Ep. 266: 'Get neffy on Us' Program

Over the past year, the food allergy world has seen some truly exciting momentum—from new treatment approaches to innovative ways to deliver life-saving epinephrine. One breakthrough that has sparked a lot of conversation is the first FDA-approved epinephrine nasal spray, offering the first needle-free option for emergency allergic reactions.

We’re thrilled to welcome someone at the center of this innovation: Rich Lowenthal, Co-founder, President, and CEO of ARS Pharma—the company behind neffy®. Rich joins us to give an inside look at neffy’s milestone year, what’s ahead for this new treatment option, and how ARS Pharma’s 'Get neffy® on Us Program' is helping expand access for families nationwide.

Resources to keep you in the know:

• Get neffy® On Us
• neffy®
• neffy® in Schools
• ARS Pharma

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Sponsored by: ARS Pharma

Thanks for listening! FAACT invites you to discover more exciting food allergy resources at FoodAllergyAwareness.org!

Transcript

Caroline: Welcome to FAACT's Roundtable, a podcast dedicated to navigating life with food allergies across the lifespan. Presented in a welcoming format with interviews and open discussions,

each episode will explore a specific topic, leaving you with the facts to know or use.

Information presented via this podcast is educational and not intended to provide individual medical advice.

Please consult with your personal board-certified allergist or healthcare providers for advice specific to your situation.

Caroline: Hi everyone, I'm Caroline Moassessi and I am your host for the FAACT Roundtable podcast. I am a food allergy parent and advocate and the founder of the Grateful Foodie Blog. And I am FAACT's Vice President of Community Relations.

Before we start today's podcast, I just want to say thank you to ARS Pharma for their kind sponsorship of AFACT's Roundtable podcast.

Over the past year, the food allergy world has seen some truly exciting momentum from new treatment approaches to innovative ways to deliver life saving epinephrine. One breakthrough that has sparked a lot of conversation is the first FDA approved epinephrine nasal spray offering the first needle free option for emergency allergic reactions.

Today we're thrilled to welcome someone at the center of this innovation,

Rich Lowenthal, Co-Founder, President, and CEO of ARS Pharma, the company behind neffy. Rich joins us to give us an inside look at neffy's milestone year, what's ahead for this new treatment option, and how ARS Pharma's Get neffy On Us Program is helping expand access for families nationwide.

Welcome back Rich to FAACT's Roundtable podcast. We're so happy to have you here. So much has happened in the last year and it's just exciting. So thank you for making the time to catch up with us today.

Rich: No, very happy to be here and thank you for inviting us.

Caroline: You're very welcome.

Before we dive in, let's start at the very beginning. So for listeners who might be new to neffy, can you walk us through what it is,

how it works and then the spark that led you to co-found ARS Pharma. What was the passion behind this innovation? I mean this is a big deal difference in our world.

Rich: Yeah, well, neffyi is a needle free epinephrine product that is sprayed into your nose. You don't have to breathe in it, just spray it into the nose. It gets absorbed in the nasal mucosa and basically gives the same pharmacokinetics and response as injection.

So the same amount of drug gets into your bloodstream and as rapidly as injection products.

You know, we'll talk about a little bit later. We've recently collected a lot of real world data as well that demonstrates it's working as well as injection, which is good.

It's really, we think, a big advancement after more than 35 years since EpiPen to allow people to have with them at all times in the community setting epinephrine so that they could treat an allergic reaction really immediately.

Cause the sooner you treat, the better the outcomes, the faster it resolves the allergic reaction.

And we know that people often are very nervous to use an injection product. They don't like to inject themselves or their children.

And so having an option which is very simple to use, so it's not intimidating. The device is very simple.

Just place it in your nose and press the plunger and it fires. And that's it. And it takes a fraction of a second and you or the child is medicated.

And then you can hopefully get quick response. Usually within about five minutes you see a response. If not you take a second dose, just like injection.

But it's less intimidating. So we're hoping people will carry it more often and they'll be more willing to use it quickly.

And if people use it more quickly, it will result in better outcomes, better clinical outcomes, because we know that the sooner you treat that allergic reaction, the better it's going to be.

So people hesitating or refusing to inject really leads to a lot of the worse outcomes in this disease.

And just to answer the second part of your question, what kind of sparked us to do this?

I had worked on some epinephrine products in the distant past,

but then also more recently I was one of the representative of FDA and got Narcan approved as well as a product for epilepsy called Valtoco, which are both nasal sprays.

And in working on those products and working with the company that owns a very unique absorption enhancing technology for nasal absorption, we decided to start a company and license that technology to use with epinephrine.

