Pear Therapeutics scored an important reimbursement milestone for prescription digital therapeutics (PDT).

In response to the company's application, the Centers for Medicare & Medicaid Services (CMS) established a new code to describe prescription digital behavioral therapy, FDA cleared, per course of treatment. The code includes prescription digital therapeutics such as Pear's reSET, reSET-O, and Somryst, which are FDA authorized for the treatment of substance use disorder, opioid user disorder, and chronic insomnia, respectively. The code is scheduled to become effective on April 1.

The coding decision facilitates options for payers to provide access to these treatment options, the Boston, MA-based company said.

“This is an important reimbursement milestone for healthcare providers, payers and patients, and marks another step towards standard of care for coverage and payment for the PDT category," said Corey McCann, MD, PhD, president and CEO of Pear Therapeutics.

Pear said it is working with payers to add prescription digital therapeutics as a standard covered benefit, helping to increase accessibility to care for those in need, and creating the opportunity to reduce overall healthcare spending. The coding decision comes at a time when mental health issues such as substance use disorder, opioid use disorder, and chronic insomnia are on the rise, exacerbated by the ongoing pandemic.

Prescription digital therapetuics 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, evaluated and authorized by regulators like FDA, and used under the supervision of a prescribing clinician, Pear noted. Unlike traditional medicines, PDTs are designed to collect real-world data for use by prescribing clinicians and for population health management by payers and health systems.

Pear Therapeutics sits atop a growing prescription digital therapeutics market

Pear Therapeutics, a company that went public through a special purpose acquisition corporation merger last year, is at the top of the list of companies in the PDT market, according to analysts of the space. The company was founded in 2013.

“Pear is a trailblazer in prescription digital therapeutics (PDTs), with three commercial, FDA-authorized products, expanding payer coverage, and a long product pipeline," Marie Thibault, a medtech analyst at BTIG and a former managing editor of MD+DI, wrote in a report earlier this year.

Thibault noted that Pear has a head start on a regulatory, commercial, and operational basis, with its PearCreate and PearConnect platforms intended to rapidly iterate and distribute new prescription digital therapeutics.

We think Pear's leadership, its ability to offer multiple PDTs of its own, and eventually host other PDTs, give the company an advantage," she wrote.