OBJECTIVES

: To establish the key differences in assessment and evidence requirements between Asia, US, and Europe for new drugs. To highlight the implications of these for global drug development and commercialization with particular focus on the drivers of pricing, access, positioning, and uptake.

METHODS

: A high level meta-analysis was conducted across relevant studies (n=32) undertaken by GfK since January 2015 involving the assessment (pricing, HTA, access, reimbursement, positioning, and uptake) of new drugs in Asia, US, and Europe. Primary focus was on decision criteria, evidence requirements, inter- and intra- country reference pricing, affordability and willingness to pay issues. The studies involved secondary and primary research, modelling, and competitive simulation. The forces of supplier and buyer power, impact of new entrants, impact of substitutes, and competitive rivalry were also considered.

RESULTS

: The analysis identified significant areas of commonality and difference in pricing and market access assessment between Asia, US and Europe. 6 payer archetypes were shown to cover all 3 regions. Commonalities and differences in evidence requirements by payer archetype were identified. Assessment systems are evolving in terms of sophistication and evidence source - from Randomized Controlled Trials (RCTs) towards the increasing importance and weight of Real-World Evidence (RWE). There is an increasing amount of price referencing between countries/regions. There is an increasing role of the “patient as payer” in some countries driven by the increasing cost of healthcare in turn driven by innovation. Affordability and patient willingness/ability to pay was shown to be a barrier to product uptake. In contrast, in some countries policies are being introduced promoting change and growth in nationally funded healthcare systems.

CONCLUSIONS: Evidence requirements and evidence sources are evolving rapidly. Differentiation, relative effective net pricing, and multi-criteria decision-making are, and will remain, important factors in pricing, access, positioning, and uptake.