If An Alzheimer’s Drug Succeeds Could Our Health System Handle it?

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Biogen, which is in late-stage testing of an Alzheimer’s drug, sponsored a Rand Corp. study questioning the health system’s readiness for effective cures for the disease. (Photographer: Scott Eisen/Bloomberg)

Microsoft founder and billionaire philanthropist Bill Gates made news this week by vowing more than $50 million to fund Alzheimer’s research. But in making that generous move he expressed a concern, which was echoed today in a new report from the Rand Corporation: Due to the aging of the population, the population of Alzheimer’s patients is growing so rapidly the healthcare system isn’t equipped to handle it, Gates warned.

Even if the research dollars being spent by Gates and others translates into an effective, disease-modifying treatment for Alzheimer’s, the task of diagnosing patients in the earliest stages of the disease and delivering the drug could still be too much for society to bear, the Rand report suggests. That’s because the number of Americans living with Alzheimer’s is predicted to more than double to 11.6 million by 2040. And there aren’t enough doctors who specialize in geriatrics, or PET scanners to diagnose the disease or infusion centers to deliver any drugs that must be given intravenously, Rand estimates.

There is one caveat that’s important to mention up front, however. The Rand study was sponsored by Biogen, which is developing an Alzheimer’s treatment. Biogen’s experimental treatment aducanumab is in phase 3 testing that’s expected to be completed by the end of 2019. A handful of other pharma companies are also in late-stage trials of their Alzheimer’s drugs or vaccines, including Eli Lilly and Merck.

Rand’s conclusion that the healthcare system won’t be ready for these drugs if they’re approved by the FDA starts with the estimate that in 2020, around 15 million Americans will have mild cognitive impairment—an early sign of Alzheimer’s. But the only FDA-approved way to confirm the diagnosis of the disease is a PET scan to look for deposits of amyloid in the brain, which has long been considered to be the main culprit for the memory-robbing effects of Alzheimer’s.

Using a variety of data sources, Rand estimated that the demand for geriatricians to diagnose the disease and PET scanning facilities to do the necessary testing would quickly outstrip the supply. What’s more, some of the experimental drugs, including Biogen’s, require regular infusions at centers with limited capacity.

The bottom line Rand prediction: In 2020, the average Alzheimer’s patient will have to wait more than 18 months to be treated, and more than 2 million people will descend into full-blown dementia over the following two decades while they’re on waiting lists for diagnostic procedures and reservations at infusion centers.

It may be a bit premature to assume this is going to be a problem for the study’s sponsor, Biogen. Recently disclosed data from a phase 1 trial showed the company’s drug produced a reduction in amyloid plaque, but exactly how that translates into symptom relief won’t be clear until results from the larger late-stage trials become available.

Furthermore, the notion that amyloid is the main culprit in Alzheimer’s has come under question recently. Earlier this year, Merck discontinued one trial of its experimental Alzheimer’s drug verubecestat, which is known as a BACE inhibitor. These drugs work upstream of amyloid, blocking the process by which the toxic form of the protein is made. But in an announcement, Merck said there was “virtually no chance of finding a positive clinical effect” from verubecestat. Another trial of the drug continues and results are expected in early 2019.

Biogen is also working on a BACE inhibitor, in partnership with Eisai. Phase 3 results are expected in 2020. Gates, meanwhile, is supporting efforts to look beyond amyloid, investing his money in the Dementia Discovery Fund, which is seeding companies pursuing entirely different theories about what drives the disease.

The uncertainty surrounding the prospects for these experimental drugs doesn’t necessarily negate concerns about whether the healthcare system is adequately equipped to treat Alzheimer’s patients. In fact, Gates expressed concerns of his own when he announced his latest funding for research. Even now, with no cure in sight, he pointed out, Americans spend $259 billion a year caring for patients with Alzheimer’s.

“Absent a major breakthrough, expenditures will continue to squeeze healthcare budgets in the years and decades to come,” he predicted.

Source : https://www.forbes.com/sites/arleneweintraub/2017/11/15/if-an-alzheimers-drug-succeeds-could-our-health-system-handle-it/

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