RISK-SHARING AGREEMENTS (RSA) IN EMERGING MARKETS- IS IT A WAKE-UP CALL OR IS IT INNOVATION TOO LATE?

Author(s)

Subbotina E1, Duttagupta S2, Yong C2, Chowdhury C2
1CBPartners, London, UK, 2CBPartners, New York, NY, USA

OBJECTIVES: Recent years have witnessed emerging market (EM) countries adopting various forms of RSAs in order to manage public financing of innovative pharmaceuticals. South Korea, Taiwan, and Russia have either provided guidance or executed pilot programs in the recent past. This research aimed to analyse existing RSA structures across these countries and identify commonalities and divergences to postulate future of RSAs in EMs. METHODS: A pragmatic review of literature (in English and local language, as appropriate) and government resources on the RSA policies was undertaken for this research. Implementation examples, including completed pilots and proposed disease priorities were also reviewed to identify key differences from the developed markets. Guidance on implementation (South Korea), pilot examples (Taiwan) and legislation and regional diversity (Russia) were analyzed. RESULTS: Common themes for RSAs in EM included evolution of legislative guidance to reflect drug development trends, infrastructure availability, industry engagement and healthcare financing uniformity across the country. In Korea, industry groups and payers have initiated discussions on evolving RSAs to include combination drugs. Financing infrastructure and data governance capabilities will reflect the agreements’ designs, as seen in Taiwan’s pilot programs. Potential restrictions on the orphan drug RSAs in Russia can arise due to the regional financing principles, limited by lack of interlinked data collection across institutions and regions. In the future, maturity of the RSAs will enable linkage to HTA requirements, such as in Korea and Taiwan, while the Russian RSAs being developed in parallel with the local HTA methodology leave uncertainty to the industry regarding their evaluation principles. CONCLUSIONS: Clear legal framework, data privacy, ownership, accessibility and evaluation principles, remain the cornerstone of success likelihood among RSAs in EMs. Several country-specific factors, including existing infrastructure and financing systems will impact the emerging RSAs, and should be taken into account to tailor implementation in any EM.

Conference/Value in Health Info

2017-05, ISPOR 2017, Boston, MA, USA

Value in Health, Vol. 20, No. 5 (May 2017)

Code

PHP286

Topic

Health Policy & Regulatory

Topic Subcategory

Risk-sharing Approaches

Disease

Multiple Diseases

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