How Do the Pricing and Reimbursement Policies for Digital Therapeutics Compare and Contrast Between the US, EU-5, China and Japan?
Author(s)
Foxon G1, Danev V2, Craddy P3, Wilson C4
1Remap Consulting, Zug, Switzerland, 2Remap Consulting, Rainow, CHE, UK, 3Remap Consulting GmbH, ZUG, ZG, Switzerland, 4Remap Consulting UK Ltd, Alderley, CHE, UK
Presentation Documents
OBJECTIVES : Digital therapeutics (DTx) are one of the categories of digital health, which is defined as products that deliver evidence-based therapeutic interventions to patients which are driven by high quality software programs to prevent, manage, or treat conditions. The Covid-19 pandemic accelerated the adoption of DTx globally. This study examines the pricing and reimbursement (P&R) policies for DTx in EU5, US, China and Japan. METHODS : Secondary research of literature was conducted to identify the most recent P&R trends for DTx in the markets in scope. National HTA bodies were searched to capture policies, frameworks and assessment criteria for DTx. The way DTx are assessed to obtain reimbursement was compared across countries. Existing P&R processes specific to DTx were examined to identify the key drivers in reimbursement decision making for these products. RESULTS : Germany is the first and only country so far that has implemented a specific P&R process for digital applications. Three of the countries (France, Italy and the UK) currently assess DTx as medical devices, although NICE in the UK has developed a framework for assessing digital health technologies. Development of a new P&R evaluation process for DTx in the next few years is anticipated in six of the countries in scope. Two countries (China and Japan) do not have a clear process for P&R of DTx. CONCLUSIONS : Whilst DTx are becoming an increasingly trending topic globally, there are challenges with their P&R evaluation. For the countries in scope, Germany is the only one with a defined DTx P&R process in place. Most countries recognise the need of a streamlined DTx reimbursement framework and have initiated or are likely to initiate the development of such policies. Interestingly, despite the substantial government investment in digital health in China and Japan, clear pathway and criteria that DTx are screened against.
Conference/Value in Health Info
2021-11, ISPOR Europe 2021, Copenhagen, Denmark
Value in Health, Volume 24, Issue 12, S2 (December 2021)
Code
POSA263
Topic
Health Policy & Regulatory, Health Technology Assessment, Medical Technologies
Topic Subcategory
Digital Health, Reimbursement & Access Policy, Systems & Structure, Value Frameworks & Dossier Format
Disease
Diabetes/Endocrine/Metabolic Disorders, Mental Health, Multiple Diseases, No Specific Disease
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