Drs Podesta and Brixner discuss possible ways to improve access to PDTs for every party involved—patient, payer, and provider.
Arwen Podesta, MD: We're in the United States where direct-to-consumer marketing of medications and of medical devices is available. These are the most effective wellness tools with the least [amount of] adverse events that could be marketed directly to patients. This would be a great avenue for patients to get on board with their needs, their family's needs, and their peers’ needs as we are educating providers so that they understand that these tools can be part of the toolbox, that they're easy to use and have very few-to-no adverse events. Patients can also be asking for it at the same time. I don't think there's any dearth of need for cognitive behavioral therapy for any sort of therapy. We have direct-to-consumer marketing of health therapeutics that are not FDA authorized. They're all over the place. I'll name Noom, Better Health, and a ton of others that are out there. Those are health therapeutics, but they're not FDA authorized, [just well marketed]. While we're in the swell of marketing, that could be useful. Not that this audience is going to be the marketer, but the payers might be open to marketing to their clients for some of these tools that may benefit them.
Diana Brixner, RPh, PhD: As long as [PDTs are] [prescription digital therapeutics] not categorized, it will give payers a reason to delay a decision because they'll wait for that categorization to happen. As far as where they should be categorized, there's not a need to make a separate category. A decision needs to be made that a PDT is a therapeutic and [have it go] through the FDA. There is evidence to show that there was an FDA-approved indication. It should be categorized like a therapeutic, and were that to happen, things would flow a lot easier. If Medicaid and Medicare CMS, if they made a categorization that increased ability for access, Medicaid or Medicare coverage decisions may then flow over into private insurance. In some cases, you'll see maybe Medicare/Medicaid patients or benefit gets covered first, and then commercial follows. If you see federal organizations agreeing to coverage, then that makes it an easier path for health plans to approve coverage for Medicare, Medicaid, and commercial populations. They look at this concept of coverage for evidence development. I'm wondering if that could maybe apply in this scenario. Can we provide a [better] road to access for PDTs by keeping in mind that data may be collected at a later point to show improved outcomes and impact on economics that could further support increased access in the future?
The recently discussed legislation by the White House on the 2022 National Drug Control Strategy can have an impact on how health plans respond in making their own individual PDT decisions. Many health plans will make their decisions independent of this legislation. If you better understand the impact of substance abuse disorder on your health plan and your members, you may decide that this is the right thing to do. We should trial this ourselves regardless of this type of decision being made by the White House. However, if the White House would release this strategy and have it be an important part of a national strategy to decrease substance abuse, then that would facilitate the decision. If you look at statistics around the impact of substance abuse disorder on society, individuals, families, social structure… it's significant. There's a potential of benefit for PDTs. I wouldn't wait for the legislation to facilitate the uptake and would hope that the uptake could show the impact, which perhaps would hasten the decision legislatively.
This transcript has been edited for clarity.
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