Asian pharma markets have been in the limelight for some time now for increasingly dynamic drug policies, expanding coverage, increasing affordability and potential economies of scale. While Indonesia and the Philippines are striving towards universal healthcare coverage, South Korea and Taiwan are focusing on managed entry agreements. China is not behind in the race with the expansion of Health Technology Assessment (HTA) in healthcare policy-making.
Since its introduction in the early 1980s, China’s HTA development has evolved through various stages for integration into existing healthcare policies. The establishment of the China National Health Development Research Center (CNHDRC), a government-led health research body, in 2008 laid the foundation for HTA action in the country. The CNHDRC plays an essential role in establishing HTA framework and processes. It is responsible for promotion, development, implementation, and monitoring of HTA. The China HTA network, comprising 34 universities, hospitals and providers, research centers and industry associations and societies, was also launched to incorporate industry expertise in developing methodologies for HTA.
In 2010, the CNHDRC collaborated with National Institute for Health and Care Excellence (NICE), UK, to gain insights and leverage their extensive experience to streamline institutionalization of HTA. China also played an integral part of a multi-country initiative called HTAsiaLink, which included countries like Japan, Korea, Malaysia, Thailand, Philippines, Taiwan, and Singapore. For China, the focus was on capacity-building, multi-stakeholder engagement, changes to IT infrastructure, and payment reform within pilot hospitals. Following strategic recommendations from various agencies, the years 2013 through 2016 saw the development of national HTA guidelines and establishment of the National Center for Drug and Technology Assessment in 2018 under CNHDRC. The objective was to effectively prioritize evidence-based decision-making and optimize resource utilization.
Keeping in mind China’s focus on cost-containment and providing sustainable healthcare services owing to its large patient population, HTA in China has gradually evolved and currently focuses on centers on drug safety, clinical- and cost-effectiveness, budget impact, innovation, and accessibility. Meeting clinical need, application and affordability are the key indicators of drug appropriateness. As of today, the National Health and Family Planning Commission (NHFPC) has commissioned HTA projects for non-small cell lung cancer, hepatitis C and hepatitis B drugs. Stem cell and immune cell therapies along with pneumococcal and human papillomavirus vaccines have also been the subjects of assessments. Pricing negotiations have followed conclusion of these reviews. The agency is thus likely to continue to focus on drugs meeting high disease burdens and unmet needs with a large impact on healthcare services. However, the details with regards to HTA dossiers and requirements are not yet clear.
In 2019, the CNHRDC led the incorporation of real-world data (RWD) in assessments, beginning to define the national opinion of HTA in the real-world setting. Not only HTA but even drug policy reforms would witness the incorporation of RWD for a holistic approach. Drug safety monitoring, survival rate, prescription costs, and surveillance data would feed the different aspects of drug assessment while data from insurance, procurement, and prescription would drive drug pricing, reimbursement or procurement policy evaluations. HTA in the real-world setting would either be government-led or based on clinical or social needs while adhering to scientific methods and quality control. Many long-standing global HTA agencies have struggled with the inclusion of real-world evidence in terms of physician and patient input or incorporating pre- and post-marketing data in their evaluations. The CNHDRC’s decision to integrate RWD at the initial stages shows commitment, ability to learn, and intention to stay relevant in this dynamic area.
China is progressively moving towards universal health coverage with a priority-setting healthcare model. Developing technical expertise and building capacity would pave the way for absolute integration of HTA with standard drug reimbursement processes. Consistent with the Chinese government’s One Belt One Road strategy to connect China with Europe, Asia, Africa and Mediterranean countries in terms of infrastructure and knowledge, this would serve the evidence needs of 33 provinces within China and provide support to nearby countries.
Chinese national policies including the China Basic Health Law, which underlines the fundamental and comprehensive regulations on affordable basic medical and health care, are increasingly highlighting the functionalities and significance of HTA. The exchange of clinical pathways, topic selection, evidence appraisal as well as the implementation of evidence-informed decisions, impact assessment, and uptake monitoring indicates a substantial influence of NICE guidelines on initial Chinese HTA assessments. With political support and international expertise, China is on the right track to establishing a seasoned HTA system in place. However, the lack of standardized methods and approaches for conducting HTA. Also, limited awareness on the use of pharmacoeconomic data as supportive evidence may pose challenges among manufacturers or hospital formularies. The actual integration into drug development practices has only just begun and may become a mandate in the distant future based on the extent of push from the government.
For further detail, stay tuned for the DRG GMAS team’s forthcoming Executive Briefing on the Future of Pricing and Reimbursement in Asian Markets.
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