Defining the digital therapeutics opportunity

Once the stuff of science fiction, digital therapeutics – or DTx – have taken their place within modern healthcare as an emerging category of medicine and are set to be increasingly influential in the way that healthcare is delivered and consumed.

They’re taking their place alongside other exciting work in digital health that sees developments in areas from sensors and wearables to mobile health and telehealth to harness technology, augment and personalise healthcare and improve patient outcomes.

Within this environment, digital therapeutics form a unique subset of digital health, but are still a part of digital health, and as the sector matures, some vital work is being carried out to provide the strongest possible foundations for the category. At the forefront of this is the Digital Therapeutics Alliance, whose recent whitepaper provides a welcome shot of rigour to the sector. Here are four key takeaways from it.

1. A definition of digital therapeutics

For such an early-stage and quickly moving area of digital health there’s a pressing need to pin down what a digital therapeutic is and isn’t.

Digital therapeutics deliver evidence-based therapeutic interventions to patients that are driven by high quality software programmes to prevent, manage or treat a medical disorder or disease. They are used independently or in concert with medications, devices, or other therapies to optimise patient care and health outcomes.

Products incorporate advanced technology best practices relating to design, clinical validation, usability, and data security. They are reviewed and cleared or approved by regulatory bodies as required to support product claims regarding risk, efficacy and intended use.

They also empower patients, healthcare providers, and payers with intelligent and accessible tools for addressing a wide range of conditions through high quality, safe and effective data-driven interventions.

2. Digital therapeutics’ categories

Each digital therapeutic corresponds to one of four categories based on its intended use and official product claims, as outlined by the Digital Therapeutics Alliance’s whitepaper:

Address a medical condition
Manage or prevent a medical disorder or disease
Optimise medication (an individual medication or class of pharmaceuticals)
Treat a medical disease or disorder.

In addition to those categories, there are also a series of core principles that the Digital Therapeutics Alliance says all digital therapeutics must adhere to:

Prevent, manage or treat a medical disorder or disease
Produce a medical intervention that is driven by software, and delivered via software or complementary hardware, medical device, service or medication
Incorporate design, manufacture and quality best practices
Engage end users in product development and usability processes
Incorporate patient privacy and security protections
Apply product deployment, management and maintenance best practices
Publish trial results inclusive of clinically-meaningful outcomes in peer-reviewed journals
Be reviewed and cleared or approved by regulatory bodies as required to support product claims of risk, efficacy, and intended use
Make claims appropriate to clinical validation and regulatory status
Collect, analyse and apply real world evidence and product performance data.

3. Place digital therapeutics within digital health

To understand the value of digital therapeutics, it is first important to explore the distinction between digital health and digital therapeutics. The term ‘digital health’ describes all technologies that engage patients for health-related purposes; as such, it encompasses a wide range of products used across the wellness and healthcare industries.

Digital therapeutics form an independent category of evidence-based products within the broader digital health landscape. Digital therapeutics are distinguished from other digital health categories through their primary function of delivering software-generated therapeutic interventions directly to patients to prevent, manage or treat a medical disorder or disease.

Digital therapeutics are a distinct subset of digital health products, separate from the likes of pure-play adherence, diagnostic and telehealth products. However, while their principal focus is on delivering direct therapeutic interventions to prevent, manage or treat a medical disorder or disease, products can also possess the unique ability to incorporate additional functionalities into a comprehensive portfolio of synchronous products and services. This includes potential integration with mobile health platforms; the provision of complementary diagnostic or adherence interventions; the ability to pair with devices, sensors or wearables; the delivery of interventions remotely; and integration into electronic prescribing, dispensing and medical record platforms.

4. Robust clinical evaluation is key

Regardless of the clinical indication being targeted, or the type of intervention being delivered, all digital therapeutics products must conduct robust clinical evaluations to ensure that products are doing what they claim to in terms of safety, efficacy, quality, and clinical outcomes.

The pay-off for healthcare companies, providers and payers is that the real-world evidence they generate will provide new opportunities for them to understand ongoing product performance, safety, efficacy and clinical outcomes. This is a new source of insight that provides incredible benefits to patients and healthcare providers.

Consequently, these products will increasingly be written into professional clinical guidelines and healthcare best practices and, depending on the product claim and area of clinical use, digital therapeutics are often being prescribed by healthcare providers, covered by payers and integrated into the traditional healthcare processes.

Next steps for digital therapeutics

As digital therapeutics take their place in the digital health landscape there are already strict standards in place in some markets, notably the US and EU, where they have to meet certain levels or amounts of rigour in their design. While digital therapeutics have differing degrees of regulatory oversight, they should all achieve similar levels of quality control – a company cannot just make a claim that it is a digital therapeutic.

If a pharmaceutical company is developing, for example, a telehealth platform, there’s certainly a place for that within digital health, but it shouldn’t try and claim it’s actually a digital therapeutic, and the same would go for any pure-play diagnostic or adherence products. Without a software-generated therapeutic intervention, such products are not going to inhabit the same space as a digital therapeutic.

Looking towards the horizon, the growth of the digital therapeutic industry will be dramatic over the next 18 months, resulting in major impacts for users, organisations and the healthcare industry:

Patients and carers will benefit from new treatment options for a broad spectrum of medical disorders and diseases that deliver highly engaging and interactive therapeutic interventions, while providing actionable insights

Healthcare providers will be able to integrate digital therapeutics as value-added therapies into their official clinical guidelines and existing care management pathways. In doing so digital therapeutics will operate in tandem with complementary therapies and increase patient safety and improve practice efficiency

Public and private payers will see clinical, service efficiency and health economic benefits and demonstrably improved clinical and health economic outcomes at a patient and population level

Regulatory bodies will be able to incorporate internationally-recognised standards and best practices relating to product design, quality, manufacture and privacy. In doing so these therapies will be able to demonstrate their safety, efficacy and cost effectiveness, based on the principles and practices of evidence-based medicine.

Digital therapeutics’ journey into the healthcare mainstream has only just begun, but the rigour being applied to the sector by the Digital Therapeutics Alliance and other stakeholders is providing them with the foundations to be accepted as an independent class of medicine, equivalent to, or as an effective adjunct to, pharmaceuticals and other treatments.

Dominic Tyer is a trained journalist and editor with 19 years of pharmaceutical and healthcare publishing experience. He serves as a contributing editor at pharmaphorum media, which facilitates productive engagement for pharma, bringing healthcare together to drive medical innovation. He is also creative director at the company’s specialist healthcare content consultancy, pharmaphorum connect.

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