Prime Therapeutics and Pear Therapeutics Announce First Comprehensive Value-based Agreement for Prescription Digital Therapeutics reSET® and reSET-O® for the Treatment of Substance and Opioid Use Disorders

Agreement aims to reduce inpatient hospitalizations and total cost of care

More than 20 million Americans struggle with drug addiction while only 10-20% receive treatment.¹ Prime Therapeutics LLC (“Prime”) and Pear Therapeutics, Inc. (“Pear”) have developed a comprehensive value-based agreement for prescription digital therapeutics (PDTs). This value-based agreement for Pear’s PDTs is the first of its kind to feature three outcome measures (Hospital Inpatient Stay, Total Healthcare Cost, and Physician Product Engagement).

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PDTs are a new therapeutic class that uses software to treat disease. Like traditional medicines, PDTs are developed in a good manufacturing practice (GMP)-compliant environment, tested in randomized controlled trials demonstrating safety and effectiveness, authorized by the Food and Drug Administration (FDA), and used under the supervision of a prescribing clinician. Unlike other digital health solutions, PDTs receive market authorization from FDA and have a product label that addresses safety and effectiveness.

Leveraging Prime’s expertise in integrating medical and pharmacy claims data, Prime and Pear have agreed to value-based terms assessing the impact of Pear’s FDA-authorized PDTs, reSET® and reSET-O®, on Hospital Inpatient Stay, Total Healthcare Cost, and Physician Product Engagement. These two PDTs treat substance use disorder (SUD) and opioid use disorder (OUD), respectively.

The value-based agreement will be available to Blue Cross Blue Shield plans that include reSET and reSET-O on their standard formulary or custom formularies. These Blue Cross Blue Shield plans serve more than 16 million commercial members.

Staying engaged in treatment is critical for people on their recovery journey. According to a new report from the U.S. Centers for Disease Control and Prevention, drug overdose deaths rose by close to 30% in the United States in 2020, hitting the highest number ever recorded.² Because substance and opioid use disorders are chronic, treatable diseases, it is imperative that patients seek out an ongoing treatment program. reSET and reSET-O offer patients a 24/7, clinically validated therapeutic via their mobile device to complement their remote or in-office addiction therapy provided by their therapist.

“Prime has been a leader at both addressing controlled substances misuse and abuse, and utilizing value-based agreements to drive prescription drug value, for more than a decade,” said Kelly Pokuta, vice president of trade relations and strategy and chief trade relations officer at Prime. “Through our agreement, Prime brought these areas of expertise together to offer members seeking treatment convenient access to innovative, software-based therapeutics through their mobile devices with the potential to improve health outcomes and decrease total cost of care.”

“Prime’s Blue plans can now provide their members seeking treatment for SUD and OUD with access to 24/7 evidence-based tools designed for the way people live today and shown to help keep patients on the path to recovery,” said Julia Strandberg, Chief Commercial Officer of Pear. “This agreement with Prime will help us continue to deliver on our commitment to expand access to people with substance or opioid use disorder, and to make PDTs a mainstream medical treatment.”

reSET and reSET-O have been measured in real-world use and their therapeutic content studied in randomized controlled trials, with results published in peer-reviewed medical journals.^3,4 Pear recently released publications showing the potential for improved real-world health outcomes and decreased treatment costs for patients using reSET-O.^5-12 Both products, which are supplemental to outpatient counseling, provide patients with algorithm-driven cognitive behavioral therapy, education, and rewards for completing the training modules, while clinicians receive access to clinical dashboards to inform in-office and tele-visits.

About Prime Therapeutics

Prime Therapeutics LLC (Prime) helps people get the medicine they need to feel better and live well. Prime provides total drug management solutions for health plans, employers, and government programs including Medicare and Medicaid. The company processes claims and offers clinical services for people with complex medical conditions. Prime serves nearly 33 million people. It is collectively owned by 19 Blue Cross and Blue Shield Plans, subsidiaries or affiliates of those plans. Follow @Prime_PBM on Twitter.

