The $56,000 annual price for Biogen Inc.'s recently approved Alzheimer's disease therapy is drawing increasing criticism ahead of a decision by the U.S. government on reimbursement policies for the medication.
The Employers' Prescription for Affordable Drugs, a coalition of health care purchasers, said in a letter to congressional leaders Monday that taxpayers and employers will have to pay billions of dollars for aducanumab, sold under the brand name Aduhelm, without knowing whether it works.
Aduhelm's approval and price are a "cautionary tale of a broken system that is in profound need for reform," the group wrote.
The Food and Drug Administration granted Aduhelm an accelerated approval this month over the objections of an advisory committee that said there was a lack of clear evidence that the drug could slow patients' cognitive decline. Regulators said Biogen must continue to study the therapy.
Despite the dispute over its benefits, Aduhelm could be taken by millions of Americans, creating a formidable new burden for taxpayers, employers and households who will ultimately pay for it. In addition to the high list price of the drug, patients who take it are expected to need regular scans to monitor treatment outcomes and side effects.
Biogen has said it expects 80% of the patients who take its drug to be on Medicare, the public insurance that covers Americans 65 and older. The federal agency that runs the program, the Centers for Medicare and Medicaid Services, hasn't yet said how it will handle coverage.
If 1 million patients take Aduhelm, the annual cost would top $57 billion, according to estimates from the Kaiser Family Foundation. That's more than the total for all drugs covered under Medicare's Part B program, which is for medications like Aduhelm that are infusions administered in a doctor's office.
Biogen is "engaging directly with public and private payers, and health systems to ensure coverage policies support access for appropriate patients," spokeswoman Allison Parks said in an email, citing agreements with Cigna Corp. and the Veterans Health Administration.
The company plans to work with Medicare on "innovative price and access agreements that would help support continued sustainability of Medicare budgets," she wrote.
It would be unusual for Medicare to limit access to a treatment that has gained a broad acceptance from the FDA. Officials may not have much room to maneuver, analysts from RBC Capital Markets wrote Tuesday in a note to clients.
"The ability for [the Centers for Medicare and Medicaid Services] to meaningfully restrict Aduhelm appears limited to us in the near-term," RBC's Brian Abrahams wrote. "We think that CMS's hands may largely be tied, barring an intervention from Congress."
A meeting of outside experts who advise Medicare on coverage decisions could be scheduled for as soon as July, the RBC analysts wrote.
The agency didn't immediately respond to a request for comment.
Alzheimer's patient groups who implored the FDA to allow the drug on the market and praised the approval also have denounced the price. "This price is simply unacceptable," the Alzheimer's Association said June 12.
Some lawmakers have lashed out how the FDA handled the approval. Sen. Joe Manchin, D-W.Va., urged the Biden administration to replace the acting FDA chief, and Rep. Jim Cooper, D-Tenn., called the treatment a "scam."
Cooper said that his wife recently died from Alzheimer's and effective therapies are needed. "But this drug doesn't seem to work," he said in a statement. "Charging $56,000 for a drug that doesn't work is a scam."
The Employers' Prescription for Affordable Drugs, which includes six large trade organizations for health care purchasers and human-resources groups, urged Congress to take up comprehensive drug-pricing reform.
The group said in its letter that the government should negotiate prices for drugs like Aduhelm where no market competition exists.
Democrats have proposed letting Medicare negotiate drug prices, but the policy faces GOP opposition and resistance from Democratic centrists who hold crucial votes.