The Promise and Potential

of Digital Therapeutics (DTx)

for
CDDM
-A new therapeutic field

A Report by:
Rights and Permissions
The material in this work is subject to copyright. Asia Pacific DTx Leadership Alliance encourages the
dissemination of its knowledge; this work may be reproduced, in whole or in part, for commercial or non-
commercial purposes, as long as full attribution to this work is given.
Attributions
Please cite the work as follows: Gupta, R. P., Singh, T. N., & Vaishnav, M. P. (2024). The Promise and
Potential of Digital Therapeutics (DTx) for DCDM- A New Therapeutic Field. Asia Pacific DTx Leadership
Alliance. New Delhi: Health Parliament and Digital Health Associates Private Limited.
ISBN: 978-81-966794-1-5
eISBN: 978-81-966794-2-2
The content presented in this publication, including the findings, interpretations, and conclusions, may not
necessarily represent the perspectives of Asia Pacific DTx Leadership Alliance. It does not guarantee the
accuracy, comprehensiveness, or timeliness of the data contained within and disclaims any responsibility
for potential errors, omissions, or inconsistencies in the information provided. Moreover, it does not accept
liability for the utilization or non-utilization of the information, methods, processes, or conclusions presented
herein. This report should not be construed as professional advice and any reliance is placed or action
taken by you on the basis of the information provided in this report will be your own professional judgment.
Acknowledgment
Project Ideated & Supervised by: Dr. Rajendra Pratap Gupta, PhD
Report Writing: Dr. Rajendra Pratap Gupta, Dr. Thokchom Nirod Kumar Singh, Ms. Mevish P. Vaishnav
Critical Review: Ms. Mevish P. Vaishnav
Design: Ms. Palak Dubey and Ms. Akshita Tyagi
Proofread: Health Parliament Team
Printing: SA Printer

3 ©Asia Pacific DTx Leadership Alliance. Health Parliament

Table of Content
Foreword 1
Abbreviations 2
Introduction 3
DTx – A Pathbreaking Innovation 4
Digital Therapeutics led Personalized Medicine –
A Paradigm Shift 5
Evolution of DTx 6
DTx Innovators 7
DTx Pioneer - BlueStar® 7
DTx – Care Rationalization & Optimization 8
DTx – Expanding Geographies & Horizons 9
DTx in Asia Pacific - Access &
Commercialization 13
DTx Pricing & Reimbursement Model 14
DTx and Medical Devices –A Merger or Marriage 15
DCDM (Digital Chronic Disease Management) –
Empathy with Excellence in Care 17
DTx – The Way Forward 17
Recommendations 21
References 22
About Asia Pacific DTx Leadership Alliance

©Asia Pacific DTx Leadership Alliance. Health Parliament 4

Foreword
The practice of medicine in the 21st century is undergoing a paradigm shift, and in these times, you will
need to evolve every few years. If we analyze the data, the biggest expenditure on healthcare is for chronic
patients, and this field is undergoing a revolutionary change primarily driven by technology.
Earlier, a doctor would meet a chronic patient once in three to six months and ask the patient to continue
with the treatment till then. The fact is that the patient of a chronic disease lives with the disease with many
ups and downs in a day, and certainly, the patient cannot connect with the doctor for every situation that
arises as it means incurring the hassle of getting the doctors’ time and, it adds to the cost burden. The
technology has come to fill this huge gap – one of the solutions is DTx.
DTx is like the digital doctor on your mobile, networked with your medical device and backed by scientific
algorithms that can help you manage your disease better without even the need to go to your doctor for
everything. We bring this interesting report that has the potential to redefine chronic disease management
(CDM) and how the doctors can handle chronic patients without meeting them regularly and yet being
updated and resulting in better clinical outcomes through appropriate Techno-Clinical interventions.
At Health Parliament, we have been driving the leadership for the healthcare sector. Between 2021 and
2023, we have done nearly series of discussions (Masterclass) with global leaders, and we finally arrived
at the conclusion that the pharmaceutical industry has to move beyond selling pills, and Chronic Disease
Management (CDM) has to use digital tools to become Digital Chronic Disease Management (DCDM); this
will be a new term going forward, and we believe, that this is the way we will redefine and handle CDM.
Integrating technology in handling patients with chronic diseases or those undergoing surgical interventions
will complete ‘Management’ of chronic diseases and post-surgical care; hence, every company, and every
practitioner of medicine needs to understand and implement DCDM. I am sure this report will help you
understand DCDM and also delve deeper into this field. In the next few weeks, we will launch a course,
‘Essentials of Digital Health’, which will touch upon this topic. Please follow up www.digitalacademy.health to
learn more about the course. I also look forward to working with you on the DTx pricing and reimbursement
models, besides other dimensions of DTx.
Closing your eyes to reality will not take the reality away, and the reality is that the days of treating the
patient in conventional ways are getting over. Let us absorb and adopt technology before our colleagues do
it before us, and if that happens, you will lose your patients/consumers.
On 2nd September 2023, we launched the Asia Pacific DTx Leadership Alliance to cater to the regional
needs. Please join the Asia Pacific DTx Leadership Alliance and take the plunge into this amazing field.

Wish you a fabulous year ahead.

Dr. Rajendra Pratap Gupta, PhD.

