NCCN Molecular Testing White Paper: Effectiveness, Efficiency, and Reimbursement

Abstract

Personalized medicine in oncology is maturing and evolving rapidly, and the use of molecular biomarkers in clinical decision-making is growing. This raises important issues regarding the safe, effective, and efficient deployment of molecular tests to guide appropriate care, specifically regarding laboratory-developed tests and companion diagnostics. In May 2011, NCCN assembled a work group composed of thought leaders from NCCN Member Institutions and other organizations to identify challenges and provide guidance regarding molecular testing in oncology and its corresponding utility from clinical, scientific, and coverage policy standpoints. The NCCN Molecular Testing Work Group identified challenges surrounding molecular testing, including health care provider knowledge, determining clinical utility, coding and billing for molecular tests, maintaining clinical and analytic validity of molecular tests, efficient use of specimens, and building clinical evidence.

A National Study of Breast and Colorectal Cancer Patients‘ Decision-Making for Novel Personalized Medicine Genomic Diagnostics

“…n Relevance of our findings for health policy & clinical practice Overall, our findings provide quantitative evidence and insight to physicians, other healthcare providers and to policy-makers on the priorities of breast and colorectal cancer patients, and their decision-making regarding the use and adoption of novel personalized molecular genomic diagnostics, along with a useful financial measure of relative value. These results can inform clinical practice about specific molecular genomic diagnostics and policy discussions about issues related to the development of further molecular diagnostics and reimbursement strategies [37][38][39]. Furthermore, our data challenges the assumption, not infrequently observed in other more general studies of patient preferences and attitudes, that patients do not care about technical aspects of treatments [40][41][42].…”

Comparison of prognostic values between combined immunohistochemical score of estrogen receptor, progesterone receptor, human epidermal growth factor receptor 2, Ki-67 and the corresponding gene expression score in breast cancer

“…The Oncotype DX employs realtime quantitative PCR (RT-qPCR) on formalin-fixed paraffin-embedded specimens, and gene-expression assays such as these are now being emphasized as an important tool for clinical decision making and are recommended by major guidelines. 9,10 Additionally, recent reports have increasingly revealed details about this gene expression profiling tool, for example, that HER2 assessment by Oncotype DX leads to a higher number of cases considered as equivocal, 11 whereas its excellent concordance between ER, PgR and HER2 assessments and immunohistochemical analysis has been reported. 12,13 On the other hand, Oncotype DX also includes analysis of gene expression levels of the genes used in the 'IHC4 score'; nevertheless its head-to-head comparison with four immunohistochemical panels is not clear.…”

Best practices for companion diagnostic and therapeutic development: translating between the stakeholders

“…Considerations around the market, the collection sites, the 'know-how' and resources of the clinical setting in geographic areas of interest, support clinical utility concerns and also impact commercial success. They also support clinical adoption by physicians, payors and patients and possibly with obtaining reimbursement [29][30][31][32][33][34][35][36].…”