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Prescription Digital Therapeutics: When Software Is the Active Ingredient

With smartphones now ubiquitous, interest has increased in digital health solutions such as telemedicine platforms and apps used to track symptoms or medication usage. In recent months, the COVID-19 pandemic has only accelerated the adoption of these technologies. While many digital health products are unregulated, prescription digital therapeutics (PDTs) are regulated by the FDA as medical devices.

What are prescription digital therapeutics?

PDTs are software-based interventions intended to prevent, manage, or treat mental or physical conditions. In contrast to the multitude of wellness apps readily available for download onto your smartphone, PDTs are held to the same standards as pharmacotherapy in terms of safety, efficacy, instructions for use, and quality. Like traditional medications, PDTs are approved by the FDA after sufficient clinical evidence is presented to support safety and efficacy, and they are prescribed to patients by healthcare providers.

Currently, four PDTs have been cleared by the FDA. These include three products developed by Pear Therapeutics (reSET®, reSET-O®, and SomrystTM) and a game-based device developed by Akili Interactive (EndeavorRxTM). reSET and reSET-O are both designed for use in conjunction with outpatient treatment programs for individuals with substance use disorders, with reSET-O specifically targeting individuals suffering from opioid abuse disorder. Somryst uses cognitive behavioral therapy to provide neurobehavioral intervention to improve symptoms of insomnia. The most recently approved PDT is EndeavorRx, which has been demonstrated to improve attention function in children who have attention deficit hyperactivity disorder.

Why develop a prescription digital therapeutic?

As in traditional drug development, the primary reason to develop a PDT is to address an unmet patient need. PDTs may offer potential for an improved safety profile compared to drugs commonly used to treat conditions such as pain, depression, and anxiety, and they also represent increased accessibility to many patients, at a lower cost. Furthermore, patients may feel more comfortable engaging with a PDT application for certain types of behavioral therapy.

In addition to the benefits to patients, the PDTs offer financial benefits to developers and sponsors. The reimbursement landscape is evolving, but payers appear willing to cover digital products that have sufficient clinical evidence supporting their use, as is the case with FDA-cleared PDTs. Also, the development of a drug-device combination product that pairs a PDT with an existing pharmacotherapy may be an attractive lifecycle management strategy. Because marketing exclusivity can be extended by three years for labeling changes requiring new clinical evidence, sponsors of drugs or biologics may want to consider how they can provide additional value to patients by pairing their products with PDTs.

What is the relevant regulatory framework for PDT clearance?

PDTs are a subset of two larger categories: Software as a Medical Device (SaMD) and Mobile Medical Applications (MMAs). The FDA defines SaMD as software intended for medical purposes that performs those purposes without being part of a hardware medical device, while MMAs are mobile applications that incorporate device software functionality meeting the criteria of a device and that either serve as an accessory to a regulated medical device or transform a mobile platform into a regulated medical device. While the FDA oversees both SaMD and MMAs, it exercises enforcement discretion regarding products that pose a low risk to patients and therefore do not require the level of scrutiny associated with PDTs.

Digital therapeutics is an emerging field with a rapidly expanding pool of industry players and partnerships. Regulatory and reimbursement stakeholders are building frameworks for approving these therapeutics and providing them to patients. The FDA has issued two key guidance documents outlining its current thinking on SaMD and MMAs:

2017 – The International Medical Device Regulators Forum guidance titled Software as a Medical Device (SaMD): Clinical Evaluation was adopted by the FDA. This guidance provides a common language and guiding principles for regulating SaMD.

2019 – The guidance titled Policy for Device Software Functions and Mobile Medical Applications replaced a previous version issued in 2015. It contains specific examples of functions of products that are and are not considered to be medical devices.

For more information on when FDA requires regulatory oversight of digital health products, see our previous post on FDA Regulation of Mobile Medical Apps.

In addition to providing these guidances, the FDA has also launched the Software Pre-Certification (Pre-Cert) Pilot Program. The Pre-Cert program seeks to provide an efficient regulatory framework for SaMD by focusing on the developers of these technologies, rather than on the specific products. It requires developers to demonstrate their commitment to quality and their plans for monitoring the real-world performance of products once they reach the market. The evaluation of this pilot program is ongoing, with seven companies participating in the development. Among these is Pear Therapeutics, the developer of the first cleared product to be evaluated using this framework (Somryst).

Premier Consulting’s experienced team of scientists and regulatory experts can help you to identify areas of unmet need to target for the development of a PDT. Or, for an existing product, Premier Consulting can maximize exclusivity opportunities while streamlining the development program and guiding FDA interactions. Contact us to find out more.

Shauna Swanson
Regulatory Scientist