The true price to administer aducanumab — a controversial new Alzheimer’s treatment — may actually be closer to $100,000 annually than other, lower estimates and is just one reason the Centers for Medicare & Medicaid Services could refuse to cover it, according to a prominent bioethicist.
Tia Powell, M.D., director of the Montefiore Einstein Center for Bioethics, said the costs associated with infusing the drug, as well as questions about how patients would be screened for the amyloid plaques that aducanumab targets, could force Medicare to deny or restrict coverage despite its broad approval by the Food and Drug Administration.
She said the day the drug was approved was “a bad day for science” in a blog for the Hastings Center.
Some six million Americans have Alzheimer’s disease or Alzherimer’s-related dementias, and about 1.5 million of them are at a stage similar to the seniors drugmaker Biogen enrolled in its aducanumab (brand name Aduhlem) trials.
Despite the drug being tested only on patients with mild cognitive loss and those not at risk of brain bleeds, the FDA agreed to make it accessible to all Alzheimer’s patients. Questions about clinical trials and the agency’s approval process have led some to quit their roles as agency advisors. In addition, even Alzheimer’s patient advocates have criticized the price at which treatment would come.
“Medicare now has an enormous problem if they decide to cover it,” Powell said during a call with LeadingAge members last week. “If they decide that they do think this drug could help people who are like those in the study, they’re going to have to cover it in such a way that it’s not available to absolutely everyone because the drug is extremely expensive.”
CMS is reviewing the FDA’s decision and “will have more information soon,” an agency spokesperson told McKnight’s Long-Term Care News on Friday.
Biogen has said it would charge $56,000 annually for the treatment, a cost that other experts have said could “blow up” Medicare. Powell noted Biogen’s costs would be in addition to neurologist visits, tests to determine eligibility, and the use of clinical staff and specialized facilities needed to infuse the drug over an hour-long session once every four weeks.
She said getting the drug into patients will run about $100,000 per patient, per year, pushing total U.S. costs higher than estimates that have ranged to $100 billion annually.
“It would (require lawmakers to) double Medicare’s appropriation, and you know what? The only thing that I can say for certain today is that we are not about to double the appropriation for Medicare,” said Powel.
Powell noted that Medicare could protect its solvency by restricting beneficiaries’ access to the drug.
“They can’t get around this unless they are willing to set limits that FDA did not or unless they’re willing to say, ‘We’re very sorry, FDA, you may like it, but we don’t,’” she said.
The Centers for Medicare & Medicaid Services set precedence for such a denial by denying coverage of certain PET scans, which are needed to check the brain for the presence of amyloid plaques. Powell said amyloids aren’t found in all dementia cases, and they are sometimes found in the brains of non-cognitively impaired patients.
A relative shortage of PET scanners should all Alzheimer’s patients demand access means some patients would need more invasive, painful ways to check for eligibility.
“They’re going to have to do something like a spinal tap, and that’s not inexpensive either,” Powell said. “And it’s a not-pleasant procedure for the older person who might be just the one who’s going to want to benefit from this drug.”