ICER Publishes Evidence Report on Digital Therapeutics for Opioid Use Disorder

 — The available evidence on the benefits of reSET-O, Connections, and DynamiCare has substantial limitations and can provide no firm estimate of net health benefit for patients with opioid use disorder versus usual care for any of these interventions —

— Cost-effectiveness could not be modeled except for that of reSET-O; even when assuming short-term improvements in retention in treatment, at its current net price this intervention only aligns with commonly cited cost-effectiveness thresholds when outcomes are assumed to persist beyond the time horizon of the clinical trial; more evidence is needed around the durability of benefit after individuals complete this program —

— At an upcoming November 18 virtual meeting, the Midwest Comparative Effectiveness Public Advisory Committee will review the evidence, hear further testimony from stakeholders, and deliberate over the comparative clinical effectiveness, other potential benefits, and long-term value for money of these interventions —

BOSTON, November 6, 2020 – The Institute for Clinical and Economic Review (ICER) today released an Evidence Report assessing the comparative clinical effectiveness and value of three digital health technologies that have been developed to treat opioid use disorder (OUD):

  • reSET-O® (Pear Therapeutics), a 12-week prescription digital app, used in conjunction with buprenorphine and small rewards, aimed at increasing retention of patients receiving outpatient OUD treatment
  • Connections (Chess Health), a digital app that combines communication with addiction experts and support groups, along with a 7-session program that teaches cognitive and behavioral skills, aimed at improving abstinence in patients with substance use disorders
  • DynamiCare (DynamiCare Health), a digital app that includes 36 classroom-based training modules, monitoring for substance abstinence, and debit card rewards for negative drug tests and appointment attendance

“While the opioid epidemic continues to ravage American communities, ICER remains committed to providing independent evaluations of the relevant clinical evidence – as we have done for abuse-deterrent opioid formulationsmedication-assisted treatment for opioid use disorder, non-drug interventions for lower back pain, and supervised injection facilities,” said Pamela Bradt, MD, MPH, ICER’s Chief Scientific Officer. “Through these assessments, we hope to help US policymakers direct the country’s resources into the services that will have the greatest impact and save the most lives. 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. 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.”

This Evidence Report will be reviewed at a virtual public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC) on November 18, 2020. The Midwest CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.

Register here to watch the live webcast of the virtual meeting.

A draft version of this report was previously open for a four-week public comment period. The updated Evidence Report and voting questions reflect changes made based on comments received from patient groups, clinicians, drug manufacturers, and other stakeholders. Detailed responses to public comments can be found here.

Key Clinical Findings

The most important clinical benefit that these technologies attempt to achieve is retention. Long-term retention — six months to two years or longer — is associated with abstinence and with the outcomes that really matter to patients: employment, reduced financial stress, decreased hospitalizations and emergency room visits, and improved relationships.

None of these three digital therapeutics has direct randomized trial evidence demonstrating how well it may enhance abstinence or retention in medication assisted treatment (MAT) for people with OUD. reSET-O was approved based on an earlier study of the same educational modules, but those modules were delivered on a computer in the clinic rather than by a smart phone app, and the contingency management incentives were fundamentally different.

However, the use of the apps is unlikely to be harmful to patients, so these interventions are at least comparable to using MAT alone. In addition, the limited evidence supporting the underlying training modules and incentives suggests that these apps may provide small incremental benefits. Therefore, all three apps were given an ICER evidence rating of “C+”.

Key Cost-Effectiveness Findings

Due to lack of available evidence for the other apps, ICER was only able to construct a cost-effectiveness model for reSET-O. Assuming a significant impact on MAT retention that is prolonged five years beyond completion of the 12-week program, ICER’s health-benefit price benchmark (HBPB) range for reSET-O is between $1,100-$1,400, a range that is consistent with reSET-O’s current estimated net price of $1,200. However, if future evidence shows that, after completing the reSET-O program, individuals revert to outcomes characteristic of standard of care, reSET-O’s price would need to be substantially discounted to reach common thresholds for cost-effectiveness.

The HBPB is a price range suggesting the highest US price an innovator company should charge for a new intervention, based on the amount of improvement in overall health patients receive from that intervention, when a higher price would cause disproportionately greater losses in health among other patients in the health system due to rising overall costs of health care and health insurance. In short, it is the top price range at which a health system can reward innovation and better health for patients without doing more harm than good.

About ICER

The Institute for Clinical and Economic Review (ICER) is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.

ICER’s reports incorporate extensive input from all stakeholders and are the subject of public hearings through three core programs: the California Technology Assessment Forum (CTAF), the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), and the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). These independent panels review ICER’s reports at public meetings to deliberate on the evidence and develop recommendations for how patients, clinicians, insurers, and policymakers can improve the quality and value of health care. For more information about ICER, please visit ICER’s website.