The data are still out on whether digital therapeutics to help treat opioid use disorders can deliver long-term improvements over standard care, according to the Institute for Clinical and Economic Review.
The U.S. drug pricing watchdog said it was unable to find strong evidence that smartphone apps for opioid use—including Pear Therapeutics’ reSET-O, Chess Health’s Connections and DynamiCare Health’s eponymous offering—provide benefits over longer time periods, such as past six months, or out to two or five years.
Typically prescribed alongside medication-assisted treatment, including with buprenorphine, the apps provide patients with connections to addiction experts, cognitive training modules and rewards for staying within their treatment regimens.
Long-term adherence to therapy has been associated with abstinence from opioids, fewer hospitalizations and emergency room visits, as well as more gainful employment over time, according to ICER—and though there are little data capturing long-term success across these metrics, it’s unlikely that including the apps presents any harm, the watchdog said.
“While these new digital therapeutics incorporate cognitive and behavioral interventions that may provide benefits to patients, there are no randomized trials demonstrating that patients benefit from any of these specific apps compared to medication-assisted treatment alone,” ICER’s chief scientific officer, Pamela Bradt, said in a statement.
“More evidence is needed to fully understand these apps’ comparative clinical and economic value, particularly evidence around how durable the benefits may be in the weeks and months after an individual completes one of these digital programs,” Bradt said.
ICER said it only had enough data to model the cost-effectiveness of Pear’s reSET-O, which was cleared by the FDA in late 2018 for a three-month course of outpatient therapy in combination with buprenorphine.
The app’s total price of about $1,200 fell within the acceptable benchmark range set by the watchdog—when assuming that its health benefits continue beyond the initial regimen and that patients stay within treatment out to five years. However, if it becomes clear that more patients revert afterward at a rate on par with the standard-of-care, ICER said reSET-O’s price should be discounted.
Alongside the release of ICER’s evidence report, Pear published real-world data gathered from more than 3,100 patients using reSET-O across the U.S.
The company said that 49% of users completed all of the app’s core modules, while two-thirds finished half of them, and 80% finished one-quarter of the program. This included use over a 24-hour period, and outside of normal clinic hours.
Among those who completed the recommended number of four or more modules per week over the first month, 88.1% passed drug screenings and 85.8% remained active in treatment through the final month of the regimen.
“We are excited to share these data as we believe this is an important confirmation of the potential for reSET-O to improve clinical outcomes at scale and address the unmet needs of [opioid use disorder] treatment,” said Yuri Maricich, Pear’s chief medical officer, and lead author of the paper published in the Journal of Current Medical Research and Opinion.
“This cohort of patients represents one of the largest datasets of community OUD treatment analyzed to date and robustly demonstrates the real-world impact of a [prescription digital therapeutic] integrated into standard of care for patients with OUD,” Maricich said.
In addition, Pear presented a separate paper this week associating reSET-O with fewer hospital admissions among 351 patients—including fewer intensive care unit, emergency room and clinic visits—leading to lower net healthcare costs by $2,150 per patient over six months, and offsetting the cost of the product in the short term.
“These newly shared data reinforce how reSET-O can improve total quality of care while reducing the main healthcare cost drivers in OUD,” said Pear President and CEO Corey McCann.
The retrospective study of healthcare claims, comparing six months before and six months after treatment with reSET-O, was published in the journal Expert Review of Pharmacoeconomics & Outcomes Research. The data were not included in ICER’s economic model, the watchdog said, due to higher-than-average healthcare utilization rates in the pre-treatment phase of the study.
ICER’s evidence report on digital apps for opioid use disorder will be reviewed by an independent appraisal committee during a virtual public meeting scheduled for later this month.