EU countries unprepared to move future Alzheimer's treatment into rapid clinical use

The health care systems in some European countries lack the capacity to rapidly move a disease-modifying treatment for Alzheimer's disease from approval into widespread clinical use, which could leave 1 million people without access to transformative care if such a breakthrough occurs, according to a new RAND Corporation study.

Researchers examined the health systems of France, Germany, Italy, Spain, Sweden and the United Kingdom and modeled the infrastructure challenges beginning in 2020 if confronted with a surge of patients seeking screening to determine if they qualify for a treatment that might prevent or delay the development of Alzheimer's.

The study found the primary problem is the need for medical specialists trained to diagnose patients who may have early signs of Alzheimer's and confirm that they would be eligible for therapy to prevent the progression of the disease to full-blown dementia.

Some nations have too few medical specialists and may require additional training of health providers to evaluate early-stage Alzheimer's patients. Another shortcoming is that there are too few facilities with capacity to deliver infusion treatments to patients.

The burden of Alzheimer's disease in high-income countries is expected to nearly double between 2015 and 2050. Recent positive results from clinical trials give hope that a disease-changing treatment could become available for routine use within a few years.

"Although there is continued effort to develop treatments to slow or block the progression of Alzheimer's dementia, less work has been done to prepare nations' medical systems to deliver such an advancement," said Jodi Liu, senior author of the study and a policy researcher at RAND, a U.S.-based nonprofit research organization. "While there is no certainty an Alzheimer's therapy will be approved soon, our work suggests that health care leaders in the European Union should begin thinking about how to respond should such a breakthrough occur."

Researchers analyzed how a new therapy might challenge the current health care system in the six nations examined. The analysis focuses on the supply of dementia specialists, diagnostic tools used to identify Alzheimer's abnormalities in the brain, and access to infusion centers that would deliver the treatment.

The RAND report estimates that as many as 1 million patients with mild cognitive impairment from the six countries could develop Alzheimer's dementia while waiting for evaluation and treatment resources over a two-decade period after approval of an Alzheimer's therapy.

The RAND analysis assumes that a therapy is approved for use beginning in 2020 and screening would begin in 2019, although researchers stress that the date was chosen only as a scenario for the model, not as a prediction of when an Alzheimer's therapy may be approved.

The study estimates that under such a scenario about 7.1 million people with mild cognitive impairment would seek timely diagnosis by a specialist. After follow-up evaluations and biomarker testing, the study estimates that 2.3 million people in the six countries ultimately may be recommended for treatment.

The analysis suggests that the health care systems in some of the European countries have insufficient capacity to diagnose and treat the large number of patients with early-stage Alzheimer's disease. The 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, 2033 in France, 2036 in Sweden, 2040 in Italy, 2042 in the United Kingdom and 2044 in Spain.

In Germany and Sweden, the main infrastructure constraint would be infusion capacity. In the other four countries, wait times caused by both specialist availability and infusion capacity would delay treatment for more significant numbers of patients. Specialist capacity is the primary rate-limiting factor in France, the United Kingdom, and Spain.

"Each of the countries we studied has a unique set of medical system constraints and addressing those issues may turn out to be challenging," Liu said. "So it is important to begin discussions now about how to address these obstacles so that each nation is best prepared if a Alzheimer's breakthrough occurs."

RAND researchers suggest that a combination of reimbursement, regulatory, and workforce planning policies will be needed to address constraints in each medical system. In addition, innovation in diagnosis and treatment delivery would help ensure that sufficient capacity is created to treat patients with early-stage Alzheimer's disease.