September 18, 2019

An FDA advisory panel this month recommended approval of an experimental treatment for peanut allergies, but writing in The Atlantic, James Hamblin questions whether the product is worth its likely $4,200 price tag—and flags research suggesting it may backfire for some patients.

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Peanut allergies have grown in prevalence

The incidence of peanut allergies in children in the United States has increased by 21% since 2010, according to the American College of Allergy, Asthma, and Immunology.

The latest estimates suggest about 2 to 5% of U.S. children have a peanut allergy—and for some, the allergies can be deadly. According to Hamblin, the allergy kills about four children annually and lands thousands more in the ED for lifesaving care.

There's a significant debate among providers about how to prevent or treat peanut allergies. Recent guidelines have recommended parents begin feeding their children peanuts at a young age to help their immune systems learn how to tolerate peanuts.

Researchers and some providers have tested a similar approach, known as oral immunotherapy, on kids who already have developed a peanut allergy. The technique involves slowly introducing children to small amounts of peanuts—but according to Hamblin, many providers view such experiments as risky, and there currently is no FDA-approved treatment for peanut allergies.

A new treatment for peanut allergies raises hope (and questions)

Aimmune Therapeutics hopes to change that with a new "peanut pill"—a capsule that, Hamblin writes, contains small amounts of peanut flour.

Researchers employed by the pharmaceutical company late last year published clinical trial results in the New England Journal of Medicine showing that after a one-year period, two-thirds of children taking the treatment could safely consume two peanuts in a controlled setting. (The researchers did not find the treatment effective among the adults enrolled in the study.)

In its petition for FDA approval, Aimmune said the results show that the pill, if taken consistently, could protect peanut-allergic individuals who accidentally ingest small amounts of peanuts. The pill does not promise to enable people to eat peanuts regularly, Hamblin writes.

Aimmune has yet to set a price for product, called Palforzia, Hamblin writes. But in a presentation to investors dated September 2019 it said pricing could range from $3,000 to $20,000 a year.

Analysts have put the potential cost at $4,200 a year, and the treatment is designed to be taken indefinitely.

Is the treatment simply overpriced peanut flour?

But Hamblin in The Atlantic argues the drug amounts to an overpriced version of peanut flour, which can be sold as a dietary supplement at a much lower cost.

Thomas Casale—chief medical adviser at Food Allergy Research & Education (FARE), a nonprofit advocacy and lobbying group that helped create Aimmune—argued that, even though supplement manufacturers can offer cheaper versions of peanut flour, having an FDA-approved version makes the treatment safer and more accessible to patients.

Casale explained that if peanut flour is sold as an FDA-approved drug, doctors could be reimbursed for it and for overseeing the administration of it, and insurance would be able to cover it, Hamblin reports.

But even setting aside price, the drug raises other concerns, according to Hamblin. While the clinical trial found that patients showed greater tolerance of peanuts in a clinical setting, outside of the laboratory they actually experienced more serious allergic events. According to Hamblin, 14% of those receiving the peanut powder pill reported a severe allergic reaction during the study period, compared with just 3% in the placebo group. A meta-analysis published in The Lancet confirmed the risk, Hamblin writes.

Feff Tice, a physician and health policy analyst at the University of California at San Francisco who examined the product, said, "This is just what we're trying to prevent—having to get taken to the ER and getting injected in school, that sort of outcome." He added, "The trials clearly demonstrated desensitization [to peanuts], but apparently at the cost of more harm, and no clear evidence of long-term benefit."

For his part, Hamblin is skeptical that the drug's benefits are worth its costs. He writes, "Based on what is currently known, the billion-dollar peanut powder is likely to have a net effect of increasing severe allergic reactions to peanuts" (Hamblin, The Atlantic, 9/13; Loftus, Wall Street Journal, 9/13). 

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