Why It’s Okay That Palforzia is Going Away

In this new episode of “Food Allergy and Your Kiddo,” Dr. Hoyt discusses the recent news regarding Palforzia, the first FDA-approved treatment for peanut allergies, which is set to be discontinued. She explains how Palforzia works, its significance in oral immunotherapy (OIT), and the implications of its discontinuation for patients. Dr. Hoyt also addresses the challenges and limitations of Palforzia, including insurance coverage and the preferences of parents for more accessible alternatives like peanut butter. The conversation emphasizes the importance of discussing transitioning options with allergists and the ongoing viability of OIT without Palforzia.

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Transcript

How Palforzia And Xolair Work

Palforzia Discontinuation Announcement

Why Palforzia Didn’t Catch On

The Case For Food-Based OIT

Safety, Billing, And Practical Barriers

Transitioning Off Palforzia

Final Thoughts And Resources

SPEAKER_01 0:04

Hello and welcome to Food Allergy in Your Kiddo. I'm your host, Dr. Alice Hoyt. Today we are talking about palphorsia. Yes, palphorsia. Don't talk much about palphorsia for all the reasons that I'm going to talk about today. But there is some pretty big news with palphorsia. Palphorsia, if you're not aware, is the only FDA approved product. It's not really a drug, it's food, that is approved for peanut allergy. Just peanut allergy. Yes, omalismab. Zoleir is absolutely approved to prevent anaphylaxis in people who have anaphylactic or potentially anaphylactic food allergies. It works, as I've talked about before, zoleir works by basically binding up your allergic antibodies, all your allergic antibodies, and pretty much making it very hard for your allergy cells to become activated because those allergic antibodies aren't hanging out on the allergy cells, aren't really able to activate the allergy cells because they're being gobbled up by the zole air. So how does palphorsia work? Palphorsia is defatted peanut flour that kiddos, adults could take it too, take small amounts of, use it for oral immunotherapy, small amounts of it that there's dose dose packs. I'm going to talk about it. But basically it helps grow tolerance to peanut so that somebody who takes palphorsia is able to get up to maintenance, which is about three, which is 300 milligrams of peanut protein, which is about the same as one average peanut. If a kiddos on maintenance palphorsia, then they're essentially eating a peanut a day. So if they were to accidentally eat peanut or eat a peanut, then we already know they're they're eating a peanut a day, basically. And so it's highly unlikely they would have a severe allergic reaction. Um so then why is palphorsia um in the news? It's because palphorsia is dis being discontinued. I'm going to read what they say on their website today. Um Stallergen's Greer, that's who owns palphorsia, will discontinue the commercialization of palphorsia. Peanut, arakus hypogea. It's a fancy scientific word for peanut. Um, and that's why, tangent, that's why if you're looking at peanut component tests, like Era H1, Era H2, Ig E, it's Arakis Hypogia, hypogea, however you want to say it. That's the scientific name for peanut. Era H, and then whichever protein it is numbered, usually in the order of discovery. So I'll start over. Stallargen's career will discontinue the commercialization of palphorsia allergen powder DNFP as of July 31st, 2026. This voluntary discontinuation is not related to product safety, quality, or efficacy. So it's not related to the safety, the quality, or the efficacy of the product. Styler Jeans Gareer will continue to meet all regulatory obligations throughout the window period and will support an orderly transition for patients currently receiving therapy. Styler Jeans Greer remains committed to patient safety, regulatory compliance, and supporting healthcare professionals and patients during this transition. If you have any questions, they give you the phone number you can call. Um and the Palforzia Pathway Patient Hub and Walgreen Specialty Pharmacies will accept the last new patient starts on January 30th, 2026. After this date, no initial dose escalation cards will be dispensed. No new Palforzia patient prescription enrollment forms submitted to the patient hub via fax directly to Walgreens Specialty Pharmacies or through the quick enroll portal will be processed after December 31st, 2025. That's in the rearview mirror, y'all. January 30th is about to be in the rearview mirror. Actually, it might be at the time this gets published. Uh, patient prescription enrollments currently in process will continue be triage to Walgreens specialty pharmacies through January 30th, 2026. After this date, any current enrollments will be canceled and no longer processed. Um so that sounds kind of sad and scary, right? Like, wait, this is like the only FDA approved product to use for peanut OIT. What are we gonna do? Well, let me tell you what we're gonna