Pear Therapeutics’ reSET & reSET-O vs. DynamiCare Health
Both Pear Therapeutics and DynamiCare Health are developers of digital therapeutics for substance use disorders (addiction). According to the Digital Therapeutics Alliance, “Digital therapeutics deliver to patients evidence-based therapeutic interventions that are driven by high quality software programs to treat, manage, or prevent a disease or disorder. They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes.”
Pear offers two prescription digital therapeutics for the treatment of addiction — reSET, for Substance Use Disorder (SUD), and reSET-O, for Opioid Use Disorder (OUD). Both products are built primarily upon cognitive behavioral therapy (CBT).
DynamiCare offers a digital therapeutics platform that works across SUDs, including stimulants, opioids, alcohol, and tobacco. DynamiCare’s platform is primarily focused on contingency management (CM), an evidence-based motivational incentives methodology. Our platform also incorporates a library of self-guided therapy content based on CBT.
Contingency management is the most powerful non-pharmaceutical intervention in the field of addiction research. Combining CM with CBT leads to even greater clinical impacts. The primary advantage of DynamiCare is that it implements CM with greater fidelity than Pear’s products because DynamiCare includes remote substance testing tied to financial incentives on a smart debit card.
Chart explanation: Effect sizes for interventions from the Dutra et al, 2008 meta-analysis were transformed into Odds Ratios and percentage success rates based on an assumption of TAU at 25% for comparison purposes. Logos are categorized based on their primary therapeutic modalities.
Although Pear’s products partially incorporate CM, in the form of gift cards for completing in-app CBT content, the burden is placed on the provider to manage the CM program, which is why reSET’s label states, “reSET is intended [to] be used in conjunction with a contingency management incentives system.” To complete the CM program, providers have to conduct in-person urine tests and manually enter the data into Pear’s platform. Research on Pear Therapeutics’ platform reported in the scientific literature that this only happens 15% of the time, limiting its effectiveness.
Rewards Convenience
Pear’s products offer rewards in the form of virtual gift cards, which can be redeemed at a selection of specific merchants. DynamiCare delivers its CM rewards on a smart debit card, which can be used widely like a VISA card, but blocks access to bars, liquor stores, and cash withdrawals. This offers patients convenience and flexibility in a familiar form factor. These features have been associated with a high degree of efficiency and patient satisfaction.
Program Duration
Pear’s products were only designed for and FDA-cleared for a 90-day period of use. This timeframe is too short to yield lasting benefit. This is because SUD is a chronic, cyclical illness of lapses and reengagement with abstinence. Unlike Pear’s products, DynamiCare’s platform fully automates CM, CBT, and other long-term supports, and its algorithm and services are designed to be used for 12 months. Being fully automated means that DynamiCare offers providers a lower burden-of-effort. With its ease of use, true random/true witnessed saliva and breath testing, direct cash equivalent rewards, an evidence-based toolkit and 12-month duration, DynamiCare aims to become a best-in-class treatment for SUD.
Customer Satisfaction Ratings
DynamiCare’s app has consistently received higher ratings than Pear’s on the Apple App Store and Google Play Store.
App store ratings of 3/22/2023. Click links for live data.
FDA Review
Pear’s reSET and reSET-O have received full marketing clearance from the FDA as a prescription digital therapeutic (PDT) for the treatment of substance use and opioid use disorders, respectively. DynamiCare does not require a prescription, because it is not intended for use as treatment itself for SUD, but rather as a tool for the patient’s use in support of their recovery in conjunction with a treatment program. As a result, DynamiCare has not applied for FDA clearance as a PDT. DynamiCare, however, has received two Breakthrough Device Designations from the FDA for its PDTs that are in development. The FDA Breakthrough Device Designation is for highly innovative medical devices that address life-threatening or severely debilitating illnesses.
Federal Anti-Fraud Review
When a treatment program offers CM in an evidence-based manner, these full-value, effective rewards may run afoul of multiple federal laws and regulations. These statutes have to do with waste, fraud and abuse. The actual laws include the Anti-Kickback Statute and regulations against beneficiary inducement. Therefore, entities offering rewards are either limited to low-level rewards or may run the risk of federal investigation and criminal sanctions. The federal agency that oversees these sanctions is the HHS Office of the Inspector General (OIG).
The only digital health entity to receive a favorable Advisory Opinion from the OIG under these restrictions is DynamiCare. This allows DynamiCare to offer patient rewards at evidence-based full value (e.g., $599 per patient per year) and with direct, cash-equivalent delivery (the risk-protective smart debit card). This status means that providers, health plans, and states that use DynamiCare are not at risk of violating federal regulations regarding patient incentives.
Contact Us
For those curious to learn more about DynamiCare’s digital therapeutics, we encourage you to contact us.