- Pear’s prescription digital therapeutics (PDTs), reSET® and
reSET-O®, are included on the January 2023 Florida Medicaid
Preferred Drug List (PDL), effective January 1, 2023
- Florida Medicaid is covering reSET® and reSET-O® for the
treatment of substance use disorder and opioid use disorder,
respectively, giving Medicaid patients in Florida access to
innovative FDA-authorized addiction treatments via their mobile
devices
Pear Therapeutics, Inc. (Nasdaq:
PEAR), the leader in developing and commercializing software-based
medicines called prescription digital therapeutics (PDTs), today
announced the inclusion of its PDTs reSET® and reSET-O® on the
January 2023 Florida Medicaid Preferred Drug List (PDL). reSET and
reSET-O, the only FDA-authorized PDTs for the treatment of
substance use disorder and opioid use disorder, respectively, have
been added to the Florida Medicaid PDL, effective January 1,
2023.
In Florida, in August of 2022, there had already been nearly
2,000 overdose deaths for the year.1 In the United States as a
whole, the CDC reported more than 107,000 overdose deaths in the
12-month period ending August 2022.2
“Pear applauds Florida leadership for bringing reSET and reSET-O
to its millions of Medicaid members in its persistent efforts to
tackle the addiction crisis and bring innovative treatment options
to those seeking recovery,” said Julia Strandberg, Chief Commercial
Officer of Pear Therapeutics. “The unmet need in addiction across
the U.S. is enormous, and Florida represents an important step in
how we are helping more and more patients by working with states to
provide covered access to our products.”
Florida Medicaid has approximately five million Florida
residents enrolled, making it the third largest state by
enrollment.
Both 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 and reSET-O.5-16 Clinicians receive access to
clinical dashboards to inform visits with patients. reSET is used
as a monotherapy for patients 18 years of age or older with
substance use disorder related to alcohol, cannabis, cocaine, and
methamphetamine, and reSET-O is used in combination with
buprenorphine-based medication- assisted treatment for patients 18
years of age or older with opioid use disorder.
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 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.
References:
-
https://www.myflfamilies.com/newsroom/pressreleases/2022/20220804-In%20Case%20You%20Missed%20It-Governor%20Ron%20DeSantis%20Announces%20New%20Opioid%20Recovery%20Program%20in%20Florida.shtml
- https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm
- Campbell ANC, Nunes EV, Matthews AG, et al. Internet-delivered
treatment for substance abuse: a multisite randomized controlled
trial. Am J Psychiatry. 2014;171(6):683-690.
- 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.
- 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.
- 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
- 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:
1080/13696998.2020.1858581
- 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: 1080/03007995.2020.1846022
- 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:
1080/00325481.2021.1884471
- 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:
1080/14737167.2021.193968
- 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: 1080/20016689.2021.1966187
- 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:
1080/21548331.2021.1974243
- Velez FF, Colman S, Kauffman L, Ruetsch C, Anastassopoulos K,
Maricich YA. Comparison of Healthcare Resource Utilization Between
Patients Who Engaged or Did Not Engage With a Prescription Digital
Therapeutic for Opioid Use Disorder. Clinicoecon Outcomes Res.
2021;13:909-916 https://doi.org/10.2147/CEOR.S334274
- Velez, F.F., Anastassopoulos, K.P., Colman, S. et al. Reduced
Healthcare Resource Utilization in Patients with Opioid Use
Disorder in the 12 Months After Initiation of a Prescription
Digital Therapeutic. Adv Ther (2022).
https://doi.org/10.1007/s12325-022-02217-y
- Shah, N., Velez, F.F., Colman, S. et al. Real-World Reductions
in Healthcare Resource Utilization over 6 Months in Patients with
Substance Use Disorders Treated with a Prescription Digital
Therapeutic. Adv Ther (2022).
https://doi.org/10.1007/s12325-022-02215-0
- Luderer H, Campbell A, Nunes E, Enman N, Xiong X, Gerwein R,
Maricich Y. Engagement patterns with a digital therapeutic for
substance use disorders: Correlations with abstinence outcomes.
Journal of Substance Use Disorders. 132 (2021) 108585.
https://doi.org/10.1016/j.jsat.2021.108585
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230118005318/en/
Media and Investors Pear
Therapeutics Meara Murphy Senior Director of Corporate
Communications meara.murphy@peartherapeutics.com
Pear Therapeutics (NASDAQ:PEAR)
과거 데이터 주식 차트
부터 5월(5) 2024 으로 6월(6) 2024
Pear Therapeutics (NASDAQ:PEAR)
과거 데이터 주식 차트
부터 6월(6) 2023 으로 6월(6) 2024