Featured Health Business Daily Story, April 29, 2016

Late-Stage Drug Pipeline Holds Hope for Alzheimer’s Treatments

Reprinted from DRUG BENEFIT NEWS, biweekly news and proven cost management strategies for health plans, PBMs, pharma companies and employers. Sign up for an $86 two-month trial subscription today.

By Angela Maas, Managing Editor
April 22, 2016Volume 17Issue 8

Alzheimer’s disease is ranked as one of the leading causes of death, and with a huge older U.S. population, incidence of the disease is only expected to rise. Innovation has not kept pace — but after a decade when Alzheimer’s drug development saw almost a 100% failure rate, there are now multiple drugs in late-stage clinical trials that could hit the market as early as 2018. Now the question is whether the U.S. health care system is prepared to put these innovative new treatments into practice.

Alzheimer’s is the leading cause of dementia, which costs between $159 billion and $215 billion annually in the U.S., according to RAND Corp. That makes it more costly than cancer or heart disease, which are the leading causes of death. The Alzheimer’s Association points out that “Alzheimer’s is the only disease among the top 10 causes of death in America that cannot be prevented, cured or even slowed.”

Yet the condition receives much less funding, noted David Morgan, Ph.D., CEO of the Byrd Alzheimer’s Institute and a founding member of ResearchAgainstAlzheimer’s (RA2), during an April 11 webinar sponsored by nonprofit organization UsAgainstAlzheimer’s (UsA2). RA2 is a network of more than 400 Alzheimer’s researchers established by UsA2. Morgan attributed this to a “general ageist attitude with legislators” who “think of Alzheimer’s as an old-timers’ disease,” as well as the fact that there are “no survivors of the disease who can come forward” and say they were helped by a particular treatment.

According to a recent report sponsored by RA2, 17 drugs are in phase III trials. These treatments “are likely to finish testing and could be available to people with the disease in the next five years,” concludes the report, which is titled Will the Next Five Years Witness an Innovation Wave in Medicines for Alzheimer’s?

Drug Benefit News

Also during the webinar, Drew Holzapfel, study lead and RA2 director, noted that only five treatments are available for people with the disease, but they only help delay or prevent symptoms from getting worse rather than treating the disease itself. “We’ve not seen a new novel drug since Namenda was launched in 2003.…More innovation is obviously needed.” However, he said, even with an overall 10% success rate in drug development, “we should prepare for success rather than prepare for failure.”

2018 could see six new entrants to the Alzheimer’s treatment class, led by Eli Lilly and Co.’s solanezumab. Five are slated for a 2019 launch, four for 2020 and two for 2021. Solanezumab, said Holzapfel, would be the first of a “handful delivered via infusion.” And “close to 10 would be oral compounds.” In addition, notes the report, about 50 drugs are in phase II trials, with about 12 in phase II/III trials.

Morgan noted that some of the drugs undergoing trials likely “will have a symptomatic effect — they’ll treat the symptoms of the disease.” And while that may not be as good as a cure, he pointed out that drugs that increase dopamine levels in people with Parkinson’s disease treat symptoms of the condition, and “it’s extended life spans by 10 years for some people.”

Other treatments may help delay onset of the disease, and others may slow the rate at which it develops. With these, people “wouldn’t necessarily take the drug and feel better, but they will be better off one year from now.” The bottom line, contended Morgan, is that while a cure would be fantastic, what’s really needed are better, more effective treatments.

Is Health Care System Ready?

But even with all these drugs in late-stage trials, there are “barriers to accessing the drugs once they receive regulatory approval,” maintained Holzapfel. For one, “we need physicians to diagnose” people with Alzheimer’s. There is an “approximately 50% diagnosis rate,” which, “when you look at other conditions like cancer, is way lower,” he said. According to the report, 90% of people with cancer and cardiovascular disease have been given that diagnosis by their doctor. Asked during the Q&A why the rate is so low, Holzapfel said that “physicians feel reluctant to deliver a diagnosis at times because of the treatments on the market.” With better drugs available, physicians “would be empowered to give a diagnosis” of Alzheimer’s, he contended.

In addition, said Morgan, primary care providers “don’t have the time it takes to do a meaningful cognitive analysis.” There now are 7,000 practicing geriatricians, but the report maintains that at least 30,000 will be needed by 2030 to treat the aging population, and the percentage of medical resident students entering the field is declining.

Reimbursement can be an issue as well. “Medicare payer levels are very difficult to survive on,” maintained Morgan. “It’s difficult to run a clinic with 100% Medicare payer mix.” And while an amyloid scanning tool is available, “it’s not reimbursed by Medicare, and it’s expensive,” pointed out George Vradenburg, co-founder and chairman of UsA2.

That could change, though. The Imaging Dementia — Evidence for Amyloid Scanning (IDEAS) Study began patient enrollment last month, pointed out Holzapfel. According to the study’s website, it “will follow more than 18,000 Medicare beneficiaries to determine the clinical value of a brain” PET scan “to detect the hallmark brain amyloid accumulation of Alzheimer’s disease in diagnosing and managing treatment.” CMS will reimburse participating facilities and interpreting physicians for the scans under its Coverage with Evidence Development policy.

One listener asked if the speakers recommended testing for the apolipoprotein E-e4 (APOE-e4) gene, which is estimated to be a risk factor in up to one-quarter of Alzheimer’s cases. “It’s a mixed response,” said Morgan, who also is a professor at the college of medicine and molecular pharmacology and physiology at the University of South Florida. If an effective medication were available, he said he would “absolutely recommend” this test to determine a person’s risk. But in the absence of one, it’s up to whether individuals want to know their risk level or not.

View the report at http://tinyurl.com/h9nmbxb.

© 2015 by Atlantic Information Services, Inc. All Rights Reserved.


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