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Report: Health System Not Ready for Alzheimer’s Therapies

Flow chart

Flow chart with projected numbers for Alzheimer’s disease diagnostics and treatment. (Rand Corporation)

16 November 2017. A new study finds the U.S. health care system does not have the capacity for large-scale screening and treatment of people with early indicators of Alzheimer’s disease. The report, Assessing the Preparedness of the U.S. Health Care System Infrastructure for an Alzheimer’s Treatment, was released yesterday by Rand Corporation, a public policy research institute in Santa Monica, California.

Alzheimer’s disease is a progressive neurodegenerative condition affecting growing numbers of older people worldwide. People with Alzheimer’s disease often have deposits of abnormal substances in spaces between brain cells, known as amyloid-beta proteins, as well as misfolded tangles of proteins inside brain cells known as tau. Rand Corp. cites data showing some 5.5 million people in the U.S. are now living with Alzheimer’s-related dementia, with that number expected to grow to 11.6 million by 2040.

The Rand study was sponsored by biotechnology company Biogen in Cambridge, Massachusetts. The company has 5 therapy candidates for Alzheimer’s disease in clinical trials, including two treatments in late-stage studies.

The Rand research team led by health policy specialist Jodi Liu sought to estimate new demands for diagnostics and treatments, particularly from people in the early stage of Alzheimer’s disease, as new treatments for the disease are approved by FDA. The authors note that a number of new drugs and biologic therapies are in late stage clinical trials, including synthetic antibodies removing amyloid-beta plaques, similar synthetic antibodies targeting accumulated tau protein tangles, blockers of enzymes that support amyloid-beta accumulations, and vaccines harnessing the immune system to stop further amyloid-beta and tau deposits.

Liu and colleagues constructed a simulation model to calculate demands put on health care providers if treatments for Alzheimer’s disease became available. The team cites evidence that many people are not screened for Alzheimer’s, even in early stages known as mild cognitive impairment, due to the lack of reliable treatments. If the late-stage clinical trials show positive results and new drugs or biologics become available, more individuals will likely agree to be screened and treated for Alzheimer’s disease if needed.

The Rand model assumes initial screening would take place in primary care settings, doctors’ offices or clinics, for signs of mild cognitive impairment. If those first tests are positive, patients would visit a neurologist or gerontologist for tests of amyloid-beta biomarkers in the brain, as shown in positron emission tomography, or PET, scans. A positive PET scan would then lead to a confirming scan, followed by treatments of drugs by intravenous infusion every 4 weeks for a year.

Results from the model indicate the U.S. health care system does not yet have the capacity to diagnose and treat the 15 million individuals with mild cognitive impairment likely to request these services. The biggest bottleneck is the lack of specialists, neurologists and gerontologists, to diagnose the presence of amyloid-beta plaques. However, lack of PET imaging equipment and infusion facilities for treatments would contribute to the backlogs. See the chart at the top for expected numbers of patients.

The researchers estimate that with the anticipated growth in case loads, patients in 2020 would wait nearly 19 months on average for treatment. Between 2020 and 2040, say the authors, some 2.1 million more people would develop Alzheimer’s while waiting for treatment. The team says that adding additional capacity would require a coordinated effort across the health care industry, at both the national and local levels, including changes in regulatory requirements and reimbursement (e.g., insurance, Medicare) practices.

“While significant effort is being put into developing treatments to slow or block the progression of Alzheimer’s dementia,” says Liu in a Rand Corp. statement, “little work has been done to get the medical system ready for such an advancement. While there is no certainty an Alzheimer’s therapy will be approved soon, our work suggests that health care leaders should begin thinking about how to respond to such a breakthrough.”

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