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Drug Alert: First-of-its-kind drug approved for treating peanut allergy

While foods like a peanut butter and jelly sandwich, peanut M&Ms or a Snickers bar might often be considered popular, although not-so-healthy staples for kids, that's not the reality for many. In fact, an allergy to peanuts is one of the most common types of food allergies, affecting about one million children in the United States. Plus, only 1 out of 5 of these children will outgrow their allergy External Site. That means many adults are also dealing with this often lifelong and possibly life-threatening condition that can lead to dozens of doctor visits, plus possible trips to the ER External Site.

There is currently no cure for a peanut allergy, so those impacted must follow a diet to avoid exposure External Site. However, even with strict avoidance, accidental exposure External Site to peanuts can happen. But, a first-of-its-kind drug called PalforziaTM has recently been approved by the Food and Drug Administration (FDA) External Site to mitigate those accidental exposures.

How Palforzia works

Palforzia is delivered orally with a powder made from defatted peanut flour. Patients taking Palforzia start with a very small amount in food, like applesauce or yogurt. The amount of powder added is increased gradually over time, which has been proven to mitigate allergic reactions to peanuts. Palforzia should be used in conjunction with a peanut-avoidant diet.

The approval of the drug was based on a study of more than 500 highly allergic individuals. After six months of therapy with Palforzia, 67.2 percent of recipients tolerated a dose of peanut protein equivalent to two peanuts with no more than mild allergic symptoms, compared to 4 percent of the people who received the placebo.

Palforzia has been approved for individuals age 4 through 17 with a confirmed peanut allergy, and is recommended to be continued when individuals turn 18 years of age, unless otherwise instructed by their provider. It is important to note that individuals who were 18 years or older did not show any benefit from Palforzia in clinical studies.

Palforzia has a list price of $890 per month, or about $11,000 per year.

Palforzia's side effects

The most common side effects reported in individuals treated with Palforzia were stomach pain, vomiting, nausea, oral burning and itching, throat irritation, cough, runny nose, sneezing, throat tightness, wheezing, shortness of breath, itching, hives, anaphylactic reaction, and ear itching.

Due to the risk of anaphylaxis, Palforzia is only available through a restricted program called the Palforzia REMS (Risk Evaluation and Mitigation Strategy) Program External Site. This safety program manages the risk of anaphylaxis associated with Palforzia to ensure the potential benefits outweigh its risks. The program is required by the Food and Drug Administration (FDA) and includes involvement from the prescribing physician and patient prior to and throughout the treatment process.

Coverage decision coming soon

As with all newly FDA-approved drugs, Wellmark Blue Cross and Blue Shield will conduct a thorough clinical review of Palforzia's safety and efficacy. Those findings will be presented to our independent medical and pharmacy experts to review the recommendations and make a decision about the formulary.

If approved, this drug will likely be added to the specialty drug list. At that time, Wellmark will implement a comprehensive utilization management program to make sure Palforzia is only used in appropriate patients.

Questions? Contact your authorized Wellmark account representative or email us at Send Email.