Founder
Asia Pacific DTx Leadership Alliance

1 ©Asia Pacific DTx Leadership Alliance. Health Parliament

Abbreviations
S. No. Abbreviations Full Form
1 AI Artificial Intelligence

2 APAC Asia Pacific Countries

3 CAD Coronary Artery Disease

4 CAGR Compound Annual Growth Rate

5 CBT Cognitive Behavioral Therapy

6 CDM Chronic Disease Management

7 CGM Continuous Glucose Monitors

8 CHF Congestive Heart Failure

9 DCDM Digital Chronic Disease Management

10 DHT Digital Health Technologies

11 DiGA Digital Health App Pathway

12 DTx Digital Therapeutics

13 ER Emergency Room

14 FDA Food and Drug Administration

15 GKV-SV German National Association of Statutory Health Insurance Funds

16 IAPT Improving Access to Psychological Therapies

17 ISO International Standards Organization

18 LMICs Low Middle-Income Countries

19 MVP Minimum Viable Product

20 ML Machine Learning

21 NCD Non-Communicable Disease

22 Rx Prescription

23 SaMD Software as a Medical Device

24 DTxC Digital Therapeutics Over the Counter

©Asia Pacific DTx Leadership Alliance. Health Parliament 2

Introduction
The profound connection between global productivity and human well-being has been particularly evident
during recent disease outbreaks, such as the COVID-19 pandemic, highlighting the intricate interplay
between (public) health and economic dynamics. The imperative for fortifying and innovating health systems
and fostering collaboration at local, regional, and global levels unfolded swiftly. The profound impact of
digital solutions was promptly acknowledged by diverse stakeholders, ranging from policymakers to the
general populace.
Just like how we saw a big change in using “digital first” methods during the pandemic, there are opportunities
to use digital tools in how we treat and manage different diseases and dynamic human health. Digital tools
can be employed independently or with pharmaceutical interventions to prevent, manage, alleviate, or
treat various medical conditions. This new pathway of employing digital tools alongside digital biomarkers
to improve quality of life with clear clinical effectiveness and approved clinical validation is the untapped
potential and promise of Digital Therapeutics.
Digital Therapeutics or DTx are designed to enhance patient care and achieve positive health outcomes.
Given the increasing significance of Digital Therapeutics (DTx) for patients, health systems, and the
pharmaceutical industry, there is a concerted effort to articulate the definition of DTx, elucidate its benefits,
acknowledge the challenges it encounters, and delineate policy areas for enhancement. In the contemporary
management of lifestyle-modifiable diseases, particularly within the chronic disease spectrum, DTx has
demonstrated ratified clinical effectiveness and presents clear economic advantages. (Digital Therapeutics
(DTx))

Figure: Digital Chronic Disease Management (DCDM) – The New Patient Journey © Asia Pacific DTx Leadership Alliance

Digital Therapeutics is a participative approach to monitor, managing wellness or a medical condition

leveraging software backed by clinical algorithms through a connected system.
Digital Therapeutics is moving the passive and episodic disease and wellness management through
a technology backed connected care model, which will lead to timely and appropriate interventions
resulting in better care and lower costs, thus building efficiency and trust in the healthcare system.
I believe, PDTx which is widely referred to as Prescription Digital Therapeutics, represents the new
model of care representing Patients, Doctors and Technology and so, rightly it is PDTx.
-Dr. Rajendra Pratap Gupta, Founder – Asia Pacific DTx Leadership Alliance

3 ©Asia Pacific DTx Leadership Alliance. Health Parliament

 We are reaching a tipping point in nomenclature that’s driven by the value of and evidence from
digital health and therapeutics: No one calls it e-banking anymore. If banking is not e-enabled, it’s
not relevant in today’s world. Similarly, we will soon refer to it simply as health and therapeutics,
and there will be an assumed, high-value digital component to it. Period.
- Dr. Anand Iyer, Chief Analytics Officer, Welldoc INC.- widely referred to as the ‘Father of Digital
Therapeutics’ & Mentor- Asia Pacific DTx Leadership Alliance

DTx – A Pathbreaking Innovation

In the recent years, multiple innovations have impacted the healthcare and the pharmaceutical industry,
which have led to both rationalization and optimization of outcome, equity, safety, and economics. For
chronic disease management, the emergence of digital health intervention and within that, a precise focus
on Digital Therapeutics, which covers both Digital Therapeutics over the Counter (DTxC) and Prescription
Digital Therapeutics (PDTx), is no less than a breakthrough. Over the last decade, this need-based
therapeutic class has emerged, leveraging software to deliver evidence-backed treatments for diverse
conditions, including diabetes, pain management, PTSD, and anxiety, and now extending to even more
complex ailments like heart diseases and cancer. This innovative approach integrates advanced digital
technologies to provide safer, personalized, and effective interventions, heralding a new era in managing
human disease/health states more dynamically and adaptable than existing pathways.

DTx use in clinical practice

DTx system (DTx product) Multi-functional

DHT product
General purpose hardware
or platform A multi-functional DHT product
can be created by combining a
DTx system or software with other
Input or output components DHT component(s), such as:
for DTx functioning
Monitoring component
Pharmaceuticals necessary
DTx Software
for DTx functioning
Diagnostic component
Patient or clinician support
components Clinical decision support
componet

Use with tandem intervention(s)

Clinician-delivered Digital Health
Pharmaceuticals Medical devices
therapies Technologies

The examples that are provided in this figure are representative of potential components.
Inclusion in the diagram does not imply necessity for clinical practice.

Figure: Use of DTx system in Clinical Practice

Source: ISO/DTR 11147.2 (Health informatics – Personalized digital health – Digital therapeutics health software systems)

©Asia Pacific DTx Leadership Alliance. Health Parliament 4

 The positive impact of Digital Therapeutics
solutions supports patients to be more
adherent to their treatment regime and adapt
with a more objective and rapid feedback
loop, enabling a more personalized care
program while also incentivizing long-term
behavior change typically for people with
chronic conditions.
-Dr. N.K. Singh, Asia Pacific DTx Leadership
Alliance

©DCDM (Digital Chronic Disease Management) Formulation Model:

