Expert: Stigma, Price Point Major Obstacles for Widespread OTC Naloxone Use

In an interview with Pharmacy Times, Allison Burns, president and CEO of EMO Health, details issues surrounding the price point of OTC naloxone and steps that can be taken to lower the price for patients. Additionally, Burns discusses the stigma around OTC naloxone and how overcoming this stigma is a huge step towards greater naloxone uptake.

Pharmacy Times: Can you give a brief overview of Narcan’s journey towards approval for OTC use? Why is its availability OTC important?

Allison Burns, president and CEO of EMO Health: Well, I want to say thank you first, for bringing some awareness to this topic. I know we'll probably discuss stigma at some point in this interview. But I think, you know, just starting off with why having Narcan (naloxone HCl; Emergent) or naloxone over-the-counter as an OTC is important because, in the last 12 months, we've seen opioid overdoses or overdoses related to opioids, whether someone knows they're ingesting them or not, have really skyrocketed. We're losing over 100,000 people each year. And we know that where naloxone is available, overdose deaths do trend down. It is a critical part of the national strategy to, I would say, work towards harm reduction, minimize those opioid related overdose deaths, and move forward, you know, as a country. And then in terms of its journey to become an OTC, like many medications that were once prescription, everything is a process. Naloxone has been around as a prescription in the medical setting for decades, so it's nothing new there. And then, in the early, probably around the early 2000s, is when we started seeing individuals who were lay people, meaning no medical training, just you know, out in the community, begin to use injectable naloxone off-label as a nasal spray. I don't know if you remember when it used to be a multiple-step process where you had to connect the white cone, which is an atomizer, to the top of it, and make it into a spray, put 1 half in either nostril, which obviously… the less steps, the better in an overdose situation or in an emergency. It started like that off label. And then finally, manufacturers came up with a device to deliver it as a nasal spray, it got FDA approval to be used as a nasal spray. And then from there, it was a prescription, and back in spring somewhere around March or April 2023, the FDA finally approved… I shouldn't say finally, it is a process, right? The FDA can't just say, “Hey, we'd love for this prescription med to go OTC,” because they are not the manufacturer. So a manufacturer would have to put in an application to the FDA. And I know that that is a process within itself. So they have to put in an application, that application goes through a process and is approved and then the product can go from prescription to OTC.

PT: What options for OTC Narcan are there right now?

Burns: So right now, since the 2023 approval, there's actually 5 that have been approved. Now are all 5 available in all 50 states? Probably not. The timeline and the availability are based on the manufacturer, and their supply chain and logistics. But there are 5 approved products. The first one was nasal Narcan spray, the brand name by Emergent, everyone I think recognizes that one. There are 4, 4 milligram products. Two, I believe, are generic. So they might have a different price point but they work in the same way. And one is actually a 3 milligram; all 5 though, are in the device that is the nasal spray. So we're not looking at – although it could happen potentially in the future – none of them are at the injectable form or any of the other formulations that are that could be used.

PT: Given its price point, how much does insurance coverage of Narcan matter in ensuring individuals are not only able to access it, but have it affordable as well?

Burns: Price, I think, is likely the major challenge or burden to the consumer, whoever is purchasing it and using it. I've seen it anywhere from around $40-$45 all the way up, to in some places, there are reports that the package of 2 can cost $100, maybe $120. The price is set by the manufacturer, which can make it, you know, we can't predict what that price will be. But that's probably the price range, somewhere around $40 to $100, maybe $120. Now, why that is a challenge, obviously, is because cost is a barrier. But another issue with that is, having gone OTC, not every insurance company is going to cover an OTC product. So the challenge is not just the OTC price; it could be that you had received a naloxone kit previously through your insurance, and now because it is available OTC, they don't cover that. Now that comes down to the individual’s insurance plan, which is usually dictated by the pharmacy benefits manager. And each plan, as you know, can be very different. Everyone needs access to it, but I would say the population that we need to focus on the most is the ones who have the characteristics of using it or needing it more often. And that tends to be, historically, individuals who have Medicaid. So right now, it's very important for state Medicaid systems to continue to cover naloxone; for example, where I am in Massachusetts, there's either no copay, or MassHealth will have a $3.65 copay, which is obviously a very big price difference than $50. So that being said, the price, I do think will be a barrier. However, this is very similar to what we saw when emergency contraception, the plan B pill, went OTC; it was covered by certain insurance companies, other ones do not, and it is around the same price point of $50. So hopefully, maybe manufacturers will be able to put out some sort of community savings plan, something that would be great, but I do expect it to be around $50. And my hope is that the insurance companies, particularly our Medicaid systems, across the United States continue to cover it for those individuals who simply don't have $50 to spend.

PT: Do you think that a stigma currently surrounds Narcan? If so, could providing it OTC lessen or increase that stigma? If not, why?

Burns: I absolutely think anytime that you are dealing with, as I think… you could say anything that’s drugs, sex, and rock and roll is going to have a stigma attached to it. Whether it is emergency contraception, or birth control, which that has, you know, we've seen a lot of information about that in the news lately. Whether it's that and it's plan B or it's you know, sex ed in high school or it's the availability of naloxone, there is stigma around any type of lifestyle choice that someone is making. In addition to that, there is self-stigma; people are embarrassed that they need to purchase something like that. And then you also have this moral hazard argument where, you know, maybe it could be misinformation, not necessarily stigma, it could be stigma, but there are some, you know, pharmacists out there who may think, “I'm giving them, if I'm selling them naloxone, that is going to make them more likely to use. Naloxone, we know, is not a get-out-of-jail-free card, it does not work 100% all the time, multiple doses are often needed. But we saw the same thing when clean syringes were at pharmacies and people said, “We're not going to sell them because it increases risky behaviors around injections,” which we know that's not true. So whenever there's something that's harm-reduction related, that's the point of harm reduction that becomes available, we do see that access to that doesn't increase risky behaviors around drug use, or other things like of course, there's not more sexual intercourse going on because we have plan B and there's not, you know, more injection drug use or use of needles because we have access to needles. In fact, we know that those types of options decrease harm. I do think that there, you know, there's stigma among pharmacists. And sometimes it's, I would go so far as it's not necessarily that it might feel like stigma, but you never know what that pharmacist or store employee, wherever you're getting this is dealing with. Not every place has the same resources, they might be down help, they just don't simply want to engage right now, they have several other things like prescriptions they have to fill, people they have to check out at the pickup line or in a drive thru line, and they simply just don't have the resources, time, or energy to assist customers looking for naloxone or wanting to fill naloxone. I think that that can sometimes come across as stigma… them being purposely unhelpful, which may not, in fact, be the case. But I do think anytime that you move something and put it on a shelf out in the public, where anybody can access it, it does decrease it, because it's putting it you know, in front of people; the more you see something, the less stigmatizing it becomes. This will probably be in aisles, whether it's, you know, next to the Band-Aids, or maybe it’s next to plan B, maybe it's next to other nasal sprays, like for allergies, maybe it's next to Flonase – fluticasone – who knows where people are going to place it in the aisles. But either way, when it's around these other products that are used for allergies and nasal spray for allergies you’d use regularly during certain seasons, it makes it less stigmatized, I would say.