Virtual Program

Our 2-day virtual summit, to be held 20-21 September, features thought-provoking plenary sessions, topical presentations and discussions, educational symposia and speakers from a diverse array of backgrounds excited to share with you a wealth of ideas, experiences, and perspectives on the latest HEOR topics in Asia Pacific. 

Special Bonus: Registration includes extended access to all session playback recordings through 21 October 2022.

Note: Times shown within the program are in Korean Standard Time (KST). The Summit will be presented in English without translation.

Are International Trials Good Enough to Support the Reimbursement of a New Technology in Asia? When and How?

Speaker(s)

Moderator: Yannan Hu, PhD, Cytel, Shanghai, China
Panelists: Louise Gek Huang Goh, PhD, Agency for Care Effectiveness (ACE), Ministry of Health, Singapore, Singapore; Luis G. Hernandez, PhD MPH MSc, Takeda Pharmaceuticals America, Inc., Westford, MA, USA; Grammati Sarri, PhD, Comparative Effectiveness Research Special Interest Group, London, UK

Presentation Documents

ISSUE:

An increasing number of Asian countries are implementing an HTA model for pricing and reimbursement decisions of new technologies. So far, several challenges emerged in evidence generation such as representation of Asian patients in multinational trials. Previous evidence in personalized medicine (e.g., PD-1/PD-L1) have showed that being Asian might be a potential prognostic factor or treatment effect modifier, contributing to differences in clinical and safety outcomes of technologies. Correspondingly, several Asian HTA bodies show a- priory preference on Asian trial data where available reflecting local populations, or international trials with a significant Asian representation. However, trials cannot always be conducted locally, and the quality and availability of local real-world evidence can be a concern for payers. Furthermore, limiting to the Asian subpopulation from international trials might produce uncertain results due to small sample size. Given this dilemma, what are the perspectives of different stakeholders, local payers in Asia, and manufacturers? When and how, international trials can meet the HTA requirements in Asia?

OVERVIEW:

Understanding when and how Asian representation in clinical trials is needed while managing the evidentiary requirements of multiple market access activities of new technologies is a challenge. The moderator will introduce the topic (5min). Panelists will then present their perspective (15min each); Dr Louise Goh will discuss why HTA bodies show preference on Asian trials or international trials with considerable number of Asian patients. Dr Hernandez will present the challenges (trial design, costs, data quality) faced by manufacturers in terms of ensuring wider (Asian) representation when technology submissions are prepared for several countries. Dr Sarri will discuss the methodological considerations on how to reliably identify if Asian background can affect treatment effect estimates through literature reviews. 10min discussion will follow. Stakeholders (industry, researchers, payers) will benefit.

Code

IP3