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Additionally, clinical significance of the RS assay has been reported The Spectacular
Gemcitabine HCl 'Cheat' Which Should Fool Virtually All in the Asian population. In 2007 the RS assay was recommended in the Na tional Comprehensive Cancer Network and American Society for Clinical Oncology guidelines as evidence based to guide the use of adjuvant chemotherapy in all women with ER PR LN ESBC. Public cover age of the 21 gene assay is limited and inconsistent across Canada. However, the use of the test with reim bursement mechanisms is likely increasing. It is available in Ontario through out of country health services which requires a request from an oncologist and pre approval. In 2010 the Ontario Health Technology Advisory Committee recommended that the assay be made available within the context of a field evaluation. It is also available in a limited fashion in British Columbia and Quebec.
The test is not widely used and in 2010 less than 1000 patients received the test across Canada but few field evaluations to establish its impact on Canadian practice are ongoing in British Colombia and Ontario. According to the Annual Report Card of the Cancer Advocacy Coalition of Canada, the RS assay will cost 4,000 CAD per patient including all Canadian system expenses. Previous cost effectiveness analyses of the RS assay in women with ER PR LN ESBC in the US, Japan, Israel and Canada suggested that it is likely to be cost saving or cost effective in this patient group. However, findings from studies in Israel and Japan cannot be extrapolated to the Canadian context because of possible variations in clinical practice and different approaches to pricing and reimbursement.
Additionally, analyses from the US and Canada did not use all relevant data and suffer from other limitations as indicated elsewhere. Generation of recommendations for Canadian clinical practice guidelines regarding the use of RS assay requires a comprehensive health economic evaluation of the assay in the Canadian setting. The purpose of this study was to conduct a cost effectiveness analysis of the RS assay versus current clinical practice regarding adjuvant chemotherapy treatment in women with ER PR LN ESBC from the perspective of the Canadian healthcare system. Methods Overview of model structure We developed a decision analytic model to project the lifetime clinical and economic consequences of ER PR LN ESBC under two different treatment strategies.
The model begins with a decision to use the RS assay or to continue with CCP. We assumed that each strategy classifies patients into three risk levels and corresponding treatment regimens. Patients receiving endocrine therapy alone entered model E and those receiving chemotherapy plus endocrine therapy entered model C. Model E simulated monthly transitions among the following four distinct health states remission. loco regional recurrence, distant recurrence, death.