Health Care System Information Sharing: A Step Toward Better Health Globally

In the face of the ever rising health care costs and declining resources, efficient and equitable health care technology reimbursement systems, based on robust health technology assessment (HTA) including economic evaluations, are vital for a sustainable health care. However, globally, HTA is not adequately utilized in health care reimbursement decisions. In most regions, it is still in its nascent phase. The use of HTA is hindered by the presence of fragmented reimbursement systems at both the national and regional levels as well as the lack of necessary resources and knowledge. Transparency and sharing of country-specific reimbursement system information is an important “first step” to improve the efficiency and fairness of health care globally [1Ackerman S. Smith M.D. Ehreth J. et al.Therapeutic and Diagnostic Device Outcomes Research. International Society for Pharmacoeconomics and Outcomes Research, Lawrenceville, NJ2011Google Scholar, 2PPRI: pharmaceutical pricing and reimbursement informationWHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies.http://whocc.goeg.at/About/PPRIGoogle Scholar]. Although efforts such as the EUnetHTA Joint Action [[3]European network for Health Technology Assessment – EUnetHTAEUnetHTA Joint Action—new phase in EUnetHTA development.http://www.eunethta.euGoogle Scholar] are underway to improve information sharing and harmonize HTA across countries, attempts to standardize the HTA requirements and processes are still in their early phase. In contrast, during the last two decades, there has been much progress in the standardization and harmonization of the regulatory process around the world through the efforts of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use [[4]International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human UseAdvancing harmonisation for better global health.http://www.ich.org/about/vision.htmlGoogle Scholar], the Global Harmonization Task Force [[5]Global Harmonization Task ForceWorking towards harmonization in medical device regulation.http://www.ghtf.org/Google Scholar], the European Commission [[6]European CommissionMedical devices.http://ec.europa.eu/health/medical-devices/index_en.htmGoogle Scholar], the European Medicines Agency [[7]European Medicines AgencyWhat we do.http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000091.jsp&murl=menus/about_us/about_us.jsp&mid=WC0b01ac0580028a42Google Scholar], and the World Health Organization [1Ackerman S. Smith M.D. Ehreth J. et al.Therapeutic and Diagnostic Device Outcomes Research. International Society for Pharmacoeconomics and Outcomes Research, Lawrenceville, NJ2011Google Scholar, 2PPRI: pharmaceutical pricing and reimbursement informationWHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies.http://whocc.goeg.at/About/PPRIGoogle Scholar, 8World Health Organization EuropePolicy: access.http://www.euro.who.int/en/what-we-do/health-topics/Health-systems/medicines/policy/acessGoogle Scholar, 9European CommissionProposal for a directive of the European parliament and of the council relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems.http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/transpadir_finalprop01032012_en.pdfGoogle Scholar]. Finding information on the reimbursement systems of different countries is challenging. Barriers such as different languages, lack of transparency, fragmentation of the available information, and limited resources impede the information flow. To answer this unmet need, the International Society of Pharmacoeconomics and Outcomes Research (ISPOR), through its members and ISPOR regional chapters, has developed publicly accessible information on country-specific decision-making processes for regulatory approval, reimbursement, and economic evaluation of health care technologies. The information is accessible through the Web-based ISPOR Global Health Care Systems Road Map (ISPOR Road Map) (http://www.ispor.org/HTARoadMaps/Default.asp) and the ISPOR Pharmacoeconomic Guidelines Around The World (ISPOR PE) (http://www.ispor.org/PEguidelines/index.asp). The ISPOR Road Map [[10]International Society for Pharmacoeconomics and Outcomes ResearchISPOR Global Health Care Systems Road Map.http://www.ispor.org/HTARoadMaps/Default.aspGoogle Scholar] provides the following information by country: 1) a concise background on the country health care system, 2) an outline of the health care decision makers and influencers, 3) health care bodies interrelations, 4) description of the decision-making processes for reimbursement and coverage, 5) data requirements for HTA, and 6) useful resources for further research. In an easy-to-read format, key information on health care reimbursement systems is provided in this comprehensive overview, filling in the gap between research, clinical practice, and decision making and drawing closer the use of evidence in health care decisions and policies. The ISPOR Road Map framework was developed by the ISPOR Health Technology Assessment Special Interest Group. The information contained in the ISPOR Road Map is provided by ISPOR members with knowledge of a country's reimbursement system. To ensure quality and accuracy, the information is reviewed by other professionals in the field as well as