Utilization of PDTs provides an array of financial considerations in treatment decisions.
Megan Coder, Pharm.D, M.B.A.: Mr. Jeffrey, I’d love to hear your perspective. When we’re talking about digital therapeutics, particularly prescription digital therapeutics [PDTs], there’s a gated mechanism in place, where it has to be covered by a third-party individual or entity and prescribed by a clinician. From your perspective, how have you been understanding this within the payer ecosystem? How are software and digital therapeutics being integrated into health care from that angle?
Paul L. Jeffrey, Pharm.D: I recently retired as senior director of pharmacy for MassHealth, which is the Massachusetts Medicaid program. We were the first Medicaid program in the United States to adopt a digital therapeutic into our formulary. That has garnered some attention about how a publicly funded state program would go through this process. My thought is that we’re at the beginning of a dramatic wave of technology enhancing the care of our patients. We’ve seen this over time. It’s a no-brainer given the impetus to bring these products writ large, everything from telehealth to reSET or reSET-O. How do we interdigitate these products into the arc of care for a particular disease state or patient?
In my previous job, we were very interested in this. We went into the pandemic, which made access to care much more challenging. It also precipitated a tremendous increase in substance use disorder and opioid-related overdose deaths. We started to figure out how we could make these products available to our members, our patients and their caregivers. I see a day coming when this becomes just another commonly used tool in putting together a package of care for a patient. It doesn’t work for somebody to simply get medication and go off on their own and try to get their disorder treated. It requires all the different support to make that occur. I see this helping both the patient and the caregiver.
One thing that has been extraordinarily useful—I’m not sure exactly how often it’s used—is the feedback loop that these provide. If a patient is being cared for and one of the elements of the care is a prescription digital therapeutic, then the patient’s engagement with that digital therapeutic is visible to the caregiver as well. Arwen, for example, could see on a dashboard for a particular patient exactly what’s going on and how much that digital therapeutic is being utilized. Digital therapeutics are just like medications. We know that a medication doesn’t work if you don’t use it, so engagement is important with the digital therapeutic as well.
One thing we’re naturally inclined to do is seek out reward for our actions. One concept that I wasn’t aware of before I got involved with this was contingency management. If somebody is engaged with a product and is rewarded for that engagement, that’s hopefully going to stimulate further engagement with the product. When my wife got her first Fitbit, every time she hit 15,000 steps and all the bells and whistles went off, she’d tell me about it. It was a motivator for her to do more. In summary, we’re at the tipping point of adding a new modality to the treatment of patients, which is likely to become universal over time. Eric talked about the 15 or 20 apps he’s familiar with; nine or 10 are FDA cleared. But the universe has hundreds of thousands of them.
MassHealth and other payers couldn’t reasonably focus their attention on 300,000 applications to determine which ones would be most beneficial. Those that go through the FDA clearance process have established a basis of evidence that is satisfactory to the standards of the Food and Drug Administration, which we use universally for drug therapy. At a minimum, we know these products have gone through that level or have met that standard. The FDA may be an imperfect organization, but it’s foundationally critical. When my evaluation team would look at a digital therapeutic or any drug, we backtracked: what evidence was being used? It met the evidence to get the FDA clearance, and then we’d go into a deeper dive on how we were going to manage it relative to how the product was designed and the clinical trials. This gives us the opportunity to focus our energy on a limited number of products that have already gone through a rigorous evaluation. That gives us confidence. In my case, it makes it easier to argue for PDTs with my senior management. If we’re going to adopt this thing, [they’re going to say] “What is it?” That’s going to be an issue. Individuals don’t know what this is. Once we go through that explanation and say it’s FDA cleared, our senior managers and others in the organization go, “That makes sense to me.” Then I can make my pitch to add this to the formulary.
Megan Coder, Pharm.D, M.B.A.: Arwen, we’d love to hear your perspective on what Paul just talked about regarding all these different topics on the value and implementation of digital therapeutics from a payer perspective and the value for clinicians too.
Arwen Podesta, M.D.: I was going to mention that I have my dashboard open, and I’m sending notes to patients who are using these digital therapeutics. I’m looking at the dashboard and looking at their success, adherence and usefulness, or if they’re not using them. It gives me a lot of feedback. I can look at their chart, enter certain things into their chart, and it gives me a lot of information that can help the treatment plan of the patient.
Regarding contingency management, that’s something we’ve used in the mental health space for many years. When we were trying to find treatments for methamphetamine in the 1980s when it was a big epidemic—not that it’s not now—and we were learning about treatment modalities that would work, contingency management was the reward. In the field of addiction, the drug dealer is the reward and the dopamine spike is the reward. If we can get salience with a behavioral therapy that’s health driven and positive, instead of that heightened dopamine from the drug, then we’re doing a big favor to help change behavior. That’s what contingency management is. It’s very useful, particularly in the addiction space but also in lots of other spaces for mental and physical health. Everyone wants a pat on the back, but you can give higher rewards that give higher adherence. Some of the prescription digital therapeutics are using contingency management.
Transcript edited for clarity.