do. We're gonna keep doing OIT the way we most OIT allergists, many, have been doing it without Pauforsia. And what I want to read, doing a lot of reading today. What I want to read is a blog post that I wrote. What did I originally write this? A couple years ago. On, I'm not gonna read it verbatim. You can go to foodallergy in your kiddo.com, search our very cool kiddo content collection, where I've been doing this for many years now. So we have a bunch of content on foodallergy in your kiddo.com. You can go to the kiddo content collection and type in palforzia, and this beautiful, in my opinion, product review for palforisia for peanut allergy will come up. Um, so I have not updated this. This is my top seven reasons. Um why back then Palforsia didn't catch on. And so you heard when I was reading from the Palforzia website that the voluntary discontinuation is not related to product safety, quality, or efficacy. So it's not that the product's unsafe, it's safe. It's not that there's a quality problem, and it's not that it's ineffective. So what is it? Well, in a nutshell, no pun intended, it's probably that you can do the same exact thing using peanut butter, which costs significantly less, and spoiler alert, has significantly less regulatory uh burden, not just for the family, but also for the physician prescribing it. Many allergists, if they have not started doing OIT, if they don't focus in super subspecialized, whatever we want to call it on food allergy. The concept of starting a service line, meaning starting to do OIT with Palforsia to me seems very like, whoa, this is this is a lot, and I'm gonna tell you why. Uh long story short, it just really overcomplicates it. It overcomplics complicates OIT. But I'm I'm gonna give a big shout out to Palforsia because thank you for existing. Um depending on where you are in your family's food allergy journey, you might not know sort of the history of doing oral immunotherapy and how up until very recently, for an allergist to do OIT oral immunotherapy, give somebody their kiddo patients, adult patients, mostly kiddos, small amounts of the allergen increasing over time, teaching the body to tolerate it. That's OIT. Lots, lots of episodes on that. Go to the kiddo content collection, check it out. The concept of doing that outside of a of a research study was significantly frowned upon by academia, by allergists doing the studies, by um health healthcare leaders. Academic medicine is not what it used to be. Um so there there was a lot of pushback and a lot of like getting kind of personal with the thought of oh my gosh, you were doing OIT and you're not doing it in an IRB-approved research study. Up until very recently, there has been data for years demonstrating that oral immunotherapy, just like allergy shots for pollen allergies, which we've been doing for decades and decades and decades, that it works. Low and slow, slow and steady, teaching the body to grow tolerance. Whether you're you're doing that to poll, whether you're doing that to be venoms, or whether you're doing it to foods. The concept that low and slow increasing amounts of gross tolerance is a well-documented one. So it was it was only until very recently when it when it wasn't frowned upon to buy academic missions, also probably by people who are just like well-intended and were like kind of afraid of this, right? Had a lot of respect for, oh my gosh, what if we what if we give somebody too much, too fast? You know, what if we take a condition like a peanut allergy will where the completely appropriate one completely appropriate management plan is to just avoid it, right? Just just avoid it. Don't eat it. Um, and what if we make a child very sick or or actually a child pass away from anaphylaxis from doing oral immunotherapy when you you could have just avoided it. Right. So I have a lot of respect for palphorsia because once palphorsia came on the market, what it really did is it demonstrated, look, OIT works. OIT works, we can safely desensitize kiddos. We can safely get kids eating at least small amounts of their allergen and not having severe allergic reactions two years ago, I think, when I wrote this, why didn't palphorsia catch on? I have a list. Number one. Allergists have been doing OIT before there was an FDA-approved product, so why change? Yes, very true. So many of the allergists that I learned about OIT from, they'd been doing OIT long before Palforzia came out, using real foods. Um, so the concept of changing what you already see has been working, that's hard. We don't like, we don't really like to change things. If it's working, if it's working well, there's not a good reason to try to change it. Why are we going to do that to a patient? Number two, allergists who are not doing OIT. Sorry, if you hear me rubbing my hands the other, it's because it's cold in my office, because it's cold everywhere right now. Um, number two, allergists who are not doing OIT prior to palphoria may not find palphorsia particularly user-friendly for themselves