What Parents Should Know About New Peanut Allergy Treatments
Palforzia was recently approved by the FDA for the treatment of peanut allergy and is the first “drug” of its kind. (The active ingredient Palforzia is actually a peanut allergen in very small doses, but because it is marketed as a medicinal product it needs to be regulated as a drug.)
Other companies sell products aimed at preventing peanut allergies, and eating peanuts at an early age can help . But this is the first product designed to treat peanut allergy in children who already have it. However, this product has its pros and cons, so here’s what you should know if you’re interested.
Treatment will not make eating peanuts completely safe.
Palforzia is not a medicine and your child will not eat peanut butter sandwiches after taking it. According to an FDA spokesman:
Even with strict avoidance, unintended exposure can and does occur. When used in conjunction with peanut avoidance, Palforzia provides an FDA-approved treatment option that helps reduce the risk of these allergic reactions in children with peanut allergies.
The idea is that small doses of peanut allergen can desensitize your child’s immune system just enough to make accidental exposure to peanuts less harmful. They will still need to avoid peanuts.
Treatment consists of three stages
The first phase, called increasing the starting dose, is a single dose that is administered under the supervision of a physician if a serious reaction occurs. The peanut powder, packed in capsules, is mixed with a semi-solid food such as yogurt, and the child eats that food. Children between the ages of 4 and 17 can start therapy.
Then there are 11 escalating dosage levels, each with a higher dosage of peanut allergen. The first day of each level is also supervised by a doctor, and the rest at home. The process can take several months.
This is followed by the Maintenance phase, in which the person needs to mix a packet of powder into their food every day (again, they recommend something like yogurt).
Effective in many, but not all, patients.
In a trial of about 500 people with peanut allergies, 67% were able to tolerate a 600 mg dose of peanut allergen after a course of Palforzia. This is typical of oral immunotherapy protocols ; others, such as milk and eggs, are also being studied, but so far this peanut product is the only one officially on the market.
If the child does not continue to take the maintenance dose, his or her protection may be diminished. But again, it is difficult to predict how any one will react.
It is expensive
Palforzia’s manufacturer, Aimmune, has set the price at $ 890 per month. No matter what stage of the protocol you are in, it is the same cost. The company offers a support plan that it says can bring personal expenses down to $ 20 a month.
Aimmune told us that it is “available through a medical exception” (meaning you can try asking your insurance company to cover it even if they don’t usually do it) and that they are hoping to get it through most plans this year … …
When I asked if it was necessary to continue the supportive treatment for life, they replied: “PALFORZIA must be taken every day to maintain the healing effect. We expect long-term clinical trials to demonstrate continued benefits from PALFORZIA. ”
The protocol is dangerous, but peanut allergy is dangerous.
Because Palforzia is composed of peanut allergens, the child who takes it can develop an allergic reaction, including anaphylaxis, which can sometimes be fatal even with the best emergency care.
Because of this, treatment can only be carried out in accordance with the terms of the Risk Assessment and Mitigation Strategy, or REMS. This means that doctors and pharmacists must have a special certification to be able to provide it, and there are also rules related to the treatment. For example, your doctor will make sure you have an Epi Pen, know how to use it, and understand that you should still avoid peanut products.
Given the risk and cost, treatment may not pay off for many families. But untreated allergies also carry the risk of anaphylaxis, so overall the risk is worth it. If treatment seems like a good idea for your child, discuss it with your pediatrician.
Updated on 02/05/2020 at 10:00 AM to include new information from Aimmune regarding the service phase and insurance.