Pear Goes Public, Pursues Reimbursement

On June 22, Pear Therapeutics Inc. announced a $1.6 billion “business combination” with SPAC Thimble Point Acquisition Corp. Renamed Pear Holding Corp., the company will trade on Nasdaq. This follows on the heels of Pear’s $100 million Series D round of investment, in which, notably, a leading national integrated delivery network (IDN) provided $20 million. It’s all a testament, says Corey McCann, MD, PhD, founder and CEO of Pear, to the health economic data the company has been able to pull together around its prescription digital therapeutic products. The recent funding round, which brings the company’s total funding to date to approximately $250 million (a combination of equity and debt) also included some tech investors like SoftBank Group.

For two of Pear’s FDA-cleared products, software alone is the primary therapy; reSET delivers CBT for substance use disorder, offering patients lessons, compliance rewards, and tracking of cravings and triggers. Somryst for the treatment of chronic insomnia provides CBT and allows for the collection of sleep metrics.

reSET-O, for the outpatient treatment of opioid-use disorder, offers CBT as an adjunct to transmucosal buprenorphine, a drug used to treat addiction. Using a concentrated sales force and a small field operation, the company has been quite successful with this product, McCann says. “We have generated about 20,000 prescriptions, which if you look at a scrip-per-rep ratio, speaks to the demand and market need for products like reSET and reSET-O.”

Pear has been assiduously working on reimbursement for its novel therapies. According to McCann, several IDNs and regional payors have issued positive coverage decisions. The company is now working with state Medicaid organizations to make reSET-O available to the people who need it; about 70-80% of patients with opioid-use disorder are on Medicaid. “It’s really important that we work with the managed Medicaid organizations and the state fee-for-service organizations to provide access to the product for patients.”

Pear Therapeutics lives at the interface of many other fields. Technically speaking, by regulatory classification, says McCann, “digital therapeutics, whether they are regulated or not, are medical devices. The specific classification would be SaMD, software as a medical device.” Pear’s products are Class II medical devices, i.e., devices of moderate risk. From the point of view of payors, “some payors consider us as a medical device, and others as a pharmacy benefit. It is split 50-50 down the middle,” McCann notes.

To be successful in this space, Pear needs to bring together pharmaceuticals, medical devices and technology in an integrated way, which can be challenging. “In the pharmaceutical space, people don’t generally take into account the ability for software to collect really robust longitudinal data, and to evolve and improve over the lifespan of a commercial product.” On the technology side, “those groups aren’t traditionally used to dealing with the FDA and regulation, they’re not used to detailing to clinicians and payors.”

As far as getting digital therapeutics paid through pharmacy benefit formularies, it’s still a bit early, McCann notes. In fact, the entire space is still a work in progress, but it’s work worth getting behind. Every clinician knows that the outcomes for a patient with a disease diagnosis and a behavioral health co-morbidity won’t be as good as for the patient without the co-morbidity. Pear Therapeutics could change the practice of medicine by tackling both at the same time.

Adapted from “Pear Therapeutics Scales Up,” MedTech Strategist, June 14, 2021.

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