The use of mobile technology and artificial intelligence (AI) has increased in all fields, and healthcare is not an exception. The uptake of digital health by both the patients and the healthcare professionals has picked up pace lately, especially in the wake of the COVID-19 pandemic. ‘Digital health’ is a vast term (1), comprising of electronic health records, telemedicine, online fitness programs, wellness applications, health monitoring gadgets, and digital therapeutics (DTx).

DTx, which is a subdomain under digital health, is defined by The Digital Therapeutics Alliance (DTA) (2) as a specialised branch of digital health which includes products that “deliver medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases and disorders”.

DTx is an amalgamation of ‘digital’ and ‘therapeutics’ – medicines that leverage the ability of software to achieve therapeutic results. DTx products are akin to a ‘digital pill’: a medicine that is delivered digitally. In fact, DTx takes medicine ‘beyond the pill’, inducing psycho-behavioural changes through mobile apps.

DTx and Evidence: DTx is a form of therapeutic intervention that is prescribed by providers to a specific set of patients, with an intention to bring about a defined therapeutic effect. There is a stringent mechanism (3), based on regulatory guidelines by regulators such as the USFDA (1) to verify the credibility claims of DTx before they are offered to the patients, based on the various performance parameters.

DTx is different from wellness apps in that DTx is expected to provide evidence for its efficacy, unlike wellness apps. Since DTx is expected to be a form of therapy, the regulations4 surrounding DTx products are also more stringent than those with wellness apps. The very foundation of DTx products is based on ‘evidence’ of their efficacy in specific health disorders.(5) Indeed, there are many published studies that have documented improved outcomes using DTX for various chronic diseases such as diabetes (6) and hypertension (7), improving medication adherence (1), sleep disorders (8), substance abuse (9), and psychiatric disorders including depression. (10,11)

Evidence for DTx should ideally be originated through rigorously conducted randomized controlled trials (RCTs). The results of these RCTs which demonstrate efficacy in clinical parameters should ideally be published in peer-reviewed, reputed journals. Through these steps and more, the DTx products must clear regulatory requirements of efficacy and safety. Next, since DTx products generally involve collection and handling of sensitive patient data, there must be proof of adequate privacy and security protections. Finally, the DTx products must demonstrate meaningful value in the real-world setting as well, as demonstrated through real world evidence (RWE) studies.(1-3)

Importance of DTx Evidence to Stakeholders: The evidence generated to prove the clinical value of DTx is essential for all the stakeholders of DTx:

  1. Physicians: DTx products assist physicians to enahnce the outcome of the treatment that is started to the patients. For example, DTx may improve medication adherence, may enable doctors to remotely monitor the health status of their patients, and may assist them to make evidence-based clinical decisions, customized as per patient’s needs. It also helps alleviate sudden escalation of patient conditions by timely intervention and therapy optimization.
  2. Patients: DTx DTx products provide evidence-based awareness and education about health-related issues to the patients. It provides regular monitoring of vital parameters, personalised reminders to take medications, schedule appointments for physician consultations and promote medication adherence by active participation. DTx renders guidance to encourage long-term behavioural changes, creating life-style modifications and better treatment outcomes.
  3. Hospitals: DTx provides evidence-based and personalized therapy to patients, in the comfort of their home-space. This enables hospitals to perform remote monitoring of patients’ health status with DTx data. DTx products can also help in lowering the chances of re-admission through remote monitoring and early intervention. All these can reduce the stress and burden on the hospital resources. DTx enables the patients to take control of managing their ailments under guided supervision, reducing additional burden on hospitals, enabling better healthcare resource allocation.
  4. Payers: DTx provides evidence-based interventions which are in line with the approved therapy for any given condition. As a result, there is an overall improvement in the health of the patients, thereby lowering patient’s risk profile. Consequently, the chances of healthcare reimbursement pay-outs are also reduced, which benefits the payers. Payers are likely to shift from service-based reimbursements to ‘value-based’ reimbursements, owing to real-time outcome reporting power of DTx.
  5. Pharmaceutical industry: DTx helps the pharma R&D by supplying RWE to aid better drug development, encouraging patient participation, reducing drug-development costs and overall time to launch products. Further, by improving treatment outcomes, DTx also helps build the brand value of the drugs. By improving treatment adherence, DTx also can improve pharma sales.
  6. Policy makers: Considering the evidence-intense nature of DTx products, policy makers are expected to bring in realistic and reasonable regulations surrounding DTx products. Many countries consider DTx under medical devices or software as medical devices. However, it is essential for DTx to be classified under a separate category on its own, because of inherent differences between DTx and devices, and similarities with conventional medicines. In fact, many countries (Germany, Belgium etc) have already done this. Regulations relating to data safety and sharing also need to be framed keeping in mind security and confidentiality concerns of the patients.

DTx aims to promote effectiveness of therapy by integrating data from multiple sources, applying advanced analytics, backed by evidence-based interventions, driven by continuous performance monitoring, directly interacting with the patient. These capabilities empower DTx to play a major role in healthcare transformation, building an integrated health ecosystem that can enable seamless transfer of data between different stakeholders, improving the quality of services, reducing costs and bring positive impact on public health.

REFERENCES
  1. Dang A et al. J Family Med Prim Care. 2020 May; 9(5):2207-2213.
  2. https://www.dtxalliance.org/
  3. https://www.nice.org.uk/Media/Default/About/what-we-do/our-programmes/evidence-standards-framework/digital-evidence-standards-framework.pdf
  4. https://dtxalliance.org/2019/11/12/digital-therapeutic-industry-leaders-promote-ethical-standards-and-product-development-best-practices/
  5. Khirasaria R et al. Perspect Clin Res. 2020 May; 11(2): 54–58.
  6. Kaufman N. Diabetes Spectrum 2019 Nov; 32(4): 301-303.
  7. Guthrie NL et al. JMIR Cardio 2019 Mar;3(1):e13030.
  8. https://pharmanewsintel.com/news/fda-approves-prescription-digital-therapeutic-for-chronic-insomnia.
  9. https://fortune.com/2017/09/14/fda-alcohol-marijuana-cocaine-mobile-app/
  10. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-digital-health-devices-treating-psychiatric-disorders-during-coronavirus-disease
  11. https://www.otsuka-us.com/discover/otsuka-and-click-therapeutics-collaborate