The true price for administering aducanumab – a controversial new treatment for Alzheimer’s disease – could actually be closer to $ 100,000 per year than other lower estimates and is only one reason why Centers for Medicare & Medicaid Services could refuse to cover it, according to a prominent bioethicist.
Tia Powell, MD, director of the Montefiore Einstein Center for Bioethics, said the costs associated with the infusion of the drug, as well as questions about how patients would be screened for amyloid plaques targeted by aducanumab, 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 Alzheimer’s-related dementias, and about 1.5 million of them are at a stage similar to that of registered elderly drug maker Biogen in its trials of aducanumab (brand name Aduhlem).
Although the drug has only been tested in patients with mild cognitive loss and those at no risk of brain hemorrhage, the FDA has agreed to make it available to all patients with Alzheimer’s disease. Questions about clinical trials and the agency’s approval process have led some to step down from their role as agency advisors. What’s more, even advocates for Alzheimer’s patients have criticized the price at which the treatment would come.
“Medicare now has a huge problem if they decide to cover it,” Powell said on a call with members of LeadingAge last week. “If they decide they think this drug could help people like those in the study, they will have to cover it in such a way that it is not available to absolutely everyone because the drug is extremely expensive. “
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Biogen said it would charge $ 56,000 a year for the treatment, a cost that other experts say could “blow up” Medicare. Powell noted that Biogen’s costs would be in addition to visits to the neurologist, testing to determine eligibility, and using the clinical staff and specialized facilities needed to inject the drug during a one-hour session every four weeks.
She said introducing the drug to patients would cost around $ 100,000 per patient per year, pushing total costs in the United States to a level above estimates that have reached $ 100 billion per year.
“That would force lawmakers to double Medicare credits, and you know what?” The only thing I can be sure of today is that we are not about to double medicare funding, ”said Powel.
Powell noted that Medicare could protect its creditworthiness by restricting beneficiaries’ access to the drug.
“They can’t get around this problem unless they’re prepared to set limits that the FDA hasn’t set, or unless they’re prepared to say, ‘We’re so sorry, FDA, you can. love him, but not us, “” she said.
The Centers for Medicare & Medicaid Services have prioritized such denial by denying coverage for certain PET scans, which are needed to check the brain for amyloid plaques. Powell said amyloids are not found in all cases of dementia and are sometimes found in the brains of patients without dementia.
A relative shortage of PET scans if all Alzheimer’s patients request access means that some patients would need more invasive and painful means to verify their eligibility.
“They’re going to have to do something like a lumbar puncture, and it’s not cheap either,” Powell said. “And this is an unpleasant procedure for the elderly person who might just be the one who is going to want to benefit from this drug.”