Dr. Rajendra Pratap Gupta and Dr. N. K. Singh

Digital Therapeutics led Personalized

Medicine – A Paradigm Shift
The DCDM model transforms Chronic Disease Management by making it a near real-time process. The
data points pertinent for the personalised care are delivered by smart connected devices that integrate
lifestyle related inputs such as sleep, diet and exercise. This model will achieve not just care optimization
algorithm, improved quality of life, avoid morbidities/ complications but increase therapeutic compliance.
Digital biomarkers refer to objectively measured indicators of medical information, often collected through
digital devices or technologies. They play a crucial role in providing precise data that can be used in
the development and optimization of therapeutic interventions, including current pharmaceutical regime/
dosage.
The concept of Digital Therapeutics involves using software as a medical intervention to treat, manage,
or prevent various medical conditions. These software-based interventions may work independently or in
conjunction with traditional treatments such as pharmaceutical agents. This approach acknowledges the
importance of optimizing pharmacodynamics (the effects of a drug on the body) and pharmacokinetics
(how the body processes a drug) to enhance overall therapeutic outcomes.
Digital Therapeutics can take various forms, including mobile apps, virtual reality programs, sensor-based
technologies, and other software solutions. They are designed to deliver therapeutic interventions that are
evidence-based, data-driven, and often personalized to individual patient needs. These interventions can
target a wide range of health conditions.
The integration of digital biomarkers and Digital Therapeutics represents a paradigm shift in healthcare,
enabling a more personalized and data-driven approach to diagnostics and treatment. By leveraging
technology, healthcare professionals can gather real-time data, monitor patient progress, and adjust
treatment plans accordingly. This not only enhances the efficiency of healthcare delivery but also empowers
patients to take a more active role in managing their health.

5 ©Asia Pacific DTx Leadership Alliance. Health Parliament

 Digital Therapeutics is an application of Real-World Data (RWD) in providing the precise and
personalized guidance with regards to diet, lifestyle and medication to manage a medical condition.
- Dr. Rajendra Pratap Gupta, Founder- Asia Pacific DTx Leadership Alliance

It’s important to note that the field of Digital Therapeutics is continuously evolving, and ongoing research and
development are shaping the landscape. The acceptance of software agents as medical devices reflects
the growing recognition of the impact that technology can have on healthcare outcomes. As technology
advances, we can expect further innovations in the integration of digital tools into the therapeutic landscape
(Kyle & Tavel, 2010)

Evolution of DTx

Source: ( Wang, Lee, & Shin, 2023)

©Asia Pacific DTx Leadership Alliance. Health Parliament 6

DTx Innovators
DTx as a therapeutic adjuvant was led by innovators and innovative products. DTx as a category is expected
to rapidly evolve in scope and scale disrupting how we handle medical conditions.

DTx Pioneer - BlueStar®

The FDA cleared product such as BlueStar® and BlueStar Rx®

Systems include: A mobile app (also available via web) for individuals living with Type 1 (T1) and Type 2
(T2) diabetes, which connects to multiple health devices and data sources and provides tailored digital
coaching and insights.
(Source: (welldoc))

Audio Drugs: The ‘binaural beats’ based on the concept of audio drugs as an adjuvant in treating anxiety
and aiding sleep is yet another category of Digital Therapeutics that is evolving fast with rapid clinical
validation. (Digital Health – Truly Transformational, Dr. Rajendra Pratap Gupta)
Lupin Digital is a new entrant from Asia Pacific into DTx focusing on cardio-metabolic conditions such as
Congestive Heart Failure (CHF) and Coronary Artery Disease (CAD). LYFE is India’s 1st clinically proven
digital cardiac rehabilitation program designed to improve heart health and quality of life.
Dr. Reddy’s Laboratories (DRL) has developed the Digital Therapeutics – Narivio, a device, designed for
migraine management, has obtained FDA clearance in the US.

7 ©Asia Pacific DTx Leadership Alliance. Health Parliament

Korea DTx
Sommz is the 1st Digital Therapeutic (DTx) approved in South Korea, operating as a software as a medical
device (SaMD), the app employs a cognitive behavioral therapy (CBT) approach validated through rigorous
clinical trials within South Korea.
Its approval is a testament to the effectiveness of its innovative use of AI, big data, and digital health
technologies, marking a significant milestone in the evolving landscape of medical device regulation. This
accomplishment stems from the implementation of a novel review process established last year, dedicated
to evaluating and endorsing cutting-edge medical devices (Taylor, 2023).
In a series of notable advancements within the South Korean digital therapeutics landscape, Nunaps
achieved the distinction of being the first to secure domestic approval for its VR-based platform addressing
visual field defects in July 2019. Subsequently, LifeSemantics followed suit with its DTx designed for the
treatment of lung cancer and chronic obstructive pulmonary disease (COPD) in the subsequent year.
Noteworthy developments continue as several Korean companies delve into investigational DTx devices
targeting diverse health concerns such as insomnia, breast cancer, stroke, and generalized anxiety disorder.
The prevalent mode of delivery for these digital therapeutic solutions involves mobile applications, often
complemented by PC integration. Recognizing the unique nature of DTx solutions, government officials are
actively working towards establishing comprehensive guidelines to effectively regulate these cutting-edge
devices (Korea Biomedical Review, 2023).
DTx offers a real potential for the pharmaceutical industry to discover new opportunities, particularly in
generating new education and awareness campaigns leveraging digital methods.

DTx – Care Rationalization & Optimization

• Reducing Dependency on Clinicians: A guided journey enabled by Digital Therapeutics can help
break the sole dependency on clinicians for all care pathway-linked data points, leading to improving
the quality of life and making the treatment pathway safer.
• Shifting from Reactive to Proactive and Participative Care: The idea is to move from a reactive
model of healthcare to a more proactive, engaging, and participative one. This shift could empower
individuals to take a more active role in their health and well-being, which relies on RWD, including
adaptation with diets and exercise-linked (digital) biomarkers.
• Relieving Clinicians and yet Enhancing the Human Touch: The goal is not to replace the human
touch but to complement it and make it more effective backed by technology. Digital Therapeutics can
provide additional support, allowing expert clinicians to focus on more critical aspects of care while still
delivering empathy and clinical effectiveness.
• Combining Physical and Digital for a Hybrid Approach: Combining the best of physical and
digital elements in healthcare, this hybrid model can address issues such as timeliness, cost, and
contextualization of care.
• Empathy and Clinical Effectiveness: Digital Therapeutics is seen to bring both empathy and clinical
effectiveness to healthcare. It has the potential to enhance the overall quality of care delivered to
patients.

