Pear Therapeutics and Serve You Rx Announce Formulary Coverage for Prescription Digital Therapeutic Somryst® and People with Chronic Insomnia

• Serve You Rx teams with Pear to lead access to Somryst, the only FDA-authorized prescription digital therapeutic (PDT) for the treatment of chronic insomnia

• Somryst will be added to Serve You Rx’s standard national formulary and covered as a pharmacy benefit for all its commercial members

• Serve You Rx and Pear will collaborate to provide access to guideline recommended first-line treatment delivered digitally that has been shown to improve the symptoms of chronic insomnia

• Pear continues to expand market access and standard formulary coverage for its portfolio of PDTs

Pear Therapeutics, Inc. and Serve You Rx announced today that Somryst®, the only FDA-authorized prescription digital therapeutic for the treatment of chronic insomnia, will be added to Serve You Rx’s formularies and be administered as a standard pharmacy benefit for its members, effective July 1, 2021. Somryst, intended for use in the treatment of patients 22 years of age and older with chronic insomnia, addresses the underlying issues of chronic insomnia by delivering cognitive behavioral therapy for insomnia (CBTi), an evidence-based approach that trains the brain and body to sleep.

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“The recommended first line treatment for chronic insomnia is non-pharmaceutical CBTi, and this prescription digital therapeutic supports that line of treatment,” said Debra Echlin, Pharm.D., CGP, Serve You Rx’s Vice President of Clinical Programs. “Somryst addresses the root of the issue by teaching patients to modify behaviors, habits, and thought patterns that may contribute to chronic insomnia.”

As part of Serve You Rx’s commitment to make treatment of chronic health conditions easier, Serve You Rx will provide prescription benefit coverage of Somryst to their members as a standard offering on all formularies.

“We are pleased that Serve You Rx continues to be at the forefront of providing access to prescription digital therapeutics. By adding Somryst on formulary along with reSET and reSET-O, Serve You Rx now covers Pear’s total product portfolio,” said Julia Strandberg, Chief Commercial Officer of Pear Therapeutics. “Together, we will deliver participating clients and members with a meaningful and accessible first-line treatment option to treat chronic insomnia.”

Unlike sleep medications, which are only recommended for short term use and can have unwanted side-effects, PDT use has been shown to deliver long-term results with persistent improvements in insomnia symptoms observed at the 6- and 12-month follow-up visits in the published clinical studies. Over six to nine weeks, depending on a patient’s pace, the PDT takes patients through algorithm-driven sleep restriction and cognitive behavioral therapy for insomnia, while also providing clinicians with timely data on patient progress via the Pear.MD dashboard. Research shows that PDT use correlates with lasting improvements in sleep outcomes at 12 and 18 months for people suffering from chronic insomnia¹. In clinical studies, patients treated with the PDT reduced the amount of time it took to fall asleep by 45%, reduced the amount of time spent awake at night by 52%, and reduced the severity of insomnia symptoms by 45%, with continued improvement at six and 12 months post treatment. Results from clinical studies have been published in JAMA Psychiatry² and Lancet Psychiatry^3,4.

At Somryst.com, individuals can obtain access to a doctor who will perform an evaluation and determine whether or not an individual is a candidate for Somryst. If an individual receives a prescription, a case worker from PearConnect, the industry’s first patient service center for PDTs, will support the individual on how to download Somryst and get started. Telemedicine allows individuals suffering from chronic insomnia to get started on Somryst without leaving their home.

PDTs are a new therapeutic class that uses software to treat disease. Like traditional medicines, PDTs are developed in a GMP-compliant environment, tested in randomized controlled trials demonstrating safety and effectiveness, authorized by FDA, and used under the supervision of a prescribing clinician^2,3. Unlike unregulated digital health solutions, PDTs receive market authorization from FDA and have a product label that addresses safety and effectiveness.

