FDA-Approved Peanut Immunotherapy Protocol Comes With a Cost

Ingrid Hein

November 15, 2020

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.

Edwin Kim

"Finally we have another treatment option," said Edwin Kim, MD, from the UNC Allergy and Immunology Clinic in Chapel Hill, North Carolina. "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 to 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 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 Kim.

This product offers some reassurance, and that matters.

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 $4200 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," 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."

The Art of Medicine

But not all allergists will be able to make the protocol work. And it's not clear whether there is room to alter treatment and offer patients with a higher tolerance a higher starting dose. What we do know, though, is that "the product leaves little room for 'the art of medicine'," Kim said.

Arnon Elizur

That art is practiced by Arnon Elizur, MD, from the Shamir Medical Center in Tzrifin, Israel, but it's backed by a rigid home-grown protocol.

Since 2010, he has treated 1800 patients for peanut allergy, updosing slowly to a tolerance of 3000 mg of peanut protein, the equivalent of 10 peanuts. He keeps the maintenance dose at four peanuts (1200 mg). His center takes a personalized approach, starting patients on the highest dose they can tolerate and working up, with daily patient check-ins from home and a staff available around the clock to answer questions and deal with reactions.

"We aim for full desensitization," Elizur told Medscape Medical News.

The peanut pill is "a big step forward" for immunotherapy, he said. It is "a standardized product, checked for bacteria and allergen content, which is available to a wide community of physicians."

But, he pointed out, "it's expensive." And it's only for peanut. "There are millions of food-allergic patients around the world. We don't want to wait for years for a product for all of them. We can use the actual food."

He questions the lifelong maintenance protocol with a daily 300 mg pill. "If you can't eat a peanut, why would you buy a drug that's a peanut?" he asked.

He also said he's disappointed that the product is not indicated for adults.

At the Shamir clinic, reactions are closely monitored. "Some are mild, others we treat with autoinjectors, epinephrine," he reported. "Those are the most undesirable."

Data from his center show that home reactions occur in about 15% of patients. But his treatment success rates are good. In an average of 8 months, he is able to get 90% of patients to full desensitization, and about 80% of adult patients.

But it's not for all patients or for all clinics, he acknowledged. "We continue to look at this balance in quality of life throughout the process. Our goal is to improve the quality-of-life threshold."

Treatment that involves "native food" is "a lot of work" and requires "a lot of investment," Elizur said. His center uses a web reporting system to maintain a 24/7 dialog with patients, "and we look at the reports every day." They also have a physician on call at all times. "Not everyone can commit to providing care throughout the day and night."

His center charges the equivalent of $US3000 per food allergy treated. "That's whether it takes 6 months or 2 years," he said.

There are more than 1000 people on his 3-year waiting list.

Immunotherapy is not easy to do, whether it's FDA-approved or not.

"This is the first year that the American College of Allergy, Asthma, and Immunology is not hosting a pro–con debate on oral immunotherapy," Kim pointed out. "We have a therapy now."

However, the pandemic has slowed treatment uptake. "Immunotherapy is not easy to do, whether it's FDA-approved or not," he explained. With at least 11 doctor visits in the first 6 months — each visit is between 30 minutes and 2 to 3 hours — it hasn't been possible to set up this year. "It's not ideal."

It will be interesting to see "how this will roll out and how it will be adopted," Kim said. "From a food allergy point of view, the next 12 months are going to be very interesting."

Kim reports receiving consulting honorarium from Aimmune, the maker of Palforzia; being on the clinical medical advisory board for DBV Technologies; and consulting for DBV, Aimmune, Allakos, Allergenis, Ukko Incorporated, Vibrant America, Duke Clinical Research Institute, and Kenota Health. Elizur has The disclosed no relevant financial relationships.

American College of Allergy, Asthma & Immunology (ACAAI) 2020 Annual Scientific Meeting.

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