7 June 2024

Press Release

EFPIA Japan

Building Sustainable Pharmaceutical Innovation Ecosystems throughEffective Health Technology Assessment (HTA) Review in Japan:
EFPIA Japan Publishes Latest Position Papers
Tokyo－7 June 2024－The European Federation of Pharmaceutical Industries and Associations Japan(EFPIA Japan; Chair: Takahiko Iwaya) today published its latest position papers for “BuildingSustainable Pharmaceutical Innovation Ecosystems through Effective Health Technology Assessment(HTA) Review in Japan”. The association’s up-to-date policy recommendations are now available atefpia.jp.

Background
EFPIA Japan made policy recommendations on the Cost Effectiveness Assessment system before it wasintroduced on a trial basis, in a viewpoint titled "Health Technology Assessment Application in SelectedMarkets and Implications for Japan ~ Putting the patient at the center of healthcare decision ~ " (2015).
Since then, as the system was formally introduced and developed, EFPIA Japan has been making its view
public and continues to ask for the improvement of the system.
Although the transparency of the Cost Effectiveness Assessment system is on the increase through therevision made in 2024, issues still remain with the operation of the system and scientific validity in a seriesof analysis and evaluation processes. In the latest viewpoint released this time, EFPIA Japan makes policy
recommendations for the optimization of the current system in Japan.

EFPIA JapanTokyo Opera City Tower, 3-20-2 Nishi Shinjuku, Shinjuku-ku, Tokyo 163-1488, Japan

OverviewSince its official implementation in 2019, the Cost Effectiveness Assessment system has rapidly
been evolving with biennial updates enhancing its robustness. Although the latest revisions in 2024
have advanced the system’s transparency, the system still faces several challenges such as
untransparent processes, unclear selection criteria for products subject to the assessment,
incomplete scientific basis for cost-effectiveness determination, potential lack of incentives forinnovation due to the expansion of price adjustment range, and limited involvement of patient
stakeholders in the processes. As such, further optimisation is warranted. EFPIA Japan believes
that:

The Cost Effectiveness Assessment system can be improved by developing a patient-centricsystem, encouraging regular payer-industry dialogue, and increasing stakeholder engagement to agreater extent through public-private-academia partnerships.

Further optimisation of the system has the potential to drive long-term innovation by balancing
patient, payer, and industry interests in a sustainable manner.

EFPIA Japan as a policy partner continues to have dialogues with multiple stakeholders to establish a drug
pricing system where diverse values of medicines are properly reflected.
About EFPIA Japan (http://efpia.jp/)
Established in April 2002, EFPIA Japan represents 23 R&D-based European pharmaceutical companies
operating in Japan. In 2022, combined sales from the member companies accounted for roughly 31% of thepharmaceutical market in Japan. The mission of EFPIA Japan is to “Contribute to healthcare and patients inJapan through the early introduction of innovative medicines and vaccines”. EFPIA Japan aims to strengthen
dialogue with decision-makers in order to improve Japanese healthcare for all.
About EFPIA (European Federation of Pharmaceutical Industries and Associations) (http://www.efpia.eu)

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents thebiopharmaceutical industry operating in Europe. Through its direct membership of 37 national associations,
40 leading pharmaceutical companies, and a growing number of small and medium sized enterprises (SMEs),
EFPIA’s mission is to create a collaborative environment that enables our members to innovate, discover,develop, and deliver new therapies and vaccines for people across Europe, as well as contribute to theEuropean economy.
Contact:Yukie Shimono
EFPIA Japan Communications Committee
Tokyo Opera City Tower, 3-20-2 Nishi Shinjuku, Shinjuku-ku, Tokyo 163-1488, Japan
Sanofi K.K.
Tel: 090-2736-8171
Email: yukie.shimono@sanofi.com

EFPIA JapanTokyo Opera City Tower, 3-20-2 Nishi Shinjuku, Shinjuku-ku, Tokyo 163-1488, Japan