PROVIDENCE, R.I. (WPRI) — Rhode Island patients are now receiving a new Alzheimer’s drug that was approved in a recent, and controversial, decision. But experts question the medication’s efficacy, and some insurance companies are choosing not to cover treatment.
On June 7, the Food and Drug Administration approved the use of Aduhelm, the first new Alzheimer’s drug in nearly 20 years, despite not a single member from the 11-person FDA advisory committee voting in favor.
In the wake of the FDA’s decision, three of the 11 committee members resigned over the FDA’s decision to approve Aduhelm.
Aduhelm, created by the Cambridge-based company Biogen, is intended to slow the cognitive decline in Alzheimer’s patients in the early stages of the disease. Approximately six million Americans are affected by Alzheimer’s disease, including roughly 24,000 Rhode Islanders, according to the R.I. Department of Health.
The controversy stems from the two Phase 3 trials of the drug, which contradicted each other. One showed that Aduhelm slightly slowed cognitive decline, while the other showed no benefit. Additionally, 40% of the Phase 3 trial participants receiving the high dose experienced brain swelling or bleeding.
Four patients at Butler Hospital in Providence are the only patients in the state receiving the monthly infusions, with more than 100 patients currently on the waiting list, according to Dr. Stephen Salloway, the director of the Butler Hospital Memory and Aging Program.
“The goal is to keep people in a milder state for longer,” Salloway told Target 12. “To delay the progression of the memory loss, if we can.”
Salloway said he’s been involved in clinical trials for Aduhelm since 2013. He told Target 12 that Biogen never paid him for the clinical trials, but that the company has paid him for trainings and consulting work.
Despite the FDA approving Aduhelm, Medicare announced in July it won’t make an initial decision about Aduhelm coverage for six months–but if it does decide to cover it, the cost burden could be historic, according to research by the nonprofit Kaiser Family Foundation.
The research found that nearly two million Medicare recipients used Alzheimer’s treatment in 2017. If half of those people are prescribed Aduhelm with a price tag of $56,000 per year, the cost to Medicare would be approximately $57 billion in a single year.
That would be roughly the same as all Medicare hospital outpatient services in 2019.
(Story continues below)
Blue Cross Blue Shield affiliates in North Carolina, Pennsylvania, Michigan, New York and Kansas have indicated they won’t cover treatment at this time.
Blue Cross in Rhode Island and Massachusetts both originally announced they would make a decision about coverage at the end of July, but they now tell Target 12 the decision won’t be made for several weeks.
Point32Health, the second biggest private health insurer in Massachusetts, told Target 12 that it won’t cover the drug, calling it “experimental and investigational.”
Dr. Caleb Alexander, who is a member of the FDA advisory committee and an internist at the Johns Hopkins Bloomberg School of Public Health, told Target 12 he wasn’t surprised so many insurance companies are refusing to cover treatment for Aduhelm.
“The fact that these institutions are declining to provide, or administer or cover this drug, speaks to the lack of evidence regarding whether it’s safe or effective,” Alexander said.
“Coverage is key,” said Salloway. “It’s really the essence here. If there’s no coverage, there’s no access. Only the rich will be able to get it.”
Salloway called the FDA’s approval of Aduhelm “a new treatment era for Alzheimer’s,” calling Aduhelm “just the beginning” for this type of treatment.
“Those are all arguments to motivate the potential of the drug,” Alexander said. “But those can’t take the place of data.”
Alexander argued that, based on the current research, Aduhelm isn’t proven to be safe or effective.
“I don’t know any scientists that aren’t funded by Biogen that believe strongly that the evidence is clear,” Alexander said. “And frankly, I don’t even know scientists funded by Biogen that will tell you the evidence is a slam dunk.”
Tolly Taylor (firstname.lastname@example.org) is a Target 12 investigative reporter for 12 News. Connect with him on Twitter and on Facebook