BOSTON & DEVON, Pa.--(BUSINESS WIRE)--Pear Therapeutics, Inc. (Nasdaq: PEAR) (“Pear”), the leader in developing and commercializing software-based medicines called prescription digital therapeutics (PDTs), today announced an agreement with COEUS HealthCare, LLC (“COEUS”), a leading life sciences technology and consulting firm, to utilize its outcomes and evidence-based reimbursement adjudication platform, COEBRA™ to help enable value-based contracting. As Pear continues to engage in clinical and contractual conversations with state Medicaid programs, its agreement with COEUS makes it easier for individual states to engage in value-based contracting to access Pear’s PDTs. Pear's commercial products, reSET® and reSET-O®, are among a limited number of products initially included in the solution and are the only PDTs on the platform.
“We are proud to be the first PDT company to work with COEUS to help streamline value-based contracting with state Medicaid programs,” said Corey McCann, President and CEO of Pear Therapeutics. “States are looking to take innovative approaches to treat patients with mental health conditions like addiction, and we believe COEUS could accelerate our progress with state Medicaid programs by facilitating value-based agreements. States are exposed to both the healthcare and societal costs associated with mental health conditions, and we believe that the value proposition for our prescription digital therapeutics is compelling.”
For several years, Centers for Medicare & Medicaid Services (CMS), has advocated for states to contract with drug and device manufacturers on a metric other than price by linking the cost of the drug/device to the value or outcome it provides.
The agreement between COEUS and Pear could help unlock the potential value that Pear’s PDTs can deliver. Hosting PDTs on the COEUS COEBRATM Platform is intended to provide scalability for Pear across multiple channels including Medicaid, Commercial and other government payers. As part of the agreement, COEUS will provide Pear a turnkey value-based solution that will be made available to most state Medicaid programs. The COEUS COEBRATM Platform will provide a composite view of the real-world therapeutic impact to both the payer and Pear by analyzing metrics from claims data and electronic medical records. The demonstration of total therapeutic impact on a patient’s illness and the resulting system savings are critical to addressing the needs of unique state Medicaid populations.
“Our COEBRA™ platform was created and designed to solve the biggest challenge of managing complex innovative contracts – interpreting detailed, real-time data sets, and accurately summarizing results,” said Marc Hixson, President and CEO of COEUS. “We look forward to working with Pear to streamline the contracting process with state Medicaid programs and help improve patient access to its innovative prescription digital therapeutics.”
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:
Warnings: reSET is intended for patients whose primary language is English or Spanish 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.
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:
Warnings/precautions: reSET-O is intended for patients whose primary language is English or Spanish 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.
About COEUS HealthCare
Established in 2019, COEUS HealthCare is the division of COEUS Holdings responsible for the development of the SaaS solution, COEBRA™, a value-based, outcomes and warranty adjudication platform. COEBRA™ supports the collection and secure housing of data that allows disparate data sources to be combined and analyzed to better demonstrate total therapeutic impact on a patient’s illness. With today’s innovative and breakthrough medicines, there may not always be a clinical marker available to measure the value of the therapy. The COEBRA™ platform offers a composite view of the therapeutic impact to both payers and manufacturers by incorporating metrics from claims data, electronic medical records, supply chain, patients and providers and wearables. For more information, visit www.coeus-healthcare.com.
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. For more information, visit Pear at www.peartherapeutics.com.
Forward-Looking Statements from Pear Therapeutics
This press release contains forward-looking statements within the meaning of the federal securities laws that are subject to risks and uncertainties and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements generally relate to future events involving, or future performance of, Pear. For example, whether Pear’s agreement with COEUS will facilitate, streamline, accelerate the progress of, or make it easier for state Medicaid programs to engage in value based contracting for Pear’s PDTs, whether Pear’s agreement with COEUS will help improve patient access to PDTs or unlock the value of Pear’s PDTs, and whether the value proposition for Pear’s PDTs is compelling, whether having Pear’s PDTS hosted on COEUS’ platform provides scalability for Pear across multiple channels including Medicaid, Commercial and other government payers, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “can”, “should”, “could”, “might”, “plan”, “possible”, “strive”, “aim”, “expect”, “intend”, “will”, “estimate”, “believe”, “predict”, “potential”, or “continue”, or the negatives of these terms or variations of them or similar terminology.
These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Pear and its management are inherently uncertain. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i), the rate at which customers integrate Pear’s PDTs into their treatment paradigms, (ii) changes in applicable laws or regulations; (iii) the possibility that Pear may be adversely affected by other economic, business, regulatory, and/or competitive factors; (iv) the evolution of the markets in which Pear competes; (v) the ability of Pear to defend its intellectual property and satisfy regulatory requirements; (vi) the impact of the COVID-19 pandemic on Pear’s business; and (vii) other risks and uncertainties set forth in Pear’s filings with the SEC (including those described in the Risk Factors section). These filings will identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements.
Readers are cautioned not to put undue reliance on forward-looking statements, which are based only on information currently available to us and speak only as of the date of this release. Pear assumes no obligation to publicly update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. Pear gives no assurance that Pear will achieve its expectations.