As the first prescription digital therapeutic approved by the FDA, the treatment will be distributed and supported by a specialist-staffed service center.
reSET — a substance use disorder treatment that was the first software-only therapeutic cleared by the FDA — is now commercially available for clinicians to prescribe to their patients, according to a release from Pear Therapeutics and Sandoz, a division of Novartis with which Pear partnered back in April.
But while physical prescription drugs are usually handled through a pharmacy, the process is a bit different for the digital therapeutic, Dr. Yuri Maricich, Pear’s chief medical officer and head of clinical development, told MobiHealthNews. Prescribing physicians will write a script that is sent to Pear’s reSET Connect Patient Service Center, which staffs specialists who guide the patient through downloading and using the app.
Outside of that wrinkle, though, Maricich said that disseminating the treatment to care centers has been “very similar” to how a pharmaceutical company might put a novel treatment into the wild.
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“We have a team of salespeople who are going out and educating clinicians about the product, its data, how to use it; and we also have a set of services that support dispensing, but they aren’t selling to the clinicians,” he said. “Also, that dispensing and fulfillment process allows the physician to access the dashboard and the therapeutic for their patient as well. And in the background we [Pear and Sandoz] work with payers around coverage and contracts. So, really, what we’re focusing on now is getting the therapeutic in the hands of patients who need it and helping clinicians understand how to use it, who’s the right patient for it, how do I prescribe it and interact with it as part of standard care.”
Still, Pear and Sandoz seem to be playing it safe with the new treatment modality — beyond general distribution and sales, the Patient Service Center is also equipped talk patients and providers through any questions or troubles they might be having.
“How a patient gets access to [reSET] and how it’s prescribed is new, so we really wanted to try to provide bespoke services to the clinician and the patient,” Maricich explained. “The Patient Service Center is available to help with troubleshooting, they have clinical staff available if there’s clinical questions, and then they also are available if there are complaints or adverse events. So they are, basically, the central node for all of those activities to help clinicians and patients get access to therapeutic and to use it.”
reSET is a 12-week digital cognitive behavioral therapy program accessed through an app and designed to accompany outpatient care delivered by a physician. According to Maricich, it is the only treatment authorized by the FDA for patients aged 18 years and older experiencing addiction to and dependency on stimulants, cannabis and cocaine.
What’s the impact
Depending on its success, Pear and Sandoz’s rollout of the novel treatment could serve as a model for any subsequent prescription digital therapies looking to go to market within the next few years. Further on down the road though, Maricich said that he anticipates patients and providers won’t require quite so much guidance.
“In 10 years time, hopefully patients won’t differentiate between ‘I’m taking my digital therapeutic and my ingestible medication.’ They’re just going to say ‘I’m taking my medication,’ and they may take it on their phone or they may swallow it,” Maricich said. “But in the meantime we’re going to have to do a lot of work to educate and support while people learn about this new treatment modality.”
This release is also a culmination of Pear’s ongoing partnership with Novartis — or more broadly, a successful relationship between a digital therapeutic maker and a global pharmaceutical company.
For Pear, that relationship has yielded the guidance and support of an organization well steeped in adapting new products for a complex market, Maricich explained.
“They have developed a model that is very successful [in] educating physicians when they’re innovative, and to work with payers as well as supporting patients. That’s really what Pear was looking for, and the goal was to find partners with that level of excellence and experience in bringing innovative treatments,” he said. “It’s not always going to be the same playbook — but that’s what pharma has done well, right? Pharma constantly is weighing new treatments and they can leverage their experience, but they can also leverage their expertise when it is something novel.”
Maricich isn’t alone in his views. During a recent discussion of his company’s digital strategy, Jacob LaPorte, global head of digital development at Novartis, also described the partnership between Pear and Novartis as a long-term effort reliant on each company’s strengths.
“I think we have an unprecedented understanding of the diseases. We have an unprecedented understanding of where the clinical need is, what works, what doesn’t work, and we have unprecedented understanding of how to bring technology like this to the market, where it requires health authority clearance and approval,” LaPorte said. “And Pear, what they’re bringing, to be clear, is the technology that they began to develop a couple years ago around how to actually create these types of digital therapies that could have an impact on various things like addiction. We want to build on what they’ve done, and offer our expertise on really taking these things and putting them in the context of an actual disease area — potential combinations with other products, and also getting these things approved by the FDA.”
What’s the trend
Pear’s dealings with Novartis isn’t limited to reSET alone. In March, the companies signed an agreement to collaborate on the development of two other similar products, one for multiple sclerosis and another for schizophrenia. These products sit alongside the rest of the digital therapeutic maker’s pipeline, which includes reSET-O for opioid use disorder, and are supported in part by the $50 million the company collected from investors at the top of 2018.
Digital therapeutics’ relationship with pharma and mainstream medicine has growing with each passing month — just the past weeks saw an $88 million agreement between Proteus Digital Health and Otsuka Pharmaceutical and the release of an official definition of the term from a consortium of digital health stakeholders.
Date: November 26, 2018