reSET’s clinician dashboard. Image courtesy of Pear Therapeutics.

Pear Therapeutics, which had been looking for a partner to market its addiction-focused digital therapeutics, reSET and reSET-O, has found one in Sandoz.

Under terms of the deal, announced Wednesday, Sandoz will provide a dedicated sales force to launch both of the products. The firms will split profit on net sales. The deal also includes an upfront payment, R&D funding, and commercial milestones.

“After a competitive evaluation process among potential partners, Sandoz emerged as the best fit,” Pear CEO Corey McCann said in a statement.

Go inside the launch of Pear’s prescription digital therapeutic at the MM&M Transforming Healthcare Conference May 17 in New York City.

The deal comes at a pivotal time for Pear. Its reSET app received regulatory clearance last September for treating patients with substance use disorder related to stimulants, cannabis, cocaine, and alcohol. The approval marked the first time the FDA had sanctioned a mobile app to treat the disorder, and spawned a new regulatory classification — what the company’s executives call “prescription digital therapeutics,” or a medical app in which the app itself actually treats the disorder.

Pear was also invited to join Apple, Verily, J&J, and five other firms in the FDA’s pre-certification pilot program for digital health. Under the program, FDA may pre-certify companies that meet minimum standards. This form of oversight could replace the need for a premarket submission for certain products, like mobile medical apps, the agency said as part of a larger digital health action plan.

Having regulators on-board is good. Sandoz, which agreed to ensure market access and reimbursement for both products, and Pear still need to convince payers and physicians to come around to the software-as-therapy concept. Ahead of the launch, slated for the second half of this year, Pear has made sure to get a head start.

“We are engaging medical directors, pharmacy directors, behavioral health medical directors, and just taking a higher, wider, deeper approach with our payer customers,” Pear’s executive director of market access and reimbursement, Everett Crosland, told MM&M in March. Pear has already engaged “about 80% of the commercial market and is reaching similar numbers in Medicaid and the federal market,” he said.

In the case of digital therapeutics, payers may lag in offering coverage. “We don’t expect coverage at scale until we’ve commercially launched the product,” Crosland noted.

Because the technology requires a physician’s prescription, Sandoz must also work to make doctors more comfortable.

“We envision having a large commercial organization made up of field sales reps, payer experts, and then a full training and implementation team [for clinicians], to accommodate the software nature of the reSET product,” Chris Lento, Pear VP of commercial operations, told MM&M, also in March.

The professional target audience includes any physician who treats substance use disorder, particularly those conducting face-to-face and group therapy, from internists and family medicine practitioners to addiction psychiatrists.

The reSET app provides a 12-week program of cognitive behavioral therapy to patients via mobile and desktop applications. In a clinical trial, reSET as a standalone therapy was shown to increase rates of abstinence and retention in an outpatient treatment program vs. face-to-face therapy.

Pear’s secondary product, reSET-O, filed with the FDA last year, is an app designed to be prescribed in combination with buprenorphine, a drug for treating opioid use disorder. In October the agency pledged to give the product an expedited review.

In March Pear also inked a deal with Sandoz’s parent, Novartis, to aid in the development of another digital therapeutic, Thrive, for patients with schizophrenia, and an unnamed product for the peripheral conditions associated with multiple sclerosis.

Partnerships between makers of digital therapeutics and manufacturers of conventional medicines are becoming increasingly common as pharma looks to become more outcomes-oriented in line with the healthcare system’s move toward value-based care. Pfizer, for instance, was an early partner with digital medicine startup Akili, which is working on a range of games and digital medicines designed to medically treat cognitive conditions such as ADHD, depression, and dementia.

“In the last year…we’ve really seen a marked shift toward digital therapeutics,” said Curtis Duggan, CEO of Blue Mesa Health, which recently allied with Merck KGaA to deliver a digital diabetes prevention program to people with type-2 diabetes.

According to Duggan, that’s after years of speaking with self-insured employers and health plans, whom he said often asked if his firm was in competition with pharma companies. “That was a very one-dimensional view of the relationship between us upstarts and the established pharma brands,” said Duggan in an interview with MM&M on stage at last month’s ePharma Summit.

He said digital therapeutics are still understood in the minds of payers mainly as monotherapy, as opposed to using them in combination with a non-digital drug. “There’s still a lot of work to be done to understand where pharmacological and non-pharmacological treatments are given in combination.”

The taxonomy, too, is a work in progress, but a digital therapeutic is usually defined as a non-pharmacological intervention that can improve patient outcomes, and usually involves providing services — the human touch — that can build healthier behavior, said Bozidar Jovicevic, VP global head of digital medicine at Sanofi, in charge of the company’s beyond-the-drug initiatives.

“I envision a world where pharma companies are not offering a drug; they’re offering a drug plus all this — hardware, software, coaching, etc.,” said Jovicevic, also on stage with MM&M at ePharma Summit. “Patients don’t need the drug only.”

Moving from providing a product to offering a wrap-around solution that has proven evidence-based outcomes and business impact can help drugmakers stand out in what is an increasingly homogenized market, one in which payers are more discerning in coverage decisions and seeking to tie the cost of drugs to outcomes.

Per the agreement with Sandoz, Pear will continue to develop both the reSET and reSET-O digital therapeutics and will also support patient services through its digital hub service.

As patients complete the behavioral therapy lessons on reSET, they self-report things like drug use, cravings, and triggers. Data is transmitted automatically to the provider, who can monitor patient engagement, adherence, and progress through a clinician dashboard.

“Our patient services system — with an opt-in from the patient and provider — will be able to make outbound adherence or compliance calls direct to patients to help them stay engaged with the therapy,” said Lento. In the clinical trial, greater engagement with the app was tied to increased abstinence.

Separately, the company is working with behavioral health technology firm Magellan Health on a pilot project to measure patients’ clinical outcomes when reSET is integrated into real-world treatment. The companies plan to develop a series of publications that clarify the value by highlighting the operational, economic, and clinical results.