And it's been a long road, but it worked out well and it actually works quite well and got approval now worldwide, really, because we also approved in Europe and Japan and just recently Australia,

and we're waiting on Canada. And also we're approved in the UK separately from Europe. So it's being approved worldwide.

Caroline: This is really exciting. Worldwide listeners. Just so you know, my son and daughter are 27 and 22.

So 25 years ago when we started this process, we never thought ever there would be these types of options because hesitation's a real problem.

And this is just so Exciting to see all this innovation happening.

This past year has just been a whirlwind for both the food allergy community and at ARS Pharma, with neffy offering a brand new way to deliver epinephrine. Actually, the first time in over 35 years, so much longer than my kids have been alive.

What has this year been like from your perspective? What milestones just stand out for Ars this year?

Rich: I mean, obviously we've had some very key milestones,

the biggest being the approval of the 1mg. So we had 2mg approved for 30kg and above later last year, so in August. But then we launched in October and made it available this year we got approval of the 1 milligram dose.

So that's for the 15 to 30 kilogram children.

And we think that's really exciting because the smaller the child, I think the bigger the needle, the bigger issue the needle is,

and the more parents are reluctant to inject them and the more scared they are of being injected, of course.

So we think that that's huge benefit. And of course, we are also working maybe 20, 27, we'll have approval of even a lower dose for seven and a half to 15 kilogram children.

And we're working on that now and should start the clinical study in early next year.

So we are working towards, you know, making sure the kids especially have an option and the parents can have a product. So that's really, I think, the one big milestone.

I mean, obviously approval in Japan and approval in the UK is a. Is also a big milestone for a company to see that other regulatory authorities are approving neffy very quickly and that they have confidence that it's going to work as well as injection.

Caroline: Thank you. And, you know, can you stop for just a quick moment and explain the size of the neffy, because it's not very big.

Rich: So neffy is really a kind of a small nasal spray device. And if you've ever seen the device used for Narcan Nasal, neffy is the same device. So it's a small sprayer.

Basically, you put your two fingers on the top of it and your thumb on the plunger.

It fits right into your hand that way and you just place it in the nose and then press the plunger. So we also provide a case.

Right now you have to ask for the case separately on our neffy.com website.

But we're working to put the case into the box with neffy when we manufacture it at the plant,

just waiting for FDA to approve that.

And then that will come with the two sprayers. So in a box you get the two sprayers and then place them in the case. The case is easy to carry.

So this fits in your pocket. It's about half the size of an iPhone, so quite easy to put into your pocket. It also can clip onto a bag. It has a clip on it so that you could hook it to a bag.

Even if you're really excited about having that, you can hook it to your belt buckle. So either way. But we're trying to make it very easy to carry so it's with you at all times.

And it's just a small spray device, it's single use. So once you use it, you throw it away and there's no priming, there's no activation, nothing. You don't have to do anything but place it in the nose and then press the button and that's it.

Caroline: Thank you. I just wanted to make sure listeners understood how mobile this is.

Now that neffy has been in the hands of doctors and patients,

can you share what the real world evidence is showing us about how neffy performs outside of the clinical trial setting?

Rich: Yeah, so we actually have close to 3,000 physicians that we gave neffy to as part of what's called the neffy Experience program. And the idea of the neffy Experience Program is the doctors are using neffy in their clinics when they're doing oral food challenge or immunotherapy and treating patients that have an anaphylactic reaction in the clinic.

And this gives the doctor that firsthand experience of using neffy I so that they have that confidence and they can explain to a patient or a mom and dad that they've used it themselves.

And it seems to work very, very well, just like injection. And that's a very, very important message for them to be able to provide.

Now, as part of that,

we recently collected data from 375 of those doctors who have used neffy. And it's in a total of about 680 patients that had anaphylaxis.

And this is as of about September that we've collected that data, and we just presented it at the American College for Asthma, Allergy and Immunology,

which was just held in Orlando last week, in fact last weekend. And of that, what we see from that data is that about 88.6% of of the patients respond completely to a single dose of neffy and the rest need a second dose.

And that compares to IM injection at about 88.9%. So pretty much the same exact result Given some variability and error, but pretty much the same as epinephrine injection. And not surprisingly, you would expect, as everybody else doctors expect, if epinephrine gets in your blood and it's at the exposures that the levels in your blood that are necessary for efficacy,

that it would work just like injection. And in fact that's what this data is showing, is that in a very large number of patients that it seems to be working exactly like injection.

