Economic Evaluation of Pharmacogenomics: A Value-Based Approach to Pragmatic Decision Making in the Face of Complexity

Abstract

Evidence of the value of pharmacogenomic testing is needed to inform policymakers and clinicians for decision making related to adoption and coverage, and to facilitate prioritization for research and development. Pharmacogenomics has an important role in creating a more efficient healthcare system, and this article addresses how economic evaluation can strategically target evidence gaps for public health priorities with examples from pharmacogenomic medicine. This article begins with a review of the need for and use of economic evaluations in value-based decision making for pharmacogenomic testing. Three important gaps are described with examples demonstrating how they can be addressed: (1) projected impact of hypothetical new technology, (2) pre-implementation assessment of a specific technology, and (3) post-implementation assessment from relevant analytical stakeholder perspectives. Additional needs, challenges and approaches specific to pharmacogenomic economic evaluation in the developing world are also identified. These pragmatic approaches can provide much needed evidence to support real-world value-based decision making for pharmacogenomic-based screening and treatment strategies.

Global implementation of genomic medicine: We are not alone

“…By integrating economic assessments into translational research not only can the utility of genomic interventions be determined, but the relative value of such interventions can be assessed to inform health care decision-makers. Expanding single-country studies of cost-effectiveness to multiple health care systems may help identify key underpinning structural components that promote favorable cost-benefit ratios [80]. Multi-national collaborations will be particularly valuable for examining different systems and models, such as those with one or a few centralized payers that can provide a more unified and systematic examination of the decision-making process.…”

The Genomic Medicine Alliance: A Global Effort to Facilitate the Introduction of Genomics into Healthcare in Developing Nations

“…The real cost-effectiveness of involving genomics in medicine is as yet unknown apart from some rather limited studies in pharmacogenomics and hereditary cancer syndromes. Although it is vital to perform cost-effectiveness analyses for the implementation of genomic medicine in developing countries, there are only a handful of such studies reported in the literature [Snyder et al, 2014]. Realizing cost-effectiveness would be a crucial step towards convincing policy makers of the utility of genomics in healthcare as a means to reduce the overall treatment costs, as well as to reduce the overall burden and minimize consequences of disease at the national level [Payne and Shabaruddin, 2010].…”

Test Pricing and Reimbursement in Genomic Medicine: Towards a General Strategy

“…This is further highlighted by the fact that many interviewed expert stakeholders disagreed about the role of clinicians [4]. Some stakeholders reported that clinicians are most reluctant to adopt companion diagnostics even when funding is guaranteed, whereas others reported that clinicians' adoption is not a barrier to access at all [39]. Whichever, close links between pathologists and clinicians help to increase clinicians' awareness about the kind of tests available and how these are appropriately used and interpreted.…”