Health Care System Is Not Prepared to Ensure Patients Will Get Access to First Novel Alzheimer’s Therapies Since 2003
WASHINGTON, March 31, 2016—Today’s Alzheimer’s disease drug pipeline, marred by more than a decade of high failure rates and public underinvestment, is offering near-term promise with 17 drugs on pace to launch in the next five years, according to a recent analysis conducted by ResearchersAgainstAlzheimer’s (RA2), an UsAgainstAlzheimer’s (UsA2) network. If only some of those drugs are successful in late-stage trials and cleared by the U.S. Food and Drug Administration (FDA), the potential innovations will be a much-needed stimulus to the goal of stopping America’s most costly disease, one that affects approximately 5.3 million Americans, a number that is expected to rise precipitously during the next few decades.
Findings from the analysis underscore an important question: once the therapies are approved, will those affected by the disease be able to access these drugs?
“Despite the recent history of disappointment for Alzheimer’s disease advancements, we are cautiously optimistic about the progress of this next wave of innovation because we are seeing well-funded trials and concerted efforts to learn from past failures,” said Dr. David Morgan, a founding member of RA2, a distinguished professor of the College of Medicine and Molecular Pharmacology and Physiology at the University of South Florida, and CEO of the Byrd Alzheimer's Institute.
“The analysis confirms that while there is a promising pipeline for Alzheimer’s patients, we must, in parallel, be encouraging more physicians to accurately diagnose and treat this disease, and work with insurers to enable access for patients to these new drugs when they are available.”
According to the RA2 analysis, there are currently 17 Alzheimer’s drugs in Phase 3 clinical trials on course to launch in the next five years. This first-of-its-kind analysis reached its conclusions following extensive examination of SEC filings, company reports, presentations at medical conferences, media releases and interviews with company executives about publicly available information on drugs in late-stage testing. In addition, academic research experts and select RA2 members provided input and review of the analysis.
In the United States, Alzheimer’s, the most common form of dementia, is the third leading cause of death, according to recent studies. Among the top 10 causes of death, it’s the only one that currently can’t be prevented, stopped or slowed. The RA2 analysis’ findings provide the hope that is sorely needed for Alzheimer’s patients and their numerous caregivers who have not seen a novel Alzheimer’s therapy since 2003, when Namenda was approved by the FDA.
“Alzheimer’s disease must be attacked at the scope and scale equal to the challenge. Alzheimer’s is a cancer-size problem requiring a cancer-size solution,” said George Vradenburg, co-founder and chairman of UsAgainstAlzheimer’s. “Our mission is to stop Alzheimer’s by 2020. Our work has focused on disrupting business as usual – increasing research resources, speeding drug development and assuring access of innovative medicines to those with or at risk of the disease. Should drugs in late-stage development prove successful, insurers and physicians will need to step up their game.”
While the analysis takes a positive approach to the innovation pipeline, it also delineates areas that America’s health care system needs to improve upon before new Alzheimer’s treatments are approved.
These areas include:
- Enhancing the training and numbers of front-line physicians, including in primary care, to diagnose and treat Alzheimer’s. In addition, the number of geriatricians needs to increase from 7,000 (current) to 30,000 by 2030. Unfortunately, fewer medical students are choosing geriatrics because geriatrics practice is not sustainable financially with a 100 percent Medicare payer mix. Neurologists and psychiatrists typically have a mix of payers.
- Improving the accuracy of diagnosis. In some settings, up to half of all cases of Alzheimer’s disease are misdiagnosed, and there is currently a significant under-diagnosis of the disease in populations around the world. The lack of an Alzheimer’s diagnosis can also negatively impact the ability of patients to adhere to other chronic care protocols. Visits to memory care specialists in neurology, psychiatry or geriatrics is encouraged.
- Improving communication between patients and physicians. Just 45 percent of people diagnosed with Alzheimer’s were actually informed of their diagnosis by a doctor, compared to 90 percent of people with cancer and cardiovascular disease who are informed of that diagnosis by their doctor.
- Treating Alzheimer’s like the fatal disease that it is, rather than as routine clinical care. The average wait time to see a neurologist was 35 days, a 25 percent increase since 2010. In contrast, a study shows that the average wait time for a cardiologist is 16.8 days, about 50 percent less than the wait time to see a neurologist.
- Addressing payment and reimbursement. There is no assurance that the Centers for Medicare and Medicaid Services (CMS) and other national health payment authorities and insurance providers will pay for or reimburse for Alzheimer’s treatments.
“The studies of the past were a necessary predicate for the future of Alzheimer’s medicine,” said Dr. Rachelle Doody, professor of neurology at Baylor College of Medicine and reviewer of the analysis. “We have learned a great deal about trials methodologies and disease targets from past studies. While the analysis shows a promising future, it is also a sobering wakeup call reminding us of the importance of health system readiness to prevent and combat this crushing disease.”
For more information, the pipeline analysis will be discussed in depth during a future Alzheimer’s Talks Teleconference on April 11 from 4-5 pm (EST). The discussion, which will be live streamed, will include remarks from Vradenburg, Morgan and study lead and RA2 director Drew Holzapfel. Visit the Alzheimer’s Talks page for more information.
To view the analysis, visit: RA2 Pipeline Report
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UsAgainstAlzheimer’s (UsA2) is an innovative non-profit organization demanding – and delivering – a solution to Alzheimer’s. Driven by the suffering of millions of families, UsAgainstAlzheimer’s presses for greater urgency from government, industry and the scientific community in the quest for an Alzheimer's cure – accomplishing this through effective leadership, collaborative advocacy, and strategic investments.
Founded in 2010, UsAgainstAlzheimer’s has worked across sectors to: (1) secure the national goal of preventing and effectively treating Alzheimer’s by 2025 and help secure nearly $500 million in additional public funding for Alzheimer’s research over the past few years; (2) drive global efforts that resulted in the leaders of the world’s most powerful nations, the G7 group, to embrace a similar 2025 goal and to call for greater levels of research investment and collaboration; and (3) forge industry commitments to improve efficiencies for an expedited drug discovery and approval process.
ResearchersAgainstAlzheimer’s (RA2) is a network of more than 400 Alzheimer’s researchers established by UsAgainstAlzheimer’s to advocate for federal research funding and policy reform in order to stop Alzheimer’s disease. RA2 believes that an effective treatment for Alzheimer’s disease is within reach if government, industry and citizens are willing to commit the resources and institute the policy changes that are necessary.