Promising early-stage trial results provide hope that a therapy for Alzheimer's disease may become available that can prevent progression to full-blown dementia. But an important challenge will arise: A substantial backlog of existing cases with early-stage disease would have to be screened, diagnosed, and then potentially treated. This report assesses the preparedness of the U.S. health care system to handle the potential caseload.

Cover: Assessing the Preparedness of the U.S. Health Care System Infrastructure for an Alzheimer's Treatment
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Assessing the Preparedness of the U.S. Health Care System Infrastructure for an Alzheimer's Treatment

by Jodi L. Liu, Jakub P. Hlavka, Richard Hillestad, Soeren Mattke

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Research Questions

  1. How prepared is the U.S. health care system to handle the potential caseload when a disease-modifying therapy for Alzheimer's disease becomes available?
  2. What can be done to reduce capacity limitations and avoid delays in access to care?

Alzheimer's disease is a progressive neurodegenerative disorder that leads to cognitive decline, dementia, and premature death. As the risk of developing Alzheimer's disease increases with age, the burden of Alzheimer's-related dementia will surge in industrialized countries with their graying populations. In the United States, for example, an estimated 5.5 million patients live with Alzheimer's-related dementia today, a number that is projected to increase to 11.6 million by 2040. Results from earlier clinical trials have led to the hypothesis that Alzheimer's dementia must be prevented rather than cured because no therapy has been able so far to reverse manifest dementia. If this new paradigm bears out in late-stage clinical trials, an important health systems challenge will arise, should one or more therapies become available: A substantial number of existing cases with early-stage disease would have to be screened, diagnosed, and then potentially treated as quickly as possible when a therapy first comes to market, in order to prevent progression to full-blown Alzheimer's dementia. This report assesses the preparedness of the U.S. health care system to handle the potential caseload. The authors used published data and expert interviews to develop a simulation model quantifying the match between health system capacity and expected demand. The report presents the results of the model and discusses their implications for patients. As many estimates in the model are subject to substantial uncertainty, the ambition of this report is not to provide an exact prediction of future capacity needs but to illustrate the magnitude of the potential problem.

Key Findings

Addressing Alzheimer's Disease in Patients

  • Alzheimer's disease is a progressive neurodegenerative disorder that leads to cognitive decline, dementia, and premature death. No disease-modifying treatment is available today but encouraging results from clinical trials offer hope that one or more therapies will become available as early as 2020.
  • This prospect raises the question of how well the U.S. health care system is prepared to handle the expected large number of patients. Almost 15 million people with Mild Cognitive Impairment, a condition that may signal early-stage Alzheimer's disease, are projected to live in the U.S. by 2019. They will have to be evaluated by specialists, undergo diagnostic testing for the disease and be treated.

Modeling a Future Caseload

  • A simulation analysis shows that projected capacity is insufficient to handle the expected case load and predicts that patients would have to wait an average of 18.6 months for treatment in 2020. Approximately 2.1 million patients would develop Alzheimer's dementia between 2020 and 2040 while on waiting lists.
  • The most pressing constraint is limited capacity of dementia specialists to evaluate and diagnose patients, but access to imaging to confirm Alzheimer's disease and to infusion centers to deliver the treatment would also contribute to waiting times.
  • Addressing the capacity constraints may turn out to be as challenging as developing an effective treatment, as it requires solving a complex puzzle consisting of payment policy, regulatory requirements, workforce considerations, and capacity planning at the national and local levels, combined with awareness campaigns.
  • No individual stakeholder will be able to put all the pieces together alone. This report intends to inform a discussion among stakeholders and create a sense of urgency to start collaborating on addressing the obstacles in a timely manner.

Recommendations

  • Our analysis suggests that wait times for specialist appointments would be the most challenging obstacle to receiving treatment for Alzheimer's disease. Two possible solutions are to increase productivity of the existing specialist workforce and to qualify more specialists for dementia care.
  • The range of diagnostic options to confirm the Alzheimer's pathology needs to be expanded. Access to PET scans could become a rate-limiting factor, albeit one that is easier to address because the ability to expand the number of scanners is not limited by workforce certification constraints. One option would be to expand the use of mobile scanners that could be shared across facilities brain-only scanners. An alternative is the use of Alzheimer's tests based on cerebrospinal fluid, which do not require dedicated equipment and can be conducted in primary care settings. Such a test is approved for clinical use in the European Union and could become available in the United States soon.
  • Home infusions may have to play an important role. While the large and entrepreneurial U.S. health care system is probably capable of adding capacity, doing so in the form of fixed infrastructure might not be desirable because subsequent years would see a much lower demand. A combination of facility- and office-based infusion chairs with home infusion delivery might be a better alternative.
  • The availability of a disease-modifying treatment will increase the need for routine screening and testing along the Alzheimer's continuum. Given the potential for a therapy, there is a need for better screening and diagnostic tests for Alzheimer's disease to ensure that patients in early stages of the disease are identified in a timely manner.
  • Reimbursement rules for diagnostic tests will matter. Rates must be low enough to attract sufficient capacity expansion but high enough to prevent generation of idle capacity. Moreover, the rate needs to be signaled well in advance of a disease-modifying therapy being approved because installing additional diagnostic scanners will take time.

This research was sponsored by Biogen, and conducted in RAND Health Advisory Services, the consulting practice of RAND Health.

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