When it comes to complementing medications, digital therapeutics can improve their use and adherence and reduce unnecessary medication, for example if rescue inhalers or opioids are being overused, or they might even be an alternative to medication, such as in back or chronic pain.
For example, Dthera Sciences’ DTHR-ALZ device for the mitigation of symptoms of agitation and depression in patients with Alzheimer’s disease received FDA Breakthrough Device Designation in August. A more established digital therapeutic, WellDoc’s BlueStar for the management of type 2 diabetes, was cleared by the FDA in January 2017.
However they are used, one of the benefits of DTx is that they produce actionable data and insights for patients, providers, payers and pharmaceutical companies. For patients in particular DTx may provide additional benefits, in terms of addressing needs not wholly fulfilled by traditional medications. So, where a chemical compound addresses a very specific indication, it could be paired with a DTx to provide holistic services around areas such as depression, mobility, pain, side effects and so on.
But regardless of the clinical indication being targeted, or the type of intervention being delivered, all DTx 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.
“Real world evidence generated by digital therapeutics is also providing new opportunities for healthcare companies, providers, and payers to understand ongoing product performance, safety, efficacy and clinical outcomes,” says Megan Coder, executive director at the DTA.
Depending on the product claim and area of clinical use, DTx are often being prescribed by healthcare providers, covered by payers, and integrated into the traditional healthcare processes. 2018 closed with another milestone for the sector when the FDA handed Pear Therapeutics its second approval for a product to help patients with opioid use disorder. The reSET-O app can be prescribed for people being treated with buprenorphine to help them come off recurrent use of opioid drugs. It is a cognitive behavioural therapy (CBT) programme that is specifically aimed at retention and is designed to help people identify the triggers that cause them to relapse and find ways to stop thinking about opioid use, and also helps them stay in outpatient treatment programmes by monitoring their engagement, providing reminders and awarding virtual prizes as a reward for compliance.
It’s being marketed through a partnership with Novartis subsidiary Sandoz and it is the first drug-paired app to be approved by the FDA. The clearance comes just over a year after Pear won FDA approval for reSET, its first app for substance use disorder (SUD) that is aimed at users of other drugs such as alcohol, cocaine, marijuana and stimulants. reSET was approved based on clinical data showing it could increase retention in outpatient treatment programmes, as well as improve abstinence.
Meanwhile, in the UK NICE last month published an evidence standards framework that aims to assure the NHS that any new digital technologies are backed by an appropriate body of evidence, though as the framework was released there was also an acknowledgement that it was just the start of a dialogue about what ‘good’ looks like in this space.
The work to speed uptake of digital health products was carried out collaboratively between NHS England, NICE, NHS Digital, MedCity, Public Health England and DigitalHealth.London, with engagement with industry, commissioners and innovators to understand what is required for health technology to thrive in the UK. The resulting standards have been developed to support digital health technology development and provide guidance on what evidence is needed when innovators present their products to NHS commissioners.
“Collaboration across all industry players and stakeholder groups is central to everything that we do,” says Megan. “Our mission is to broaden the understanding, adoption, and integration of clinically-validated digital therapeutics into healthcare through education, advocacy, and research. Our vision is to enable expanded access to high quality, evidence-based digital therapeutics for patients, healthcare providers, and payers in order to improve clinical and health economic outcomes.”
Building consensus in the industry about how DTx are defined and understood is no easy task, particularly as the technology continues to develop. As part of its efforts the DTA has been developing collaborations that will support the growth of the industry long term, in terms of clinical uptake and utilisation, policy development and standards for product development. “We’ve also begun building a community of thought leaders that are truly dedicated to ensuring that digital therapeutics are delivering meaningful clinical and health economic outcomes to patients and their caregivers,” Megan notes.
Its outreach work includes convening thought leaders to establish foundational industry-level validation, operational, value and regulatory best practices and frameworks. But it’s the DTA members who are collectively promoting the need to apply evidence-based approaches to the development, manufacture, utilisation and support of high quality, patient-centred digital therapeutics.
“DTA members and partners are committed to safeguarding DTx product quality and integrity across the industry, while simultaneously encouraging the development of therapies that are highly engaging, interactive, and meaningful,” says Megan, adding:
As it does so, there are several key things for firms exploring DTx to consider from a standards point of view. Internationally-recognised standards are, of course, really important to digital therapeutics in terms of design, manufacture, quality management, cybersecurity, patient privacy and so on.
“As we move toward the international uptake and use of these products across regulatory jurisdictions, it is incredibly important that there are well-recognised frameworks for: 1.) payers and regulatory bodies as they assess the safety, efficacy, and quality of these products, but also 2.) for healthcare providers and patients to develop the appropriate respect, understanding, and expectations for DTx products. High quality in products being used alongside or in place of traditional therapies should be an underlying assumption for all digital therapeutics. From an industry perspective, incorporating international standards in DTx can help us meet those assumptions and expectations,” says Megan.
When it comes to how highly regulated they are at the moment, that often depends on a DTx’s particular claims of risk, efficacy, and intended use. Digital therapeutics are regulated by regulatory or equivalent national bodies under the ‘software as a medical device’ (SaMD) category. The International Medical Device Regulators Forum (IMDRF) has put out a number of documents around the understanding and evaluation of SaMD. While many other countries are looking at developing systems to specifically address the review and clearance of digital therapeutics, national bodies like the FDA in the US and the UK’s NHS and NICE are becoming leaders in this particular space.
But even though DTx are regulated in large part as medical devices, there are many parallels to the pharmaceutical industry’s traditional drug development process, says Megan, citing areas such as quality systems, robust manufacturing processes, pre-market clinical validation and regulatory clearance.
“Each of these products are being developed to prevent, manage, or treat medical conditions that are often undertreated or untreated,” says Megan. “There are significant investments these companies are making in product development, human factors testing, clinical validation, regulatory compliance, market access, and product support to ensure product safety, efficacy, and quality.”
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.