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.
Highlights
High variability in alleles of human genes coupled with the heterogeneity of disease patterns signify the uniqueness of each and every pathological case requiring a more targeted approach to treatment.At present, it is evident that 90% of all conventional remedies are not efficacious in 50%–70% of cases, and in the areas of oncology and neuroscience, approximately 25%–62% of patients fail to respond to standard therapeutics [1,2]
Based on evaluated divergences in the interpretation and application of the IVD Directive 98/79/CE, the European Commission initiated a fundamental revision of the regulatory framework for in-vitro diagnostics, necessary to ensure a high level of human health and safety, facilitate competitiveness of the IVD industry, promote innovation and allow rapid cost-effective market access for innovative Dx [15]
Patient stratification is an important aspect where appropriate companion diagnostics can offer substantial value by guiding therapies towards those patients who are likely to obtain maximal health benefits and reduced side effects, and costs for those patients who are not likely to benefit from these therapies
Summary
High variability in alleles of human genes coupled with the heterogeneity of disease patterns signify the uniqueness of each and every pathological case requiring a more targeted approach to treatment. In 2013, the European CDx market accounted for less than 5% of the total in-vitro diagnostics (IVD) market (EUR 10.5 billion) and less than 0.04% of the total spending on healthcare in Europe [4] Such a small market share is directly correlated to the novelty of the “therapy-test” concept, and to an underdeveloped reimbursement policy, absence of value-based public sector pricing, clinical trial challenges, cumbersome and dissonant approval guidelines, low public awareness on “Rx-CDx” combinations etc. To realize the potential of “therapy-test” pairings, companies have to revise their market access strategies, creating value for all stakeholders at various institutional levels (patients, physicians, payers, policy makers etc.) This requires thorough understanding of stakeholders’ needs and careful study of critical points in the “therapy-test” product lifecycle with an ultimate goal—to accelerate patients’ access to quality “Rx-CDx” pairings without any reimbursement delays and additional costs. This study aims at understanding the major advancements and challenges associated with “Drug-Diagnostic” pairings, which facilitate or impede the access to stratified medicine
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