Pear Therapeutics, Inc., (Nasdaq: PEAR), a developer of software-based medicines called prescription digital therapeutics (PDTs), announced an agreement with Point32Health, a health and wellbeing organization founded by Tufts Health Plan and Harvard Pilgrim Health Care. Through this agreement, more of Point32Health’s members suffering from substance use disorder (SUD) or opioid use disorder (OUD) will have access to Pear’s FDA-authorized digital therapeutics and help them on their recovery journeys.
Prescription Digital Therapeutics
In the era of digital technology, consumerism in healthcare means patients demand the same seamless digital experience they get when dealing with other service-oriented industries. Digital health tools, more specifically digital therapeutics, that facilitate innovative methods and modalities to improve care, enable lifestyle change, and create efficiencies are progressing quickly. And as patients continue to adopt digital interactions, healthcare organizations are rapidly leveraging these technologies to improve care and the patient experience. Advancements in the increasingly dominant role of mobile technology and artificial intelligence (AI) in our daily lives have broadened PDT’s capacity in healthcare. PDT’s could play a critical role in care delivery throughout the pandemic and make health care more accessible and convenient.
Digital therapeutics deliver medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases and disorders. Products are held to the same evidence and regulatory oversight standards as traditional medical treatments. PDT’s are typically used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes. These digital therapies empower patients, clinicians, and payers with intelligent and accessible tools for addressing a wide range of conditions through high-quality, safe, and effective data-driven interventions.
Pear prides itself as a leader in digital therapeutics and has built a pipeline of potential new therapies across disease areas.
According to the announcement, Pear is pushing the boundaries of technology to transform medicine. It is currently developing the new therapeutics class of prescription digital therapeutics with three FDA-authorized products and a robust pipeline of product candidates across additional therapeutic areas. With Pear’s PDTs, patients have 24/7 remote access to their treatment program and to clinicians who can monitor progress to inform their treatment approach, regardless of physical proximity.
Pear recently released publications showing the potential for improved real-world health outcomes and decreased healthcare resource utilization for patients using reSET. Pear’s reSET and reSET-O, for the treatment of SUD and OUD, respectively, have been measured in real-world use and their therapeutic content studied in randomized controlled trials, with results published in peer-reviewed medical journals. Both products, adjunctive to outpatient counseling, provide patients with cognitive behavioral therapy, fluency training, and contingency management. At the same time, clinicians receive access to clinical dashboards to inform in-office and telehealth visits.
We are pleased to enter into this relationship with Point32Health to further support their members with access to innovative, FDA-authorized treatments for addiction without fear of stigma. Amid the pandemic and increasingly more potent substances and substance combinations, drug overdose deaths have risen to record levels. Our reSET and reSET-O PDTs are safe and effective treatments designed to help patients stay in recovery.Julia Strandberg, Chief Commercial Officer at Pear Therapeutics
About Pear Therapeutics
Pear Therapeutics, Inc., which is traded on Nasdaq as PEAR, is the parent company of Pear Therapeutics (US), Inc. Pear is the leader in developing and commercializing software-based medicines, called prescription digital therapeutics (PDTs). Pear aims to redefine care through the widespread use of clinically validated software-based therapeutics to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Pear has the first end-to-end platform to discover, develop, and deliver PDTs to patients and a pipeline of products and product candidates across therapeutic areas, including the first three PDTs with disease treatment claims from the FDA. Pear’s product, reSET®, for the treatment of substance use disorder, was the first PDT to receive marketing authorization from the FDA to treat disease. Pear’s second product, reSET-O®, for the treatment of opioid use disorder, was the first PDT to receive Breakthrough Designation. Pear’s third product, Somryst® for the treatment of chronic insomnia, was the first PDT submitted through FDA’s traditional 510(k) pathway while simultaneously reviewed through FDA’s Software Precertification Pilot Program.
Point32Health is a leading health and wellbeing organization, delivering an ever-better health care experience to everyone in Point32Health communities. Building on the quality, nonprofit heritage of its founding organizations, Tufts Health Plan and Harvard Pilgrim Health Care, Point32Health leverages its experience and expertise to help people find their version of healthier living. To make this happen Point32Health offers a broad range of health plans and tools that make navigating health and wellbeing easier.
Important Safety Information from Pear Therapeutics about reSET
Indications for Use:
reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older, who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12-week (90 day) prescription-only treatment for patients with substance use disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse.
It is intended to:
- increase abstinence from a patient’s substances of abuse during treatment, and
- increase retention in the outpatient treatment program.
Important Safety Information for Clinicians:
Warnings: reSET is intended for patients whose primary language is English with a reading level of 7th grade or above, and who have access to an Android/iOS tablet or smartphone. reSET is intended only for patients who own a smartphone and are familiar with use of smartphone apps (applications).
Clinicians should not use reSET to communicate with their patients about emergency medical issues. Patients should be clearly instructed not to use reSET to communicate to their clinician any urgent or emergent information. In case of an emergency, patients should dial 911 or go to the nearest emergency room.
reSET is not intended to be used as a stand-alone therapy for substance use disorder (SUD). reSET does not replace care by a licensed medical practitioner and is not intended to reduce the amount of face-to-face clinician time. reSET does not represent a substitution for a patient’s medication. Patients should continue to take their medications as directed by their healthcare provider.
Patients with substance use disorder experience mental health disease and co-morbid medical problems at higher rates than the general population. Patients with substance use disorder also have higher baseline rates of suicidal ideation, and suicide attempts, and suicide completion. Clinicians should engage in their normal care practices to monitor patients for medical problems and mental health disorders, including risk for harming others and/or themselves.
The long-term benefit of treatment with reSET on abstinence has not been evaluated in studies lasting beyond 12 weeks (90 days) in the SUD population. The ability of reSET to prevent potential relapse after treatment discontinuation has not been studied.
The effectiveness of reSET has not been demonstrated in patients currently reporting opioids as their primary substance of abuse.
Important Safety Information from Pear Therapeutics about reSET-O
Indications for Use
reSET-O is intended to increase retention of patients with Opioid Use Disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only prescription digital therapeutic.
Important Safety Information:
Warnings: reSET-O is intended for patients whose primary language is English with a reading level of 7th grade or above, and who have access to an Android/iOS tablet or smartphone. reSET-O is intended only for patients who own a smartphone and are familiar with use of smartphone apps (applications). Clinicians should not use reSET-O to communicate with their patients about emergency medical issues. Patients should be clearly instructed not to use reSET-O to communicate to their clinician any urgent or emergent information. In case of an emergency, patients should dial 911 or go to the nearest emergency room.
reSET-O is not intended to be used as a stand-alone therapy for Opioid Use Disorder (OUD). reSET-O does not replace care by a licensed medical practitioner and is not intended to reduce the frequency or duration of in-person therapy. reSET-O does not represent a substitution for a patient’s medication. Patients should continue to take their medications as directed by their healthcare provider.
Patients with opioid use disorder experience mental health disease and co-morbid medical problems at higher rates than the general population. Patients with opioid use disorder have higher baseline rates of suicidal ideation, and suicide attempts, and suicide completion. Clinicians should undertake standard of care to monitor patients for medical problems and mental health disease, including risk for harming others and/or themselves.
The long-term benefit of reSET-O has not been evaluated in studies lasting beyond 12 weeks (84 days) in the OUD population. The ability of reSET-O to prevent potential relapse after therapy discontinuation has not been studied.