©Asia Pacific DTx Leadership Alliance. Health Parliament 8

 Digital Therapeutics reduces the workload of clinicians from non-essential interventions. On one
hand, it reduces the number of patient interactions, and yet it improves the ‘touch with the patient’
with clinically essential touch points, thereby leading to a more satisfied patient with better clinical
outcomes.
-Dr. Rajendra Pratap Gupta, Founder - Asia Pacific DTx Leadership Alliance

DTx – Expanding Geographies & Horizons

Germany
Germany has set the standard for DTx integration in Europe. Their digital health app pathway (DiGA) allows
reimbursement of DTx solutions. To sell DTx products in Germany, companies must acquire a CE mark from
the EU, undergo evaluation for scientific merit, safety, and user interface and also achieve a permanent
DiGA listing, allowing physician prescription and reimbursement by state insurance. The reimbursement
rates however are determined by the German National Association of Statutory Health Insurance Funds
(GKV-SV)
United States (US)
The FDA serves as a single regulatory body for a population of over 330 million inhabitants. Regulatory
pathways are well-established, and reimbursement options are growing. Most commonly, DTx products
enter the FDA regulatory process through the 510(k) or De Novo avenues.
UK
In the UK, there are comprehensive regulations on digital health products. In this case, there is no separate
definition for DTx, as all such products are regulated as medical devices. However, the Improving Access
to Psychological Therapies (IAPT) program defines DTx as a digitally enabled therapy provided through the
internet under the guidance of clinicians and which is utilized as a secondary tool to aid treatments provided
by healthcare professionals.
Japan
In Japan, DTx is defined as a software program that contributes to the diagnosis, treatment, and prevention
of diseases according to the software as a medical device guideline of the Ministry of Health, Labor and
Welfare. Any such application is regulated as a medical device (class I–IV). Most of the DTx can either be
used by healthcare professionals or directly by patients that are supervised by healthcare professionals.
Australia
In Australia, DTx is defined as software that diagnoses, prevents, monitors, treats, and/or alleviates disease/
injury or which controls and/or monitors anatomical or physiological functions of the body in accordance
with the Therapeutic Goods Act and Software as a Medical Device Guidelines of the Therapeutic Goods
Administration. Any such application is regulated as a medical device (class I–III). In Australia, DTx does
not necessarily require implementation by a healthcare professional, but the class designation is lowered
one level there upon.
Other Countries
DTx is a dynamic field, and its impact continues to evolve worldwide. Various countries are recognizing and
adopting DTx into their national frameworks. These products are valued for improving patient care globally.
(For more specific information about DTx in different countries, you can stay engaged with the Asia Pacific
DTx Leadership Alliance).

9 ©Asia Pacific DTx Leadership Alliance. Health Parliament

 Digital therapeutics coverage determination standards by country
South
Category US UK Germany Japan Australia
Korea
Government Decision Centers for Decision Decision Ministry of Decision
Department (Ministry of Medicare (National (GKV*) Health, Labour (Department of
Health and and Medicaid Health Service) and Welfare of Health)
Welfare), Services Assessment Japan
Assessment Assessment Assessment
(National (National (MSAC)
(Health Institute
Insurance Institute
for Health for Health
Review and and Care
Assessment) and Care
Excellence) Excellence)
NA NA ∆ ° ° NA
Status
of health
insurance (Conditional
coverage application)

NA NA Various Smoking NA
diseases, cessation
Indications including treatment
Mental disease mental disease,
tinnitus, stroke,
cancer, and
obesity

Equivalent to Equivalent to When the effect When the Equivalent to Equivalent to

the existing the existing is equivalent to 124 product the existing the existing
Coverage medical medical or better than requirements treatment medical
device (when device (when the existing are satisfied, materials (e.g., services
determination the adequacy equivalence technology and and a clinical classification (when safety,
of coverage to the existing a cost-efficient effect has been validity, similar effectiveness,
and economic technology or superior demonstrated functions, new and cost
feasibility or superior clinical effect is functions, effectiveness
have been performance verified manufacturing have been
demonstrated) has been cost, import demonstrated)
demonstrated) cost, cost-
utility)

Usability test NA NA ° ° NA NA

Pricing NA Decision is Decision Decision is When there NA

made through is made in made through is existing
Method negotiations in consideration of closed technology, the
consideration outcomes based negotiations decision is made
of market on collected between the based on this
values and data German health
When there
development/ insurance
is no existing
production costs agency and
technology, the
(non-disclosure) manufacturers
decision is made
(annual
based on cost
renegotiations)
calculations

Source: ( Ju, Sim, Lee, & Lee, 2022)

©Asia Pacific DTx Leadership Alliance. Health Parliament 10

 Method of
Name of Name of Functions Method of
Indications coverage Price
country device provided reimbursement
application
Conditional Fee for use of Total
Space Depression CBT
listing* product £53
UK
Product:
Labor costs
£24 (Avg.)
Labor
cost: £29

Fee for use of €297.5

Deprexis Depression CBT Formal listing
product (90 days)

Multiple €743.75
Elevida CBT
Sclerosis (90 days)
Stress, €599
HelloBetter CBT
Burnout (90 days)
€464
Somnio Insomnia CBT
(90 days)

€476 (90
Velibra Anxiety disorder CBT
days)
Mental disorder €476
Vorvida caused by CBT (90
alcohol abuse days)
Health status Temporary
CANKADO Breast cancer Labor costs
monitoring listing €499.8
PRO-React (90 days)
Onco

Germany Companion Personalized €345.1

patella powered Patella pain exercise (90
by medi therapy days)

Health Status
ESYSTA APP Diabetes €249.86
(HbA1c)
& Portal mellitus (90 days)
Monitoring

Depression, €540
Selfapy* CBT
Anxiety (90
disorder, days)
Agoraphobia or
Panic disorder

