Home » The controversial Alzheimer’s drug could cost $334 billion – nearly half the DoD’s budget

The controversial Alzheimer’s drug could cost $334 billion – nearly half the DoD’s budget

by archyw

Enlarge / Pedestrians pass Biogen Inc. Headquarters in Cambridge, Massachusetts, on Monday, June 7, 2021. Biogen Inc.’s shares soared after its controversial Alzheimer’s disease therapy was approved by US regulators.

Concern is mounting over the price of the controversial new Alzheimer’s drug, Aduhelm. Advocates, lawmakers and critics are particularly concerned about what the drug’s $56,000-a-year list price will do to Medicare. The federal insurance program is available for over 65s, which covers the vast majority of the approximately 6 million adults with Alzheimer’s in the US. 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 physician-administered drugs e combined retail controlled drugs.

The Food and Drug Administration granted Aduhelm approval earlier this month, generating widespread and intense criticism. Experts and industry observers called the decision “shameful” and “dangerous,” noting that clinical trials with Aduhelm have not clearly shown the drug is actually effective in treating Alzheimer’s. The fact that Aduhelm’s manufacturer Biogen set the list price so high only intensified the criticism.

An analysis earlier this month by the Kaiser Family Foundation pointed out that if just a quarter of the 2 million Medicare beneficiaries currently using Alzheimer’s treatment – ​​about 500,000 beneficiaries – started taking Aduhelm, it would cost Medicare is estimated at $ 29 billion per year In 2019, Medicare spent $37 billion on all physician-administered drugs in total.

A new analysis released Monday by Stat pushed the numbers even further. The agency estimated that if all 5.8 million Medicare-eligible adults with Alzheimer’s started taking Aduhelm, it could cost Medicare $334.5 billion a year. Stat noted that $334.5 billion is nearly half of the entire Defense Department budget – or about 4 million Tesla Model Xs (for those who think in terms of Teslas). The impressive total also significantly exceeds Medicare’s spending on physician-administered and retail drugs combined, which totaled about $220 billion in 2019.

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“Serious Concerns”

Obviously, it is 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 moves, the FDA has approved Aduhelm for use in all Alzheimer’s patients, although Biogen has only tested the drug in people with mild disease. And despite the lack of efficacy data, many patients are hopeful and eager to try the drug. Aduhelm is the first newly approved drug for Alzheimer’s in nearly 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 major industry watchdog called three senior FDA officials to the decision to resign or be fired. Meanwhile, three expert advisers to the regulator have resigned in protest. The advisers were part of an 11-member panel that voted overwhelmingly against approval last November.

Now, lawmakers are acting on drug litigation. Last week, Senators Bill Cassidy, MD (R-La.) and Elizabeth Warren (D-Mass.) convened a hearing to “examine the nagging new questions and challenges” that Aduhelm’s approval raises for Medicare. And on Friday, the House Oversight and Reform Committee announced that it is opening an investigation into Aduhelm’s approval and pricing.

.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 the criticisms calmly. Biogen CEO Michel Vounatsos defended the price, saying in a conference call earlier this month that: “We believe the price is proven by the value it is expected to add to patients, caregivers and society.” And FDA interim commissioner Janet Woodcock, meanwhile, told Stat that she is simply “not too concerned” about the increasingly intense reaction.

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