by a member of an official health care body within the country. Members from ISPOR and ISPOR regional chapters from more than 50 countries are participating in this initiative. Because, in most cases, pharmaceuticals and devices are reimbursed by different decision-making bodies, and by different pathways, the ISPOR Road Map information on pharmaceuticals reimbursement is separate from medical devices. Presently more than 25 road maps from more than 20 countries are available on the ISPOR Road Map. The ISPOR PE [[11]International Society for Pharmacoeconomics and Outcomes ResearchISPOR Pharmacoeconomic Guidelines Around The World.http://www.ispor.org/PEguidelines/index.aspGoogle Scholar] provides a list of 33 key features of a country-specific guidance document for the economic assessment of a new pharmaceutical product. The key features, derived from Hjelmgren et al. [[12]Hjelmgren J. Berggren F. Andersson F. Health economic guidelines—similarities, differences and some implications.Value Health. 2001; 4: 225-250Abstract Full Text PDF PubMed Scopus (284) Google Scholar], are as follows: 1) type, 2) title and year of the document, 3) affiliation of authors, 4) main policy objective, 5) standard reporting format included, 6) disclosure of funding/author's interests, 7) target audience, 8) perspective, 9) indication, 10) target population, 11) subgroup analysis, 12) choice of comparator, 13) time horizon, 14) assumptions required, 15) preferred analytical technique, 16) costs to be included, 17) source of costs, 18) modeling, 19) systematic review of evidences, 20) preference for effectiveness over efficacy, 21) preferred outcome measure, 22) preferred method to derive utility, 23) equity issue stated, 24) discounting costs, 25) discounting outcomes, 26) sensitivity analysis—parameters and range, 27) sensitivity analysis— methods, 28) presenting results, 29) incremental analysis, 30) total cost/effectiveness, 31) portability of results (generalizability), 32) financial impact analysis, and 33) mandatory or recommended or voluntary [12Hjelmgren J. Berggren F. Andersson F. Health economic guidelines—similarities, differences and some implications.Value Health. 2001; 4: 225-250Abstract Full Text PDF PubMed Scopus (284) Google Scholar, 13International Society for Pharmacoeconomics and Outcomes ResearchComparative table (compare selected countries on selected key features).http://www.ispor.org/PEguidelines/COMP1.aspGoogle Scholar]. The ISPOR PE provides the option to interactively create a comparative table of two or more countries by selecting from the key features listed above. The ISPOR PE also provides a hyperlink to the economic evaluation document or full text of the guidance document (if in the public domain). Guidance documents in the ISPOR PE are dated on the basis of the publication date and are categorized as follows: •Published PE Recommendations—country-specific economic evaluation guidelines or recommendations published by experts in the field but are not “officially” recognized or required by the health care decision-making bodies/entities in this country/region for reimbursement.•PE Guidelines—country-specific “official” guidelines or policies concerning economic evaluation that are recognized or required by the health care decision-making bodies/entities in this country/region for reimbursement.•Submission Guidelines—country-specific “official” guidelines or policies concerning drug submission requirements with an economic evaluation part/section and are required by the health care decision-making bodies/entities in this country/region for reimbursement. Members from ISPOR and ISPOR regional chapters from more than 50 countries are participating in this initiative. Presently, the ISPOR PE contains information on 33 country-specific pharmaceutical economic evaluation guidelines and are reviewed annually by professionals in the field within the country, to ensure the quality and accuracy. The Asia-Pacific region, one of the fastest growing emerging health care markets in the world, has the widest variations in the health care systems across countries. An array of health care delivery systems exists, ranging from fully developed universal health coverage, with an established full HTA process and economic evaluation, to fragmented health care systems with minimal health care coverage, unclear national guidelines and regulations. Limited resources and the rising cost of health care, though a common global trend, are more deeply felt in Asia-Pacific countries. Main contributing issues are large populations, high economic growth, and increasing demand for better health services. As a result, major reforms are underway in several countries, whether with an emerging health care system or with a fully developed one [10International Society for Pharmacoeconomics and Outcomes ResearchISPOR Global Health Care Systems Road Map.http://www.ispor.org/HTARoadMaps/Default.aspGoogle Scholar, 14Yang B.M. Lee K. Growing application of pharmacoeconomic and outcomes research in health care decision-making in the Asia-Pacific region.Value Health. 