COEUS’ COEBRA™ Platform to Facilitate Value and
Outcomes Based Agreements for Government and Commercial Payers
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.
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“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.
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:
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.
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.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230110005453/en/
Pear Therapeutics Meara Murphy Senior Director, Corporate
Communications meara.murphy@peartherapeutics.com
COEUS HealthCare Owen Murphy SVP, Marketing 215.680.0155
omurphy@coeusholdings.com
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