Now with the 1mg so far we've had a little bit higher response of close to 93% of the kids respond to a single dose of the 1 milligram. But that data's still early and maturing.

So we will see how that goes in the next round and we'll continue to collect this data because having that real world data and showing neffy is working the same as injection,

we know that neffy is much easier to use, less intimidating, will be used earlier.

This is more of in a controlled clinical setting. So they're using it as soon as they think the patient needs to have epinephrine, they're having anaphylactic reaction, they need epinephrine.

And in the real world we don't want you to hesitate, we want you to treat as soon as possible when you have symptoms. But this is a really good piece of evidence now that in that real world setting we're working exactly like injection and as I said, we'll collect more data over time,

but we're really pleased. This is a fairly large pool of patients at this point and this type.

Caroline: Of information is so critical to families like mine where we see something and we're excited about it and we see studies, but we might not fully understand the studies. So to hear that there's these real world examples of it working,

that gives us that comfort and that confidence because again, this is the first time we've ever seen anything so new.

Keep saying it. It's exciting, but it really is exciting.

Rich: And then we also, by the way, independent doctors at the same meeting, the American College, also presented case reports that also were demonstrating that neffy worked very well. And in some cases in very, very serious events where even people had gone unconscious and then they were given neffy and it worked just like you'd expect injection to work.

So I think the pool of evidence, not just what we've collected, but also what independent doctors are publishing as case reports and other data they're publishing, will really help people be very confident in using neffy.

Caroline: And so now let's shift to access something that really matters deeply to every family. Managing food allergies. Can you walk us through the Get neffy on Us program?

Rich: Yeah. So at Ars, we're very focused on trying to make neffy as affordable as possible for everybody in our system. In the United States, it's very, very complicated. So we are still almost halfway through the process of getting coverage and as as broadly as possible, and that includes Medicaid and everybody.

So we're trying to get as much as possible coverage for the entire population with this disease. What we've experienced is that doctors sometimes are overwhelmed. So doctors are very busy, especially allergists.

They're under a lot of pressure to see more patients and taking the time to explain neffy and talk to their patients about nefi. And then if a prior authorization is necessary by your insurance company, that takes up a lot of the doctor's time.

So some doctors are actually reluctant to offer neffy to a patient purely because of the amount of time it might take them and the risk of having a prior authorization where they then have to do a lot of paperwork to try to get insurance coverage.

So what we've done.

And by the way, one other point on this, it's also a huge burden to the patient and caregiver that if they want neffy, they have to schedule an appointment with the doctor.

That could be three to six months waiting time. And for me personally,

it takes a few hours for me to go to my doctor, sit in the waiting room,

have an appointment,

get back home. It takes literally half my day of the work. It's a real burden even for the patient and caregiver to go and see the doctor just to get a prescription.

So what we're trying to do is make it a little bit easier for both the patients and caregivers and the doctors to get neffy and also facilitate that access, that coverage.

So we've done a few things. So the Get neffy on Us Program,

which we've just initiated the past couple weeks,

now allows you to get nefi through a virtual prescriber,

meaning you can go to a new website called getneffy.com and@getneffy.com, you would get a virtual prescriber. That prescriber would ask you a few questions. The process takes maybe 10 minutes,

and they would be able to prescribe neffy for you,

or your doctor can suggest that it's a lot easier for them.

They can see you even in the exam. They may not have to see you,

but they know you want neffy or you ask them for neffy and they could refer you to getneffy.com and we could do the busy work for the doctor so they don't have to deal with it.

Now@getneffy.com,

you will get a prescriber, a doctor or a PA that the physician's assistant, I should say so clear for everybody who can prescribe.

They would make sure it's appropriate for you.

They would prescribe if your insurance company already covers neffy, which is a about 58% of commercial insurance.

And then we've got about eight states of Medicaid that are covering it as preferred, meaning no permission, you just go to the pharmacy and pick it up. If that's the case for your particular insurance coverage,

you would be able to just have them send it to any pharmacy you want and you can go pick up the neffy or you can have it mailed to your home.

Now, the exciting part of this program is it will cost you nothing,

meaning if your insurer covers it,

the cost of the virtual prescriber is covered by ARS and we will lower the copay down to zero,

up to a limit. Of course, our Coupon limit is $200,

so we give a $200 discount off your either deductible or copay. And then you can get neffy for zero. And the really exciting part is you can get two boxes of neffy for zero because almost all insurance companies accept the prescription for two two packs of neffy.

Most people want more than one two pack to manage their life. So you can get two right away. And then if more is needed, you could always come back later and try to get more in a month or so.

