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APACMed
The Voice of MedTech in Asia
Overview of Country Health Technology Assessment (HTA) Guidelines for Digital Health Technologies (DHTs)
Value assessment and reimbursement of digital health solutions are crucial to bring more high-quality care to patients. Policies that improve the coverage of these solutions are strongly needed in the Asia-Pacific region.
This infographic on this page focuses only on HTA frameworks specific to digital health
South Korea
Guideline for the national health insurance (NHI) coverage – eligibility for Innovative Health Technology Assessment Track
Considerations
Scope: Innovative medical technologies
- Currently only artificial intelligence (AI) medical imaging, and 3D Printing
- To be updated for other innovative technologies including Digital Health Technologies (DHTs)
Reimbursements
Assessment criteria for Reimbursement
According to the level of improvement in clinical utility and cost effectiveness, DHTs are classified from Level 1 to 4.
Separate additional reimbursement price is granted to Level 3 and 4:
- Level 3 – Clinically significant improvement in treatment outcomes or diagnostic abilities / new diagnostic value and treatment effectiveness.
- Level 4 – Cost-effectiveness is clinically and significantly demonstrated in addition to Level 3.
Authors: Ministry of Health and Welfare (MOHW), Health Insurance Review and Assessment Service (HIRA), The Korean Society of Radiology, the Korean Society of 3D Printing in Medicine.
Published in December 2019.
France
Guide to the specific features of clinical evaluation of a connected medical device (CMD) in view of its application for reimbursement via LPPR1
Condsiderations
Are considered connected medical devices (CMDs):
- Devices intended for use for medical purposes (CE-mark)
- Devices for individual use (implanted or used by patient)
- Devices requesting reimbursement by the National Health Insurance
Reimbursements
Assessment criteria for Reimbursement
Evidence standards evaluated by the CNEDiMTS2 have to demonstrate:
- Individual benefits: morbidity-mortality, patient or carer’s benefits, or any related and validated measurement tool supporting the product’s claim
- Other benefits, related to the stakeholders’ contributions (accessibility, care practice and organisation, quality of care, safety)
- Lack of harmful effect on the individual
Reimbursement (LPPR)
The reimbursement decision would be based on the actual clinical benefits (ACB) and the added clinical value (ACV), if sufficient ACB. The ACV will be a key contributing factor to price negotiations with CEPS3, to be listed in the LPPR.
Authors: CNEDiMTS (Medical device and Health technology Evaluation Committee) of HAS (Haute Autorité de santé)
Published in January 2019.
Germany
The Fast-Track Process for Digital Health Applications (DiGA) according to Section 139e SGB V
Considerations
DiGA (Digitale Gesundheits anwendungen) is a medical device of the risk class Ⅰ or Ⅱa (MDR/MDD CE-marks). Its main function is based on digital technologies. The DiGA has to be used by the patient only or by the patient and the HCP.
To be listed in the directory, a DiGA must meet the following requirements:
- Product qualities – Safety and Suitability for use, functionality, quality, data protection, information security, interoperability, etc.
- Positive healthcare effect – Medical benefit and Patient-relevant improvement of structure and process
Reimbursements
If the DiGA already has a comparative study demonstrating a positive healthcare effect, it can apply for final listing for reimbursement. If not, it undergoes a preliminary testing period of 12 months, during which statutory health insurances will reimburse the costs provisionally.
Authors:
Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), Federal Ministry of Health (Bundesministerium für Gesundheit, BMG)
Published in April 2019.
United Kingdom
Evidence Standards Framework for Digital Health Technologies
Considerations
Classifying Digital Health Technologies (DHTs) by function allows for evidence tiered stratification based on the potential risk to users.
DHTs are organized in 4 categories, with increasing user-benefits: tier 1, 2, 3a, and 3b.
Evidence standards will be based on two elements:
- Evidence of effectiveness, relevant to the intended use of the technology
- Evidence of economic impact, relative to the financial risk
Reimbursements
The evidence evaluation does not necessarily lead to reimbursement decision.
Authors: The National Institute for Health and Care Excellence (NICE), MedCity, National Health Service (NHS) England, Public Health England
Published in March 2019.
For more information, please contact:
Anh Bourcet
Reimbursement Working Group Chair
Jaehyun Suh
Lead Project
Roberta Sarno
Digital Health Manager at APACMed
We would like to thank all the Reimbursement working group members for their work during this project. Special thanks to Vishnu Sunil for his contribution.
Who We Are
APACMed provides a unifying voice for the medical devices and in-vitro diagnostics industry in Asia Pacific. Founded in 2014, APACMed strives to promote innovation and impact policy that advances healthcare access for patients.
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