Overview of Health Technology Assessment (HTA) from Asia Pacific Perspective Hong Li, PhD., MPH Group Director, Bristol-Myers Squibb Adjunct Associate Professor University of Cincinnati, USA; and DUKE-NUS Graduate Medical School, Singapore 1 st International HTA Symposium in University of Tokyo, Japan September 6, 2012
Disclaimer The author is a full-time employee of Bristol-Myers Squibb (BMS) and an adjunct faculty of two listed universities. The author is not receiving an honorarium for this talk The contents of the presentation are not confidential or proprietary information of BMS The content of this talk represents the views of the author and are not necessarily an official position of the institutions where he is employed or who he is affiliated with 2
Outline of the Presentation Healthcare spending and research and development (R&D) costs in Asia Current health technology assessment (HTA) (and agencies) in Asia and key features Suggestions for enhancing HTA in Japan 3
Health Expenditure in Asia as % of GDP (2010), US Canada UK Japan South Korea Taiwan China Malaysia India Singapore Thailand 5.8 5.1 4.4 4.1 4.0 3.9 6.9 9.6 9.5 11.3 17.9 Given the size of populations in most Asian countries, the current percentage of health expenditure as % of GDP restricts governmental budgets for healthcare programs 0.0 2.0 4.0 6.0 8.0 10.0 12.0 14.0 16.0 18.0 20.0 Percentage of Gross Domestic Product (GDP) http://en.wikipedia.org/wiki/healthcare_in_taiwan http://data.worldbank.org/indicator/sh.xpd.publ/countries 4
Percentage of GDP of R&D 4.0 % of GDP 3.5 3.0 2.5 2.0 1.5 1.0 0.5 3.2 3.3 3.4 3.4 3.4 2.5 2.6 2.6 2.7 3.4 2.8 2.9 2.2 2.2 2.3 2.3 2.4 2.4 Japan OECD Total United States These values are for all R&D including pharmaceuticals. The fact that R&D expenditure is a high percentage of Japan s GDP reflects the importance this country places on R&D. 0.0 2004 2005 2006 2007 2008 2009 Year http://www.oecd-ilibrary.org/social-issues-migration-health/health-key-tables-from-oecd_20758480 5
Enormous Efforts in Global Drug R&D will Bring More New/Innovative Drugs into Asia Cancer Related 1,527 Biotechnology Medicines 1,022 Diabetes Related Mental Health Antivirals 96 187 270 This global R&D development in innovative medicines will bring challenges to countries, including those in Asia, in regulatory authorizations and appreciation of value for pricing and reimbursement (P&R) 0 200 400 600 800 1000 1200 1400 1600 Number of Medicine Candidates (2010-2012) http://www.phrma.org/research/publications 6
Global Health Technology Assessment (HTA) is Moving into Emerging Markets/Asia Pacific Recently Established HTA South Korea (ref Australia) Taiwan (ref Canada/US) Brazil (ref Canada/UK) HTA Under Review Singapore (ref UK/Aus) Hong Kong (ref UK/Aus) Thailand (ref UK/Aus) China (ref?) Turkey (ref UK) In Discussion India Japan Russia 7
Various Types of HTA Agencies in Asia Country Agency Type China Various university centers Academic Malaysia MaHTAS (Health Technology Assessment Section) and HTAU (Health Technology Assessment Unit) MoH/Government Singapore Research & Technology Assessment Department MoH/Government South Korea HIRA (Health Insurance Review & Assessment Agency)/NECA (National Evidence-based Healthcare Collaboration Agency) MoHW/Government Taiwan HTA Division- Center for Drug Evaluations DoH/Government Thailand HiTAP (Health Intervention & Technology Assessment Program) MoPH/Government http://www.ispor.org/htadirectory/index.aspx 8
Most of the Asian HTA Programs are Research Oriented & Drug Focused Country MaHTAS/Malaysia R&TAD/Singapore HTA/CDE/Taiwan HiTAP/Thailand Purpose (1) To ensure appropriate use of health care technology by influencing decision-makers through collection, analysis, dissemination of information on safety, effectiveness, costeffectiveness, and health impact of technologies. (2) To provide evidence for informed decision making to policymakers, health care providers and consumers To evaluate the benefits, risks and clinical effectiveness of health techonolgies to support policy-makig in the management and planning of health services in Singapore To enhance the efficiency and quality of drug evaluation, thus promote public health and welfare including timely access to innovative medicines To establish a national standard and body of knowledge for health technology assessment in Thailand that not only achieves an international standard but also takes into account the resources and infrastructure constraints in the Thai setting 9
A Funneling Process for Decision Making in Asia Potential Impacts from HTA? Number of medicines approved by a country s regulatory agency Number of medicines considered for listing by national formulary Number of medicines with prices that are eventually accepted PROs: refrain from a fixed budget to focus on most needed CONs: longer time lag and fewer number of new medicines under coverage 10
Key Features of HTA in Asia Most of the programs are run by government South Korea and Taiwan have nationally legislated built-in healthcare insurance including HTA like assessments. In Thailand, the Medical Device Act requires assessments for device purchases that are above certain costs Some local pharmacoeconomic guidelines are written but require better implementation Focus on pharmaceuticals listing in national formulary; medical device/procedures are catching up Insufficient quality of local data and HTA methodologies Need more qualified staff/researchers 11
Suggestions for Enhancing HTA in Japan Consider a legal framework for HTA processes (separate to regulatory approval purposes) to ensure a clear understanding of the objectives and how HTA fits within the health system based on local policy, culture, values, and medical practice for a proper and transparent HTA process in Japan Leverage current healthcare infrastructure in Japan with a focus on improving efficiency Have an early dialogue and full engagement with all stakeholders including industry and patient groups Balance between healthcare budget and unmet medical needs for the entire population focusing on long term benefits Generate a comprehensive plan for development of methodology, data, and qualified staff/researchers suitable for Japan 12
Thank you hong.li@bms.com 13