Cerebrum Fall 2021

NEUROETHICS

False Hope and Deep Pockets

Aduhelm. At least six affiliates of Blue Cross and Blue Shield have said they will not cover the costs because the drug is still experimental or because clinical benefit has not been established, according to the Boston Globe . The most worrisome issues concern the drug's price tag. Biogen wants to charge $56,000 a year for the drug, which by some measures does not look all that exorbitant. As I wrote in a column on price gouging published May 13, 2019,

BY PHILIP M. BOFFEY T HE FIRST NEW DRUG TO TREAT ALZHEIMER’S disease in nearly two decades was initially hailed as an important advance but quickly became notorious for its exorbitant pricing and for raising a slew of ethical concerns. The drug, which will be sold under the brand name Aduhelm, was developed by Biogen, an American multinational company based in Cambridge, Mass. It was approved by the Food and Drug Administration (FDA) under a controversial “accelerated approval” process despite a nearly unanimous recommendation against approval by an advisory committee of experts. Three members of the panel quit in protest. The evidence supporting Aduhelm’s safety and effectiveness is astonishingly skimpy. Of two phase 3 clinical trials conducted by the company, only one showed hints that Aduhelm might slow cognitive decline slightly, while the other showed no benefit. After additional analysis, Biogen concluded that in one of the trials a high dose appeared to slow decline—but only by a fraction of a point on an 18-point rating scale. On the downside, some 30 to 40 percent of the patients receiving the high dose suffered brain swelling or bleeding. Despite that skimpy resume, the FDA decided to approve the drug under its accelerated approval program which allows it to rely on a surrogate endpoint that is “reasonably likely” to predict a clinical benefit. The biomarker it relied on was the presence of amyloid beta plaques in the brain. Experts on both sides of this controversy agree that Aduhelm substantially reduced the presence of plaques. But they disagree on whether that matters. Although such plaques are often associated with Alzheimer’s, there is no evidence that reducing the amount of plaque will slow the disease. Peter Bach, a leading expert on drug pricing, notes that multiple comparative clinical trials have cast doubt on the theory that reducing the build-up of plaque will attenuate the progression of Alzheimer’s. That leads him to suspect, he said in an email, that “the one allegedly somewhat positive study of Aduhelm was very likely to be a false positive finding.” Both the Cleveland Clinic and Mount Sinai’s Health System in New York City have decided not to administer

drugs to treat multiple sclerosis had soared to $60,000 a year, drugs to treat

brain cancer had reached $30,000 a month ($360,000 a year), and a drug to treat nerve destruction from a very rare disease was priced at an astronomical $450,000 a year. That is not an indication that Aduhelm is reasonably priced. Rather, it is evidence that the whole drug-pricing system in this country is out of whack. Biogen’s $56,000-a-year for the drug alone is not the total cost. The doctors whose offices administer the drug intravenously once a month get paid for their services, posing a huge conflict of interest when they decide who to treat and for how long. Other associated costs, such as diagnostic tests to determine whether a patient has a lot of plaques and monitoring tests to determine how a patient is progressing could add tens of thousands of dollars a year to a patient’s annual bill. Those costs will fall heavily on Medicare, which is supported by the American taxpayer, on those with private insurance, whose costs are borne by individuals or their employers; and on the uninsured, who may find the costs prohibitive. Even many insured patients may not be able to afford their copayments. Estimates by the Kaiser Family Foundation suggest that the costs to Medicare and the patients who use the drug could reach anywhere from $29 billion to $57 billion a year. Given the underwhelming evidence and all the uncertainties, how should Aduhelm be priced? The Institute for Clinical and Economic Review (ICER) calculated that a fair annual price for this drug, which it deems likely to become one of the top-selling drugs in the history of the US, would lie between $2,500 and

14 DANA FOUNDATION CEREBRUM | Fall 2021

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