Hospitals are taking a cautious approach to rolling out aducanumab, Biogen's Alzheimer's drug sold under the brand name Aduhelm.
The FDA approved Aduhelm June 7, marking the first approval the agency has granted to an Alzheimer's treatment since 2003. It is the first treatment approved by the FDA intended to slow cognitive decline from Alzheimer's, as the Alzheimer's drugs the FDA has previously cleared are aimed at alleviating symptoms rather than slowing the disease's progression.
Aducanumab was cleared using an accelerated approval pathway, which the FDA uses when a treatment's approval would provide earlier access to treatments for patients with serious diseases where there is an unmet need.
The drug's approval has been a much-debated topic among healthcare and pharmacy leaders, both before and after the FDA announcement. Two days after the approval was announced, Endpoints News released survey results from more than 1,400 respondents in the pharmaceutical and biotech industries, finding 80 percent of respondents disagreed with the decision, 15 percent agreed, and 5 percent were on the fence.
Attitudes may be different among clinicians, though. Cara Leahy, DO, the director for cognitive disorders at Owosso, Mich.-based Memorial Healthcare, called the FDA's decision "compassionate," as it gives patients access to a drug that could benefit them while regulatory and healthcare professionals continue to learn about it.
"This glimmer of hope is needed in a lot of ways," Dr. Leahy said. "It's needed for patients, and also for clinicians, who see these patients all day every day. They can picture the faces of who this might benefit. It's a needed hope for both sides here in medicine."
Rany Aburashed, DO, chief of neurology at Memorial Healthcare, shares his colleague's hope that Aduhelm will help patients. He said Memorial clinicians will educate Alzheimer's patients and their families about the treatment, taking a considered approach to each patient's individual circumstances.
"This is not a shotgun approach to dementia," he said. "Our approach is going to be very measured."
Memorial has been preparing for a new Alzheimer's drug for several years, as the system knew there is a dire need for drugs that treat the disease. Dr. Leahy said Memorial has been tracking a group of patients who fit the diagnosis of mild cognitive impairment and mild dementia as a result of Alzheimer's disease. Some of these patients have gone through amyloid confirmation, and the system has developed a pipeline for referrals to get those patients into the clinic for Alzheimer's new treatments.
Memorial is also paying close attention to the clinical trial data Biogen submitted to the FDA so it can determine which Alzheimer's patients have a low risk for side effects. Dr. Leahy said the system is working to assess patients' risk for amyloid related imaging abnormalities through blood testing and genotyping.
Krist Azizian, PharmD, chief pharmacy officer at Los Angeles-based Keck Medicine of USC, said his health system's Alzheimer’s program is "interested in all treatments that could potentially benefit patients." He said the system is developing screening criteria to select appropriate candidates for the drug, which is administered on-site via intravenous infusion.
He also said Keck is creating guidelines for monitoring patients during and after Aduhelm treatment, including brain imaging through PET-CT and MRI scans.
Both Keck and Memorial are working to support patients with the cost of the drug, which is $56,000 annually, assessing local and national programs that could alleviate the cost burden.
While uncertainties remain about how the drug will benefit patients, many clinicians are hopeful about the innovation that has arisen from Alzheimer's treatments' 20-year drought.
"There is no question we are seeing the fruits of scientific labor," Dr. Aburashed said.