F072 DTx series 1/5: How do DTx differ from medications or digital health apps? (Jessica Shull)

Digital therapeutics (DTx) are clinically validated digital solutions with proven positive effects on disease management and outcomes. They must undergo a clinical trial to prove their efficacy, however, they are not regulated the same as new medications, says Jessica Schull, European Lead for the Digital Therapeutics Alliance (DTA), shaping advocacy and organizational engagement for the DTx industry in European countries.

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While there probably won’t be a DTx cure for COVID-19, DTx do have the potential to greatly help patients in the currend COVID-19 crisis. As written by the Digital Therapeutics Alliance, “patient access to and utilization of digital therapeutics could improve health outcomes, consequently reducing chronic disease-related hospitalizations, mitigating additional pressures on healthcare providers during the COVID-19 outbreak. Their use could reduce vulnerable populations’ potential coronavirus exposure.”

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One of the challenges during the current coronavirus pandemic is getting reliable and accurate information. The World Health Organisation launched a dedicated messaging service in Arabic, English, French and Spanish with partners WhatsApp and Facebook, and also opened an account on TikTok to spread relevant coronavirus related information as broadly as possible. Additionally, in collaboration with the White House and Center for Disease Control in the US, Apple launched a special COVID-19 screening tool.

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DTx and their definition 

Source: https://dtxalliance.org/

Digital therapeutics have a long, history, and have been discussed already in 2010. In 2017 the term digital therapeutics was coined and DTA set itself a mission to build clarity in the industry. At the moment, says Jessica Shull, the work of the Alliance is to spread the awareness about DTx among governments and medical professionals.

DTx are used for mental health, multiple sclerosis and cancer where they help with improved outcomes, by improving adherence. “Kaiku Health showed that with more accurate recording of patient’s well-being, cancer therapies can be modified more accurately which results in a improved quality of life and longer life expectancy,” says Jessica Shull.

DTx clinical trials and regulation

DTx go through randomised clinical trials, same as medications, explains Jessica Shull. The difference compared to Pharma can be that digital solutions already have a user base they can reach out to when conducting trials. The other difference is that DTx is regulated by medical device regulation, which differs from medicines regulations. 

Can DTx have side effects?

Because DTx therapies are so new, real-world data is hardly coming in and it it is unknown if these interventions could have negative side effects (such as addiction from the VR experience). One thing to keep in mind, comments Jessica Shull, is that DTx are usually designed as a regiment — something to be used for a limited period of time.

If drugs have known interactions with other drugs, it is not clear yet, if there can be interactions in a patient uses more than one DTx, which is another mission DTA will also be looking at in the future. 

Digital therapeutics are not digital diagnostics

Which is why for example, the Apple Watch with its ECG monitor does not fall under digital therapeutics. Digital diagnostics fall more in the broader group of medical devices, explains Jessica Shull.

Reimbursement…?

Jessica Shull.

While some DTx are already covered by insurance, it’s mostly private insurances that offer them to their customers. Changes are happening in Germany, which is the first European country with a clearer legal framework for digital health. Another challenge is to increase awareness among doctors. “Many doctors are not tech-savvy and doubt that digital solutions could help them,” mentions Jessica Shull. 

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Some questions addressed: 

• The first discussions or mentions of DTx go all the way to 2010. It seems they been more widely discussed hardly in the last two years. Can you take us through the development in the last 10 years? Milestones, etc.?

• DTx are psychology driven digital solutions targeting various conditions, from ADHD, obesity, anxiety, depression, etc. The difference between a DTx and a wellness app is that DTx efficacy is supported by clinical trials. Can you name a few vivid examples of such clinical trials and their outcomes?

• What are the standards of clinical evidence for DTx? How do they differ from classical clinical trials standards?

• What are the trends in DTx reimbursement? Are these software applications available direct to consumer? Are insurance companies picking them up? How much do people like them?

• If DTx follow the same rules than chemical or biological therapies, meaning they are tested in clinical trials, need to be approved by regulatory bodies, can they also have negative side effects?

• DTx can deliver interventions that improve a range of patient benefits including better symptom management, efficacy, safety, adherence, proper use of medication devices, improved quality of life, better outcomes and preventative measures. They also offer an enhanced patient experience. Can you think of an example that illustrates the enhances the patient experience and improved quality of life?

• DTx Alliance: what are the current successes and plans for the future?