Pear Therapeutics Launches PEAR Assistance Program to Ensure Access to Prescription Digital Therapeutics, reSET® and reSET-0®, for People Living with Addiction

“Addiction is a treatable chronic disease that requires ongoing access to safe and effective care, especially in this time of remote care. FDA-approved addiction therapies should be available for all patients who need them,” said Kevin Roy, Chief Public Policy Officer for Shatterproof. “We applaud steps to provide coverage of these therapies, as well as assistance for those who lack coverage. Patients need support now more than ever.”

PDTs have a critical role to play for patients in recovery, especially in today’s newly complicated treatment environment. Under current circumstances, the advantages of PDTs to clinicians and patients with addiction treatment needs are significant. PDTs can treat patients without physical proximity, extend care over distances and beyond treatment facilities, promote deeper connection between patients and their care team through physician-monitored cognitive behavioral therapy, and empower patients to strengthen their self-assessment skills and better navigate their care.

“Addiction is a chronic, relapsing and remitting medical disease of the brain. In fact, relapse rates with addiction are similar to those of other chronic illnesses such as asthma and hypertension. And yet the former is neither treated nor covered to the same extent as the latter chronic conditions,” said Lipi Roy, M.D., MPH, FASAM, Clinical Assistant Professor, NYU Langone Health. “In reality, patients with addiction rely on coverage by their health insurers for treatment and unfortunately, such coverage is rare.”

The PEAR Assistance Program is designed for patients who are being treated by a licensed US healthcare provider on an outpatient basis and prescribed a PDT that is included in the program. Qualifying patients have limited or no health insurance coverage, have demonstrated qualifying financial need and live in the United States. For more information about how to apply for assistance, contact us at https://www.resetforrecovery.com/recovery-challenges or call the reSET Connect Patient Service Center (1-833-MY-RESET) Monday through Friday between 8:00 a.m. and 8:00 p.m. EST. Aligned with social distancing guidelines, once reSET-O or reSET is prescribed, patients can work with their physicians to remotely enroll for access to the digital therapeutic and begin treatment.

“Pear is working with private and public insurance providers to generate patient access for PDTs,” said Corey McCann, M.D., Ph.D., President and CEO of Pear Therapeutics. “Many patients who are currently fighting the battle of addiction would benefit from reSET and reSET-O and the PEAR Assistance Program provides that access now.”

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 and whose reading level is at the 7^th grade level 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 represent a substitution for a patient’s medication. Patients should continue to take their medications as directed by their healthcare provider.

reSET should not be used by individuals outside active enrollment in a SUD treatment program. It should only be used as an adjunct to face-to-face counseling and contingency management. reSET is not intended to reduce the amount of face-to-face clinician time.

The long-term benefit of treatment with reSET on abstinence has not been evaluated in studies lasting beyond 12-weeks 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 full Clinician Brief Summary for reSET for more information.

reSET-O Important Safety Information

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 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).

reSET-O should not be used by individuals outside active OUD treatment. It is not intended to replace treatment by you, the patient’s medical provider. It should be used as an adjunct to clinician treatment, buprenorphine treatment and contingency management.

reSET-O is not intended to be used as a stand-alone therapy for Opioid Use Disorder (OUD). 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. The ability of reSET-O to prevent potential relapse after therapy discontinuation has not been studied.

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.

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

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. 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.

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