Panelists at the 2023 PBMI Annual National Conference mentioned post-marketing studies and changing the mind-set about what a prescription entails.
If digital therapeutics are to ever to become a part of everyday healthcare, they are going to need to get through an obstacle course of practical problems such as lack of billing codes, the absence of standardization and payers having many cooks in kitchen when it comes to coverage decisions, agreed the members of a panel on nonprescription digital therapeutics at the 2023 PBMI Annual National Conference.
But the panelists also agreed that there other, possibly higher hurdles in the way that involve establishing standards of evidence, careful thinking about the patient population and changing the mindset about what prescription benefits entail.
There’s an implicit bias that a prescription benefit is, by definition, a medication, said Nate Harold, R.Ph., Pharm.D., vice president of clinical services for MedOne Rx, a mid-size pharmacy benefit manager that works primarily with self-insured employers. “We have to work through and help them understand really what they are trying to achieve through their prescription benefit, which is getting a positive clinical outcome at a really great price point in their member that has a health care need. And you can do that with medications, you can do that with digital therapeutics, you can do that with devices support structures, you can do that with health coaching services.”
Andy Molnar, CEO of the Digital Therapeutics Alliance, a trade and lobbying group for the industry, emphasized the need for developing supporting evidence for digital therapeutics and touted an 54-pageguide that his organization has developed to show digital therapeutics manufacturers and payers how to assess a digital therapeutic. Molnar tempered his optimism about digital therapeutics with some caution about when they will become part of ordinary prescribing. Currently, digital therapeutics are not the first thing prescribers think of. “It will be. I am sure of that,” Molnar said. “Maybe not in five years. Can we go like 15?”
Michael Steelman, vice president, managed markets, of Dexcom, which makes and markets continuous glucose monitors, stressed the importance of identifying the right patients for a digital therapeutic and the advantages of a varied, flexible approach. He mentioned Calm, a free sleep and meditation app that is sold directly to consumers, after Molnar mentioned Calm in his remarks.
“The internal debates we have are, first of all, who is the patient population? Who are we trying to help? And what’s the best way to commercialize that, and it may very well be, like Calm, that it’s best to do direct to the consumer,” said Steelman, adding, though, that it in other cases it might make sense to test a digital therapeutic in clinical trials and sell it through employers.
Matt Alberico, MBA, senior vice president of growth at DarioHealth, a digital therapeutics company, spoke about access issues. He said there is a misperception that, particularly among those with health insurance coverage through Medicaid, that access to a smartphone is a problem. People have phones, Alberico said; the problem is access to Wi-Fi or minutes of data usage.
“That’s why an asynchronous platform is super important,” he said. “We actually think it’s more important to move people into that environment because it gives people the ability to interact with the healthcare system, with a clinician, with a coach, with a digital platform on their devices, on their own time when they actually have access to it.” Alberico added that many digital therapeutics have not delivered on their promises of engagement and outcomes. By contrast, he said Dario has a 10-30 rule. “We basically have a pathway that if you follow it, and we partner from a data perspective and (on) communication and awareness, we can drive 30% engagement in a population of people with a disease. If you don’t follow those, we can guarantee you’ll get 10%.”
The lively, hourlong session was moderated by Bill Rush, MBA, senior director, value and access, digital healthcare solutions, at Sanofi, touched on a range of topics. The immediate, practical problems didn’t go unmentioned. Molnar, for example, mentioned the lack of Medicare reimbursement category and that digital therapeutics can’t be billed for through the J-code used for injectable drugs or the National Drug Code used for drugs generally. “Even we have a PBM that says this is great, we love it, then it gets to the people that implement it and they say we don’t know how to do this. And a lot of that stems from Medicare.” Molnar also spoke about PBMs bringing some standardization to the field with formularies for digital therapeutics.
Harold observed that uptake by providers is another challenge. “Even when we deploy a solution, with funding within a benefit, there’s got to be a bit of an uptick rate. If it’s prescription therapy that a prescriber is going to write for, they have to be willing to write for it — we have to see those prescriptions come through,” he said. “We can support (digital therapeutics) through some of our medication therapy management programs where we can provide recommendations to prescribers to say this might be a good option to manage this patient. But there’s a just a general education understanding that has to occur across the provider community to utilize these (digital therapeutics) as a tool in their toolkit."
Another issue with payer-funded digital therapeutics discussed by Harold is that payers might see them as a short-term expense that may produce reduced expenses over a longer period. The question of the return on investment is especially challenging for employers with high turnovers in their workforces, he said.
With all the certainty about digital therapeutics and the evidence behind them, Harold said that payers are favorably disposed to vendors who put some of their fee at risk with payment hinging on patients achieving some result.
In the same vein, Harold and Molnar also talked about the need for real-world evidence studies.
“I think there’s still this unknown of, are patients going to use these products or are they going to stay on the product for as long as they need to (achieve) the therapeutic outcome,” said Molnar, acknowledging that such studies can be expensive and may come after money has already been spent on clinical trials. Harold also acknowledged the expense but said post-marketing studies would “instill confidence” and “show that these solutions either work or they don’t work and provide that confirmation.”
Alberico mentioned the importance of quickly shifting focus and adapting to current circumstances. Once it became clear the GLP-1 drugs were going to be a major concern for payers, Dario created a GLP-1 companion in eight weeks. “I think you want to evaluate how quickly these partners can move and really be an innovation extension of what you are doing,” he said.
Alberico said digital therapeutics should also be seen as a way of addressing rising healthcare costs. Digital therapeutics might, for example, be used in step therapy that includes a behavior change component.
“I think the mind-set of adding in a behavior change component to any of these conditions is what will get us there more rapidly,” Alberico said, with “there” being the time when digital therapeutics become commonly prescribed.