And most insurers seem to accept that.

So that's the neffy Get neffy on Us Program through the getneffy.com website where you can now skip the doctor visit or you can go to your doctor and they can refer you there so that it's very easy for them.

They don't have to worry about doing anything. We'll prescribe, we provide training materials.

We will cover any prior authorizations that are needed. Our virtual prescriber will do the work necessary to get you prior authorization if your insurance company is not yet covering neffy automatically.

And so that really makes it a lot easier, not only for the patients and caregivers, but even for the doctors.

And the doctors can focus on patient care and not worried about paperwork from insurance companies.

Caroline: It is so time consuming just to get a prescription called in by your doctor like you said to go for the appointment and it does take up a lot of time.

So thank you for explaining this to us,

how this program works and how people can access it. And listeners, I'm going to make sure in the show notes,

all the links are there for you. So if you're driving and listening and you didn't get a chance to write this down, which we hope you don't do when you're driving, we'll have it all in show notes for you.

So thank you, Rich, for giving us those details.

So now I want to shift gears for just a quick minute. There's just been a lot of buzz right now about neffy being available in schools for their undesignated epinephrine option.

And you created a program specifically to help make that happen.

So can you break down how the neffy in Schools Program works and what steps can schools take to access it? What can we do as listeners?

Rich: Yep.

So we're actually very excited about neffy In Schools. And obviously we know that a lot of children, their first time they ever experience an allergic reaction is at school and they get exposed to something they've never been exposed to.

They get bit by a bee or wasp in school, and that is the first time they've ever experienced that. And they have a very severe allergic reaction. So having stock epinephrine in the schools is very important.

We know that the auto injector programs have all expired, that they're not supplying most schools anymore, and schools have to purchase it. Now, for grade schools especially, that's difficult. So we started the neffy in schools program to try to help support those grade schools and get neffy to the schools.

Now, with that said, I should say one thing first, that there is legislation in every state in this country that supports having what we call stock epinephrine in the schools, which means epinephrine that's not prescribed to a child.

Now, in every state, if your child has a prescription for neffy, you can bring it to school. There's no question about that.

These are laws that protect the school personnel who use that stock epinephrine on a child who has not been previously diagnosed or prescribed by doctor.

So that's the reason for the laws, is really to protect the school nurse or the school, maybe the principal or somebody else that has to come and help that child and dose them,

that they are not held liable because that was not prescribed by a doctor. That's really what those laws are about. Luckily, we got an army of nurses helping us because the Nurses are very excited about getting nefi.

And what they are doing is they are helping us convince the local legislators in those states to change that law. So right now, 20 states have changed the law already.

So neffy is available in those 20 states. And we have already supplied neffy to 6,000 schools nationwide in those 20 states. Of course, now we can't supply it to your school until that legislation is updated to allow for needle-free options or all options of epinephrine that are approved by the FDA.

Let's say that would be kind of the best language.

And then we're also very confident that almost all states are in the process of updating their legislation.

So if your state is not qualified yet,

such as California, where I am, is not yet qualified, but we know the legislation's already passed and the governor should sign it soon. And it's going to be available as of January 1st for schools in California.

So. And that's happening all over the country. So no matter what state you're in, we think pretty confidently that by next year all schools in the country should be able to get nefi and we'll supply it to the school.

So that's kind of where we're at. And the program we think is very valuable. And the other thing that we're doing, by the way, is on our professional website,

which is a different website than the consumer website, but it's meant for nurses and doctors. On our professional website, we also supply a lot of training materials for the nurses.

We do webinars and we have the videos on the website for them, also have downloadable training information. So they could train other nurses in the community or they can train other people at the school.

We do a lot of work to help the nurses understand neffy and get trained.

Even though training with this device is not technically required by the FDA because they're in a school environment and they're treating children like this, they really feel compelled that they should train.

They want to have documentation that they train. So we're also facilitating all that for them. And really that's really helpful because those nurses also become counselors to caregivers, to moms and dads, and especially in the lower income level, where going to a doctor is expensive,

but they can go to the school nurse and get advice and information and not have to pay anything. So by training all those nurses, not only on neffy, but on anaphylaxis in general, recognizing, I mean, our training goes through recognizing the signs and symptoms,

how to treat it, and all sorts of parts of the whole process. Of reaction and having to address it and what they should do, it really adds a lot of value because then these nurses also can help train the parents.

And as I said, especially parents that can't afford to go see a doctor all the time,

they just have certain questions or they want to know about the different options,

or they want to know how to use neffy, then that nurse can help that mom and dad understand it and really get acquainted with the product and also understand how to recognize a severe allergic reaction when it starts.

