Healthcare Payers: A Gate or Translational Bridge to Personalized Medicine?

Abstract

Healthcare payers represent stakeholders who can act as either a bridge or a gate to the translation of personalized medicine into routine clinical practice. To date, the slow realization of the promise of personalized medicine has been partly attributable to the lack of clear evidence supporting the clinical utility of genetic and genomic tests and the lag in development of clinical guidelines for the use and interpretation of tests. These factors, along with a paucity of clear guidance from healthcare payers and clinical experience with genomic tests, serve as impediments to timely and consistent reimbursement decisions. The design of alternative strategies for collaborative evidence-generation, clinical decision support and educational initiatives for healthcare providers, patients and the payers themselves are critical needs to achieve the full benefit of personalized medicine in day-to-day healthcare settings.

Innovative Governance Models for Emerging Technologies

“…19 For molecular diagnostic tests, payers such as CMS have increasingly called for demonstrations of clinical utility to make this showing. 20 Similar to the FDA, CMS has provided little specific guidance about how to demonstrate clinical utility for molecular diagnostics. In the absence of such guidance, test developers must either meet with CMS and local contractors individually or use CMS' past reviews of molecular diagnostic tests to generate a rough prediction about what types of evidence will be required for their tests.…”

Driving Forces Behind the Past and Future Emergence of Personalized Medicine

“…Knowing that a certain genetic alteration drives the proliferation of a disease, a targeted treatment which is particularly effective in the respective patient group can be developed. Also, this knowledge can be used to identify the responders to targeted treatments in advance, save costs and time, and spear patients the side-effects of treatment failures [ 5 , 12 , 13 , 15 ]. The identification of treatment responders, in turn, requires a diagnostic test, which is why today’s personalized medicine can be defined as tandems of therapeutic and diagnostic product [ 13 , 15 ].…”

“…After all, a successful implementation of today’s and future personalized treatments requires an appropriate reimbursement structure. As companion diagnostics represent a novel field, the lack of adequate reimbursement schemes has frequently been criticized [ 5 , 29 ]. The current reimbursement infrastructure in most European countries fails to properly assess the value provided by combinations of drug and diagnostics [ 29 ].…”

“…Recently developed personalized therapies have proven to significantly improve the treatment success in critical fields such as oncology [ 2 , 3 , 4 ]. Diagnostic tests are used to assess whether or not a targeted treatment will be effective in a certain patient so that the overall patient group is stratified into responders and non-responders [ 5 , 6 ]. This is why Collins describes personalized medicine as “dramatic paradigm shift”, because it bridges the gap from the traditional “one size fits all” approach to a test-and-treat strategy [ 7 ].…”

Biospecimens, biomarkers, and burgeoning data: the imperative for more rigorous research standards

“…In an increasingly cost-conscious healthcare environment, regulatory approval of a biomarker will not be a guarantee for reimbursement or clinical adoption. New biomarker tests will need to show that they change clinical practice and reduce cost, either by improving health outcomes or by eliminating expensive treatments of limited efficacy [61][62][63].…”