(108) A Prescription Digital Therapeutic for OUD: 36-Week Real-World Clinical Data

Background: The epidemic of opioid-related overdoses and deaths continues to worsen.(1,2) Opioid use disorder (OUD) is an often-chronic condition requiring long-term treatments with durable clinical benefits. Prescription digital therapeutics (PDTs) are FDA-authorized software-based treatments delivering evidence-based behavioral therapies on mobile devices that are supported by efficacy data from randomized controlled trials.(3,4) The assessed PDT delivers cognitive behavioral therapy, fluency training, and contingency management as an adjunct for patients with OUD being treated with buprenorphine therapy.

Objective: To evaluate real-world use and clinical outcomes, including health care resource utilization (HCRU) among patients with OUD who were treated with a PDT over a 9-month period (36 weeks).

Methods: A retrospective observational evaluation of patients treated for 12, 24, and 36 weeks with a PDT for OUD. Engagement and retention data in weeks 9-12, 21-24, and 32-36 were collected via the PDT and analyzed with descriptive statistics. Substance use was evaluated as a composite of patient self-reports and urine drug screens (UDS). Missing UDS data were assumed to be positive. A responder analysis of patients who achieved 80% or greater abstinence on the composite measure was conducted. A regression analysis of hospital encounters for 12 weeks vs. 24 weeks vs. 36 weeks controlling for covariates was also conducted in subpopulations of the dataset.

Results: In a cohort of 3,817 individuals with OUD who completed a 12-week PDT prescription, a second cohort of 643 patients was prescribed a second 12-week prescription, for a total treatment time of 24 weeks, and 206 patients had a third prescription for a total treatment time of 36 weeks. Median age of the 36-week cohort was 40 years, 64% female.
At 36 weeks of treatment, abstinence in the last 4 weeks of treatment was 88%, and 93% of patients were retained in treatment (defined as having any activity in the PDT). In the responder analysis, 94% of patients in the 36-week group had ≥80% negative self-reports or UDS across the 12 weeks of their third prescription.
Increasing length of treatment was associated with lower hospitalization rates and medical costs. Individuals treated with the PDT for 12 weeks (N=324) had a 43% decrease in unique hospital encounters compared to a control group (N=64) who were not treated with the PDT. Patients treated for 24 weeks (N=103) had an additional 27% decrease in unique hospital encounters compared to patients in the 12-week cohort, and patients treated for 36 weeks (N=17) had a 45% reduction compared to those in the 24-week cohort. Projected hospital-related costs per patient over 9 months were $13,749 for patients not treated with the PDT, $7,822 for patients treated for 12 weeks, $5,714 for patients treated for 24 weeks, and $3,144 for patients treated for 36 weeks.

Conclusions: These data present real-world evidence that treatment for 9 months (36 weeks) with the a PDT for patients with the often-chronic condition of OUD is associated with high levels of engagement, improved outcomes, and fewer hospital encounters compared to treatment for 12 or 24 weeks alongside standard buprenorphine therapy.

References:
1. National Academies of Sciences Engineering and Medicine. Medications for Opioid Use Disorder Save Lives. Washington, DC: The National Academies Press 2019.

2. Centers for Disease Control and Prevention. Increase in fatal drug overdoses across the United States driven by synthetic opioids before and during the COVID-19 pandemic. https://emergency.cdc.gov/han/2020/pdf/CDC-HAN-00438.pdf. Accessed August 1, 2021.
3. Campbell AN, Nunes EV, Matthews AG, et al. Internet-delivered treatment for substance abuse: a multisite randomized controlled trial. Am J Psychiatry. 2014;171(6):683-690.
4. Christensen DR, Landes RD, Jackson L, et al. Adding an internet-delivered treatment to an efficacious treatment package for opioid dependence. J Consult Clin Psychol. 2014;82(6):964-972.

Diversity, Equity, and Inclusion: As real-world evidence this evaluation of a prescription digital therapeutic for opioid use disorder was inclusive of all-comers. Additionally, our organization is currently working on projects related to the prescription digital therapeutic evaluated in this study that seek to assess equitable distribution of the treatment throughout a large healthcare system.