Agoraphobia,
Social €428.8
Invirto CBT
phobia, Panic (1 year)
disorder
€116.97
Kalmeda Tinnitus CBT
(90 days)
Personalized
Mawendo Patella pain exercise € 119
therapy

11 ©Asia Pacific DTx Leadership Alliance. Health Parliament

 Method of
Name of Name of Functions Method of
Indications coverage Price
country device provided reimbursement
application
Monitoring €219.98
M-sense Migraine and behavioral (90
therapy days)

Migräne

CBT, monitoring
of stress/ €499.8
Mika Malignant tumor
symptoms/ (90 days)
adverse events
Panic disorder, €576 (90
Mindable CBT
agoraphobia days)

Personalized
€239
Nichtraucher Smoking cognitive
(90
Helden cessation behavioral
days)
coaching
Germany
€249 (90
Novego Depression CBT
days)
Support
Oviva decreased body
Direkt fur Obesity weight (e.g.
Adipositas self-monitoring,
e-learning)

Follow-up €499 (90

Rehappy Cerebral stroke
management days)§
Relief of €239.97
ViViRA Low back pain
symptoms (90 days)
Support
decreased body
€499.8
zanadio Obesity weight (e.g.
(90 days)
self-monitoring,
e-learning)

Support for
smoking
Smoking cessation Formal Service
Japan Japan CureApp
cessation (provision of listing fee
messages
or video)

Source: ( Ju, Sim, Lee, & Lee, 2022)

©Asia Pacific DTx Leadership Alliance. Health Parliament 12

 In summary, while Germany leads in European DTx integration, the US remains an enticing market
due to its size, regulatory clarity, and reimbursement opportunities. DTx is a dynamic field, and its
impact continues to evolve worldwide. The potential of DTx to achieve wider market acceptance
will need innovative pricing-reimbursement models. Given its diversity and the high burden of
chronic diseases, the APAC region will evolve a successful DTx Model that can be replicated
globally.

DTx in Asia Pacific - Access &

Commercialization
If we look at the number of people suffering from chronic conditions, and weigh the benefits of DTx for
DCDM, it is clear that Asia Pacific needs DTx more than any other region in the world, given that Asia
Pacific is home to 4.3 billion people (60 per cent of the world’s population) (UNFPA, 2024)
APAC’s number of Chronic diseases and patients with co-morbidities will see the biggest impact – Diabetes
and Hypertension.

Figure: Mortality linked with elevated glucose for adults, estimated mortality rates, 2000 and 2019

The development of Digital Therapeutics and its potential beneficial impact on nations in the APAC could be
huge, as it delivers enhanced outcomes, minimizes risk, and impacts clinical efficiency for target therapeutic
outcomes while also enhancing the quality of life of the patient across many clinical conditions that lends
itself to optimization of both care process and outcome.
The evolution of pharmaceutical therapeutics is a captivating narrative that unfolds across centuries,
showcasing the remarkable progress in medical science. Pharmaceutical therapeutics, the cornerstone
of modern medicine, is dedicated to the treatment and prevention of diseases through pharmacological
interventions. Initially rooted in ancient remedies and herbal lore, the field has undergone a transformative
journey, culminating in cutting-edge advancements.

13 ©Asia Pacific DTx Leadership Alliance. Health Parliament

To kick off at the outset for any DTx start-up, it is important to explore multiple channels, such as working
with healthcare providers, while sustaining focus on PDTx categories. Recognizing that patients are
increasingly seeking online tools, we must initiate a new category DTxC (Digital Therapeutics Over the
Counter) or Direct to Consumers. The providers need to work with payers and prescribers to improve the
DTx offerings. The ultimate goal for any DTx must be to benefit the health of the overall population, ensuring
it’s accessible to the majority to improve access and outcome of population health, and bringing it under
the purview of insurance could be good pathway to fulfil the needs of the people and to be commercially
viable for providers.

DTx Pricing & Reimbursement Model

Recognizing that Healthcare should not be interpreted as always life and death issues, pricing the DTx
program needs a considered approach. Pricing considerations in the domain of Digital Therapeutics should
intricately align with population metrics and the targeted service scope. The implementation of a DTx model,
ensuring 80:20 and not 20:80 accessibility, emphasizes the pivotal role of scalability in driving affordability.
This principle could stand as a reliable compass, guiding the forefront of Digital Therapeutics (DTx) and
pricing design in such health systems in LMICs (Low Middle Income Countries). While the application
of premium pricing strategies is debatable, it may not be the optimal model for achieving favorable unit
economics as reflected by recent setbacks in mature markets like the US. The intricate interplay of these
factors warrants a comprehensive debate, particularly within the context of the APAC landscape, presenting
avenues for further exploration and refinement.
Developing a pricing strategy and a specific program involves considering factors like population and target
demographics.

DTx adoption is a pre-requisite for scale, and hence, a freemium model will be a good way to start
or cross-subsidizing it through innovative pricing mechanisms by the pharmaceutical or medical
devices industry.
- Ms. Mevish P. Vaishnav, Group COO – Digital Health Associates

Furthermore, DTx emerges as a potential liberator for the pharmaceutical industry and clinicians. Beyond
the recent focus on digital tools due to the pandemic, it addresses the chronic issues within the healthcare
system, offering a transformative possibility for the future.
The pharmaceutical industry could benefit from increased patient compliance and medication management
while reducing side effects and co-morbidity onset. According to a report, the pharmaceutical industry lost
USD 637 billion (in 2016) due to non-adherence to medication (Gupta, 2021).

