Tag: OIT

FDA Approves Palforzia for Treatment of Peanut Allergy

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Our providers and staff at Allergy, Asthma & Food Allergy Centers are excited to learn of the FDA’s decision to approve Palforzia as the first “drug” for the treatment of peanut allergy, as this signifies greater acceptance of oral immunotherapy (OIT) as mainstream treatment for life-threatening food allergies.

Based on our 3+ years of direct experience treating peanut-allergic patients with OIT and the collective 10+ years of experience from other private practice OIT centers across the country, the safety and efficacy data of the Palforzia “drug” is comparable to our method of using readily available sources of peanut protein to perform oral desensitization. This is where the similarities end.

First, the highest treatment dose of Palforzia is 300 mg of peanut protein, about the equivalent of 1 whole peanut or 1/4 teaspoon of peanut butter. Thus, the primary goal of this drug is to raise the threshold of having an allergic reaction to an accidental ingestion of peanut protein (“bite-proof”), which in itself can be a remarkable achievement for peanut allergy sufferers. On the other hand, our protocol is designed to allow patients to reach a daily maintenance dose of 2000 mg (2 grams) of peanut protein, equal to 8 whole peanuts or 2 teaspoons of peanut butter. Furthermore, this maintenance dose actually allows them to safely ingest at least 6000 mg (6 grams) of peanut protein, equal to 24 whole peanuts or 2 tablespoons of peanut butter. This provides the majority of our patients the freedom to eat any amount of peanut protein they wish. That being said, each patient and family may have a different safety goal in mind, and our OIT protocol also provides the flexibility to achieve this goal.

Second, Palforzia is only approved for the treatment of peanut-allergic patients between the ages of 4 and 17 years. Our OIT program has no age limits. In fact, some of our most impressive outcomes have been seen in our infants with peanut allergy!

Additionally, there is no OIT “drug” close to FDA approval for the treatment of food allergies other than peanut. We currently have patients undergoing OIT for egg, milk, tree nuts, wheat, soy and sesame.

Finally, the company that makes Palforzia has set the annual price for their “drug” at $10,680 (or $890 per month) with no guarantee of health insurance coverage at this point. Our current OIT patients/families will spend on average less than $200 in total for peanut flour capsules supplied by a local compounding pharmacy. Beyond that, they are using store-bought roasted peanuts or peanut butter. Palforzia may simply not be a cost-effective option, especially for the level of protection it will provide for those with peanut allergy.

For those of you interested in learning more about all treatment options for peanut allergy, please call our office to schedule an appointment with one of our board-certified allergists. As always, Drs. Borts, Warrier and Vitale are accepting new patients in our main (Sunset Hills, MO) office. Furthermore, Dr. Palis primarily sees new patients in our Swansea, IL office, only 15 miles east of downtown St. Louis.

Peanut oral immunotherapy (OIT)- one step closer to FDA approval

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Many people or families affected by peanut allergy are likely aware that on Friday, September 13, 2019, an FDA advisory panel voted 7 to 2 to recommend Aimmune’s peanut oral immunotherapy (OIT) product originally identified as AR101 (now with the brand name Palforzia). Here is a link to a New York Times article regarding this. While the vote is non-binding, the FDA usually follows their advisory panel’s recommendation. If approved, Palforzia will be indicated as a treatment to reduce the incidence and severity of allergic reactions after accidental exposure to peanut in those aged 4 to 17 years of age with a confirmed diagnosis of peanut allergy. 

The data reviewed by the panel showed a 9.1% risk of anaphylaxis with Palforzia compared to 3.5% risk for placebo with dose escalations (updosing). There was an 8.7% risk of anaphylaxis with Palforzia compared to 1.7% risk for placebo while on maintenance dosing. Epinephrine use during dose escalations was 10.4% for Palforzia compared to 4.8% for placebo, and 7.7% for Palforzia compared to 3.4% for placebo while in the maintenance phase. 

