The promise and some pitfalls | PBMI Annual National Conference 2022

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Some of the evidence for digital therapy suffers from selection bias and relatively short studies, panelists from the Pharmacy Benefit Management Institute said today. They also discussed making the digital therapeutics data stream accessible and useful to payers and clinicians.

The promise of digital therapies to transform healthcare, especially when it comes to chronic disease management, is here, participants in a lively panel discussion on digital therapies agreed today at the 2022 National Annual Conference. from the Pharmacy Benefit Management Institute (PBMI) in Orlando, Florida.

“We always understood that we could tell people what to do,” said Jeffrey Dunn, Pharm.D., MBA, clinical director, of The Cooperatives Benefits Group. “They have to buy into the plan, they have to be committed or their behavior won’t change. So that’s where these things (digital therapies) can potentially play a huge role.

But Dunn and the other panelists delved into the thorny issues and the obstacle course of obstacles looming in the face of widespread acceptance of digital therapies by the payers who bear the costs and the doctors, nurses and other clinicians who would recommend them or would prescribe them.

Other members of the afternoon panel were Patty Taddei-Allen, Pharm.D., MBA, BCACP, BCGP, vice president, clinical programs and services, at WellDyne and Bill Rush, senior director of value and access to digital healthcare at Sanofi. Timothy S. Regan, RPh, CPh, Vice President at AmerisourceBergen/Xcenda moderated.

Taddei-Allen spoke about some of the weaknesses in the evidence that digital therapy companies offer as proof that their products are effective. She cites selection bias — study participants who are not representative of a population — and relatively short study periods. Few studies are designed to compare a strategy that uses digital therapeutics with standard of care, she noted.

But Taddei-Allen also mentioned some inherent problems with digital therapies that make studying them difficult. Due to changes in operating systems and other software, a digital therapeutic may need to be modified, making it a moving target for study. “It’s not like a drug, it’s the molecule, it’s what it is,” she said.

Taddei-Alen also noted that some digital therapies are designed to prevent or avoid an event or conditions. It is difficult to prove that an intervention prevented something from happening compared to, for example, an intervention designed to lower a biomarker.

Diabetes was Taddei-Allen’s top pick for a disease where digital therapeutics holds the most short-term process with inflammatory conditions, such as rheumatoid arthritis, close behind. For Dunn, mental health was the first choice, and he noted that there are many prescription digital therapies based on cognitive behavioral therapy on the market today.

Rush said full-fledged, long-term randomized clinical trials for digital therapies would be extremely expensive. He advocated for an evidence base that would include looking for real-world evidence and retrospective cohorts.

Rush also said that successful pilot projects for digital therapies and their evaluation need to be careful about selecting a patient population and the problems (endpoints) they are trying to solve.

Accessing the data generated by digital therapeutics and making it available in a useful way to payers and clinicians was mentioned several times. Dunn has addressed the issue, in various ways, many times.

“Can (the data) somehow be inserted through an API (application programming interface), or something into the systems we already have, because it’s not possible to expect that our nurses or pharmacists managing care would have to remember or use 15 or 20 different systems,” Dunn said.

“It’s always about getting the data and getting it in a way that we can actually use it – and that’s been a challenge so far,” Dunn said later in the discussion.

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