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Equity Perspectives

With the alarming spread and costs of Alzheimer’s threatening Medicare, industry, government, and academics are scrambling to find more effective treatments for this fatal disease.

How’s this for a shocking statistic: 5.3 million Americans (two-thirds of them women) currently have Alzheimer’s disease, an incurable illness that causes progressive decline in memory and other aspects of cognition—and the number could more than triple by the year 2050, according to new projections by the Alzheimer’s Association?1

The costs? In 2015 alone, total payments for Alzheimer-related health care, long-term care, and hospice are expected to hit $100 billion (and even more for other forms of dementia, as shown in Chart 1). By 2050, that could rise to $589 billion per year, mostly in payments to Medicare and Medicaid.2 (See Chart 2.)

Some experts fear the current rate of spending on Alzheimer’s could bankrupt Medicare unless Congress steps up funding for research and, more importantly, support for people who already have the disease.3

"Despite increasing momentum in Alzheimer's research, we still have two main obstacles to overcome,” said Bill Thies, Ph.D., senior scientist in residence at the Alzheimer’s Association.

“First, we need volunteers for clinical trials. Volunteering to participate in a study is one of the greatest ways someone can help move Alzheimer's research forward. Second, we need a significant increase in federal research funding. Investing in research now will cost our nation far less than the cost of care for the rising number of Americans who will be affected by Alzheimer's in coming decades."

"The risk of Alzheimer's increases with age, and as baby boomers get older, the number of people developing the disease will rise to levels far beyond anything we've ever seen before," said Keith Fargo, director of scientific programs and outreach for the Alzheimer's Association.4

 

Chart 1. Half of the Costs for Current Alzheimer and Other Dementia Fall on Taxpayers
Cost of care by payment source for Americans 65 and older with Alzheimer’s and other dementias, 2015*

Source: These numbers come from a model created for the Alzheimer’s Association by The Lewin Group and updated in January 2015. The model estimates total payments for health care, long-term care, and hospice for people with Alzheimer’s disease and other dementias, based on cost data from the 2008 Medicare Current Beneficiary Survey.
*Data are in 2015 dollars. Totals may not add up due to rounding

 

Chart 2.  Medicare and Medicaid Costs for Alzheimer’s Are Expected to Soar by 2050
Costs of care for Americans age 65 and older living with Alzheimer’s and other dementias, 2015–50

Source: Alzheimer’s Association.
*All cost figures are reported in 2015 dollars. Totals may not add up due to rounding.

 

Picking Stocks
During her 15 years of covering the pharmaceuticals and biotechnology sectors, Lord Abbett Research Analyst Lavina Talukdar has plumbed the pipelines of a number of companies to assess which drugs have the potential to transform the Alzheimer’s market. 

“The challenge for Alzheimer’s is that it really is a disease that starts long before the first symptoms of it appear,” said Talukdar. “Patients might start laying down the protein-causing plaques in the brain 20 years before they even have symptoms such as forgetfulness. So even if you have the best drug ever, it’s going to take time to show any kind of benefit.”

While there doesn’t appear to be any cure on the horizon, some progress has been made on drugs that slow the progression of the disease by removing plaque that accumulates in the brain, which in turn allows for nerve cells to start functioning more normally. For now, though, there are only five Food and Drug Administration-approved drugs that treat the symptoms of Alzheimer's. But some of those drugs stop symptoms only for six months, maybe a year, which means patients would continue to decline when their prescriptions ran out.

“The United States has been a graveyard of new drugs coming to the market,” Talukdar said. “But while some drugs targeting plaque-forming protein pieces called beta-amyloid have failed, the Food and Drug Administration [FDA] has been receptive to more intelligently designed clinical trials that draw on the positive aspects of previous tests that strengthened the hypothesis that such proteins might be the right target.”

One company, for example, has been allowed to conduct another Phase 3 clinical trial (after two previous failures) that involves only patients with a mild form of Alzheimer’s, Talukdar added. One reason for such accommodation is due to positive, consistent results seen with mild Alzheimer’s patients, who comprise at least 50% of the Alzheimer’s population. Another reason is that 25% of the patients in the previous test did not actually have Alzheimer’s but rather another form of dementia, as evidenced by PET scans that failed to show the kind of plaques this particular Alzheimer’s drug was supposed to target. As a result, one critical step in the new Phase 3 trial will include PET scans of every participant to confirm the diagnosis of Alzheimer’s.

The drug being tested is a monoclonal antibody that binds to the beta-amyloid, preventing such proteins from clumping together to form plaques that are considered the hallmark of Alzheimer’s.    

While clinical results to date have been somewhat disappointing, optimism about the drug’s efficacy with a narrower patient population helped shares of its parent company rise 20% year to date (as of August 6, 2015).

“If that trial is positive, then the FDA is likely to approve the drug based on the most recent trial,” Talukdar said. “The potential safety of that drug looks phenomenal.”

Harnessing Brainpower
According to one pharmaceutical  executive, key elements of most current clinical trials were made possible by the Alzheimer’s Disease Neuroimaging Initiative (ADNI)—a partnership among the National Institutes of Health, the Alzheimer’s Association, and the pharmaceutical industry.

“ADNI has played an important role in mapping out the natural history of the disease, facilitating both fluid- and image-based biomarker assessments…which in turn can make it possible to identify patients with the amyloid plaques or Tau protein tangles”5 in the brain that [go with] Alzheimer’s,” the executive said.6

His company has an FDA-approved PET imaging agent for amyloid plaquesthat is being used to identify patients with relatively mild cases of Alzheimer’s. It also has a Tau-imaging agent in Phase 2 trials.

“Another partnership in Alzheimer’s research is studying the possibility of preventing the loss of cognitive function in people with inherited mutations that cause early-onset Alzheimer’s disease,” he added. “The DIAN Trials Unit at Washington University School of Medicine—part of the Dominantly Inherited Alzheimer’s Network, an international web of research institutions established with funding from NIH [National Institutes of Health]—is conducting a worldwide clinical study of three experimental medicines in these patients.” 7

Some experts believe this collaboration is reminiscent of the efforts that achieved dramatic successes against polio in the 1950s and HIV/AIDS in the 1980s and 1990s.

                                                                                                  --Reported by Steve Govoni

 

Alzheimer’s Association, “2015 Alzheimer’s Disease Facts and Figures,” July 2015.
Ibid.
Kathleen Parker, “Alzheimer’s Costs Will Bankrupt Medicare Unless Congress Acts,” The Washington Post, July 28, 2015.
Melissa Healy, “With Millions More Expected to Develop Alzheimer's, More Research Funding Demanded,” Los Angeles Times, July 20, 2015.
According to the Alzheimer’s Association, Tau protein is the chief component of tangles, the other  brain abnormality found in Alzheimer’s patients. Researchers are investigating strategies to keep tau molecules from collapsing and twisting into tangles, a process that destroys a vital cell transport system.
6 John C. Lechleiter, Ph.D., “Continuous Innovation Against Cancer,” speech, CED Life Science Conference, March 3, 2015.
7 Ibid.

 

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