Uncertainty over costs
Aducanumab’s true costs, to patients and to taxpayers, remain unknown. The $56,000 per year currently cited by its manufacturer “doesn’t count the PET scans and MRIs,” Dr. Knopman noted. “We’re probably pushing $100,00 a year for the first year of treatment.”
Most of that expense will likely be borne by Medicare, he said, and if not, “that will exacerbate existing health care disparities. People who can pay out of pocket are a pretty limited group.”
Dr. Scharre agreed that the costs of treatment were concerning, and that “at least you should be able to narrow it down and hopefully just use health care dollars for people who might stand to benefit,” he said – namely patients in an earlier stage of disease.
The Alzheimer’s Association’s Dr. Carrillo declined to address the high price of aducanumab or its implications, saying only that the association is “very invested in all aspects of access including covering costs associated with the drug and the rest of treatment.”
Access also means “infrastructure, access to physicians to diagnose, access to diagnostics,” Dr. Carrillo said.
Dr. Cummings said aducanumab’s price would likely come down through negotiations with the Centers for Medicare & Medicaid Services, copayments, and bulk purchases.
The FDA has offered no guidance on how long treatment with aducanumab should last, or what should prompt withdrawal of treatment, meaning that patients could, in theory, stay on it to the end of their lives – raising costs further.
Critics have also noted that a built-in financial incentive under Medicare Part B, which covers infusion drugs, could result in overprescription of aducanumab. Under Medicare Part B, prescribing physicians are reimbursed 6% of a drug’s average sales price.
Geriatricians wary
On social media and in the lay press, geriatricians have been among the most outspoken opponents of the FDA decision and the Alzheimer’s Association’s advocacy of aducanumab.
Eric Widera, MD, a geriatrician at the University of California, San Francisco, said that the specialty might be less likely than others to embrace aducanumab. “I think part of the reasons geriatricians don’t make a lot of money is they have strong commitment to their values,” Dr. Widera said.
Dr. Eric Widera
The American Geriatrics Society opposed the drug’s approval, citing concerns about evidence, side effects, and cost. “Additional considerations are the unintended consequences of overstressing Medicare’s limited financial reserves, and of challenging health care systems … to divert precious resources to an expensive treatment of uncertain value,” the society’s president, Peter Hollmann, MD, and chief executive officer, Nancy E. Lundebjerg, wrote in a June 2 letter to the FDA.
Dr. Widera said the approval was likely to undermine confidence in the FDA and in the Alzheimer’s Association, which receives significant funding from drug manufacturers, including Biogen and Eisai. “There’s a lot of reasons that the Geriatrics Society could have done what the Alzheimer’s Association did, and yet they came out against it, which I applaud.”
Dr. Widera pointed to a study showing that dementia patients were less likely to be on an antidementia drug if they were treated by a geriatrician, compared with a psychiatrist or a neurologist. But whether the specialty will prove as cautious with aducanumab remains to be seen. Some geriatricians will be tempted to open lucrative infusion centers, he predicted.
What is especially worrisome, Dr. Widera said, is that aducanumab’s label offers no guidance as to when to withdraw treatment. “We’ll probably see something similar to what happened with the cholinesterase inhibitors” – the class of marginally effective antidementia drugs that includes donepezil (Aricept, Pfizer) and rivastigmine (Exelon, Novartis). “No one thinks about deprescribing them. People are prescribed them even in their last months of life. There is no reason to think these infusions won’t be continued for a very long time, well beyond how long people were dosed in the trials.”
“Taking care of someone with dementia is hard enough,” Dr. Widera added. “We can’t even get normal support in the home for someone with dementia. But we are more than happy to throw money to Biogen for a drug they have not yet showed benefit for. Hopefully in 5 years we’ll have a drug that actually works,” Dr. Widera said. “After 5 years of giving this to people at $50,000 a year.”