Market access update
Digital therapeutics: value, evidence, and access in the Asia-Pacific region
Digital therapeutics (DTx) are evidence-based therapeutic interventions often developed in combination with a device and/or therapeutic agent, that are designed to prevent, manage, or treat a variety of medical conditions and address challenges such as medication adherence and poor disease control. Given the therapeutic nature of DTx, they are often held to a higher standard than digital monitoring or diagnostic devices, with additional requirements to generate evidence, demonstrate data control, and satisfy regulatory oversight.1,2
In the previous articles in this series, we described the evidence requirements for securing reimbursement of DTx in global markets. In this article, we will explore the current developments and trends in DTx access in the Asia-Pacific region, including the role of superapps in navigating the diverse regulatory and reimbursement landscapes.
An overview of selected markets in the Asia-Pacific region and their maturity in digital therapeutics regulatory frameworks
DTx are gaining momentum across the Asia-Pacific region, driven by a growing burden of chronic diseases and an interest in both developing and utilizing digital applications in the post-COVID era. Several countries in the region have established regulatory frameworks for DTx products, while other markets are in the process of developing such frameworks.
An overview of selected Asia-Pacific markets and their maturity in DTx regulatory framework development is provided in the table below.
While there is significant traction in terms of regulatory frameworks, reimbursement policies for digital therapuetics vary across the Asia-Pacific region
In Japan, DTx coverage is determined after evaluation by the Ministry of Health, Labour and Welfare of Japan (MHLW), as well as review and approval by the Central Social Insurance and Medical Council (CSIMC/Chuikyo). Functional considerations, manufacturing and import costs, as well as economic value are evaluated to inform reimbursement decisions. The first approved DTx in Japan was the CureApp, which received PMDA regulatory approval for treatment of nicotine addiction in August 2020, followed by hypertension in March 2022. Both indications are reimbursed under the national health insurance.9
In Australia, DTx products are reimbursed through multiple pathways depending on the therapeutic area and intended purpose. Examples of pathways that can be used for reimbursement of DTx in Australia include the Pharmaceutical Benefits Scheme (PBS), the Medical Benefits Schedule (MBS), the National Diabetes Services Scheme (NDSS), and the National Disability Insurance (NDIS).
Medicare reimburses telemedicine consultations (up to 85%), cardiac remote monitoring (up to 75%), and diabetes remote monitoring for those on the NDSS (100% reimbursement). An example of a DTx product covered under the NDSS is the DexcomG6 device, which is integrated with a variety of different diabetes management applications.10-15
Beyond reimbursement, the Australian government also promotes the development of digital health and DTx through policy and R&D initiatives. The Australian Taxation Office and the Department of Industry, Innovation, and Science administers R&D tax incentives to offset innovation activities.
In 2021, ResApp Health Limited, a digital health company developing smartphone applications for the diagnosis and management of respiratory disease, received $818,826 in R&D tax incentive.
Additionally, the Australian Digital Health Agency has a developed a National Digital Health Strategy and Framework for Action to drive national and regional digital health initiatives across Australia.16-17
In South Korea, the Ministry of Food and Drug Safety (MFDS) oversees the regulation of DTx. The MFDS has developed a set of guidelines for the review and approval of DTx to ensure the safety and effectiveness of these products before granting market authorization.
In February 2023, the MFDS approved the first DTx device, Somzz, for the treatment of insomnia.18 The MFDS has also developed guidelines for the evaluation and clinical trial design for insomnia treatments, and is planning to develop additional guidelines for DTx targeting other indications.19 Criteria for the reimbursement of DTx products are not yet established but are in development.20,21
In Singapore, the government-funded Integrated Health Information Systems (IHiS) has started to co-develop and drive the uptake of some DTx products, but criteria for reimbursement and value assessment frameworks are yet to be developed. The IHiS has developed and deployed an in-house system known as Health Discovery Plus (HD+), which runs on the Microsoft Azure platform. The IHiS encourages patients to take ownership of their health using HD+, which supports monitoring programs for different vital signs across various settings such as polyclinics, hospitals, and senior activity centres.22
Public-private partnerships in the DTx space have also been established in Singapore. For example, Holmusk, the National Healthcare Group and the Institute of Mental Health have agreed to co-develop tools to enable earlier detection and intervention in mental health disorders such as depression by using advanced analytics.23
A Singapore healthtech startup, Biofourmis, received the first ever Breakthrough Device Designation from the US Food and Drug Administration (FDA) for a novel DTx for heart failure, called BiovitalsHF, in July 2021.24 BiovitalsHF is a medical application that augments guideline-directed use of heart failure medications to manage patients in combination with traditional pharmacotherapy.24
As of early 2023, the Central Drugs Standard Control Organization (CDCSO) in India has not developed or adopted any guidelines for DTx. However, APACMed, the regional trade association for the medtech industry, has given recommendations and guidance to CDCSO on the regulation of DTx and software as a medical device. India is expected to develop and implement guidelines soon, given its rapidly expanding medical technology and digital health sector.25,26
Adoption of digital therapeutics, personalized medicine, and telemedicine is increasing in the Asia-Pacific region
Adoption of DTx in the Asia-Pacific region is increasing, with the COVID-19 pandemic accelerating the shift towards telehealth and digital solutions. Personalized medicine, which incorporates patient-specific data to tailor treatment plans, is also gaining momentum in the region.
