Parents of kids with peanut allergies might have been excited with the news of a new drug therapy approved by the FDA in January.
Palforzia by Aimmune is peanut protein in a capsule that increases a patient’s tolerance to peanuts while decreasing their reaction to them. An initial dose is given in a doctor’s office. A doctor then increases the dose, beginning in their office to make sure the patient can handle that dosage, and then the patient takes it daily at home until the next time they return to the doctor’s office to increase the dose. The highest dose is 300 milligrams, which is about the equivalent of a peanut.
"This is kind of the first glimmer of hope," says Dr. Allen Lieberman of Austin Family Allergy & Asthma. "Parents have been disappointed. There hasn't been any good therapy."
It’s designed to help a patient handle an accidental interaction with peanuts without a severe reaction, but it’s not designed to make the patient peanut-allergy free. The protection from a severe reaction only lasts as long as the patient is continuing to take Palforzia every day. The treatment is for kids ages 4-17.
You cannot take it if you have uncontrolled asthma or eosinophilic esophagitis (too many white blood cells in the esophagus) or other eosinophilic gastrointestinal disease.
Kids also cannot exercise for two hours after each dose, and they have to take it on a full stomach and be awake for at least the next hour.
Of the 500 children in the study, the 67.2% of the kids who got the Palforzia tolerated eating 600 milligrams of peanut protein compared to only 4% of the kids who got the placebo.
Now here’s the rub: Aimmune has set the price of Palforzia at $890 a month or about $11,000 a year. The hope is that insurance companies will eventually cover that cost now that it’s FDA approved.
Before Palforzia was approved, some allergists had been doing a similar therapy for people with peanut allergies.
Lieberman has been offering an off-label treatment for children — and adults — for more than two years. He uses peanut flour in a capsule at first and then has patients work their way up to eating actual peanuts until they get to at most eight peanuts a day. All the initial dosing and updosing gets done in his office to make sure there isn’t a severe reaction.
Like Palforzia, patients cannot have active asthma or have had an recent anaphylaxis incident (a life-threatening reaction) to peanuts. Patients also have to be cooperative. They have to be able to follow directions and eat the peanut flour or peanuts and not stop doing that. Some kids just aren’t that cooperative.
The interesting thing is that most kids who have peanut allergy naturally don’t like the taste of it, he says, so that can make requiring them to eat it difficult.
Parents are looking for therapies like this to avoid their child having a severe reaction if they go to a restaurant or friend’s house and accidentally get exposed to peanuts in their food. It’s not that they don’t want their child to be able to eat a peanut butter sandwich, he says. "It’s if they go to someone's house or misread a label, they don't anaphylax," he says.
"It allows people to open up their lifestyle," he says. "They feel better with traveling; they feel better about eating out in restaurants. It can be really liberating."
With the off-label (because it's not a drug or FDA-approved) therapy Lieberman does, it’s the cost of office visit co-pays and the peanut capsules, which are not expensive, and eventually a jar of peanuts.
"It’s pennies compared to what the drug costs," he says.
He says about 75% to 80% of his patients doing this therapy do well. About 20% to 25% have reactions they can’t bear such as stomach distress.
Parents, though, might be wanting something that is more studied and has regulated dosing that getting FDA approval provides. That’s where Palforzia will be their choice if it can be made affordable through insurance.