Now let’s review the projected cost for the FDA approved product. Analysts have estimated the cost for Palforzia to be $4,200 a year for an individual patient. This is the cost of the standardized peanut flour alone and does not take into account the cost for office visits. Currently, the cost for peanut allergic patients going through our customized OIT program at Allergy, Asthma & Food Allergy Centers (AAFAC) is approximately $2/capsule, which would total $730/year IF TAKING IT DAILY FOR THE ENTIRE YEAR. As our peanut OIT patients know, if things are going smoothly, after approximately 16 weeks (112 day), our patients have transitioned to actual peanuts (sometimes this transition occurs sooner) for a cost of ~$224, which is obviously much, much lower than the cost of the “drug” Palforzia. Additionally, there is no recurring annual cost since patients are consuming regular store bought peanut products for their maintenance doses.  Some other practices just starting OIT this summer (2019) in the greater St. Louis area are taking another approach. Instead of billing insurance, they offer peanut OIT on a cash basis. At Allergy, Asthma & Food Allergy Centers, the typical expense to reach a maintenance dose is less than $2500, though this depends on an individual’s insurance plan (insurance companies set the amount for office visit copays and deductibles), so the out of pocket expenses could be significantly lower. Our practice goal is to ensure as much access to OIT as we can by making it as affordable as reasonably possible for our community. We know what it is like to have food allergies in our own families- the fear, the insecurity, the near constant worry when our kids with food allergies are in an environment we cannot control- which is the main reason we pioneered OIT in the St. Louis area. We have now expanded to Illinois to give even more patients and families suffering with food allergies additional options for treatment. Our office there is located at 510 Fullerton Road, Swansea, IL 62226.

So what exactly is the “drug” Palforzia (AR101)? While the FDA classifies it as a drug, it is basically standardized peanut flour in a capsule. The standardization is necessary for clinical trials and FDA approval, but there is no evidence that using Palforzia is superior to using regular peanut flour that is commercially available for OIT (as practices across the country have been doing for more than a decade). Nevertheless, we at Allergy, Asthma & Food Allergy Centers are very excited that at least some form of OIT will soon achieve FDA approval. This is a big step in giving more people a choice when it comes to managing peanut allergy, though as mentioned above, people in the greater St. Louis region have had the option of OIT through our practice since 2016, and we currently have patients going through OIT not only for peanut but also for cow’s milk/dairy, egg, wheat, soy, sesame, and tree nuts.

Oral immunotherapy is not for the faint of heart. It takes a lot of dedication and courage from patients and their families. While there are real risks, including both anaphylaxis, eosinophilic esophagitis, and lack of tolerability due to gastrointestinal issues for some patients, some of the concerns regarding anaphylaxis with OIT have been a bit sensationalized. The risk of having a serious reaction when purposely exposed to an allergen is of course higher than when trying to just avoid the allergen, JUST AS IT IS WITH ALLERGY SHOTS for seasonal/environmental allergens. However, both with allergy shots and with OIT, treatment is administered in a controlled fashion, so individuals know exactly what triggered the reaction and how much they consumed compared to accidental exposures to a food allergy. Many people have died from accidental exposures, but there are no known deaths in the U.S. associated with OIT. In fact, when a life threatening reaction occurs with OIT, there is usually an associated underlying circumstance (illness, exercise, hot showers, etc) that led to the reaction.

Going back to the example of allergy shots, you do not hear investigators, the press, or other individuals saying that allergy shots should not be administered due to the increased risk of anaphylaxis. There are generally risks with any form of medical treatment, but the potential improvement in the quality of life for an individual and family after either allergy shots (also done at AAFAC) or OIT can be HUGE, even LIFE CHANGING, as people who have been through these treatments in our office (and other places) can readily attest. While some investigators suggest that there is no evidence of an improved quality of life with OIT, we strongly disagree and address it in a previous post https://aascare.com/food-oit-and-quality-of-life/

Food allergy and OIT have become somewhat of a sub-specialty for allergists, and not all allergy offices will be equipped or even have an interest in offering this treatment. There are reasons for this, and this blog post from OIT 101 addresses this issue.

We at Allergy, Asthma & Food Allergy Centers look forward to continuing to partner with our patients and their families to improve health outcomes for environmental allergies, asthma, and food allergies! Thank-you for your trust and dedication!