In addition, there is a growing need for interoperability between DTx products and other healthcare technologies, such as wearable devices, remote monitoring technologies, and mobile health applications.
Although telemedicine is not classified as DTx, it provides an additional channel for patients to access healthcare remotely. Active adoption and utilization of telemedicine services have also been increasing evident across Asia-Pacific markets.
- In India, Practo is a prominent telemedicine platform that connects patients with doctors through video consultations, enabling remote access to healthcare services.
- Ping An Good Doctor, a Chinese telemedicine platform, provides comprehensive online healthcare services, including virtual consultations, appointment booking, and prescription delivery.
- A Singapore-based telemedicine platform, Doctor Anywhere, offers a range of telehealth services such as video consultations, online prescription services, and medication delivery. Doctor Anywhere has expanded to neighboring countries in Southeast Asia.
- Halodoc, a major telemedicine provider in Indonesia, offers a variety of services such as remote diagnosis, home based lab tests, and medication delivery.
Singapore’s health technology assessment body, the Agency for Care Effectiveness, has also noted that the pivot from a fee-for-service model towards a value-based healthcare model through bundled payments and value-based reimbursement could drive the implementation and uptake of telemedicine in public healthcare institutions.27 In Singapore, allowing patients to use the Community Health Assistance Scheme subsidies and MediSave for telemedicine services for selected chronic conditions could also be beneficial. 27
The role of superapps in navigating the diverse regulatory and reimbursement landscapes in the Asia-Pacific region
Improved collaboration between technology manufacturers, government, and key local health agencies is needed to navigate the diverse regulatory and reimbursement landscapes across the region to support patient access to DTx for improved health outcomes.
In addition to public partnerships, collaboration with superapps could also be important in achieving optimal access in local markets as their role in healthcare administration IT infrastructure grows.
A superapp is typically a mobile application that can provide a variety of services (e.g., payment, delivery, financial transaction processing, links to procure transport or services, effectively becoming an all-encompassing, self-contained commerce and communication online platform that embraces many aspects of personal and commercial life.
Examples of such applications in the region include GrabHealth by Grab, WeDoctor by Tencent, and Pulse by Prudential.28-30 Superapps may also unbundle niche services such as telemedicine and delivery of medications and outsource these to partner applications. One example of this is the partnership between the superapp Go-Jek and Halodoc.31
Looking ahead, the potential to integrate DTx with superapps and existing healthcare systems provides an opportunity to revolutionize access to healthcare resources, information, and personalized treatment plans.32 This innovative combination could provide a seamless experience for both patients and healthcare providers, empowering patients with timely and convenient access to healthcare services regardless of their location or socioeconomic status. This advancement would promote more equitable healthcare provision throughout Asia-Pacific markets.
Supporting your unique access challenges for digital therapeutics in the Asia-Pacific region
The increasing focus on patient-centric healthcare and value-based pricing models will require manufacturers of DTx to demonstrate clear and measurable benefits, along with economic advantages for patients and healthcare systems.
By showcasing their value to patients and society, these manufacturers can maximize reimbursement coverage and adoption, ultimately driving improved patient outcomes and more effective healthcare systems.
Our policy, access, value, and evidence experts in Singapore are uniquely placed to help you navigate the dynamic nature and rapidly evolving markets of the Asia-Pacific region; please get in touch for a confidential conversation.
Read the full report: “Digital therapeutics: policy, access, value, and evidence”
In the next section of the free report, we shine a light on the US landscape and the role of early FDA and payer engagement in access for DTx. Read the full report here.
Digital Therapeutics Alliance. https://dtxalliance.org; [accessed May 2023].
Dang, A., Arora, D., & Rane, P. (2020). Role of digital therapeutics and the changing future of healthcare. Journal of Family Medicine and Primary Care, 9(5), 2207.
TGA. “Regulation of software based medical devices” 2023. https://www.tga.gov.au/how-we-regulate/manufacturing/medical-devices/manufacturer-guidance-specific-types-medical-devices/regulation-software-based-medical-devices.
China Center for Food and Drug International Exchange. Announcement of the Center for Device Evaluation of the State Food and Drug Administration on the release of the guidelines for the registration and review of medical device software (2022 revision). https://www.ccfdie.org/cn/yjxx/ylqx/webinfo/2022/03/1648289422496885.htm.
PMDA. “Updates on Medical Device and IVD Regulation in Japan.” 2023. https://www.pmda.go.jp/files/000250261.pdf
HSA. “Regulatory Guidelines for Software Medical Devices – A Life cycle Approach.” 2022. https://www.hsa.gov.sg/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/regulatory-guidelines-for-software-medical-devices—a-life-cycle-approach_r2-(2022-apr)-pub.pdf.
Asia Pacific Medical Technology Association. Digital health regulation in Asia-Pacific: China and Korea. Dated October 2021:7. https://apacmed.org/content/uploads/2021/10/DHC-Regulatory-Paper_China-Korea.pdf.
Asia Pacific Medical Technology Association. Digital health regulation in India: Overview and best practices. 2021. https://apacmed.org/content/uploads/2021/10/Digital-Health-Regulation-in-India_Position-Paper.pdf
Digital Therapeutics: Value, Evidence, and Access insight