or for their patients. So here we go. Palphorsia must be refrigerated, and in many cases, patients are shipped their doses from the company. The doses come in capsules that contain specific amounts of peanut powder, and those capsules are open and mixed into small amounts of applesauce or other food to be ingested by patients. Dose changes can be logistically challenging since the company sends the doses, and if the doctor wants to decrease the dose to an allergic reaction or some other reason, then the family may not actually have that amount, that dose, because they get the doses in the capsules. Um, and so the doctor needs to have a supply of different dose packs in their office, which can be burdensome for the allergists. Um, and then what if what if your patient lives like five hours away from you, right? Like, so it's it's doable, right? And if there were no other option, then like, hey, I love options. Like it's it's great to have an option. Um but when you could just use peanut butter or PB2 powder or peanut puff or some other food that has just straight peanut where you can very clearly calculate the peanut content, then what what why? Why are you gonna overcomplicate it? Um, number three, the age is approved for palphoresia. Yeah, this is old. Um, four to 17 years, exclude babies in most preschoolers. Okay, so it did drop down. It did drop down. Um, but really when we should start OIT is as soon after the diagnosis is made. That means if a five-month old tastes peanut butter, has high facial swelling, check labs or check skin testing, it's positive, we need to start immunotherapy immediately. Immediately. Because that is going to help that child's immune system grow to tolerate the food. The longer they go avoiding a food, we know this. The longer they go avoiding the food, the more that allergy kind of sets in. Because the less we're doing to intervene to grow tolerance to the food. Um, number four, palphorosia isn't always covered by insurance. Um, and at that time it was the case for both private insurance and Medicaid. Um, and this is where it gets really complicated. Number five, OIT doesn't have a clear billing code for doctor's appointments. So doctors do not get paid to prescribe a medication. That's very frowned upon. We don't get paid like, okay, you're gonna prescribe this amount of the medicine, you're gonna get paid this much. Um, doctors get paid in most cases by the service, the services they provide. So when a patient, when you go in to see a patient, or when I'm sorry, when you go in to see your allergist, that allergist, if if what y'all are doing that day is sitting down, talking through um your child's case, making management plans, then you'll be billed for an office visit. Office visit, the doctor's taking time to talk to you. That billing can um it is of varying levels from pretty basic to very complex. That's one way to bill um an office visit when a patient comes, when patients come in to see us. Another way that doctors bill office visits is by time the amount of time that they spend with a patient. Um, but there's not a way to bill for OIT. There are ways to bill for allergy shots. There are ways to bill for all of these other procedures. But when a patient comes in to have their oral immunotherapy dose in the office and they sit there for at least two hours for the start appointment or one hour for updose appointments, there's not a clear CPT code or a way to bill that. And so allergists have been left to figure out the legal, because also when you start getting government insurance involved, you start dealing with legal stuff, and nobody wants any sort of like Medicare, Medicaid fraud situation going on. But dealing with legal, um, how do we build this? How do we how do we build this appropriately? Um, and so a lot of times the billing is just built on an office visit. So whenever an insurance company reimburses the doctor to talk about allergies, that's what they're being reimbursed when they come in um to the office to do when the patient comes in the office and and take a dose of OIT. Now, a dose of OIT has a risk of anaphylaxis. Anaphylaxis has a risk of death. And so you can see this kind of goes back to one of my other points is taking on a service line like oral immunotherapy, there is a risk to it. And you want to be, as an allergist, you want to be really prepared. If you're gonna start a service line, you want to be prepared to make it amazing, right? You don't want to halfway do this stuff, especially when you're dealing with something that can potentially cause anaphylaxis. You have to have all your ducts in row, you have to have the resource, you have to be able to be on call when patients have questions, like all the things, right? So not having a clear way to bill for it, which means you're expending resources on something that's incredibly important, incredibly of value, but can also have risk, also requires staff, right? Requires you as the allergist to be on call, to be there, all these things, right? Um