Alzheimer's Drug Approval an FDA Blunder? Our Readers Weigh In

Megan Brooks

June 30, 2021

The US Food and Drug Administration (FDA) approval of the anti-amyloid agent aducanumab (Aduhelm) for the treatment of Alzheimer's disease (AD) isn't sitting well with Medscape readers.

The vast majority of physicians in the United States — including neurologists and primary care physicians (PCP) — believe the FDA should not have approved the drug, results of Medscape reader poll show.

 

The FDA approved aducanumab June 7 amid significant controversy and against the recommendation of its own advisory panel not to approve the drug, with most of the panel citing insufficient evidence of efficacy.

The backlash was swift, with multiple panel members resigning in protest after the FDA went ahead and cleared the drug.

Very few Medscape readers who responded to an online poll believe it was the right move. In fact, 87% of US-based physicians and 89% of neurologists disagree or strongly disagree with the FDA's thumbs-up.

The results are about the same when PCPs and neurologists are combined (87%). About two thirds (64%) of physicians practicing outside the US also feel this way.

Lack of Evidence

So what's the problem? Fifty percent of US physicians and 46% of neurologists (48% of PCPs/neurologists) feel they don't have enough information from the clinical trials of aducanumab to decide whether or not to prescribe the drug; 59% of physicians outside the US feel this way.

Aducanumab was approved using the FDA's accelerated approval pathway, which fast-tracks a drug that may provide a meaningful therapeutic advantage over existing treatments for a serious or life-threatening illness.

Yet FDA advisory committee members who voted against approval felt the evidence of efficacy from the clinical trial results was not strong enough or was uncertain at best.

The majority of physicians responding to our poll agree; 60% of US physicians and 61% of neurologists say data are "unclear" about the benefits and risks of the drug for patients with early AD. More than half (55%) of physicians outside the US feel the same.

In addition, 30% of US physicians and 33% of neurologists think the data show the risk of aducanumab outweighs the benefit. Only 3% and 4%, respectively, feel the clinical trial data show the benefit outweighs the risk.

Not surprisingly, 78% of US physicians and 81% of neurologists are against routine use of the drug in patients with AD; 13% and 8%, respectively, are unsure whether it should be used. More than half of physicians outside the US (56%) don't believe the drug should be used and 21% are unsure.

The majority of US-based physicians (79%) and neurologists (68%) responding to the Medscape poll do not plan to prescribe aducanumab to their patients with AD; 12% and 13%, respectively, aren't sure whether they will prescribe it or not; 8% and 19%, respectively, report they will prescribe the drug only to patients with early-stage AD.

Pressure from patients with AD who want to take the drug (and their families) is of concern among Medscape readers, with 42% of US-based physicians and 53% of neurologists "very concerned" about facing pressure to prescribe aducanumab.

The hefty price tag could also spell trouble; 76% of US-based physicians and 80% of neurologists who plan to prescribe aducanumab are concerned, or very concerned, about potential difficulties in accessing the drug because of cost.

According to the manufacturer, the wholesale cost of treatment with aducanumab — which requires an infusion once every 4 weeks — is about $4312 per infusion, making the annual cost around $56,000 for a high dose.

More than 850 physicians in and outside the US, including more than 100 neurologists, responded to the Medscape poll.

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