The controversial approval of Biogen’s Alzheimer’s drug aducanumab (Aduhelm) last week is having a messy aftermath. Clinicians’ responses range between excitement and disapproval, with questions abounding on how to advise patients and about the cost to patients and Medicare.

With no guidelines in place, and conflicting clinical trials data yet unresolved, physicians are “just winging it,” one doctor told medical news outlet Stat.  

“There are people that are so desperate, they’re going to try anything. I want to make sure that we’re doing it as safely as possible,” said geriatrician Sharon Brangman, M.D., of SUNY Upstate Medical Center in Syracuse, NY. “We’re still in the process of figuring that all out. There were no guidelines yet released that help us understand the infrastructure we have to have in place.”

Aduhelm, which may slow disease progression by removing toxic brain plaques, is administered in 10 mg/kg doses using intravenous infusion for about one hour every four weeks. Risks are known to include brain swelling, which occurred in a third of clinical trial participants, and small brain bleeds, which were noted in up to 19% of patients, reported Stat’s Elizabeth Cooney. Recipients will need to undergo several magnetic resonance imaging, or MRI, brain scans throughout their treatment to watch for these side effects.

But some doctors, researchers and patients’ advocates remain enthusiastic about the drug’s potential to give hope to desperate patients and their families — particularly in the absence of any other treatment to slow the disease’s progression. The approval could energize the Alzheimer’s research world and encourage development of other new therapies, observers say. It also may help to boost continued exploration into the role of amyloid-beta brain plaques, a treatment target that had begun to lose favor after years of clinical failures, some contend.

But even Aduhelm’s strongest supporters have concerns about the rollout, especially its price tag. The Alzheimer’s Association, for example, is now calling on Biogen to change the drug’s astronomical pricing. At $56,000 per year, the cost is “simply unacceptable,” the organization said in a statement released Saturday. 

“For many, this price will pose an insurmountable barrier to access, it complicates and jeopardizes sustainable access to this treatment, and may further deepen issues of health equity,” it said.

The cost could have broad implications for Medicare and its beneficiaries, according to a Kaiser Family Foundation report. Aduhelm will be covered under Medicare Part B as a physician-administered medication. In one estimate, total spending for one year alone would be almost $29 billion — that’s to cover just a fourth of the patients who used retail Alzheimer’s drugs covered under Medicare Part D in 2017. This cost would be paid by Medicare and the the drug’s recipients, an amount well above the spending on any other drug covered under Medicare Part B or Part D, based on 2019 spending, the foundation noted.

“To put this $29 billion amount in context, total Medicare spending for all Part B drugs was $37 billion in 2019,” the report’s authors stated.