— Independent appraisal committee determines current evidence is inadequate to demonstrate a net health benefit for reSET-O, Connections, or DynamiCare; and that reSET-O at its current price represents low long-term value for money

— To prove the value of digital health technologies that have a therapeutic function, experts on policy roundtable call for randomized controlled trials, or at a minimum, high-quality observational studies using an appropriate comparator and patient-relevant outcomes —

BOSTON, December 11, 2020 – The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report and Report-at-a-Glance assessing the comparative clinical effectiveness and value of three digital health technologies (DHTs) 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

This assessment is another facet of ICER’s work to deliver independent evaluations of the clinical evidence related to a wide-range of potential interventions addressing the opioid crisis, including abuse-deterrent opioid formulationsmedication-assisted treatment for opioid use disordernon-drug interventions for lower back pain, and supervised injection facilities.

“Medication-assisted treatment (MAT) saves lives and money, and new interventions should be developed, tested, and implemented that can augment the number of individuals who can access MAT, reduce stigma, and ensure that individuals receive care in a format that helps them achieve their goals,” said Steven D. Pearson, MD, MSc, ICER’s President. “Digital health technologies that can augment access to effective treatment modalities may improve outcomes for many individuals, but it is vital that adequate evidence be generated to evaluate the relative effectiveness of different options so that each person can receive effective treatment tailored to maximize their health. Poor evidence that leads to ineffective use of DHTs represents a health risk to individuals, a financial risk to the health system, and a moral risk for us all that society will fail in its responsibility to use its resources to the greatest effect in combatting an ongoing national epidemic.

In addition to submitting DHTs to well-run clinical trials that demonstrate safety and effectiveness across patient-relevant outcomes, developers in this emerging field should be prepared to provide a full dossier to payers and providers that includes robust data on related components of value: durability of effect, impact on health-care utilization and clinician productivity, patient experience, IT security and patient privacy, and generalizability to a large and diverse population. As the DHT industry continues to mature, the entire health system will demand the same level of evidence and rigor that it currently does from the biopharmaceutical industry.”

ICER’s report on these therapies was reviewed at the November 2020 public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), one of ICER’s three independent evidence appraisal committees.

Voting on Clinical Effectiveness and Contextual Considerations

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 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.

During the public meeting, a majority of the Midwest CEPAC panelists found that the evidence is not adequate to demonstrate a net health benefit for patients treated with reSET-O, Connections, or DynamiCare.

During their deliberations, panel members also weighed the DHTs’ other potential benefits, disadvantages, and contextual considerations. Approximately half of the panelists found that reSET-O and other DHT modalities will differentially benefit an historically underserved or disadvantaged community, and approximately one-third voted that reSET-O offered a new mechanism of action compared to that of other treatments for OUD. However, approximately one-third of the panelists felt that ICER’s economic model assumptions were too optimistic about the durability of reSET-O’s clinical benefits.

Cost-Effectiveness Findings and Voting on Long-Term Value for Money

Among the three DHTs, only reSET-O was judged to have enough evidence to support a cost-effectiveness evaluation.  Given the limitations of the available evidence on comparative effectiveness and incremental cost effectiveness, and considering other benefits, disadvantages, and contextual considerations, the majority of Midwest CEPAC panelists voted that reSET-O represents low long-term value for money at its current price.

Based on short-term data on reSET-O, and optimistically assuming that its impact on MAT retention is prolonged 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 individuals revert to outcomes characteristic of standard of care following the end of the reSET-O program, 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.

Due to lack of available evidence, ICER did not construct a cost-effectiveness model for Connections and DynamiCare, and the Midwest CEPAC did not vote on these apps’ long-term value for money.

Key Policy Recommendations  

Following the voting session, a policy roundtable of experts — including clinical experts, patient advocates, and representatives from payers and the DHT manufacturers — convened to discuss the implications of the evidence for policy and practice. Key recommendations stemming from the roundtable discussion include:

  • Manufacturers should provide robust evidence of the clinical effectiveness and broader impact of new DHTs. For DHTs like those featured in this report that have a function of guiding or enhancing treatment outcomes, a minimum evidence requirement is high-quality observational or quasi-experimental studies with an appropriate comparator and relevant patient outcomes. However, many DHTs should undergo formal evaluation through randomized controlled trials to minimize the risk of bias in trial results. 
  • In addition to evidence on relative safety and effectiveness in the short term, manufacturers should be prepared to provide a full dossier of evidence to payers and providers that includes robust information on 1) the durability of beneficial clinical effects; 2) the impact on health care utilization; 3) the impact on clinician productivity; 4) the usability as measured by clinician and patient experience; 5) the security of IT components; 6) the generalizability of results to diverse patient populations and health systems; and 7) the scalability to larger populations.
  • Manufacturers and researchers should design trials of DHTs to be able to identify potential subgroups of patients who benefit most from a DHT and those who are less likely to benefit. Existing evidence may also be reanalyzed for this purpose.
  • Given the limited evidence supporting the efficacy of DHTs for OUD, alternative payment models — such as outcomes- or subscription-based contracts, or limited pilots within clinics that can help fill the current evidence gaps — may be appropriate if coverage is provided. 
  • The FDA should develop a clear taxonomy of DHTs, with different levels of risk and other factors, and clarify evidence requirements that are robust enough to inform patients, clinicians, health systems, and payers regarding the safety and comparative effectiveness of their use in representative patient populations.

ICER’s detailed set of policy recommendations, including considerations for establishing prior authorization criteria, is available in the Final Evidence Report and in the standalone Policy Recommendations document.

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.