Digital therapeutics are software-based interventions used to prevent, manage, or treat medical disorders. They are clinically validated and work independently or with other treatments like medications. The digital therapeutics market is growing rapidly and was estimated at $1.8 billion in 2018, expected to reach $7.1 billion by 2025. Digital therapeutics can help change patient behavior, enable remote monitoring, and add value to healthcare delivery. Major barriers include distinguishing digital therapeutics from general health apps and obtaining reimbursement. The future of digital therapeutics includes reforming drug development and significantly impacting healthcare delivery models.

1. The Role of Digital
Therapeutics in Reshaping
the Future of Healthcare
ISPOR Chapter LeadershipTraining
Dr.Amit Dang
Founder and CEO
KYTAdhere & MarksMan Healthcare Communications
Hyderabad, India

2. Digital health explosion
• mHEALTH
• Telemedicine (telehealth)
• Smart devices
• Sensors
• Wearables
• Health IT
• Personalized medicine
• RWE studies

3. What is ‘Digital Therapeutics’(DTx)?
Digital Health
Digital Medicine
Digital
Therapeutics
(DTx)
• Includes various platforms
and systems that apply
technological solutions to
enhance healthcare
delivery
• Includes digital products
which aid in diagnosis,
therapy and monitoring of
patients
• Provides evidence-based
software-driven
therapeutic interventions
that prevent, manage, or
treat a medical disorder

4. History of DTx
• 1995 - Technology driven care by Joseph Kvedar
• 1999 - Term ‘E-patient’was coined by Dr. Tom Ferguson
• 2000 - Publications based on digital products
• 2012 - Formal use of the term ‘DTx’

5. Digital Therapeutics Alliance (DTA)
• Defines DTx as ‘delivering evidence-based therapeutic
interventions to patients that are driven by software, to
prevent, manage, or treat a medical disorder or disease’
• Used independently or in concert with medications, devices,
or other therapies to optimize patient care and health
outcomes
• Products are reviewed and approved by regulators to
supplement the product claims regarding risk, efficacy, and
intended use
• ‘clinically validated’
• ‘rigorous’
• ‘focused’
• ‘FDA-approved’

6. How does DTx work?
• Change in patient behaviour
• Remote patient monitoring
• Saves clinician’s time
• Adds value to the traditional healthcare delivery system

7. Disease Mx via DTx
• Chronic diseases (personalized health coaching)
• Neurological disorders (online self-care programme )
• Substance addiction (digital application of CBT)
• Medication adherence (mobile apps,AI, pill sensors )

8. Barriers in the adoption of DTx
• Difficulty in distinguishing DTx from the more general health
and wellbeing applications in the general digital health market
• Increase in physician’s burden by data overload
• Difficult to separate unproven or low-value applications
• Reimbursement decisions for digital therapy

9. DTx market
• More than 315,000 (as noted in 2017) health-related
applications are currently available in the market
• Estimated at USD1.8 billion in 2018, and is expected to
reach USD7.1 billion by 2025
• USD12.5 billion investment into digital health ventures in
2020
• Biggest applications of DTx include diabetes and weight loss,
followed by COPD, developmental disorders PTSD

10. DTx in the post-COVID era
• Teleconsultation
• Remote patient monitoring
• Monitoring and improving patient adherence
• Cloud-based patient data management
• Site-less clinical trials

11. DTx market boom in post-COVID era
• FDAapprovals/ clearances
• Large-scale acquisitions of DTx firms
• Pharma investments into DTx
• Pharma co-development deals
• Foundation of DTx-specific society

12. Future of DTx
• DTx is reforming the landscape for new medicines
• Can significantly influence healthcare delivery
• Can impact product reimbursement processes
• Emergence of new data-sharing processes
• Inception of new payment models

13. Regulatory aspects of DTx - USFDA
• The USFDAconsiders DTx to be Mobile Medical
Applications (MMAs).
• Applications helping patients organize and track their health
information
• Applications providing easy access to information related to
conditions or treatments
• Applications helping patients self-manage their disease or
condition (e.g., wellness applications) without providing
specific treatment
• No specific methodology to evaluate the companies formally
as yet

14. DTx incorporation guidance by other
regulators
• The National Institute for Health and Care Excellence
(NICE), together with NHS England and NHS Digital in the
UK, is trying ways to accelerate the uptake of digital
innovations
• Academy of Managed Care Pharmacy (AMCP) has also set
some guidelines for entities to qualify as DTx

15. Conclusion
• Digital therapeutics are here to stay
• Ready to address chronic and other difficult-to-treat conditions
• Expected to significantly influence healthcare delivery
• Have the potential to change what pharmaceutical industry sells
• Pharmaceutical companies are taking a thoughtful approach to DTx
• USFDAand NHS are also recognizing the potential of DTx
• Big investments are happening in the DTx field
• Soft skills are essential to bring about effective regulatory changes in
DTx

16. amit.d@marksmanhealthcare.com
Thank You!