Conference Coverage

FDA-approved peanut immunotherapy protocol comes with a cost


Peanut allergy immunotherapy now comes with approval from the US Food and Drug Administration (FDA), but it also comes with protocols, standards, and paperwork. Whether it will be widely adopted has yet to be determined.

A few dozen allergists around the world have been offering food allergy immunotherapy for many years, having developed their own measuring techniques using store-bought food.

But the vast majority of allergists are not interested in developing home-grown treatments, not only because it involves research and development, but also because it comes with legal risks.

“Finally we have another treatment option,” said Edwin Kim, MD, from the UNC Allergy and Immunology Clinic in Chapel Hill, N.C. “This is what we were waiting for. It’s not cowboy stuff; this works.”

In January, the FDA approved peanut allergen powder (Palforzia) for patients 4-17 years of age, as reported by Medscape Medical News.

The pill contains measured doses of peanut flour and comes with a protocol that will allow allergists to bring patients to a peanut tolerance of 300 mg (about one peanut) and a black-box warning about anaphylaxis risk.

And before allergists can prescribe it, they must take a Risk Evaluation and Mitigation Strategy course to learn about dosing and the allergic reaction protocol.

“That may scare some away,” said Dr. Kim, who discussed the FDA-approved option during his presentation at the American College of Allergy, Asthma & Immunology 2020 Annual Scientific Meeting.

Allergic reaction, including the potential for anaphylaxis, has always been an issue with immunotherapy.

“People make the argument that there is a difference” between an expected allergic reaction – such as one that occurs after the administration of immunotherapy – and an unexpected reaction, he said. Because an expected reaction can be treated quickly, “some feel these expected reactions don’t matter so much.”

“Others say a reaction is a reaction” and argue that if, a treatment causes reaction, then it doesn’t make sense, he explained.

It comes down to patients – they must be willing to take a risk to develop tolerance and improve their quality of life – and the allergists willing to treat them.

The peanut powder involves paperwork, preauthorization forms, denials of care, a higher price tag, regimented procedures, and a prerequisite number of visits with patients. “Not everyone will want to do this,” said Dr. Kim.

The regimen involves three phases. During initial dose escalation, five doses are administered in the office on day 1. Then, over the next 6 months, updoses are administered during 11 in-office sessions and a 300-mg tolerance is achieved. Finally, to maintain tolerance to one peanut, daily doses are administered at home.

The drug cost alone is about $4,200 a year, according to Institute for Clinical and Economic Review . Peanut flour from the grocery store is cheaper, but comes with the risk of bacteria or other contamination.

“This product offers some reassurance, and that matters,” Dr. Kim said.

It’s good to have more options for food allergy treatment. “We need a more proactive way to treat food allergy; avoidance is not good enough,” he explained. “And presumably, at some point, the patient will be able to eat a grocery-store peanut instead of buying the pills.”


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