Market Access Advancements and Challenges in "Drug-Companion Diagnostic Test" Co-Development in Europe

Abstract

The pharma ecosphere is witnessing a measured transformation from the one-size-fits-all or blockbuster model of drugs to more informed and tailored personalized treatments that facilitate higher safety and efficacy for a relevant sub-population. However, with several breakthroughs still in a nascent stage, market access becomes a crucial factor for commercial success, especially when it comes to co-creating value for pertinent stakeholders. This article highlights diverse issues from stakeholder perspectives in Europe, specifically the ones which require immediate resolution. Furthermore, the article also discusses case studies articulating potential solutions for the issues discussed.

Keywords: Stratified medicine; companion diagnostics; cost-effectiveness; market access; value addition.

Figure 1

Perfect “Rx-CDx” co-development scenario in the context of market access. Adapted from Kostas et al [6].

Figure 2

Growth in health expenditure per capita in select European markets, 2000–2012 (USD PPP). This figure shows an increase in healthcare expenditure per capita (in USD, purchasing power parity) between 2000 and 2012. The growth in healthcare spending signifies the financial pressure on state budgets and a need for novel cost-effective therapeutic solutions [18].

Figure 3

This highlights key differences in reimbursement policy approaches for oncology diagnostics and therapeutics. In most of European countries, the coverage for Dx tests occurs at the local and regional levels, while Rx is primarily reimbursed at the national level (except Austria). Such discrepancy creates additional challenges for “therapy-test” producers, as they have to approach miscellaneous payers using different clinical benefit and cost-effectiveness data sets. Adapted from [2,5].