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 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, 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 $8,300, a far cry from the $56,000 the company is seeking. The institute charged that the FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms.” It estimated that Biogen could rake in “well in excess of $50 billion per year” while waiting for evidence to confirm that patients were actually benefiting.
The FDA’s approval process itself was rife with ethical conflicts. In one highly improper move, a top FDA official held an off-the-record meeting with a key Biogen executive in 2019, apparently violating long-standing rules and practices designed to keep the approval process transparent and unbiased. The revelation by the medical news site STAT caused such an uproar that the acting head of the agency felt obliged to ask the inspector general of the Department of Health and Human Services to investigate the circumstances that led to the drug’s approval. That inquiry is not yet complete, but the emerging evidence suggests an overly cozy relationship between the regulators and the industry. On September 1, two House committees launched a joint investigation into the appropriateness of the FDA’s handling of Alduhelm.