Prescription Digital Therapeutics Offer Another Tool for Substance and Opioid Use Disorders

During AMCP Nexus 2020 Virtual, a panel discussed prescription digital therapeutics (PDTs), a new therapeutic class being integrated into standard of care, including how they can support and advance managed care pharmacy and how they will complement care pathways and lead to better access and health.

The panel included Katie Archer, director of health and welfare plans benefit design, planning, and analysis at The Hartford Financial Services Group; Yuri Maricich, MD, chief medical officer and head of development at Pear Therapeutics; Fulton Velez, MD, MS, MBA, head of health economics and real-world evidence at Pear Therapeutics; and Renee Wallace, PharmD, clinical pharmacist at Serve You Rx.

PDTs are software to treat human disease either alone or in conjunction with other medications under the supervision of a physician. PDTs are manufactured like drugs; evaluated in randomized, controlled trials; and are subjected to rigorous review by the FDA. They can be covered under pharmacy or medical benefit. Pear Therapeutics has developed the first three PDTs on the market: reSET, approved for substance use disorder (SUD); reSET-O, approved for opioid use disorder (OUD); and Somryst, approved for chronic insomnia.

Ms. Archer said The Hartford benefits team saw that PDTs could be a potential treatment for SUD and OUD. PDTs have also gotten a lot of exposure during COVID-19, “as everyone is looking for quality, remote treatment during the pandemic,” she said, noting that The Hartford is the first to cover reSET and reSET-O.

She explained that the physician generally writes a 90-day prescription, and the patient downloads the app, which reinforces provider treatment plan and provides 24/7 access to care through cognitive behavioral therapy; contingency management, which provides rewards for the desired behaviors; and tracking of cravings and triggers. All patient progress results are shared with the care team via a clinical dashboard.

According to Pear Therapeutics data, reSET has a 76% treatment retention rate for patients who added reSET to their 12-week outpatient treatment plan compared with 63% of patients who did not. In addition, the retention rate was 82% versus 68%, respectively, for reSET-O. “There is no silver bullet for treating SUD and OUD,” she said. “This is a great new tool in our arsenal.”

She explained that this is a low-cost option with no harms, only benefits saying, “We want to be a leader in helping other employers arm their employees and families.” Implementation and training “were easier than expected,” she said. They added the prescription codes to their formulary, covering it at the preferred brand level. Once approved and added to coverage, they developed patient and provider communication tools to promote the use of PDTs.

Ms. Wallace then talked about why and how they added reSET/reSET-O to their formulary. They are a full-service pharmacy benefit manager representing a vast array of industry and business sectors. “We support various organizations in preventing opioid overdoses and helping those with SUD in getting the treatment they need,” she said.

Their opioid risk management program has a multipronged approach to detect duplicates, refills too soon, and excessive doses. They offer Narcan and provide safe drug disposal information with opioid prescriptions but were interested in reSET and reSET-O because other solutions are still needed to fight the opioid epidemic.

She noted that COVID-19 has taken center stage from the opioid epidemic, but overdoses have increased during the first four months in 2020 compared with same time period in 2019. The lack of media coverage does not mean that the opioid epidemic has gone away and continued focus on the crisis is needed. Ms. Wallace said reSET and reSET-O are a unique opportunity to fight the opioid epidemic and help support the treatment recovery journey using a novel approach.

Dr. Velez discussed the first real-world evidence for reSET and reSET-O. The study’s objective was to look at the extent to which reSET-O works in the real world compared with clinical trials.

Researchers conducted a retrospective study of HealthVerity PrivateSource 20 claims database to assess the impact of reSET-O on health care resource utilization among patients receiving treatment for OUD. Data were collected for six-months pre- and post-index. The study included 351 adults (mean age, 37 years) with four or more weeks of medical enrollment following the index date. Following reSET-O initiation, inpatient stays, intensive care unit stays, emergency department visits, and hospital outpatient department surgical utilization were reduced. Partial hospitalization and evaluation and management hospital inpatient services increased. Hospital-based health care resource utilization was the biggest driver of decreased costs.

He said that it was interesting to see that mental health rehabilitation services, behavioral health rehabilitation services, and case management services increased—indicating that patients were more engaged in their recovery journey. The cost change per-patient was -$2,150.02. Findings from this study indicate a strong potential for quality improvement and near-term total cost reduction, the researchers concluded.

Dr. Maricich then introduced their newest PDT, Somryst, which is a nine-week neurobehavioral intervention for patients aged 22 years and older with chronic insomnia. Somryst delivers three mechanisms of action: sleep restriction/consolidation, cognitive restructuring, and stimulus control. 

Two randomized, controlled trials were submitted to FDA for the approval of Somryst, which showed that patients who used Somryst showed statistically significant improvement in Insomnia Severity Index compared with the control cohort at all timepoints post-baseline, demonstrating the “durability” of the treatment, he said. The time taken to fall asleep (sleep onset latency) was also statistically significantly improved with Somryst compared with controls post-baseline. 

Presentation: W2 AMCP Partner Session: Case Studies of How Prescription Digital Therapeutics Help Payers Achieve the Quadruple Aim. AMCP Nexus 2020 Virtual.