Assessing the potential cost-effectiveness of retesting IHC0, IHC1+, or FISH-negative early stage breast cancer patients for HER2 status

Louis P. Garrison, Deepa Lalla, Melissa Brammer, Joseph B. Babigumira, Bruce Wang, Edith A. Perez

Research output: Contribution to journalArticlepeer-review

23 Scopus citations


Background Fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC) tests are commonly used to assess human epidermal growth factor 2 (HER2) status of tumors in patients with breast cancer. This analysis evaluates the likely cost-effectiveness of expanded retesting to assess HER2 tumor status in women with early stage breast cancer. Methods We developed a decision-analytic model to estimate the incremental cost-effectiveness ratio (ICER) of expanded reflex testing from a US payer perspective. Expanded reflex testing is defined as retesting tumor specimens from patients whose tumors are IHC0, IHC1+, or FISH-negative on their first test. In the base case, we assumed that 80% of patient tumors are initially IHC-tested and 20% are FISH-tested. Testing outcomes for IHC and FISH with and without retesting were based on published meta-analyses. The cost of tests and treatment and the long-term health outcomes were obtained from the literature. Results In the base case, we estimated that 2.27% of women who received expanded reflex testing would be HER2-positive and receive trastuzumab treatment: the projected ICER was $36,721 per life year or $39,745 per quality-adjusted life year (QALY). This varied between $47,100 per QALY and $35,500 per QALY if we assumed that 1%-8% of patients retested were then HER2+, respectively. The results of deterministic and probabilistic sensitivity analysis were robust. This strategy would result in 4700 (2000-17,000) patients being eligible to receive trastuzumab treatment annually. Conclusions Retesting patients who are IHC0, IHC1+, or FISH-negative is projected to be a cost-effective clinical strategy.

Original languageEnglish (US)
Pages (from-to)3113-3122
Number of pages10
Issue number17
StatePublished - Sep 1 2013


  • HER2
  • HER2 testing
  • Herceptin
  • adjuvant
  • cost-effectiveness
  • cost-utility
  • early breast cancer
  • economics
  • pharmacoeconomics
  • trastuzumab

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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