Digital therapeutics companies have long promised they can improve clinical outcomes while reducing healthcare costs. Pear Therapeutics now has peer-reviewed evidence supporting that claim, at least for opioid use disorder treatment—and the implications extend far beyond one company or one condition.
Research published in the journal Expert Review of Pharmacoeconomics & Outcomes Research demonstrates that Pear’s reSET-O digital therapy reduced hospital encounters and lowered net healthcare costs by $2,150 per patient over six months. For an industry that has sometimes struggled to prove its value proposition with hard data, these findings represent significant validation.
The timing matters. COVID-19 accelerated adoption of digital health solutions across medicine, but particularly in behavioral health where telehealth and app-based interventions gained rapid acceptance. As the pandemic worsened Americans’ mental health and substance use patterns while discouraging in-person care, digital therapeutics emerged as both necessary alternatives and potentially transformative tools.
Pear’s research suggests that digital therapeutics for substance use disorders aren’t just pandemic workarounds—they may deliver genuine clinical and economic value that persists beyond the current crisis.
What reSET-O Actually Does
ReSET-O holds the distinction of being the first digital therapy for opioid use disorder to earn FDA approval. This regulatory milestone matters because it differentiates prescription digital therapeutics from the thousands of wellness apps available in commercial app stores without clinical validation or regulatory oversight.
The solution works through app-based tasks designed to help patients manage and recover from substance use disorders. These aren’t generic motivational messages or educational content—reSET-O delivers evidence-based cognitive behavioral therapy modules adapted for digital delivery and specifically tailored for opioid use disorder.
Critically, reSET-O is designed as an adjunct to medication-assisted treatment, not a replacement. Patients using the digital therapy also receive buprenorphine or other FDA-approved medications for OUD. This combination approach reflects clinical consensus that medication-assisted treatment represents the most effective intervention for opioid use disorder, but behavioral support enhances outcomes.
The app provides structure, skills training, and reinforcement that supplement the pharmacological effects of medications like buprenorphine. Patients complete modules at their own pace, receiving immediate feedback and rewards for progress. The digital format allows for daily engagement that would be impossible with traditional once-weekly therapy sessions.
Study Design and Patient Population
Pear Therapeutics evaluated 351 patients who used reSET-O, tracking their outcomes over the first six months. While the study details in the press release are limited, several aspects of this research approach warrant attention.
A six-month tracking period is meaningful for substance use disorder outcomes. Many studies focus on shorter timeframes that may capture initial enthusiasm but miss longer-term patterns. Six months allows observation of whether patients sustain engagement with the digital therapy and whether clinical benefits persist beyond the novelty phase.
The sample size of 351 patients provides reasonable statistical power for detecting meaningful differences in utilization and costs. While not a massive population health study, it’s substantial enough to generate confidence that findings aren’t artifacts of small sample quirks.
Publishing in a peer-reviewed journal subjects the research to external scrutiny. Expert reviewers evaluated the methodology, analysis, and conclusions before publication—a higher bar than white papers or conference presentations that some digital health companies rely on for evidence claims.
What the press release doesn’t specify is whether this was a randomized controlled trial comparing reSET-O users to a control group receiving standard treatment, or an observational study tracking outcomes in reSET-O users. That methodological detail matters for interpreting the strength of causal claims about the digital therapy’s impact.
The Cost Savings Breakdown
The finding that reSET-O reduced net healthcare costs by $2,150 per patient over six months translates to meaningful savings at scale. For a managed care organization or health system treating hundreds or thousands of OUD patients, these per-patient savings compound into substantial total cost reductions.
The cost savings came through reduced clinical encounters across multiple settings. The study found decreases in inpatient hospitalizations, intensive care unit stays, and emergency department visits. This utilization pattern suggests reSET-O helps patients avoid the crises that drive expensive acute care use.
For opioid use disorder patients, acute care encounters often result from overdoses, infections from injection drug use, withdrawal complications, or exacerbations of co-occurring medical conditions. If digital therapy helps patients maintain recovery, manage cravings, and avoid relapse, reducing these crisis events follows logically.
The $2,150 per-patient savings likely reflect avoided costs rather than direct spending reductions. Patients using reSET-O didn’t necessarily incur $2,150 less in billed charges—instead, they avoided hospitalizations and ER visits that would have cost approximately that amount if they had occurred.
This distinction matters for understanding the business model. Payers realize savings through avoided utilization. Providers operating under fee-for-service models might actually see reduced revenue if their patients have fewer crisis encounters, though value-based payment models could align incentives around these outcomes improvements.
What This Means for Payers
For health plans and managed care organizations, Pear’s research provides ammunition for coverage decisions. Digital therapeutics require reimbursement policies, prior authorization protocols, and infrastructure to support prescribing and monitoring. These administrative investments need justification through demonstrated value.
Evidence of $2,150 per-patient savings over six months makes that business case considerably easier. Even accounting for the cost of the digital therapy itself—which Pear hasn’t publicly disclosed but likely runs substantially less than $2,150 for six months—the net savings appear favorable.
Payers have been cautiously interested in digital therapeutics but often hesitant to establish broad coverage without robust outcomes data. FDA approval provides regulatory confidence, but economic evidence determines whether payers will actively promote digital therapeutics or treat them as marginal benefits.
