Public-health and media critics failed to stop federal approval of Aduhelm,
new drug for Alzheimer’s. So now they’re mounting an assault on the drug’s cost to stop Medicare from paying for it. Their sudden and rare concern for the federal fisc is illuminating, and not in a good way.
“It’s unconscionable to ask seniors and taxpayers to pay $56,000 a year for a drug that has yet to be proven effective,” Oregon Sen. Ron Wyden tweeted after the Food and Drug Administration approved Aduhelm this month. “Medicare must be able to negotiate a fair price for prescription drugs.” He means impose price controls, while others want Medicare to restrict coverage of the drug.
The healthcare policy shop Altarum last week projected Aduhelm would increase prescription drug spending by more than 8% by mid-decade. The sages at Axios hype: “Biogen’s new Alzheimer’s treatment could be experts’ nightmare drug spending scenario: An extremely expensive product that millions of desperate patients could be eligible for—and it may not even work.” Note the bow to “experts.”
Nobody has said Aduhelm is a cure, but it is the first treatment following hundreds of failures that has shown evidence in clinical trials of removing amyloid plaque—a hallmark of the disease—and slowing cognitive decline.
Critics are right that it’s not clear that amyloid causes Alzheimer’s. But the leading research hypothesis is that a buildup of harmful amyloid plaque in the brain triggers a cascade of chemical changes that interfere with neuron communication and cause brain loss. Critics also note that some two dozen drugs aimed at removing amyloid have failed to meaningfully affect the course of the disease.
Yet many trials hadn’t properly screened patients to ensure they had Alzheimer’s. Some drugs were also tested on late-stage patients who had irreversible brain loss. And some failed to clear amyloid because they didn’t target the right molecules in the brain.
Biogen learned from these failures, and the FDA noted that Aduhelm was the first drug to show “proof of concept” in an early stage trial that clearing amyloid could slow decline. This was supported by a Phase 3 trial in which patients receiving the highest dosage showed 25% to 28% less decline in memory and problem-solving compared to the placebo group after 78 weeks.
Critics point to Biogen’s second Phase 3 trial in which patients didn’t seem to benefit. But the trials weren’t identical. Patients in the negative trial received the highest dosage for less time. Aduhelm’s critics ignore these complexities, but the FDA’s job is to review the totality of evidence.
The FDA approved Aduhelm under its accelerated approval program, which Congress formally authorized in 2012 to give patients earlier access to drugs that treat serious conditions and fill an unmet medical need. Instead of meeting a primary endpoint like extending lifespans, drugs must merely meet a “surrogate endpoint” like shrinking tumor size.
The FDA approved Aduhelm because it significantly reduced amyloid. Many of Aduhelm’s critics in the public-health crowd have criticized the FDA’s accelerated approval program for years. They don’t believe drugs with incremental benefits should be approved.
“If pressure from drugmakers and their lobbyists compels F.D.A. administrators to continue to loosen their standards, we need a new organization to review drug approvals and make evidence-based assessments of their clinical impact, as other countries do,” two directors of the Harvard Medical School Program on Regulation wrote in the
New York Times
But the FDA did consider Aduhelm’s clinical impact. What it didn’t consider was the financial impact, as many other countries do. Yet a 2017 study by the Partnership for Health Analytic Research found that pre-launch predictions of sales for new drugs on average were inflated by 5.5 times.
One reason is that competition from new therapies often drives down costs. A drug price war last decade between Gilead and
caused Hepatitis C treatment net prices to fall by nearly 80%. Competition may also occur with Alzheimer’s treatments as several therapies that have shown promise in clinical trials aim to seek approval in the next few years. If Aduhelm doesn’t prove to be effective, doctors won’t prescribe it.
Researchers will also learn more about the disease from how patients respond to Aduhelm. Alzheimer’s and other types of dementia are expected to cost the nation $355 billion this year. If Aduhelm delays the progression of the disease for some patients even by a year or two, it will save tens of billions of dollars in Medicaid, home care and other health costs.
The hostility to Aduhelm illustrates the healthcare paternalism of American progressives. They believe we spend too much money on old people. They want to put the government in charge of paying for all health care, and then put “experts” in charge of determining what treatments patients can receive so that the elderly can go gently into the night.
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Appeared in the June 22, 2021, print edition.