity to address incident cases would not need to be as high.
- We use a simulation model to assess the preparedness of the health care system infrastructure in six European countries — France, Germany, Italy, Spain, Sweden, and the United Kingdom — to evaluate, diagnose, and treat the expected number of patients.
- Projected peak wait times range from five months for treatment in Germany to 19 months for evaluation in France. The first year without wait times would be 2030 in Germany and 2033 in France, and 2042 in the United Kingdom and 2044 in Spain. Specialist capacity is the rate-limiting factor in France, the United Kingdom, and Spain, and treatment delivery capacity is an issue in most of the countries.
- If a disease-modifying therapy becomes available in 2020, we estimate the projected capacity constraints could result in over 1 million patients with mild cognitive impairment progressing to Alzheimer's dementia while on wait lists between 2020 and 2050 in these six countries.
- In addition to increasing specialist and infusion capacity in each individual country, joint actions and planning in Europe can help provide better coordinated and more timely care for Alzheimer's patients.
- A combination of reimbursement, regulatory, and workforce planning policies, as well as innovation in diagnosis and treatment delivery, is needed to expand capacity and to ensure that available capacity is leveraged optimally to treat patients with early-stage Alzheimer's disease.