'Software as a drug' for addiction seeks FDA approval
Treating patients with chronic substance addiction could soon involve digital therapy, according to Corey McCann, CEO of software developer Pear Therapeutics. The firm's new system, reSET, is currently under review by the US Food and Drug Administration (FDA). With current rates of drug addiction extremely high in the US, reSET offers a different approach to help those who need it, along with investment opportunities in the digital therapeutics market. The advent of software as a drug marks a "watershed moment for digital health", said McCann.  

LAS VEGAS — Digital therapy could soon be prescribed and reimbursed like a pharmaceutical drug for patients with chronic substance use disorder.

"This could be a watershed moment for digital health," said Corey McCann, MD, PhD, chief executive officer of Pear Therapeutics, the developer of the software. The product, known as reSET, is currently under review by the US Food and Drug Administration (FDA), and there have been "a lot of positive conversations back and forth with the FDA," he reported.

"We have a good deal of clarity around the label and timelines, so I think it's fair to say that we'll see this happen in 2017," Dr McCann told Medscape Medical News.

Dr McCann took part in a discussion on the opioid epidemic here at the Consumer Technology Association 2017 Digital Health Summit, where leaders in digital health technologies talked about various strategies to manage the crisis.

Pear Therapeutics is working toward a reimbursement model for digital therapy that mirrors the steps a pharmaceutical company takes to approve a new drug. "Based on our conversations, we are eager to pursue a label for our product for the treatment of substance use disorder, to enhance abstinence and to enhance retention in treatment," he explained.

This could be a watershed moment for digital health.

With rates of opiate addiction soaring in the United States, there is a need for new and innovative ways to deal with the problem. A digital solution would radically disrupt the traditional management of chronic disease, and has given investors reason to see big potential in the digital therapeutics market. "Software as a drug" has the potential to grow to a $6 billion market in the next 5 years, according to a recent research report by Goldman Sachs, which looked at an analysis by Psilos.

The basis of the digital therapy software, which delivers a comprehensive behavioral program, is the belief that environmental contingencies can play a powerful role in encouraging or discouraging drinking or drug use. It provides patients with a set of rewards for abstinent behavior and requires them to complete a set of on-screen modules that leverage the community-reinforcement approach.

The reSET software, which is also available as an app, has been studied in randomized clinical trials of patients with substance use disorders related to opiates, stimulants, cannabis, cocaine, and alcohol.

Treating Addiction

The company's pivotal clinical trial involved 507 patients from 10 outpatient addiction treatment programs, as previously reported by Medscape Medical News (Am J Psychiatry. 2014;171:683-690). The 252 patients in the control group received usual care for 12 weeks, and the 255 in the intervention group received usual care, but four internet-based modules, completed on site or remotely each week, replaced 2 hours of counseling.

The 62 modules teach basic cognitive behavioral skills for relapse prevention, such as refusing drugs, managing thoughts about using, conducting functional analyses, and improving psychosocial functioning (communication, mood management, family and social relations, time management). They also cover the prevention of HIV, hepatitis, and other sexually transmitted infections.

Patients who completed the required software modules each week and proved abstinence through negative urine tests or alcohol breathalyzer screens earned contingency-management vouchers, or low-cost rewards, which were distributed by the research staff.

Retention in treatment was better in the intervention group than in the control group. In patients abstinent at study entry, rates of abstinence were equally high in the two groups; in patients not abstinent at study entry, the odds of abstinence was twice as high in the intervention group as in the control group.

The rate of abstinence during study weeks 9 to 12 was higher in the intervention group than in the control group (58.1% vs 29.8%; P < .01). In addition, patients in the intervention group had significantly more half-weeks of abstinence than those in the control group (11.1 vs 8.8; P = .008), and more consecutive half-weeks of abstinence (8.0 vs 5.1; P = .001).

The authors of that study noted that it was impossible to disentangle the unique effects of the computerized community-reinforcement approach and contingency management. That limitation was addressed in a second study looking at digital therapy for opiate addiction.

Second Study on Digital Therapy to Augment Methadone Program

Clinically relevant results with reSET-O, which addressed opiate addiction, were shown in another study by Pear Therapeutics (J Subst Abuse Treat. 2014;46:43-51).

In that trial, 160 people receiving a daily dose of methadone were randomly assigned to standard treatment with 1 hour of counseling each week or to 30 minutes of counseling plus 30 minutes of digital therapy.

All participants received contingency management in this study, which consisted of $50 for completing baseline and monthly clinical assessments and $10 for each urine sample provided.

Contingency-management incentives, often used as part of a packaged intervention, were shown to make an independent contribution to a community-reinforcement approach delivered by highly trained therapists (Arch Gen Psychiatry. 2003;60:1043-1052). However, the reSET-O study is the first to demonstrate the effectiveness of a computerized community-reinforcement approach "in the absence of contingency-management incentives," the study investigators report.

Abstinence was better in the intervention group than in the usual-care group, and the drop-out rate was lower.

Other digital therapies from Pear Therapeutics used in combination with pharmaceuticals have been shown to be effective for people with schizophrenia or PTSD.

Reimbursement for Digital Therapy

Digital therapy "is not a panacea," Dr McCann cautioned. "It's not the sort of thing that you just download and it will produce a result." When used with a medical support, he said, the software shows good efficacy. "We have remarkably good retention data. There's a certain degree of power that comes with a physician prescription," Dr McCann explained. "We are working toward a reimbursement model."

The idea of seeking FDA approval for the software as a treatment intervention is supported by Maxine Stitzer, PhD, professor of psychiatry and behavioral sciences at the Hopkins Bayview Medical Center in Baltimore, who was involved in the first reSET study.

"We could now prescribe this mobile therapy to our patients. I think that's good," she said.

"This is the modern age; why should we be dragging our feet?" she asked. The fact that all patients receive the same material is a bonus. "It's the same for everyone, but patients can go over it at their own pace." In fact, she said, a lot of the material is standard cognitive behavior therapy that would be delivered by a counselor, but in this case it is delivered online.

She pointed out that some groups of people had difficulty with the software, especially those with a lower level of education. The concept of reimbursement for digital therapy is good, she said, "but we do want to make sure that it is efficacious in the way it is being delivered."

Others said they agree.

"For the right patient, I would be willing to try an app," said session moderator Arshya Vahabzadeh, MD, chief medical officer for Brain Power. He said he applauds Pear Therapeutics for going through clinical trials to test their approach. "It's a high bar, and it would suggest robustness. Not all companies are doing that; it's too expensive for most digital companies."

"There is research showing that people with mental illness are willing and able to use devices," Dr Vahabzadeh reported. "But I have to say that some psychiatrists, in particular those focusing on psychotherapy instead of medication management, may be reluctant to prescribe an app because of the effect the technology might have on the doctor–patient therapeutic relationship."

"It could put a wedge between them," he pointed out.

Dr McCann is chief executive officer of Pear Therapeutics. Dr Stitzer and Dr Vahabzadeh have disclosed no relevant financial relationships.

Consumer Technology Association 2017 Digital Health Summit. Presented January 6, 2017.