if if you can't get paid for that, or it's unclear how you get paid for that, or you don't feel like it is paying for itself, it's really hard to take that on. Number six, OIT is time-intensive, whether using a pharma-developed product or a pantry item. Um, yes, absolutely. Um what did I write here? When you need your child's medicine, you need your child's medicine. Having to wait for a shipment um from a pharmaceutical company is not attractive, um, or not from the pharmaceutical company, from from the dispensing pharmacy. Um and and it just takes time. So number seven, and this is probably one of my favorites, if not the favorite, simple parent preferences. As a parent, if I'm giving something to my child, I would like to be able to taste it. If I have the option of treating my child with a pharmaceutical product or peanut butter that I can go to the store that I can taste, that I can help normalize for my child, right? So I'm eating it too, they can they get to take little little bits, we increase the amount. Um that's that's the way I want to do it. That's that's what when palforzia was first coming on the market, I would ask my patients, I was like, so what do you think about this? And they would just rather use use a product that that they're going and they're buying. They, you know, they come, they know it's coming from their trusted uh supermarket. Not that the the pharmacy can't be trusted, but it's just it's just different when it's a pharmaceutical product compared to peanut butter. So that in a nutshell um is why I suspect in part palphorcia hasn't done well. Now, to get palphorsia approved, it required very good studies that were very well done. Um and all of that costs so much money, right? And and getting a drug over the finish line costs more money than I can probably really even understand. Um and so while it's look, I never like to see an option go away. None of my patients have ever chosen palphorsia when we talk about the other options, but I like options. And it's also it's it's just not good for options to go away. What I wish would have happened is I wish we could have. I wish we had a CPT code for it. Um, though, just because you get a code for something, uh just because you get a procedure code that you can build, doesn't mean that insurance or whomever is going to, probably more private insurance, I should say, is going to reimburse you what you think you should be in reimbursed for that service. But it's it's really hard to ask doctors to take on this service line that does pose risk, that does require after hours discussion in many cases, if it's gonna actively cost their practice money and increase the risks at uh of kids having reactions, right? So it's very interesting. Um if you are concerned, if you are on palphorsia, you're like, oh my gosh, what am I gonna do? We've been on palphorsia. Your allergist should be able to transition you pretty easily to PB2 powder or peanut butter. Um, how palphorsia works is that it's peanut powder. It's peanut protein in there. That's what's so important about any product you're using for oral immunotherapy is you have to have the allergenic protein in it. Um so if you're concerned that you won't have anything to transition to, please talk with your allergist about it. Uh they're they're Are many options in transitioning if you're somewhere in buildup or if you're on maintenance? Also, depending on your kiddo's age, staying on maintenance or trans transitioning off of palphorsia and onto peanut butter. I love peanut butter. I think I've talked about peanut butter probably ad nauseum regarding OIT. Um, because peanut butter sticks in your mouth, it's tacky. The mouth is where a lot of the magic happens with developing tolerance. And that's what we're really seeing as more good data come out about how sublingual immunotherapy can be so powerful. If you haven't listened to or watched on our YouTube plug for our YouTube channel, Hoit Food Allergy. Um, if you haven't listened or watched the episode where I discuss with Edwin Kem his slit study, you should definitely go back and listen to that. All this to say that palphorsia is going away. You have other options. Talk to your allergist, options that are probably going to be better for you. But that all is my two cents. I would love to hear your two cents. So drop them in the comments. Go to food allergy in your kiddo.com, sign up for my newsletter, Joyful Living. Y'all know I'm all about less stress, more joy. We don't need to sensationalize, fear monger, or anything when it comes to food allergy. Just talked about the facts, right? And opinions. Right? So I hope you've enjoyed this episode. God bless you. God bless your family.

SPEAKER_00 24:19

Thanks so much for tuning in. Remember, I'm an allergist, but I'm not your allergist. So talk with your allergist about what you learned today. Like, subscribe, share this with your friends, and go to foodallergy in your kiddo.com where you can join our newsletter. God bless you and God bless your family.