Reduced emergency department utilization particularly appeals to payers. ED visits for OUD-related crises are expensive and often preventable. Any intervention that demonstrably reduces ED use while maintaining or improving clinical outcomes merits serious consideration from payers managing both costs and quality metrics.
The challenge for payers is establishing infrastructure to support digital therapeutic prescribing. Unlike traditional medications dispensed through pharmacies, digital therapeutics require different distribution and monitoring systems. Pear and other digital therapeutics companies have worked to streamline these processes, but they remain more complex than filling conventional prescriptions.
Provider Implications and Adoption Barriers
For providers treating opioid use disorder, digital therapeutics like reSET-O offer tools to extend clinical reach without proportional increases in staffing. A clinician managing dozens of patients receiving medication-assisted treatment can’t provide intensive behavioral support to everyone. Digital therapy supplements limited clinician time.
However, adoption barriers exist. Providers must learn about available digital therapeutics, understand appropriate use cases, navigate prescribing processes, and monitor patient engagement and outcomes. These new workflows require time and training that busy clinicians may struggle to accommodate.
Reimbursement for prescribing and monitoring digital therapeutics also remains inconsistent. If providers invest time in digital therapy management without clear payment, adoption will lag regardless of clinical evidence. The evolution of billing codes and payment policies for digital therapeutics will significantly influence uptake.
Patient engagement presents another challenge. Not all patients have smartphones or sufficient digital literacy to use app-based therapies effectively. While smartphone penetration has increased dramatically, populations most affected by opioid use disorder may face barriers including homelessness, incarceration, or poverty that limit technology access.
Digital therapeutics companies including Pear have worked to address these barriers through simplified interfaces, provision of devices when needed, and patient support resources. But real-world effectiveness depends on sustained patient engagement with digital interventions—something many digital health applications struggle to achieve.
The Broader Digital Therapeutics Opportunity
While reSET-O remains the only FDA-approved digital therapeutic for opioid use disorder, Pear’s research findings signal opportunities for similar solutions across substance use disorders and behavioral health more broadly.
The company has raised $134 million to date, reflecting investor confidence in the digital therapeutics model. That capital supports development of additional products, clinical trials to generate evidence, and commercialization infrastructure to support adoption.
Pear offers digital therapeutics for other conditions beyond OUD. The company’s portfolio includes solutions for substance use disorder generally, chronic insomnia, and other behavioral health applications. The research approach validating reSET-O’s value can be replicated for these other products.
Beyond Pear, numerous companies are developing digital therapeutics for mental health and addiction. The space has attracted substantial venture capital and strategic investment from pharmaceutical companies and healthcare systems seeking to expand beyond traditional treatment modalities.
However, the field faces questions about which conditions are most amenable to digital therapeutic interventions, what level of human support is needed to supplement digital tools, and how to sustain patient engagement over time. Pear’s evidence for cost savings and reduced acute care utilization provides a proof point that rigorous evaluation can demonstrate value.
Regulatory Pathways and Evidence Standards
The FDA’s Digital Health Center of Excellence has established pathways for digital therapeutic approvals, but the bar remains high. Companies must conduct clinical trials demonstrating safety and effectiveness comparable to standards for pharmaceutical products. This represents significant investment in research and regulatory navigation.
For investors and healthcare organizations evaluating digital therapeutics companies, FDA approval serves as a quality signal distinguishing prescription digital therapeutics from unregulated wellness apps. The regulatory scrutiny provides confidence that products deliver on clinical claims.
The requirement for peer-reviewed publication of outcomes research further strengthens evidence standards. Payer and provider decision-makers increasingly expect published data rather than accepting company-generated white papers or case studies.
As the digital therapeutics field matures, these evidence standards will likely separate winners from the multitude of mental health and addiction apps flooding app stores. Companies willing to invest in rigorous clinical research and regulatory approval processes may ultimately capture more value despite higher upfront costs.
Looking Ahead
Pear Therapeutics’ research demonstrates that digital therapeutics for opioid use disorder can deliver measurable clinical and economic value. The $2,150 per-patient cost savings and reduced hospital encounters provide concrete evidence that payers and providers can use to justify adoption decisions.
As COVID-19’s impact on substance use disorders and mental health continues reverberating, digital interventions that expand access to evidence-based treatment while reducing costs address urgent needs. The pandemic accelerated digital health adoption by years, creating openings for innovations that might have faced longer paths to acceptance.
For the digital therapeutics industry broadly, Pear’s peer-reviewed evidence of cost savings represents validation that rigorous research can substantiate value propositions that have sometimes relied more on promise than proof. Other companies pursuing FDA approval and outcomes research may find smoother paths to payer coverage and provider adoption as the field establishes track records of demonstrated value.
The opportunity extends well beyond opioid use disorder. If digital therapeutics can show similar clinical effectiveness and cost savings for other substance use disorders, anxiety and depression, PTSD, and other behavioral health conditions, the addressable market becomes enormous. The behavioral health workforce shortage, growing treatment demand, and persistent access barriers create ideal conditions for scalable digital interventions.
Whether digital therapeutics ultimately transform behavioral health care or remain supplemental tools depends on continued evidence generation, reimbursement policy evolution, and real-world implementation success. Pear’s reSET-O research represents one important data point suggesting the transformation is possible—now the industry must prove it can deliver that promise at scale.
