The United States Food and Drug Administration gave the manufacturer Biogen special approval despite concerns about the evidence for the drug, technically called aducanumab, to be effective, resulting in an immediate reaction:
But the cost of the drug is enough to raise questions.
Consider difficult math. It is not known exactly how many patients would be eligible for the drug under the closer FDA approval restricting use to people with mild impairment or dementia. But at $ 56,000 per person, the cost to treat 500,000 patients – a fraction of the estimated 6 million Americans with Alzheimer’s disease – would reach $ 29 billion in a single year.
By comparison, Medicare Part B, the seniors’ hospital insurance plan, spent a total of $ 37 billion on all drugs in 2019.
Why is this drug so expensive? There are millions of people and their families who want a new treatment for Alzheimer’s disease. Any Alzheimer’s treatment.
The impossible problem. Over 120,000 Americans die of Alzheimer’s disease each year, making it one of the leading causes of death in the United States.
But treatment for the disease has been stalled for years, and the FDA had not approved a new drug to treat the disease since 2003.
Why do people say it’s not effective? Clinical trials, started in 2015, were divided over the drug’s actual effectiveness in slowing the disease, and were halted in 2019, showed no clinical benefit. Biogen then worked with the FDA on a post hoc review of the trials that found marginal improvement.
Why has it been approved if it is not clinically effective? It is because high doses of the drug reduced plaques that the FDA approved the drug, although studies have not definitively shown its effectiveness and despite the fact that more than a third of people in clinical trials have suffered swelling of the brain.
“I can’t say if I’ve noticed it every day, but I think overall I’m doing a lot better at looking for where my glasses are – things like that,” Knap said.
The Washington Post spoke to Phil Gutis, 54, a former reporter who has been on the drug for five years and swears by it.
“There was just a haze that I remember having been a few years ago that I don’t really feel like now,” Gutis told the Post.
The price of $ 56,000, they point out, is for the drug only. The actual cost of the infusion will be higher, and diverting money to this treatment could divert other effective dementia care.
“Like our patients, we desperately want to see innovative treatments to prevent and treat Alzheimer’s disease,” they write. “Instead, the approval of aducanumab set a perilous precedent that could usher in the approval of countless expensive treatments with uncertain benefits and even harms.”
In November, an external advisory committee was almost unanimous in its opposition to the drug’s approval, and three members resigned after their recommendation was rejected.
What does the FDA say? “In all of the studies in which it was evaluated, however, Aduhelm consistently and very convincingly reduced the level of amyloid plaques in the brain in a dose and time dependent manner,” Dr Patrizia Cavazzoni, director of the FDA Center for Drug Evaluation. and Research said when it received expedited approval. “Reduction of amyloid plaque is expected to lead to reduced clinical decline.”
After that ? The Biogen Company is still in a position to earn billions of dollars from Medicare through “fast track approval,” although more studies are conducted into the drug’s actual effectiveness. He has nine years to conduct this study, according to Ramchandran and Ross. Nine years!
At the end of the line. Certainly, if there is a drug that saves lives, or even a drug that improves life, it should be covered. But the cost of it should also put the cost of other programs – to fix roads and bridges, lift children out of poverty, or tackle climate change – into some perspective, especially since Congress debate how much it will invest in infrastructure and a broad set of social programs put in place by Democrats.