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Palforzia is the food product approved by the FDA to treat peanut allergy. In this article, I review Palforzia and why it hasn't taken off in popularity.
As a board-certified allergist, I am constantly evaluating and re-evaluating therapies to effectively treat food allergies. I've written and spoken at length about oral immunotherapy, which is the most mainstream treatment for food allergy (keeping in mind that avoidance is not a treatment, per se, for food allergy though is absolutely a management strategy). In more recent years, I've discussed sublingual immunotherapy with the Food Allergy and Your Kiddo audience. I offer both OIT and SLIT at the Institute.
I'm asked by my colleagues if I offer patients Palforzia. I do, but rarely are patients interested. "Why would we use that if we could use peanut butter?" There's really no good answer. But let's dive deeper into why, in my opinion, Palforzia did not launch like some thought it would, and is Palforzia a good option to treat peanut allergy.
Before I start, what really is Palforzia? Per the Palforzia prescribing information:
"PALFORZIA (Peanut (Arachis hypogaea) Allergen Powder-dnfp) is a powder for oral administration. PALFORZIA is manufactured from defatted peanut flour. PALFORZIA is available in capsules containing 0.5 mg, 1 mg, 10 mg, 20 mg, and 100 mg peanut protein, and a sachet containing 300 mg peanut protein. Each dose meets specifications for quantities of Ara h 1, Ara h 2, and Ara h 6, measured by immunoassay alone or in combination with high performance liquid chromatography. Depending on the dose level, PALFORZIA contains the following inactive ingredients: microcrystalline cellulose, partially pregelatinized maize starch (0.5 mg, 1 mg, 10 mg, 20 mg capsule presentations only), magnesium stearate, and colloidal silicon dioxide."
In short, Palforzia is peanut flour that's been aliquoted into specific doses, and those doses are contained within capsules. Capsules are not swallowed - capsules are opened, and the flour is dropped onto yogurt, pudding, etc., then consumed by the patient.
Okay, so why hasn't Palforzia really caught on with allergists?
#1 Allergists have been doing OIT before there was an FDA-approved product (so why change?).
Allergists were doing OIT long before Palforzia came along. For years now, OIT allergists have been using store-bought products - ie real foods - to teach the immune system to tolerate foods. Products include supermarket-sold peanut flours, powders, and butters. For other food allergies, pasteurized liquid egg whites and pasteurized cows milk have been used. It's hard to justify a change without a good reason, especially when protocols using easily-accessible foods have worked well using the same approach proven by Palforzia studies to induce tolerance - small, increasing amounts of allergen over a prolonged period of time.
#2 Allergists who were not doing OIT prior to Palforzia may not find Palforzia particularly user-friendly for themselves or for their patients.
Palforzia 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 opened and mixed into a small amount of apple sauce or other food to be ingested by the patient.
Dose changes can be logistically challenging since the company sends the doses, and, if the doctor wants to decrease the dose due to an allergic reaction or some other reason, the family may not have the dose to which the doctor would like to decrease. While doctors are provided an office supply to help with this, it's still a burden for the doctor to store and for the patient to have to drive to the doctor's office for this (especially when some allergist office's are hours away from a patient's home). It's doable, but it's much less convenient than simply using peanut butter and changing the amount to whatever smaller measurement your doctor advises.
#3 The ages approved for Palforzia (4-17 years) exclude babies and most preschoolers.
This early childhood age often is a great time to do OIT because the immune system is more plastic when a child is younger and, thus, tolerance is more easily developed.
It's also easier for younger kiddos' schedules as opposed to the schedules of older kids and teens.
All OIT protocols (pharma and "supermarket" OIT, as I call it) require a safety window, meaning a time before and after dosing where the patient needs to be relatively calm and can't do activities that increase heart rate or body temperature (because these increase the risk of allergic reaction).
The safety window is typically one hour prior to dosing and two hours after dosing. This is doable in older kids, but it definitely can take some scheduling acrobatics, plus younger kids are less likely to have severe reactions than older kids. That said, all kiddos are different, and OIT can safely be done in all ages (so if your kiddo is older and about start OIT, be encouraged! Slow and steady and it's not a race!).
#4 Palforzia isn't always covered by insurance.
This may be the case for both private insurance and Medicaid.
And it gets more complicated (keep reading - #5 below...)
#5 OIT doesn't have a clear billing code for the doctors appointments.
This is kinda in the weeds but important, and it applies to supermarket OIT too.
Billing codes allow doctors to bill their patient-encounters to insurance companies and, thus, be reimbursed for their services (i.e. this is how doctors get paid). There is no specific billing code for OIT. This means that doctors, especially those new to OIT, may be uncertain about how to bill for visits for OIT, and these visits can last hours and potentially result in allergic reactions - from a practice model standpoint, that means a lot of resources are being utilized, and these resources cost money. If a doctor can't confidently bill for these potentially high-resource OIT appointments, they are less likely to begin offering the service.
Also, to do OIT well, an allergist needs to be available after-hours and on weekends to assist families with dosing questions. That's asking a lot of anyone, much less a physician who doesn't really have a good way to bill for those services within the current insurance model.
One issue I've seen recently is that, now that there is an FDA-approved product (Palforzia), insurance companies are clamping down on using peanut butter since it has not been FDA-approved. The term "experimental" rears its head despite the evidence for using foods, like peanut butter, to induce tolerance (where do they think the whole idea for Palforzia came from? It's just peanut powder!!!). I'd like to think this is ignorance on the part of the insurance company, that they simply don't know that Palforzia is just a food and not some sort of magical, unique powder, but it's hard not to assume that this actually is just another way insurance companies try to avoid paying for needed services.
#6 OIT is time-intensive, whether using a pharma-developed product or a pantry item.
When you need your child's medicine, you need the medicine. Having to wait for shipment is not an attractive quality of any product. Say you forgot your Palforzia when packing for a trip or it got lost during travel - it's just easier to be able to go to the grocery store and buy a jar of peanut butter than request more meds from a company.
#7 Simple parent preferences.
Parents tend to prefer giving their children something they - the parents - can also taste/eat (compared to a pharmaceutical product that they - the parents - can't taste as that would be taking away some of their child's dose.
Also, parents like the idea of treating their child with the food they'll actually end up eating. And the same food that their siblings eat.
I've heard this from parents since before Palforzia launched and it continues to ring true. Many parents would just rather use supermarket products than a pharma product.
So that's my two cents on Palforzia for peanut allergy.
That is not a comprehensive list as there are other reasons why allergists are choosing not to offer Palforzia and, in some cases, why their institutions are not allowing them to offer it. Many of the issues are due to logistics, not science.
That said, Palforzia works. It's a blessing that it's gotten this far because it has gone through all the hoops to truly prove that OIT is able to decrease the likelihood of having a life-threatening reaction to a food. When you have options, you have choices and the freedom to make the best choice for your kiddo.
