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Overview of Country Health Technology Assessment (HTA) Guidelines for

 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

Optimising Strategies

The assessment of digital health solutions is crucial to bring more high-quality value-based care to the market and to patients, and APACMed is keen to partner with key stakeholders of the ecosystem in optimising regional strategies.

Assessing Value of DHT

There is a need for a holistic and more appropriate framework to assess the value of DHTs.

Reviewing Our Approach

With this analysis, APACMed aims to review the existing approaches used by policymakers to assess the value of DHTs in APAC and beyond.

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Guideline for the national health insurance (NHI) coverage – eligibility for Innovative Health Technology Assessment Track

To date, South Korea is the only country in APAC that has developed a value assessment and reimbursement guidelines for DHTs.

Considerations

Scope: Innovative medical technologies

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:

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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.

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):

Reimbursements

Assessment criteria for Reimbursement

Evidence standards evaluated by the CNEDiMTS2 have to demonstrate:

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.

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Authors: CNEDiMTS (Medical device and Health technology Evaluation Committee) of HAS (Haute Autorité de santé)

Published in January 2019.

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:

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.

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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.

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:

Reimbursements

The evidence evaluation does not necessarily lead to reimbursement decision.

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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.

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