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

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BOSTON & MILWAUKEE – (COMMERCIAL THREAD) – Pear Therapeutics, Inc. and Serve You Rx today announced that Somryst®, the only FDA-approved digital prescription therapy for the treatment of chronic insomnia, will be added to the Serve You Rx formularies and will be administered as a standard pharmaceutical benefit to its members, effective July 1, 2021. Somryst, intended for use in the treatment of patients 22 years of age and older with chronic insomnia, treats the underlying problems of chronic insomnia by providing cognitive behavioral therapy for insomnia (CBTi), an evidence-based approach that trains the brain and body to sleep.

“The recommended first-line treatment for chronic insomnia is non-pharmaceutical CBTi, and this digital prescription therapy supports this line of treatment, ”said Debra Echlin, Pharm.D., CGP, vice president of clinical programs at Serve You Rx. “Somryst gets to the root of the problem by teaching patients to change behaviors, habits and thought patterns that can contribute to chronic insomnia.

As part of Serve You Rx’s commitment to facilitate the treatment of chronic health conditions, Serve You Rx will provide its members with prescription benefit coverage from Somryst as a standard offering on all forms.

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

Unlike sleeping pills, which are only recommended for short-term use and may have unwanted side effects, the use of PDT has been shown to provide long-term results with persistent improvements in insomnia symptoms seen. during follow-up visits at 6 and 12 months. in published clinical studies. Over six to nine weeks, depending on the patient’s pace, the PDT guides patients through algorithm-based sleep restriction and cognitive behavioral therapy for insomnia, while providing clinicians with up-to-date data on the progress of the patient. patient via the Pear.MD dashboard. Research shows that PDT use correlates with lasting improvements in sleep outcomes at 12 and 18 months for people with chronic insomnia1. In clinical studies, patients treated with PDT reduced the time to fall asleep by 45%, the time spent awake at night by 52%, and the severity of insomnia symptoms by 45%, with continued improvement. at six and 12 months after treatment. The results of clinical studies have been published in JAMA Psychiatry2 and Lancet Psychiatry3.4.

On Somryst.com, people can access a doctor who will perform an assessment and determine whether or not a person is a candidate for Somryst. If a person receives a prescription, a case worker from PearConnect, the industry’s first patient service center for PDT, will help the person download Somryst and get started. Telemedicine allows people with chronic insomnia to get started on Somryst without leaving their home.

PDTs are a new class of therapy 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 efficacy, cleared by the FDA, and used under the supervision of a prescribing clinician.2.3. Unlike unregulated digital health solutions, PDTs receive market authorization from the FDA and have a product label that addresses safety and efficacy.

About Serve You Rx

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

About Pear Therapeutics

Pear Therapeutics is the leader in digital prescription therapies, or PDTs. Pear aims to redefine medicine by discovering, developing and delivering clinically validated software therapies to deliver better patient outcomes, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Pear has a pipeline of product and product candidates across all therapeutic areas, including the top three PDTs with FDA disease treatment claims. Pear’s flagship product, reSET®, for the treatment of substance use disorders, was the first PDT to receive market authorization from the FDA to treat the disease. Pear’s second product, reSET-O®, for the treatment of opioid use disorders, was the first PDT to receive the breakthrough designation. Pear’s third product, Somryst®, for the treatment of chronic insomnia, was the first PDT submitted via the traditional 510 (k) route to the FDA while simultaneously being reviewed under the pilot software pre-certification program of the FDA. For more information, visit Pear at www.peartherapeutics.com.

About Somryst®

Somryst is a 9-week prescription digital therapy (PDT) for chronic insomnia. Somryst is used on a mobile device, such as a smartphone or tablet. Somryst is only available by prescription. A licensed healthcare provider (HCP) should prescribe Somryst and the use of Somryst should only be undertaken under the supervision of an HCP.

Indications for use of Somryst and important safety information

Somryst is a digital prescription therapy only intended to provide neurobehavioural intervention (Cognitive Behavioral Therapy for Insomnia – CBT-I) to patients 22 years 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 judgment to determine if Somryst is right for your patient.

  • Somryst is not intended for use in an emergency. Please ask patients to call 911 or go to the nearest emergency room in the event of a medical emergency.

  • Patients should be clearly instructed not to use Somryst to communicate serious, critical or urgent information to their healthcare provider.

  • Somryst is not intended for use as a treatment without the supervision of a healthcare provider.

  • Somryst is not intended to be a substitute for any drug treatment.

  • Somryst contains sensitive medical information. Please ask patients to protect their information by password-protecting their smartphone and tablet, ensuring that no one else can access their device.

  • Restricting (and consolidating) sleep in Somryst may cause drowsiness, especially in the early stages of PDT use. Somryst should not be used if the patient needs to be alert or careful to avoid serious accidents in their work or daily life. Examples include:

    – Long-haul truck drivers

    – Long-distance bus drivers

    – Air traffic controllers

    – Heavy machinery operators

    – Some assembly line work

  • Usage data collected in Somryst therapy courses is not intended to be used as a stand-alone assessment of treatment progress.

Note: In the early stages of treatment, increased daytime sleepiness can be expected, but it is usually temporary. Please ask the patient to see their health care provider if these experiences do not go away after a few weeks, as this may indicate that they have another sleep disorder or medical condition other than insomnia. Please advise the patient that if they have difficulty staying awake while performing potentially hazardous tasks (such as driving) at any time during treatment, they should avoid these hazardous tasks or discontinue the sleep restriction component of therapy. .

This press release does not include all the information necessary to use Somryst safely and effectively. For more information, please see the full clinician summary instructions for Somryst.

The references:

1Batterham, PJ, Christensen, H., Thorndike, FP, Ritterband, LM, Gerwien, R., Enman, N., Botbyl, J., Maricich, Y. CBT Online for Insomnia Intervention Improves Sleep in Adults with Insomnia and Depressive Symptoms. Virtual SLEEP 2020.

2Ritterband LM, Thorndike FP, Ingersoll KS, et al. Effect of web-based cognitive behavioral therapy for insomnia intervention with one-year follow-up: a randomized clinical trial. JAMA Psychiatry. 2017; 74 (1): 68-75. doi: 10.1001 / jamapsychiatrie.2016.3249.

3Christensen H, Batterham PJ, Gosling JA, et al. Effectiveness of an online insomnia program (SHUTi) for the prevention of depressive episodes (the GoodNight study): a randomized 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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