©Asia Pacific DTx Leadership Alliance. Health Parliament 14

 With ‘software’ becoming a ‘drug’, the digitalization of
the pharmaceutical industry is a foregone conclusion
- Dr. Rajendra Pratap Gupta, Founder- Asia Pacific
DTx Leadership Alliance
Taylor, Ronte and Haughey, 2017
Figure: Massive loss due to non-adherence by customers

DTx and Medical Devices

– A Merger or Marriage
The evolution of Digital Therapeutics and medical devices represents a transformative convergence at the
intersection of healthcare and technology. Digital Therapeutics, comprising software-based interventions
designed to treat medical conditions, have seen a rapid evolution fueled by advancements in information
technology, artificial intelligence, and data analytics. These digital interventions offer a novel approach to
healthcare, providing personalized and often remote solutions for disease management and prevention.
Simultaneously, the evolution of medical devices has been marked by innovations ranging from traditional
diagnostic tools to sophisticated wearable devices and implantable technologies. Medical devices play a
crucial role in monitoring, diagnosing, and treating various health conditions, enhancing patient care, and
improving outcomes.
The synergy between Digital Therapeutics and medical devices is evident in the emerging trend of their
merger. The integration of software-driven therapeutic interventions with cutting-edge medical devices creates
a powerful synergy, offering comprehensive and patient-centric solutions. For example, wearable devices
equipped with sensors can collect real-time health data, which can then be analyzed by Digital Therapeutics
platforms to provide personalized treatment plans.

15 ©Asia Pacific DTx Leadership Alliance. Health Parliament

 Medical Devices

Software as a Software in a
Medical Device Medical Device
(SaMD) (SiMD)
While SaMD is a generic term
for software intended to be
Digital Health Digital used for one or more medical
Technologies Therapeutics purposes, the term DTx is limited
(DHT) (DTx) to software that intervenes with
treatment based on clinical
evidence for the treatment,
management, or prevention of
diseases or disorders.

Figure: Relationship of DTx, medical devices, and DHTs

Source: ISO/DTR 11147.2 (Health informatics – Personalized digital health – Digital therapeutics health software systems)

This convergence holds tremendous promise across multiple healthcare domains. In chronic disease
management, for instance, a patient’s vital signs monitored by a wearable device can be seamlessly
integrated into a Digital Therapeutics program that adjusts treatment protocols in real-time. This dynamic
interplay between Digital Therapeutics and medical devices not only enhances the efficacy of interventions
but also promotes a more holistic and patient-centred approach to healthcare.
As this relationship between DTx and medical devices continues to unfold, we can anticipate a future where
the boundaries between Digital Therapeutics and medical devices blur further, giving rise to integrated
solutions that leverage the strengths of both realms. This transformative synergy holds the potential to
revolutionize healthcare delivery, offering more personalized, efficient, and accessible options for improving
human health and well-being.
The integration of data analytics, artificial intelligence, and wearable devices marks a revolutionary approach
to healthcare, offering unprecedented opportunities for disease management and prevention, accounting
for major chunk of the healthcare revenues. We foresee many synergistic relationships firming up between
the DTx companies, pharmaceutical companies and medical devices companies and eventually, this will
result in their mergers or acquisitions.

The future of medical devices lies in moving from hardware to software and ultimately, all
medical devices dealing with patients will become DTx-enabled devices, and this is the future.
- Dr. Rajendra Pratap Gupta, Founder- Asia Pacific DTx Leadership Alliance

©Asia Pacific DTx Leadership Alliance. Health Parliament 16

DCDM (Digital Chronic Disease Management)
– Empathy with Excellence in Care
DCDM brings not only empathy but also clinical effectiveness, riding on the back of technology. In this
phygital (physical plus digital) world that combines the best of physical and digital realms, the goal is
to strike a balance. DCDM gently interrupts the traditional care model, providing a valuable supplement
that fill the gaps in terms of cost, context, and timeliness. The DTx evolution towards a blended approach
acknowledges the unique strengths of clinical proficiency and technical competence.

The US FDA recognizes the general plus 1 for higher severity cases that demand ongoing
monitoring by clinicians. Digital Therapeutics (DTx) introduces a novel concept of managing
chronic disease conditions by synthesizing a digital dose of non-molecular drug formulations.
In DTx, the digital element becomes an integral part of the molecular formulation of existing
drugs, providing contextualization, clinical evidence, lifestyle modification, medication titration,
compliances and care provider support while also addressing cyber security concerns.
Moreover, the digital aspect encourages accelerated learning, allowing for the identification
of more patient subtypes and expanding the possibilities for therapies beyond current
knowledge and disease management pathways. This innovative approach acknowledges
the potential for combining digital elements with traditional pharmaceuticals to enhance
treatment strategies, improve patient outcomes.

DTx – The Way Forward

Figure: Patient Journey - Conventional Care Model

17 ©Asia Pacific DTx Leadership Alliance. Health Parliament

 Figure: Patient Journey - 21st Century Medicine Model

ER: Emergency Room

eR X: Electronic Prescription
RPM: Remote Patient Monitoring

DCDM, when it is seen as an integral element of 21st century medicine, shows the dynamic ability of
various therapeutics agents to be titrated basis a more real-time feedback loop akin to the biological model
inside the human organism, helping not just to lower morbidities and mortalities rates but also optimizes the
spends from health insurance and improves the overall quality of human life and productivity. Behavioural
refinement achieved on nutrition, sleep, and exercise are natural outcomes that happen serendipitously
from such a win-win-win synthesis paving new pathways for innovators in healthcare delivery.

While the potential of DTx is unquestionable, there will be failures in the beginning before
we reach the right place. It will be incomplete if we fail to mention failures in this field but as
always, pioneers have the biggest challenge; to set the path for the leaders and that is what is
happening right now. I believe the APAC region holds the key to finding the right path and the
destination to a successful DTx integration in healthcare.
-Dr. Rajendra Pratap Gupta, Founder – Asia Pacific DTx Leadership Alliance

©Asia Pacific DTx Leadership Alliance. Health Parliament 18

 Pear Therapeutics, which has three FDA-cleared prescription apps to help treat substance use
disorder and insomnia, filed for bankruptcy , as the company struggled to get insurers to pay for its
technology. While doctors were willing to prescribe Digital Therapeutics and patients were willing
to use them, “that isn’t enough,” Pear’s CEO Corey McCann.
“Payors have the ability to deny payment for therapies that are clinically necessary, effective, and
cost-saving.”
Source: (Pear Therapeutics Files For Bankruptcy As CEO Blames Shortfalls On Insurers, 2023)

Despite ups and downs of growth and investment cycles, the cumulative evidence and the growing number
of Digital Therapeutics initiatives are poised for continued expansion (while a few will hit closure / delayed
growth during the learning curve) with the potential to make existing therapies scale and ensure more
equitable access to science. Projections for the future suggest that DTx may play a crucial role in augmenting
traditional therapeutic approaches for various medical conditions. Digital Therapeutics could significantly
enhance patient outcomes and quality of life by harnessing the power of data-driven insights, real-time
monitoring, and adaptive interventions.

