Real-world economic value of a 21-gene assay in early-stage breast cancer

Am J Manag Care. 2017 Dec 1;23(12):e416-e420.


Objectives: Value-based payment reforms shift cost-containment responsibilities to the physician. Although gene expression profiling (GEP) utilizing a 21-gene panel among patients with early-stage, axillary lymph node-negative, hormone receptor-positive, HER2/neu oncogene-negative breast cancer is able to identify a cohort that may achieve excellent outcomes without adjuvant chemotherapy, high up-front costs (list price, $4175) could dissuade usage.

Study design: Retrospective review of consecutive patients with breast cancer treated at a single cancer center.

Methods: Chart review of 227 patients 70 years or younger with outpatient costs (ie, drug average sales price, reagent costs, physician charges) during first 6 months of treatment.

Results: Of these patients, 68% underwent GEP, with 52%, 43%, and 5% having low, intermediate, and high recurrence risk scores, respectively. Adjuvant chemotherapy was utilized less in genomically profiled cohorts (19% vs 29%; P = .08) and was consistent with recommendations of the recurrence scores. The mean 6-month outpatient costs were $24,955 with adjuvant chemotherapy and $2654 with hormonal therapy. Patients with stage II cancer undergoing GEP received adjuvant chemotherapy at a lower frequency (28.6% vs 86.7%), but patients with stage I cancer who underwent testing were slightly more likely to receive chemotherapy (15.8% vs 14%) because the test identified patients with higher-risk tumors. Universal GEP testing of patients with stage II cancer would have resulted in net savings of $11,494 per patient inclusive of test cost; stage I testing would have increased costs by $4505. Similar trends for grade 2/3 tumors (-$2394) and grade 1 tumors (+$6047) were noted.

Conclusions: Universal GEP testing of women 70 years or younger with stage II or grade 2/3 lymph node-negative breast cancers would result in lower outpatient costs, inclusive of the diagnostic test, within the first 6-month episode of care.

MeSH terms

  • Breast Neoplasms / economics*
  • Breast Neoplasms / genetics
  • Chemotherapy, Adjuvant / economics
  • Female
  • Gene Expression Profiling / economics*
  • Gene Expression Profiling / methods
  • Genetic Testing / economics*
  • Genetic Testing / methods
  • Humans
  • Male
  • Neoplasm Staging
  • Receptor, ErbB-2 / genetics
  • Retrospective Studies


  • ERBB2 protein, human
  • Receptor, ErbB-2