Concern is mounting over the price of the controversial new Alzheimer’s disease drug, Aduhelm. Advocates, lawmakers and critics are particularly concerned about what the drug’s $ 56,000 per year list price will do to Medicare. The federal insurance program is available to people aged 65 and over, which covers the vast majority of the approximately 6 million adults with Alzheimer’s disease in the United States.
As it stands, the cost of Aduhlem – an intravenous drug administered by a physician – has the potential to eclipse the amount of money Medicare spends on all other drugs administered by a physician. and combined retail prescription drugs.
The Food and Drug Administration approved Aduhelm earlier this month, drawing widespread and intense criticism. Experts and industry watchers called the move “shameful” and “dangerous,” noting that Aduhelm’s clinical trials have not clearly shown that the drug is actually effective in treating Alzheimer’s disease. . The fact that Aduhelm’s maker, Biogen, has set the list price so high has only intensified criticism.
An analysis conducted earlier this month by the Kaiser Family Foundation pointed out that if only a quarter of the 2 million Medicare beneficiaries who are currently using treatment for Alzheimer’s disease, or around 500,000 beneficiaries, would start taking Aduhelm , it would cost Medicare about $ 29 billion a year. In 2019, Medicare spent $ 37 billion on all medications administered by a physician.
A new analysis released Monday by Stat pushed the numbers further. The outlet estimated that if the 5.8 million Medicare-eligible adults with Alzheimer’s disease started taking Aduhelm, it could cost Medicare $ 334.5 billion per year. Stat noted that $ 334.5 billion is almost half of the Defense Department’s total budget, or roughly 4 million Tesla Model Xs (for those who think in Tesla terms). The jaw-dropping total also significantly exceeds Medicare spending on combined physician-administered and retail prescription drugs, which totaled around $ 220 billion in 2019.
It is of course impossible to predict how many people will end up taking Aduhelm and how long they will stay on treatment. But rising cost estimates are not out of the question. Among its many controversial measures, the FDA has approved Aduhelm for use in all patients with Alzheimer’s disease, although Biogen has only tested the drug in people with mild illness. And despite the lack of efficacy data, many patients are optimistic and eager to try the drug. Aduhelm is the first newly approved drug for Alzheimer’s disease in almost two decades.
But critics say the drug has only raised false hopes among patients and their families, as well as eroding regulatory standards. Earlier this month, a leading industry watchdog called on three senior FDA officials on the decision to quit or be fired. Meanwhile, three expert advisers to the regulator resigned their posts in protest. The advisers were part of an 11-member panel that overwhelmingly voted against approval last November.
Now lawmakers are taking action against the contested drug. Last week, Sen. Bill Cassidy, MD (R-La.) And Elizabeth Warren (D-Mass.) Called for a hearing to “consider new vexatious issues and challenges” raised by Aduhelm’s approval for the ‘Health Insurance. And on Friday, the House Committee on Oversight and Reform announced it was opening an investigation to get Aduhelm’s approval and pricing.
“We have serious concerns about the high price of Biogen Aduhelm’s new Alzheimer’s disease drug and the process that led to its approval despite questions about the drug’s clinical benefits,” representatives Carolyn Maloney (DN.Y .) and Frank Pallone Jr. (DN. J.), who are leading the investigation, said in a joint statement.
So far, Biogen and the FDA seem to be taking criticism without hesitation. Biogen CEO Michel Vounatsos defended the price, saying on a conference call earlier this month: “We believe the price is justified by the value it should bring to patients, caregivers and patients. the society. And acting FDA commissioner Janet Woodcock told Stat she was just “not that concerned” about the escalating backlash.