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• W2586919660 abstract "6133 Background: FISH or IHC tests are commonly used to assess HER2 status: patients whose tumors are IHC 0, IHC 1+ or FISH negative are typically not retested to assess HER2 overexpression. Recent evidence shows that adjuvant patients can have tumors that are HER2+ by one test and HER2- by the 2nd and still benefit from treatment with trastuzumab (T). Also, the product label for T recommends not relying on a single test to assess HER2 status. This analysis evaluates the likely cost-effectiveness of assessing HER2 status in women with early stage breast cancer by implementing a strategy of expanded reflex testing. Methods: We developed a decision-analytic model to assess the incremental cost-effectiveness ratio (ICER) of reflex testing strategies from a US payer perspective. Expanded reflex testing is defined as retesting patients whose tumors are IHC0, IHC1+ or FISH negative on their first test. In the base case, it was assumed that 80% of patient tumors are initially IHC-tested, and 20% FISH-tested. Estimated testing outcomes for IHC and FISH with and without retesting were based on published meta-analyses. Key inputs from the literature included: cost of tests—IHC ($89) and FISH ($482); cost of T treatment ($45,000); life years gained (1.84); and quality-adjusted life years (QALYs) gained with adjuvant T (1.70). In the base case, we estimated that 3.1% of the women who received expanded reflex testing would be found to be HER2 positive and receive T treatment. Sensitivity analysis varied this between 1% and 8%. Results: In the base case, the projected ICER is $34,000/QALY. This varied from $50,000 to $29,000, if we assumed 1% to 8% of patients retested were then HER2+, respectively. This strategy would result in 2,000-17,000 additional women receiving T annually. Conclusions: The cost-effectiveness ratio for expanded reflex testing is below commonly cited thresholds for cost-effectiveness even if only 3% of the retested population were classified HER2+ on retesting. This improves as the proportion of patients who are classified as HER2+ upon retesting increases. Retesting patients who are IHC0, IHC1+ with FISH or those FISH negative with IHC is projected to be a cost-effective clinical strategy." @default.
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• W2586919660 date "2011-05-20" @default.
• W2586919660 modified "2023-09-27" @default.
• W2586919660 title "Assessing the potential cost-effectiveness of retesting IHC0, IHC1-positive, or FISH-negative early-stage breast cancer patients for HER2 status." @default.
• W2586919660 doi "https://doi.org/10.1200/jco.2011.29.15_suppl.6133" @default.
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