And we think that really adds value to the community. So not only having that epinephrine in the school in case of an emergency and they have that extra epinephrine that's available, but also to help the moms and dads in this program, by the way, if the school uses the epinephrine,

we will replace it and if it expires, we'll replace it. So it's an ongoing effort on our part to supply those schools and keep them supplied over time.

Caroline: And just a quick side question here. If someone is listening today and they want to make sure their school nurse knows about neffy or this program,

what can they do? Should they direct them to that professional website?

Rich: Well, actually if there's school nurses out there and they want to participate, we actually have a different link for neffy in schools that I think we'll provide as well. And they can go directly to that.

You can also search Google neffy In Schools and I think it comes up pretty readily so you can find it pretty easily. The professional website is really nephi pro.com pro. It really has more information for healthcare providers.

So that's a separate way website from our normal website that's intended for consumers.

Caroline: Thank you. So now our time has come to an end which went really fast. This has been really wonderful. But before we say goodbye today, is there anything else you want listeners to hear from you?

Rich: I think they should just know that we are working very hard, especially on access. We're trying to make neffy as affordable as possible. Our zero pay program obviously is even less copay than a generic auto injector.

So Nephi, we hope for many of you already who have commercial insurance, who's covering like United Healthcare or a lot of the other big PBMs like Express Scripts, they're all covering neffy Cigna and then you can get it there for zero copay.

We think that's real value added to even the patient's caregivers because you're already paying much more than that. For a generic auto injector. So it's not just the benefit of the device, but the cost is even lower to you.

We are working with some insurers. There are some Blue Cross companies that are slow to cover nefi or are blocking nefi.

That tends to be a way that Blue Cross companies manage their premiums because they try to basically delay covering new medications as long as they can.

And it also helps them budget in those new medications. So they just routinely don't cover medications for a longer period of time.

But we are working very hard to get Blue Cross companies that are not already covering. Some do cover, like in Massachusetts,

but a lot of them are not covering. And there's a few that are even blocking the use of neffy, such as in Michigan. Blue Cross of Michigan is blocking the use of nefi.

So if you're in Michigan, you can complain the Blue Cross. And if you're a Blue Cross customer, why they're blocking when other Blue Cross companies and other companies like United Healthcare are covering without any restrictions.

On top of that, we're working very close with CVS.

We're trying to get CVS to cover neffy through both Aetna and Caremark. So if you're under Caremark again, it's more for CVS what benefits CVS. So we are working with them.

We are trying to get final agreement on covering neffy.

We feel more and more confident that will happen in the near future and then we'll be able to expand our coverage to the CVS family, which is basically Caremark. Aetna and Anthem follows Caremark, but Anthem is independent, so Anthem may actually move a little quicker than Caremark.

So we are working very hard to get the coverage and we know that's important for a lot of people. We do protect consumers with a discounted cash pay price of 1:99 in case your insurer refuses to cover is one of those few that are blocking neffy or refuses a prior authorization.

We are offering a cash pay price. So.

So you could still get neffy at a reasonable discount. And I just want to mention one more thing before we close on that cash pay price is that cash pay price is only available online through either the get nefi.com or through our online pharmacy at neffy.com, which is BlinkRx.

So your doctor would send the prescription to BlinkRx or you would get the prescription from our get nefi.com virtual prescriber, which is Upscript,

and then you would be able to get that $199 price through them. It's not available at the pharmacies and if you go to a pharmacy they typically will give you a retail price without insurance coverage of about 800 to $1,000.

So it is a fairly big discount on what they would price it at a pharmacy. We would encourage people who either don't have insurance coverage or have poor coverage, have high deductibles and still want to get nefi.

That that's the best option is to go online and get nefi and we'll protect you as much as possible, try to get you coverage through your insurer with a prior authorization or through Medicaid.

And worst case scenario we would offer the 199 cash pay price thank you.

Caroline: So much Rich for your time and sharing all this great hot off the press information. I mean, a lot of this information is new since September,

so we really appreciate you getting us all up to date on this, so thank you so much for your time. You're ridiculously busy, obviously expanding around the world, so we're very happy you chose to spend some time with us today.

Thank you.

Rich: Oh thank you very much for having us.

Caroline: Before we say goodbye today, I just want to say thank you one more time to ARS Pharma for their kind sponsorship of FAACT's Roundtable Podcast.

Caroline: Thank you for listening to FAACT's Roundtable Podcast.

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