Home / Business / Controversial Alzheimer’s drug could cost $334 billion—nearly half of the Department of Health budget.

Controversial Alzheimer’s drug could cost $334 billion—nearly half of the Department of Health budget.

A multi-storey glass building on a tree-lined campus.
expand / A pedestrian walks past Biogen Inc. headquarters in Cambridge. Massachusetts On Monday, June 7, 2021, Biogen Inc. shares soared after a controversial Alzheimer’s treatment was approved by US regulators.

Concerns are growing about the price of the controversial Alzheimer̵

7;s new drug, Aduhelm. And critics are particularly concerned about what the drug’s $56,000-a-year list price will do to Medicare. The federal insurance program, available to people 65 and older, covers the majority of the roughly 6 million adults with Alzheimer’s disease in the United States.

Cost of Aduhlem, an intravenous drug administered by a doctor It has the potential to overshadow the amount Medicare spends on other drugs. paid by the doctor and Retail prescription drug combinations

The Food and Drug Administration approved Aduhelm earlier this month. This caused widespread and intense criticism. Experts and industry observers have called the decision “disgraceful” and “dangerous,” noting that Aduhelm’s clinical trials have not clearly shown the drug to be effective in treating Alzheimer’s. The fact that Aduhelm’s manufacturer, Biogen, has set a very high list price only aggravates the criticism.

An analysis earlier this month by the Kaiser Family Foundation showed that if just a quarter of the 2 million Medicare beneficiaries who are currently using Alzheimer’s treatment – ​​500,000 or more beneficiaries – start using Aduhelm. It costs Medicare about $29 billion a year. In 2019, Medicare spent $37 billion on all prescription drugs.

A new analysis released Monday by Stat has pushed the numbers further. The store estimates that if all of the 5.8 million Medicare-eligible adults with Alzheimer’s disease started using Aduhelm, it could cost Medicare $334.5 billion a year, Stat noted, 334.5 billion. The dollar is nearly half of the total budget for the Department of Defense, or about $4 million Tesla Model Xs (to those who think in terms of Teslas). The eye-catching sum is also higher than Medicare spending on doctor-prescribed drugs. and prescription drugs combined which totaled about $220 billion in 2019.

“Serious concern”

Of course, it is impossible to predict how many patients will need Aduhelm and how long they will stick with the treatment. But estimating the cost of mushroom cultivation is not a problem. Amid many controversial moves, the FDA approved Aduhelm for use in all Alzheimer’s patients, although Biogen only tests the drug in people with mild disease. and even without performance data Many patients are hopeful and eager to try the drug. Aduhelm is the first newly approved drug for Alzheimer’s disease in nearly two decades.

But critics say Such drugs create false hopes. only among patients and their families including falling regulatory standards at the beginning of last month An industry-leading watchdog group calls for the top three FDA officials behind the decision to resign or be fired. meanwhile Three expert advisors to the regulator have resigned in protest. The advisors were part of an 11-person committee that overwhelmingly voted against the approval last November.

Lawmakers are now working on the controversial drug. Last week, Sens. Bill Cassidy, MD (R-La.) and Elizabeth Warren (D-Mass.) called for a hearing to It “reviews pesky new questions and challenges,” Aduhelm’s approval to Medicare and last Friday. The Council’s Oversight and Reform Commission has announced that it is opening an investigation into Aduhelm’s approval and pricing.

“We are very concerned about the price of Biogen’s new Alzheimer’s drug Aduhelm and the process leading to its approval despite questions about the drug’s clinical benefit,” said Rep. Carolyn Maloney (DN). .Y.) and Frank Pallone Jr. (DN. J.), who led the investigation, said in a joint statement.

So far, Biogen and the FDA seem to have taken a leap of critics. Biogen CEO Michel Vounatsos defended the price, saying on a conference call earlier this month: “We believe the price is justified by the expected value. It will bring to patients, caregivers, and society.” Acting FDA Commissioner Janet Woodcock told Stat she was “not that worried” about the escalating backlash.

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