About Pear Therapeutics

Pear Therapeutics is the leader in prescription digital therapeutics, or PDTs. Pear aims to redefine medicine by discovering, developing, and delivering 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 a pipeline of products and product candidates across therapeutic areas, including the first three PDTs with disease treatment claims from FDA. Pear’s lead product, reSET®, for the treatment of Substance Use Disorder, was the first PDT to receive marketing authorization from 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. For more information, visit Pear at www.peartherapeutics.com.

reSET Important Safety Information

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 7^th 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.

This Press Release does not include all the information needed to use reSET safely and effectively. Please see the Clinician Brief Summary for reSET for more information.

reSET-O Important Safety Information

Indications for Use:

reSET-O prescription digital therapeutic is a 12-week (84 day) software application 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 digital therapeutic.

Important Safety Information for Clinicians:

Warnings: reSET-O is intended for patients whose primary language is English with a reading level of 7^th 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.

This Press Release does not include all the information needed to use reSET-O safely and effectively. Please see the Clinician Brief Summary Instructions for reSET-O for more information.

References:

1. https://www.aamc.org/news-insights/21-million-americans-suffer-addiction-just-3000-physicians-are-specially-trained-treat-them
2. https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm
3. Campbell et al., American Journal of Psychiatry. 2014. 171(6):683-690.
4. Christensen DR, Landes RD, Jackson L, et al. Adding an Internet-delivered treatment to an efficacious treatment package for opioid dependence. J Consult Clin Psychol. 2014;82(6):964-972. doi:10.1037/a0037496.
5. Yuri A. Maricich, MD, Xiaorui Xiong, PhD, Robert Gerwien, PhD, Alice Kuo, BA Fulton Velez, MD MBA, Bruce Imbert, MD PhD, Keely Boyer, MBA, Hilary F. Luderer, PhD, Stephen Braun, BA, Karren Williams, PhD (2020): Real-World evidence for a prescription digital therapeutic to treat Opioid Use Disorder, Journal of Current Medical Research and Opinion, DOI:10.1080/03007995.2020.1846023.
6. Fulton F. Velez , Sam Colman , Laura Kauffman , Charles Ruetsch & Kathryn Anastassopoulos (2020): Real-world reduction in healthcare resource utilization following treatment of opioid use disorder with reSET-O, a novel prescription digital therapeutic, Expert Review of Pharmacoeconomics & Outcomes Research, DOI: 10.1080/14737167.2021.1840357
7. Weijia Wang, Nicole Gellings Lowe, Ali Jalali & Sean M. Murphy (2021) Economic modeling of reSET-O, a prescription digital therapeutic for patients with opioid use disorder, Journal of Medical Economics, 24:1, 61-68, DOI: 10.1080/13696998.2020.1858581
8. Yuri A. Maricich, Warren K. Bickel, Lisa A. Marsch, Kirstin Gatchalian, Jeffrey Botbyl & Hilary F. Luderer (2020) Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder, Current Medical Research and Opinion, DOI: 10.1080/03007995.2020.1846022
9. Fulton F. Velez, Hilary F. Luderer, Robert Gerwien, Benjamin Parcher, Dylan Mezzio & Daniel C. Malone (2021) Evaluation of the cost-utility of a prescription digital therapeutic for the treatment of opioid use disorder, Postgraduate Medicine, DOI: 10.1080/00325481.2021.1884471
10. Fulton F. Velez, Charles Ruetsch & Yuri Maricich (2021) Evidence of long-term real-world reduction in healthcare resource utilization following treatment of opioid use disorder with reSET-O, a novel prescription digital therapeutic, Expert Review of Pharmacoeconomics & Outcomes Research, DOI: 10.1080/14737167.2021.193968
11. Fulton F. Velez & Daniel C. Malone (2021) Cost-Effectiveness Analysis of a Prescription Digital Therapeutic for the Treatment of Opioid Use Disorder, Journal of Market Access & Health Policy, 9:1, DOI: 10.1080/20016689.2021.1966187
12. Yuri A. Maricich, Robert Gerwien, Alice Kuo, Daniel C. Malone & Fulton F. Velez (2021) Real-world use and clinical outcomes after 24 weeks of treatment with a prescription digital therapeutic for opioid use disorder, Hospital Practice, DOI: 10.1080/21548331.2021.1974243

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