Biotech Develops Prescription Software for Mental Health

Tara Haelle

December 12, 2019

The biotech industry is stepping in to help bridge the gap in access to healthcare for mood disorders, addiction, and other common mental health conditions with a new type of treatment — prescription digital therapeutics.

Prescription digital therapeutics, or "PDTs" as they are known in the industry, are a "hybrid of traditional tech and traditional biotech" that can be thought of as "software as a drug," said Corey McCann, MD, PhD, president and CEO of Pear Therapeutics, a company developing digital products for the treatment of addiction.

"We're sort of the budding pharma industry within digital," he said. "This is really the beginning of a whole new treatment modality."

PDTs include apps, interactive websites, and more comprehensive digital platforms with indications for treating very specific conditions, such as opioid use disorder or depression that's comorbid with multiple sclerosis, he explained. They must be HIPAA-compliant and are covered by many private and public payers.

The shortage of mental health care providers and facilities in the United States continues to leave millions of Americans without access to the care they need. Although telemedicine is able to address many of these shortfalls, particularly for people in rural areas or other regions with little access to care, huge gaps remain.

The Mental Health Parity Act is very poorly enforced, and so not providing any care is still a reasonably suitable solution for many insurance companies. Dr Corey McCann, president and CEO of
Pear Therapeutics

"The mental health parity act is very poorly enforced, and so not providing any care is still a reasonably suitable solution for many insurance companies," said McCann, who spoke on a "Slaying Addiction" panel at HLTH: Create Health's Future 2019, a biotech conference held in Las Vegas.

In addition, "there is sufficient autonomy within mental health that you hear all sorts of non–evidence-based opinions on what people should or should not receive, and they're rooted in anecdotal evidence — on a good day," he said.

Pear's two currently available products, reSET and reSET-O, are rooted as solidly in evidence as any other treatment for addiction, he told Medscape Medical News. reSET is indicated for the treatment of alcohol, cannabis, cocaine, or stimulant substance use disorders, and reSET-O, the first digital therapeutic to receive FDA breakthrough designation, is indicated for treatment of opioid use disorder specifically in combination with buprenorphine.

These software products are prescribed in the same way as prescription drugs and regulated by the FDA as medical devices are, but their function falls somewhere outside both of these categories. They are evidence-based treatments with clinical studies to back them up, but they do not replace therapy sessions or medications, McCann explained. Rather, they are an entirely new tool that complement and supplement usual care.

"The principal problem from our viewpoint is there's not enough access to treatment," said Kevin Moore, PsyD, a psychologist and director of integrative medicine at Crossroads Treatment Centers, an opioid-dependency treatment center serving about 25,000 patients across 10 states.

"We scale up as much as we can, but there's not enough therapy available," he said. Crossroads has adopted reSET and reSET-O because it "helps to fill this very large treatment gap."

"The exciting thing about reSET and reSET-O is that they provide cognitive behavioral therapy lessons that people can learn wherever they have their phone and on whatever time schedule works for them," said Moore. That said, "It's not a replacement. It's not a therapy itself. It enhances the types of conversations that I have with patients that I see."

Customization and Data Collection

In addition to providing easy access to care, PDTs help with another problem. The biggest takeaway from the other speakers at the HLTH 2019 panel was "the degree of heterogeneity that we see within the crisis," said McCann.

Heterogeneity is a challenge that biotech is well suited to address, since digital products can be customized to very specific populations, he told Medscape Medical News.

Digital therapeutics offer another advantage that drugs, therapy, and traditional medical devices cannot: data collection. In therapy especially, activities such as journaling and tracking cravings can be crucial to improvement, but compliance is low, said Moore.

"I've been a therapist for 20 years, and I've been trying to get people to collect this data for 20 years," he said. "To have this information for the first time is hugely helpful to me, and therefore to patients."

Some of the companies working on digital therapeutics, such as Happify Health, offer nonprescription wellness products which, unlike PDTs, do not require FDA clearance. In a regulatory sense, if a PDT is like a drug, wellness apps are like supplements.

