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The FDA has recently approved Palforzia for managing peanut allergies, making it the first treatment of its kind. (Interestingly, Palforzia contains peanut allergen in minimal doses, but as it’s classified as a treatment, it falls under drug regulations.)
While other companies have offered products designed to prevent peanut allergies, and early exposure to peanuts might be beneficial, Palforzia stands out as the first solution specifically for children already diagnosed with peanut allergies. However, it comes with its own set of advantages and drawbacks, so here’s what you need to consider.
This treatment does not guarantee complete safety when consuming peanuts
Palforzia is not a cure, and it won’t allow your child to enjoy peanut butter sandwiches post-treatment. As stated by an FDA representative:
Despite strict avoidance measures, accidental exposures to peanuts can still happen. When combined with peanut avoidance, Palforzia offers an FDA-approved solution to help lower the risk of allergic reactions in children with peanut allergies.
The concept behind this treatment is that minimal doses of peanut allergen can slightly desensitize a child’s immune system, making accidental exposures less severe. However, peanuts must still be avoided.
The treatment process consists of three stages
The initial stage, known as Initial Dose Escalation, involves a single supervised dose administered in a medical setting to monitor for severe reactions. The peanut powder, provided in capsules, is mixed into a soft food like yogurt, which the child then consumes. This therapy is available for children aged 4 to 17.
Following this, there are 11 Up-Dosing phases, each involving progressively higher amounts of peanut allergen. The initial day of each phase is conducted under medical supervision, with subsequent doses administered at home. This entire process can span several months.
Next is the Maintenance phase, where the individual must mix a daily packet of the peanut powder into a soft food, such as yogurt, as recommended.
While effective for many, it doesn’t work for all patients
In a study involving approximately 500 individuals with peanut allergies, 67% were able to tolerate a 600mg dose of peanut allergen after completing the Palforzia regimen. These results are consistent with those seen in other oral immunotherapy approaches, such as those for milk and egg allergies, which are still under research. However, Palforzia remains the only approved product of its kind on the market.
If the child stops taking the maintenance dose, their level of protection may diminish. However, individual reactions can vary and are difficult to predict.
The treatment comes with a high price tag
Aimmune, the manufacturer of Palforzia, has priced the treatment at $890 per month, regardless of the treatment phase. The company provides a financial assistance program that claims to lower monthly costs to as little as $20.
A representative from Aimmune mentioned that the treatment is 'available through medical exception,' allowing patients to request insurance coverage even if it’s not typically included. They are also working to secure coverage under most insurance plans within the year.
When questioned about whether the maintenance phase is lifelong, the response was: 'PALFORZIA must be taken daily to sustain its effectiveness. Ongoing clinical studies are expected to demonstrate the long-term benefits of continuing the treatment.'
While the treatment protocol carries risks, peanut allergy itself is equally hazardous
As Palforzia contains peanut allergens, there is a risk that children taking it may experience allergic reactions, including severe anaphylaxis, which can be life-threatening even with prompt emergency treatment.
Due to these risks, the treatment is only available under a Risk Evaluation and Mitigation Strategy (REMS). This requires doctors and pharmacists to obtain special certification to prescribe or dispense it, and strict guidelines must be followed. For instance, your doctor will ensure you have an epi-pen, know how to use it, and understand the importance of continuing to avoid peanut products.
Given the potential risks and high cost, many families may find the treatment impractical. However, leaving a peanut allergy untreated also poses a significant risk of anaphylaxis, making the treatment a potentially worthwhile option. If you believe this therapy could benefit your child, discuss it thoroughly with their pediatrician.
Updated 2/5/2020 at 10am to include new details from Aimmune regarding the maintenance phase and insurance coverage.
