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Watchdog group stands behind its negative review of Biogen’s now-approved Alzheimer’s drug

Aduhelm, Biogen's recently approved drug for early Alzheimer's disease, carries a price tag of $56,000 a year.Jessica Rinaldi/Globe Staff

An influential drug-pricing watchdog group is standing behind its withering assessment of Biogen’s $56,000-a-year Alzheimer’s medicine despite the federal government’s controversial approval of the treatment.

The Boston-based Institute for Clinical and Economic Review, or ICER, said in a May 5 draft report that the experimental drug had generated “insufficient” evidence that it would help patients. Given the medication’s modest benefits and potential side effects, the group concluded it merited an annual cost of $2,500 to $8,300 if approved by the Food and Drug Administration, which many experts considered unlikely at the time.

But the FDA did approve the drug, called Aduhelm, on June 7, over the objections of the agency’s scientific advisory committee, including three members who quit in protest. On Wednesday, ICER said in its 128-page final report that it still believes Biogen didn’t produce enough clinical trial evidence that the drug would benefit patients. Its price and value, the group says, remain a “mismatch.”

The group did raise its range of a reasonable annual price tag by several hundred dollars, to between $3,000 and $8,400. ICER said the increase reflected the FDA’s decision to require fewer MRI tests than expected on patients who receive the drug to check for potential side effects, including brain swelling. But ICER didn’t change its overall critique of the medication, which was called aducanumab before approval.

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Dr. David Rind, chief medical officer for the watchdog group, said that people understandably dread Alzheimer’s disease and that the first medicine that halts or reverses the most common cause of dementia will deserve a high price. But, he said, “we agree with many independent experts that the current evidence is insufficient to know whether or not aducanumab slows the loss of cognition.”

Chris Leibman, Biogen’s senior vice president for value and access, said in a June 10 letter to ICER that was made public Wednesday that executives are “deeply disappointed and fundamentally disagree” with the group’s draft report. But he said the Cambridge biotech wouldn’t provide a point-by-point response until a later date.

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One of the most closely watched experimental drugs in recent history, Biogen’s medication is a monoclonal antibody made from the immune cells of older people with no or uncommonly slow cognitive decline. It is administered in monthly intravenous infusions.

The drug is intended to slow cognitive decline in people with early symptoms of Alzheimer’s — about 1 to 2 million Americans, Biogen says — although the FDA hasn’t limited usage to just them.

Aduhelm generated contradictory results in two late-stage clinical trials. In one study, Biogen said, a high dose could delay cognitive decline by 22 percent or about four months over 18 months, an encouraging result. The other trial failed to reach its goal.

Biogen and the FDA are facing a fierce backlash and congressional inquiries over the approval and pricing of the drug, which is expected to be a multibillion-dollar blockbuster. On Last Friday the Democratic chairs of two key House committees announced an investigation of the therapy.

Analysts have predicted that Medicare and its enrollees, who pay a share of their prescription drug costs, will spend from $5.8 billion to $29 billion on the drug annually, which could be more than what the federal government spends on some entire agencies. Critics say Medicare won’t be able to afford the medicine.

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Steven Pearson, a physician with a master’s degree in health policy and management from Harvard University, founded ICER 15 years ago to analyze prescription medicines and get drug makers to charge only what the nonprofit says they are worth. It has no regulatory authority but has gained clout as more Americans blanch at dizzying drug prices.

ICER is scheduled to host an online forum on July 15 to discuss Aduhelm and the nonprofit group’s analysis. Executives from Biogen, neurologists, patients, caregivers, and members of advocacy groups are among those expected to participate. Also expected is Dr. Mark McClellan, the former commissioner of the FDA and administrator of the Centers for Medicare and Medicaid Services.


Jonathan Saltzman can be reached at jonathan.saltzman@globe.com.