Medical science in the 21st century will be driven by data science and DTx is an enabler to
make it happen.
-Dr. Rajendra Pratap Gupta, Founder – Asia Pacific DTx Leadership Alliance

The global Digital Therapeutics market, valued at approximately $4.5 billion in 2022, is anticipated to
experience robust growth with a projected CAGR of 31.6% from 2022 to 2027, ultimately reaching an
estimated value of $17.7 billion. In parallel, the market achieved a size of $5.0 billion in 2022, and market
analysts from IMARC Group forecast a further expansion, expecting it to reach $15.0 billion by 2028. This
outlook reflects an anticipated compound annual growth rate (CAGR) of 20.2% from 2023 to 2028. The
Digital Therapeutics sector is poised for substantial advancement, driven by technological innovations, and
increasing recognition of its efficacy in healthcare.
As technology continues to advance, the integration of Digital Therapeutics into mainstream healthcare
holds promise in expanding the scope of treatable conditions and in ushering in a more patient-centric
and precision-oriented era of medicine. In the evolving landscape of Digital Therapeutics (DTx), a nuanced
perspective prevails, emphasizing the absence of a singular panacea. The recognition of this absence
underscores the imperative for comprehensive scientific validation in the realm of human treatment. The
endeavour to explore and harness the potential of digital interventions mandates an approach grounded
in rigorous empirical scrutiny.
A collaborative framework between Digital Therapeutics, pharmaceuticals, and medical devices is
advocated. The call is for a departure from a rigid paradigm, suggesting a shift toward a more adaptable
and sophisticated evaluation methodology that accommodates the distinctive qualities of digital therapeutic
modalities.Embedded within the discourse is an appreciation for the symbiotic relationship between effective
entrepreneurship and the advancement of Digital Therapeutics. The narrative leans toward a perspective
wherein entrepreneurial success hinges on the ability to navigate complexities and enact strategies that
enhance the efficiency of Digital Therapeutic interventions.

19 ©Asia Pacific DTx Leadership Alliance. Health Parliament

Despite a few failures, the overarching sentiment is one of optimism, acknowledging the extant success
stories in the application of Digital Therapeutics to patient care. This optimistic tone extends into the future,
forecasting a decade-long landscape wherein early adopters are poised to reap the benefits of a maturing
Digital Therapeutics domain. Such foresight hints at a trajectory in which Digital Therapeutic solutions
become increasingly integrated into mainstream healthcare practices, meaningfully contributing to patient
outcomes and overall well-being.
The landscape of funding, unit economics, and investments in Digital Therapeutics (DTx) is poised for
change. However, the essence of DTx is enduring, and this decade may marvel at the debates surrounding
its mainstream integration. Amid the tidal wave of Digital Health, the collective pursuit remains centred on
assisting individuals effectively nudging behavioral changes through DTx.
A significant breakthrough of this decade challenges the conventional pharmaceutical model, emphasizing
a move beyond the pill approach. As digital interventions gain prominence, addressing the inhumane
aspects of healthcare becomes pivotal.
Digital Therapeutics represents a transformative approach to healthcare by integrating digital avatars,
physical coaches, and therapists into a cohesive system across states or countries. This innovative method
goes beyond geographical limitations, offering personalized and scientifically-based care accessible to
people from all walks of life. This holistic system effectively addresses chronic illnesses and liberates
pharmaceutical companies and clinicians from traditional constraints. With continuous support for conditions
such as diabetes, cardiac care, and mental health issues, among others, DTx emerges as a comprehensive
and accessible healthcare solution for everyone, and the hope and potential it has to deliver could impact
economic scale proportion for many burgeoning health systems across the world.
In the realm of evolving healthcare, Digital Therapeutics (DTx) stands as a notable force for change,
offering a potential shift from exclusive reliance on clinicians. The introduction of guided and engaging
digital experiences signifies a move towards a more participatory model of healthcare, enabling individuals
to play a more active role in their well-being.
The transition from a reactive to an engaging healthcare model holds promise but prompts a thoughtful
consideration of its implications. While Digital Therapeutics complements clinical expertise, the balance
between human touch and digital support requires careful navigation. This shift aims to empower individuals.
The elevation of expert clinicians in this paradigm suggests a positive trajectory, allowing them to focus on
critical aspects of care. However, the integration of technology introduces a delicate balance, seeking to
enhance clinical effectiveness without diminishing the human connection that is integral to compassionate
care.
The integration of Digital Therapeutics presents a balanced outlook, acknowledging both the potential
benefits and challenges. The future for DTx is unlike “one pathway fits all” but leveling the over-expectation
of how a powerful idea like DTx could do and should do in any health system will play out in the coming
years despite the ups and downs cycle it is currently in. While clinical effectiveness and validation are
the crux, the larger innovation is needed to gain market access and equity, with regulatory pathways and
insurance acceptance. There is no definite market size that we can arrive at for DTx, but given that the
global healthcare market is poised to be about USD 10 Trillion, even a tiny fraction of the same attributed
to DTx will lead to USD 10-30 billion DTx market in the next five years. The actual number could be much
higher if the healthcare players can operate cohesively as an ecosystem.

