AMCP 2022: Reality-Checking Digital Therapeutics As They Take Off

Digital therapeutics are barreling their way into American healthcare with promises that their special brew of technology, data, convenience and behavior-changing psychology can improve the treatment of many chronic conditions, especially those affecting behavioral health. But digital therapeutics are also stirring up a lot of questions about their limitations, the evidence for their safety and efficacy, and how payers should go about deciding whether they should be covered.

Michael Angelini

Michael Angelini, Pharm.D., M.A., a professor of pharmacy practice at the Massachusetts College of Pharmacy and Health Sciences University in Boston, and Soumya Vishwanath, Pharm.D., senior manager, formulary management, at Magellan Rx Management in Cambridge, Massachusetts, gave an overview of digital therapeutics and the approaches that payers are taking to them at the Academy of Managed Care Pharmacy’s annual meeting, AMCP 2022.

Angelini provided a brisk survey of the pros and cons of digital therapeutics for behavioral health. Vishwanath presented research on some of the approaches that payers are taking while conceding that there is a shortage of publicly available information.

Citing several industry reports, Vishwanath’s presentation showed a minimal number of health plans are currently covering digital therapeutics and that 50% do not have a strategy in place for evaluating them for coverage, and 10% do not see a need for a special strategy.

Vishwanath noted that there are more than 350,000 health-related apps. For the purposes of this discussion, digital therapeutics were defined as “evidence-based therapeutic interventions driven by high-quality software programs to prevent, manage or treat a medical disorder.”

Soumya Vishwanath

Vishwanath, citing several sources, said 68% of digital therapeutics currently in development (“in the pipeline”) are for psychiatric and neurologic conditions. Data she shared showed a tally of 23 digital therapeutics for behavioral health being currently available, 10 in a pivotal trial, and 46 in early-phase, proof-of-concept research. By Vishwanath’s count, there are a total of 137 digital therapeutic products for behavioral health in the pipeline.

Angelini’s list of the advantages of digital therapeutics relative to treatment drugs for behavioral health conditions included the lack of drug-to-drug interactions (“there is one less thing to think about”), overdoses (“you are not going to overdose in the typical sense”) and side effects (although he mentioned reports of minor headaches). The drawbacks mentioned in his rapid-fire overview included the possibility that patients will stop using the digital therapeutic because they get bored and a chance that patients will get other people to use the therapeutic for them. Other items on Angelini’s list of cautions and provisos were the efficacy of the therapeutics for medically complex patients, security of information that patients are providing and inequities because some people may have a poor internet connection or an older device. Angelini also said that digital therapeutics are not going to be useful in acute behavioral health episodes. “If you are sitting there injecting heroin into a vein, you are not sitting there saying, ‘If I use this app, perhaps I will pull the needle out,’” Angelini said.

Vishwanath grouped strategies that health plans can use to evaluate digital therapeutics into three categories: identifying stakeholders and initial logistics to evaluate products, solidifying objective criteria for evaluation and pinpointing whether the coverage would come under the medical or pharmacy benefit.

She said it was also important to limit the scope of the evaluation because of the large number of healthcare apps. “So, what is the priority of your organization?” Vishwanath asked rhetorically. “Is it digital health? Is it digital medicine? Is it digital therapeutics? Prescription digital therapeutics? Or prescription digital therapeutics in a specific area or a specific disease state?”