About Serve You Rx

Serve You Rx is a national pharmacy solutions provider based in Milwaukee, Wisconsin that specializes in pharmacy benefit management, mail order services, and specialty medication management. For more than 30 years, Serve You Rx has been collaborating with benefit advisors, third-party administrators, and employer groups to design and deliver strategies that reduce prescription drug costs and improve consumer access to affordable and clinically appropriate medication therapies. Learn more about Serve You Rx at serveyourx.com.

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.

About Somryst®

Somryst is a 9-week Prescription Digital Therapeutic (PDT) for chronic insomnia. Somryst is used on a mobile device, such as a smartphone or tablet. Somryst is available by prescription only. A licensed Health Care Provider (HCP) must prescribe Somryst and use of Somryst should be undertaken only under the supervised care of an HCP.

Somryst Indications for Use and Important Safety Information

Somryst is a prescription-only digital therapeutic intended to provide a neurobehavioral intervention (Cognitive Behavioral Therapy for Insomnia – CBT-I) to patients 22 years of age and older with chronic insomnia. Somryst treats patients with chronic insomnia by improving a patient’s insomnia symptoms.

Safety Information and Warnings

Somryst is not for everyone. Please use your clinical judgement to determine whether Somryst is right for your patient.

• Somryst is not for emergency use. Please instruct patients to dial 911 or to go to the nearest emergency room in the event of a medical emergency.
• Patients should be clearly instructed not to use Somryst to communicate severe, critical, or urgent information to their Health Care Provider.
• Somryst is not meant to be used as treatment without supervision of a Health Care Provider.
• Somryst is not meant to be a substitution for any treatment medication.
• Somryst contains sensitive medical information. Please instruct patients to protect their information by password-protecting their smartphone and tablet, ensuring no one else may access their device.
• Sleep Restriction (and Consolidation) within Somryst can cause sleepiness, especially in the early stages of using the PDT. Somryst should not be used if the patient needs to be alert or cautious to avoid serious accidents in their job or daily life. Examples include:
  
  - Long-haul truck drivers
  
  - Long-distance bus drivers
  
  - Air traffic controllers
  
  - Operators of heavy machinery
  
  - Some assembly line jobs
• The usage data collected in therapy lessons by Somryst are not intended to be used as a standalone assessment of treatment progress.

Note: In the early stages of treatment, increased daytime sleepiness may be expected, but is usually temporary. Please instruct the patient to consult with their Health Care Provider if these experiences do not go away over a few weeks, as it may indicate that they have another sleep disorder or medical condition other than insomnia. Please instruct the patient that if they have trouble staying awake while performing potentially dangerous tasks (like driving) at any point in the treatment, to avoid these dangerous tasks or stop following the sleep restriction component of the therapy.

This press release does not include all the information needed to use Somryst safely and effectively. Please see the full Clinician Brief Summary Instructions for Somryst for more information.

References:

¹Batterham, P.J., Christensen, H., Thorndike, F. P., Ritterband, L.M., Gerwien, R., Enman, N., Botbyl, J., Maricich, Y. Web-delivered CBT for Insomnia Intervention Improves Sleep Among Adults with Insomnia and Depressive Symptoms. Virtual SLEEP 2020.

²Ritterband LM, Thorndike FP, Ingersoll KS, et al. Effect of a Web-Based Cognitive Behavior Therapy for Insomnia Intervention With 1-Year Follow-up: A Randomized Clinical Trial. JAMA Psychiatry. 2017;74(1):68–75. doi:10.1001/jamapsychiatry.2016.3249.

³Christensen H, Batterham PJ, Gosling JA, et al. Effectiveness of an online insomnia program (SHUTi) for prevention of depressive episodes (the GoodNight Study): a randomised controlled trial. Lancet Psychiatry 2016; 3: 333–41.

⁴Batterham P, Christensen H, Mackinnon A, et al. Trajectories of change and long-term outcomes in a randomized controlled trial of internet-based insomnia treatment to prevent depression. BJPsych Open. 2017; 3(5), 228-235. doi:10.1192/bjpo.bp.117.005231.

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