"One of the key differences between a wellness product and an FDA-cleared product is the claims you can make about the impact on the disease and the symptoms," explained Chris Wasden, EdD, head of Happify Digital Therapeutics Alliance. In addition, FDA-cleared PDTs are integrated into the workflow of physicians, whereas wellness products, such as Happify's app, are aimed at consumers and don't require any interaction or coordination with a healthcare provider.

FDA Approval Pathways

The US Food and Drug Administration (FDA) does not recognize or use the term PDT and currently uses the 'medical device pathways' to clear software products that require prescriptions for specific indications.

Digital therapeutics fall under class 2 devices. Class 1 devices are low-risk devices like toothbrushes and tongue depressors that don't need premarket approval, and class 3 are high risk devices, often implantable, which require extensive clinical evidence to show safety and efficacy. Class 2 devices pose moderate risks to patients and require premarket clearance, but they don't necessarily need multiple studies showing safety and efficacy independent of other similar products.

There are two clearance pathways for Class 2 medical devices: 510(k) and de novo. The 510(k) pathway requires manufacturers to compare their product to "a similar, already FDA-cleared device on the market whose characteristics are similar enough to the new product that the manufacturer can base safety and efficacy claims on the existing predicate product," according to FDA spokesperson Stephanie Caccomo.

One of the first PDTs to receive FDA clearance through the 510(k) pathway was Welldoc's BlueStar for type 2 diabetes, cleared in 2013. Welldoc currently has seven FDA-cleared software products on the market. Another company, Palo Alto Health Sciences, has two: Freespira for panic disorder and Freespira for PTSD.

In September 2017, Pear's reSET was the first mobile medical application to receive FDA clearance through the Class 2 de novo pathway, reserved for products with no predicate device. The reSET-O app was approved 3 months later. Pear is now participating with eight other companies in the FDA's Software Precertification (Pre-Cert) Pilot Program, a new regulatory framework being tested for future medical software products.

Wasden expects another half dozen PDTs to clear the FDA and hit the market in the next year or two. Pear is already awaiting approval on Somryst for comorbid depression and insomnia and has a product for schizophrenia in a clinical trial. Most of the new therapies are being developed through partnerships with pharmaceutical companies, healthcare systems, or both. Happify, for example, recently announced an agreement with Sanofi to develop a product treating anxiety and depression specifically in people with multiple sclerosis.

"We'll take an intervention that's already been shown to work with a clinician and say we want to make this fun and engaging and useful," Wasden explained. "Now we're going to apply some of the Happify secret sauce to our gaming — we make it simple and easy and friendly to do — and then we hold you accountable for completing the intervention so you get the therapeutic benefit."

Wasden said the company has identified 30 therapeutic areas where the intersection of anxiety or depression with an underlying disorder could benefit from a product they develop specifically for that comorbidity. He rattled off some of the conditions linked to comorbid anxiety or depression: chronic obstructive pulmonary disease (COPD), cardiovascular disease, HIV, epilepsy, gastroesophageal reflux disease (GERD), heart failure, chronic kidney disease, and other chronic diseases.

"With some of these diseases, anxiety is higher than depression, and with others, depression is higher than anxiety," he said. "With MS, depression is higher than anxiety, but with psoriasis or any type of dermatitis, anxiety is higher than depression."

Happify is already working with pharmaceutical companies in dermatology and in cardiovascular health. Several of the conditions, such as cardiovascular and metabolic ones, have biomarkers that Happify can track in assessing their product's effect, such as blood sugar and blood pressure.

Less Time, More Patients

Most clinical trials for these products, however, focus on validated mental health endpoints, because both the need and potential are so great in the mental health space.

"What we have seen in healthcare broadly is that there is less time for more patients," Moore, the psychologist at Crossroads Treatment Centers, told Medscape Medical News.

Therapies like reSET, which use gaming and rewards to guide patients through lessons and encourage them to continue buprenorphine treatment, have the potential to expand providers' reach and patient compliance simultaneously.

"This makes clinician time more effective because folks have the information. It's a very natural augmentation that we desperately need," said Moore.

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