2009; 12: S1-S2Abstract Full Text PDF PubMed Scopus (11) Google Scholar]. Information in the ISPOR Road Map and the ISPOR PE describes the health care systems and outlines the undergoing health care reform that is taking place in Asia [10International Society for Pharmacoeconomics and Outcomes ResearchISPOR Global Health Care Systems Road Map.http://www.ispor.org/HTARoadMaps/Default.aspGoogle Scholar, 11International Society for Pharmacoeconomics and Outcomes ResearchISPOR Pharmacoeconomic Guidelines Around The World.http://www.ispor.org/PEguidelines/index.aspGoogle Scholar]. Japan, one of the countries in Asia with a well-established health care system and several decades of universal health coverage, is undergoing major changes. To address the rising health care costs, implementation of a full HTA process, which includes economic evaluation, is underway to be completed by 2014 for pharmaceuticals [15Shibuya K. Hashimoto H. Ikegami N. et al.Future of Japan's system of good health at low cost with equity: beyond universal coverage.Lancet. 2011; 378: 1265-1273Abstract Full Text Full Text PDF PubMed Scopus (100) Google Scholar, 16International Society for Pharmacoeconomics and Outcomes ResearchJapan—medical devices & diagnostics.http://www.ispor.org/HTARoadMaps/JapanMDD.aspGoogle Scholar]. Australia, considered a point of reference with its established health care system and well-developed process for reimbursement and coverage, including economic evaluation and value-based pricing, has also undergone recent changes in its health care system. As of 2011, to provide the population with affordable, reliable access to medicinal products in a timely manner, new pharmaceuticals are processed concurrently rather than consecutively by the Therapeutics Goods Administration and the Pharmaceutical Benefits Advisory Committee. The aim of the concurrent review process by the Therapeutics Goods Administration (for safety, efficacy, and labeling) and by the Pharmaceutical Benefits advisory Committee (for comparative effectiveness and cost-effectiveness) is to reduce time toward listing medicinal products in the Pharmaceutical Benefits Schedule [17Hu W. Yoongthong Sh Whitty J. et al.National drug policies to local formulary decisions in Thailand, China, and Australia: drug listing changes and opportunities.Value Health. 2012; 15: S126-S131PubMed Google Scholar, 18International Society for Pharmacoeconomics and Outcomes ResearchAustralia—medical devices & diagnostics.http://www.ispor.org/HTARoadMaps/AustraliaMDD.aspGoogle Scholar]. Several other countries in the Asia-Pacific region, with a developing health care system, are following suit and undergoing major changes in the health care sector. In Taiwan, HTA was implemented as part of its reimbursement process and established as a separate entity in 2007. In addition, universal patient coverage has reached 99% of the population [19International Society for Pharmacoeconomics and Outcomes ResearchTaiwan—medical devices & diagnostics.http://www.ispor.org/HTARoadMaps/TaiwanMDD.aspGoogle Scholar, 20International Society for Pharmacoeconomics and Outcomes ResearchTaiwan—reimbursement process.http://www.ispor.org/HTARoadMaps/Taiwan.aspGoogle Scholar]. China is currently revamping its health care system, to be completed by 2020. China's goal is to provide universal health care coverage for all citizens through health insurance, as well as a fully comprehensive national essential drug system by that date. In 2009, first steps in establishing the essential drug system were taken and a new essential drug list was issued [17Hu W. Yoongthong Sh Whitty J. et al.National drug policies to local formulary decisions in Thailand, China, and Australia: drug listing changes and opportunities.Value Health. 2012; 15: S126-S131PubMed Google Scholar, 21International Society for Pharmacoeconomics and Outcomes ResearchChina Mainland—medical devices.http://www.ispor.org/HTARoadMaps/ChinaMD.aspGoogle Scholar]. In addition, in their continuing effort to reform their health care systems, Asia-Pacific countries have recently developed new guidelines on pharmacoeconomic evaluation and/or HTA. These guidelines were not available a few years ago in countries such as China, South Korea, Taiwan, and Thailand. Thailand had even taken a step further by mandating an economic evaluation of a new health technology as part of its reimbursement process and is currently considering economic evaluation as one of the requirements for regulatory approval [11International Society for Pharmacoeconomics and Outcomes ResearchISPOR Pharmacoeconomic Guidelines Around The World.http://www.ispor.org/PEguidelines/index.aspGoogle Scholar, 14Yang B.M. Lee K. Growing application of pharmacoeconomic and outcomes research in health care decision-making in the Asia-Pacific region.Value Health. 2009; 12: S1-S2Abstract Full Text PDF PubMed Scopus (11) Google Scholar, 22International Society for Pharmacoeconomics and Outcomes ResearchThailand—pharmaceutical.http://www.ispor.org/HTARoadMaps/AustraliaMDD.aspGoogle Scholar]. In conclusion, countries throughout the region struggle for an accessible, affordable, and sustainable health care system. To achieve these goals, changes in policies are underway to redefine the existing system and are having a major impact on all health care stakeholders. ISPOR, as a forum for health care information sharing, is continually updating its ISPOR Road Map and ISPOR PE to assist decision makers, researchers, as well as other health care stakeholders to improve health globally.