Abstract
The scope and ambitions of biomedical institutions worldwide currently working toward the integration of personalized medicine (PM) require recognizing the potential profound impact on regulatory standards and on the economic functioning and financing of healthcare. Against this background, researchers and policymakers must manage the arising challenges for the healthcare systems. In this paper we study the literature related to the consequences of PM on health insurance and care systems. Using the PRISMA research protocol, we search the existing body of literature and analyze publications dealing with insurance (419 papers) in the field of PM. After a detailed reading of the 52 studies included in our analysis, we synthesize challenges in three fields that must be addressed to avoid hindering the implantation of PM. The key issues that we highlight concern (1) a lack of clear and consistent data on the economic relevance of PM, (2) a value-oriented and cost-efficient definition of reimbursement thresholds, (3) the implementation of PM in the prevailing healthcare system. In the meantime, we provide several solutions to these concerns; we present (a) risk-sharing contracts that can deal with the emerging coverage challenges, (b) criteria that could constitute future reimbursement thresholds and (c) examples of successful implementations of PM into healthcare systems. Our findings are relevant for policymakers and health insurance companies for redefining the guidelines for the healthcare schemes of the future.
Highlights
Personalized, stratified, precision or genomic medicine bear the same logic: a particular problem requires a tailored solution, i.e., a specific genetic mutation leading to a health condition should be treated with a specific drug
The top-down approach consists of establishing standards for the health technology assessment (HTA) at a national or international level
They suggest that the so-called multiple criteria decision analysis (MCDA) should incorporate parameters related to “value creation” complementing the efficacy and effectiveness criteria of a technology
Summary
Personalized, stratified, precision or genomic medicine bear the same logic: a particular problem requires a tailored solution, i.e., a specific genetic mutation leading to a health condition should be treated with a specific drug. Financial cover for personalized drugs and genetic sequencing is, yet unestablished with the institutional payers that are in the scope of our study Such payers are typically the government when regarding health insurance in terms of social insurance or the private insurers when looking at private health insurance coverage. Most often we lack commonly accepted figures on clinical utility and cost-efficiency of PM This renders insurers rather skeptical (Cohen et al 2013; Trosman et al 2015; Messner et al 2016) and keeping policymakers from listing such drugs and treatments in the catalog of what social security and social health insurance cover. One key challenge is to provide a means to generate data and knowledge while limiting costs In this systematic literature review, we analyze the different challenges for integrating PM into healthcare systems from the payers’ perspective. In Appendix A we provide a comprehensive synopsis of the reviewed papers
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