The ISPOR Asia Consortium Industry Committee virtual meeting was successfully held on 12 October 2021 with 89 participants. This meeting brought together stakeholders interested in health technology innovation in the Asia Pacific, particularly industry colleagues to connect and learn about new developments around regulation changes in HTA in the European Union, and how these reforms may potentially impact HTA and decision-making in the Asia Pacific region. The meeting was moderated by Dr Sang-Soo Lee, Chair of ISPOR Asia Consortium Industry Committee. The meeting is comprised of three parts including a presentation following by a panel discussion and the final Q & A session.  

 

EU Regulation and Changes in Health Technology Assessment

 

Ms Silke Walleser Autiero, European HTA expert (Principal Reimbursement & Health Economics Analyst of Medtronic, Switzerland) gave a presentation on the recent changes in HTA in Europe. She presented her activities in Medtech Europe HTA working group and shared her insights on the future movement. HTA has been recognized as one of barriers to market access of medicines and some medical technologies in Europe. Once a certain technology has proven its safety, efficacy, and quality, it may need to go through an evaluation of its clinical and economic value compared to existing medical technologies or health interventions before being fully granted to market access.

 

HTAs are carried out at national level and manufacturers need to undergo multiple different evaluation process to access key European Union (EU) markets. This has led to some criticism about duplication of work and delays of the market access. Over the last 10 years, the EU has attempted to harmonize HTA across the region with EUnetHTA. Now, with the view to harmonize HTA processes across the region even more, the European decision-makers (European Parliament, Commission and Council) voted for a European legislation on HTA. The legislation will mandate joint EU-wide clinical assessments of certain medical technologies to support national-level pricing and reimbursement decisions. The focus of the regulation will be on joint clinical assessments, but the health economic evaluation and decision-making will be at country-level. The new law is expected to be in place in 2024.

 

After Silke’s presentation, four distinguished HTA experts in the Asia Pacific region joined the panel discussion: 1) Andrew Wilson (Australia PBAC), 2) Kun Zhao (China CNHDRC, 3) Sukyeong Kim (South Korea NECA), and 4) Takashi Fukuda (Japan National and Institute for Public Health). They talked about the current status of HTA and shared their views and perspectives in the developments of HTA in their countries.

 

There is still a long way to go even within the EU to have a truly shared HTA. One of the important distinctions is that as the technical aspects of effectiveness and safety in comparative effectiveness and safety separated from decisions around the economic value are essentially left to the member states, this is the reason why the EU has been having discussions with various groups. Silke emphasized that a lot of HTA is actually quite difficult to separate some of elements partly because of different healthcare clinical practice and different countries which impact on why people use different types of therapies. It is particularly true in medical technology area because of the different state of development, different healthcare systems and the different funding models within the systems which have fee-for-service arrangements. These leave us thinking about how this new EU HTA regulation impact to Asia Pacific and how we can do better by learning from EU experience.

 

Being asked about Japan’s current situation and what Japan can adopt, Dr. Fukuda commented that after starting HTA in 2019, 16 out of 25 products have been subjected to evaluation. As one product takes about 1.5 years to 2 years to evaluate, and Japan released 5 evaluation results so far. However, he highlighted that the way Japan uses the result is slightly different from other countries as Japan does not use HTA results for coverage decisions. In other words, even if a product is found not to be cost effective in the assessment study, the government will not de-list the product. The HTA result is used for the price adjustment, usually lowering the reimbursement price. He agreed that it seems very reasonable to share the results of clinical assessment because many other countries also conduct systematic review of the clinical evidence as such process is common to others.

 

Introduction of ISPOR Latin America Industry Committee’s Initiatives & Projects

 

Dr Homero Monsanto, Chair of the ISPOR Latin America Industry Committee, provided an overview of the initiatives supported by the committee which fall into four workstreams: 1) Value of Health Technologies, 2) Real-World Evidence (RWE), 3) Education, and 4) Communication. The committee has conducted and published an analysis of value assessment frameworks in the region and continues to work on the use of RWE for healthcare decision making in the region. Informal surveys among committee members have identified some hot topics for education and discussion, being HTA/Reimbursement evolution and priorities for assessment in a Value Based Healthcare environment, Value-based alternative payment models focused on innovative contracting, risk-sharing agreements or performance-based contracting models, and the impact of COVID-19 in healthcare system in the region, the most frequently mentioned. Finally, Dr Monsanto provided a summary of the committee’s participation in the Virtual ISPOR Latin America Summit 2021 held virtually on September 30 and October 1, 2021 with two panels, one on RWE and another one on value-based healthcare in Latin America.

 

To learn more and to join ISPOR Asia Consortium Industry Committee, please contact us here.