Digital therapeutics may not have yet earned cult status within the healthcare industry, but their promise in non-communicable diseases — that are often caused or worsened by unsavory behaviors — is hard to deny, as Big Pharma makes a deeper foray into clinically-validated digital interventions designed to encourage sustainable lifestyle changes to complement traditional therapeutics.
Novartis $NVS unit Sandoz along with partner Pear Therapeutics on Monday launched reSET, an FDA-approved digital therapeutic designed to deliver cognitive behavioral therapy over 12 weeks to patients with substance abuse disorder (SUD) who are in outpatient treatment under the supervision of a doctor.
“Adding reSET to outpatient therapy enhances behaviors associated with recovery. It leverages new technology to help patients improve abstinence in substances of abuse and stay in treatment programs longer than outpatient therapy alone,” said Sandoz chief Richard Francis in a statement.
Poor treatment outcomes are the norm for SUD — a chronic, relapsing disease caused by the persistent use of alcohol and/or drugs — as inconsistent access and quality of treatment as well as disparities in payment and insurance for behavioral health services have culminated in low rates of abstinence and high dropout rates for a type of therapy that is usually resource-intensive and necessitates face-to-face clinician interactions. In 2014, about 21.5 million Americans aged 12 and older (8.1%) were classified with a substance use disorder in the past year, according to estimates from HHS’ Substance Abuse and Mental Health Services Administration.
The FDA approved reSET last year on the basis of a NIDA-sponsored trial involving 399 patients with SUD. Patients were randomized to receive standard treatment — comprising intensive face-to-face counselling — or reduced amount of face-to-face counselling plus the digital therapeutic. Patients on the digital therapeutic more than doubled the rate of abstinence compared to standard face-to-face counselling.
Digital therapeutics is an umbrella term that includes technology such as wearable devices, mobile apps and telemedicine platforms — which is typically driven by software to prevent, manage, or treat disorders, independently or in concert with medication and/or medical devices. These tools are largely designed to address chronic diseases such as diabetes, heart or respiratory disorders, by targeting behaviors such as diet, exercise and lifestyle that have a significant impact on the incidence and management of disease. Prescription digital therapeutics — such as reSET and Abilify Mycite, the first digital pill that carries an embedded sensor to track if patients are taking their medication properly — are validated in randomized clinical trials to demonstrate safety and efficacy.
Pear Therapeutics is also developing digital therapeutics for a host of other disorders including schizophrenia, PTSD and general anxiety disorder. Although the rapid penetration of smartphones and tablets and lower healthcare costs have driven the growth of the global digital therapeutics market, privacy concerns could temper the pace of adoption. Still, according to Allied Market Research the size of the market is set to grow to $7.83 billion in 2025 from $1.75 billion last year.
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