©Asia Pacific DTx Leadership Alliance. Health Parliament 20

Recommendations
As we venture into this evolving landscape, a thoughtful and measured approach is essential to ensure that
the positive aspects of Digital Therapeutics are harnessed without compromising the essential human and
safety elements of healthcare, and we need a multi-stakeholder approach to increase the scope and scale
for DTx.
All those involved in the DTx must adhere to the Principles of Digital Health released by the Academy
of Digital Health Sciences (www.digitalacademy.health) to ensure that the adoption of any digital health
intervention sets the bar higher for healthcare and wellbeing with the integration of technology.
Recommendations for the Pharmaceutical Industry: The Pharmaceutical Industry should invest in
DCDM, adopt the freemium model to start with, and the adoption of DTx will increase exponentially.
Recommendations for the Doctors: Doctors should start using and recommending Digital Therapeutics
solutions to patients with co-morbidities, then gradually move to patients with chronic diseases considering
the evidence, effectiveness, user-friendliness and affordability.
Recommendations for the Regulators: Regulators need to have an open approach to DTx and start
working with the innovators in this domain to build an agile regulatory system that safeguards innovation
and patients.
Recommendations for Standardization Bodies like ISO: Set a formal standard that integrates with
evolving innovation in the DTx domain and make it publicly accessible for innovators to benchmark and
develop products while normalizing it with other international standards and global standardization bodies.
Recommendations for the Insurance Sector: The insurance sector should start considering DTx
solutions for chronic diseases starting with co-morbidities.
Way forward by Asia Pacific DTx Leadership Alliance: We will be working with the pharmaceutical &
medTech industry, doctors, regulators, and the insurance sector to work on the DTx Pricing-Reimbursement
model, evidence generation in support of DTx for DCDM. We need to be more patient-centric and need-
centric. There is a huge gap, and there needs to be DTx solutions to every disorder and every medical
condition. We will host roundtables on various aspects of DTx to nurture the leadership in this important
field.

21 ©Asia Pacific DTx Leadership Alliance. Health Parliament

References
Gupta, R. P. (2021). Digital Health: Truly Transformational. New Delhi: Wolters Kluwer.
Jennings, K. (2023, April 7). Pear Therapeutics Files For Bankruptcy As CEO Blames Shortfalls On Insurers. Retrieved
from Forbes: https://www.forbes.com/sites/katiejennings/2023/04/07/pear-therapeutics-files-for-bankruptcy-as-ceo-
blames-shortfalls-on-insurers/?sh=43e4c1ee2bd6
Bloom, D. E., Cafiero-Fonseca, E. T., Candeias, V., & Jané-Llopis, E. (2014). Economics of Non-Communicable
Diseases in India: The Costs and Returns on Investment of Interventions to Promote Healthy Living and Prevent,
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States using a multi-state population model. Front Public Health. doi:10.3389/fpubh.2022.1082183
welldoc. (n.d.). A Novel Approach to Interpreting Glucose Data. Retrieved from welldoc.com: https://www.welldoc.
com/clinical-research/
Ju, J. H., Sim, B., Lee, J., & Lee, J. Y. (2022, March 17). Reimbursement of Digital Therapeutics: Future Perspectives
in Korea. Korean Circulation Journal. doi:https://doi.org/10.4070/kcj.2022.0014
Wang, C., Lee, C., & Shin, H. (2023, March). Digital therapeutics from bench to bedside. NPJ Digit Med. doi:10.1038/
s41746-023-00777-z
Kyle, S., & Tavel, J. (2010, November). What are biomarkers? Current Opinion in HIV and AIDS, 463-466. doi:10.1097/
COH.0b013e32833ed177
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eu/press-publications/publications/techsonar/digital-therapeutics-dtx_en
Taylor, P. (2023). South Korea approves its first digital therapeutic. Retrieved from Pharmaphorum: https://
pharmaphorum.com/news/south-korea-approves-its-first-digital-therapeutic
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and%20India.

©Asia Pacific DTx Leadership Alliance. Health Parliament 22

About Asia Pacific DTx Leadership Alliance:
In order to advance the adoption and integration of DTx solutions for improved patient outcomes, the Asia
Pacific DTx Leadership Alliance is proposed as a collaborative platform aimed at fostering innovation,
driving adoption, and leading the advancement of Digital Therapeutics across the Asia Pacific region.

Structure of Asia Pacific DTx Leadership Alliance:

• The Alliance leadership council comprises all founding members who joined from various stakeholder
groups. It comprises key leaders nominated by the founding organizations responsible for strategic
decision-making, resource allocation, and governance.
• All companies will nominate one individual from their organization for the alliance on a rotational basis.
• The members will be a part of the alliance on a yearly term basis. The term can be extended based on
their interest and contribution to further the objectives of the alliance.
• The alliance will hold quarterly meetings of the stakeholder groups, members in different regions will
host this from time to time.
• We will also invite chapters from different geographical areas led by the founding members.
• The Asia Pacific DTx Leadership Alliance is being hosted by Digital Health Associates through Health
Parliament.

Join the Movement- DTx

• Digital Therapeutics will redefine how we manage chronic patients, and the evidence is mounting in
favour of Digital Therapeutics to help in better treatment outcomes. It is imperative that we should be at
the forefront of driving the digital transformation of healthcare and make it patient-centric by leveraging
the potential of DTx.
• Asia Pacific DTx Leadership Alliance follows a unique ecosystem approach – explicitly catering to the
unique needs and challenges of the Asia Pacific region.
• We are focusing on developing a knowledge resource center for DTx. The alliance will create a robust
network and a knowledge pool that promotes knowledge creation, sharing, cross-sectoral partnerships,
and joint initiatives to advance Digital Therapeutics for improving health outcomes.
• This will remain a membership-led alliance to help shape this promising domain and help the healthcare–
pharmaceutical industry to be at the forefront of change.

To know more, please write to: evp@parliament.health, contact@parliament.health

23 ©Asia Pacific DTx Leadership Alliance. Health Parliament

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