What, Where, and How to Collect Real-World Data and Generate Real-World Evidence to Support Drug Reimbursement Decision-Making in Asia: A reflection Into the Past and A Way Forward.

BACKGROUND: Globally, there is increasing interest in the use of real-world data (RWD) and real-world evidence (RWE) to inform health technology assessment (HTA) and reimbursement decision-making. Using current practices and case studies shared by eleven health systems in Asia, a non-binding guidance that seeks to align practices for generating and using RWD/RWE for decision-making in Asia was developed by the REAL World Data In ASia for HEalth Technology Assessment in Reimbursement (REALISE) Working Group, addressing a current gap and needs among HTA users and generators. METHODS: The guidance document was developed over two face-to-face workshops, in addition to an online survey, a face-to-face interview and pragmatic search of literature. The specific focus was on what, where and how to collect RWD/ RWE. RESULTS: All 11 REALISE member jurisdictions participated in the online survey and the first in-person workshop, 10 participated in the second in-person workshop, and 8 participated in the in-depth face-to-face interviews. The guidance document was iteratively reviewed by all working group members and the International Advisory Panel. There was substantial variation in: (a) sources and types of RWD being used in HTA, and (b) the relative importance and prioritization of RWE being used for policy-making. A list of national-level databases and other sources of RWD available in each country was compiled. A list of useful guidance on data collection, quality assurance and study design were also compiled. CONCLUSION: The REALISE guidance document serves to align the collection of better quality RWD and generation of reliable RWE to ultimately inform HTA in Asia.

Real-world data for health technology assessment for reimbursement decisions in Asia: current landscape and a way forward.

There is growing interest globally in using real-world data (RWD) and real-world evidence (RWE) for health technology assessment (HTA). Optimal collection, analysis, and use of RWD/RWE to inform HTA requires a conceptual framework to standardize processes and ensure consistency. However, such framework is currently lacking in Asia, a region that is likely to benefit from RWD/RWE for at least two reasons. First, there is often limited Asian representation in clinical trials unless specifically conducted in Asian populations, and RWD may help to fill the evidence gap. Second, in a few Asian health systems, reimbursement decisions are not made at market entry; thus, allowing RWD/RWE to be collected to give more certainty about the effectiveness of technologies in the local setting and inform their appropriate use. Furthermore, an alignment of RWD/RWE policies across Asia would equip decision makers with context-relevant evidence, and improve timely patient access to new technologies. Using data collected from eleven health systems in Asia, this paper provides a review of the current landscape of RWD/RWE in Asia to inform HTA and explores a way forward to align policies within the region. This paper concludes with a proposal to establish an international collaboration among academics and HTA agencies in the region: the REAL World Data In ASia for HEalth Technology Assessment in Reimbursement (REALISE) working group, which seeks to develop a non-binding guidance document on the use of RWD/RWE to inform HTA for decision making in Asia.

Economic evaluation of rotavirus vaccination in children of Bhutan.

BACKGROUND: Diarrhoea remains one of the top ten causes of under-five child morbidity in Bhutan, and rotavirus is a significant cause of child diarrhoeal hospitalisations. This study sought to determine the health outcomes, cost-effectiveness, and budget and human resource implications of introducing rotavirus vaccines in the routine immunisation program to inform Bhutan's decision-making process. METHODS: We used UNIVAC model (version 1.3.41) to evaluate the cost-effectiveness of a rotavirus vaccination programme compared with no vaccination from a government perspective. We also projected the impact of rotavirus vaccination on human resources and budget. Acost-effectiveness threshold was determined to be 0.5 times the gross domestic product (GDP) per capita (equivalent to the United States dollar ($) 1,537) per Disability-Adjusted Life-Year (DALY) averted.One-way deterministic and probabilistic sensitivity analyses, and threshold analyses were performed to capture parameter uncertainties. RESULTS: In Bhutan, a rotavirus vaccination programme over 10 years (2020 to 2029) can avert between 104 and 115 DALYs, at an incremental cost ranging from $322,000 to $1,332,000. The incremental cost-effectiveness ratio (ICER) across four vaccination programmes compared to no vaccination scenario were $9,267, $11,606, $3,201, and $2,803 per DALY averted for ROTARIX, RotaTeq, ROTAVAC, and ROTASIIL, respectively. The net five-year budget impact of introducing a rotavirus vaccination programme ranged from $0.20 to $0.81 million. The rotavirus vaccination programme has a potential to reduce the workload of health care workers such as paediatricians, nurses, dieticians, and pharmacists; however, the programme would require an additional 1.93-2.88 full-time equivalent of health assistants. CONCLUSION: At the current cost-effectiveness threshold, routine rotavirus vaccination in Bhutan is unlikely to be cost-effective with any of the currently available vaccines. However, routine vaccination with ROTASIIL was under the cost-effectiveness threshold of one times the GDP per capita ($3,074). ROTASIIL and ROTAVAC would provide the best value for money in Bhutan.