Using the 21-gene assay to guide adjuvant chemotherapy decision-making in early-stage breast cancer: a cost-effectiveness evaluation in the German setting

Abstract

Objective:

The 21-gene assay (Oncotype DX Breast Cancer Test (Genomic Health Inc., Redwood City, CA)) is a well validated test that predicts the likelihood of adjuvant chemotherapy benefit and the 10-year risk of distant recurrence in patients with ER+, HER2− early-stage breast cancer. The aim of this analysis was to evaluate the cost-effectiveness of using the assay to inform adjuvant chemotherapy decisions in Germany.

Methods:

A Markov model was developed to make long-term projections of distant recurrence, survival, quality-adjusted life expectancy, and direct costs for patients with ER+, HER2−, node-negative, or up to 3 node-positive early-stage breast cancer. Scenarios using conventional diagnostic procedures or the 21-gene assay to inform treatment recommendations for adjuvant chemotherapy were modeled based on a prospective, multi-center trial in 366 patients. Transition probabilities and risk adjustment were based on published landmark trials. Costs (2011 Euros (€)) were estimated from a sick fund perspective based on resource use in patients receiving chemotherapy. Future costs and clinical benefits were discounted at 3% annually.

Results:

The 21-gene assay was projected to increase mean life expectancy by 0.06 years and quality-adjusted life expectancy by 0.06 quality-adjusted life years (QALYs) compared with current clinical practice over a 30-year time horizon. Clinical benefits were driven by optimized allocation of adjuvant chemotherapy. Costs from a healthcare payer perspective were lower with the 21-gene assay by ∼€561 vs standard of care. Probabilistic sensitivity analysis indicated that there was an 87% probability that the 21-gene assay would be dominant (cost and life saving) to standard of care.

Limitations:

Country-specific data on the risk of distant recurrence and quality-of-life were not available.

Conclusions:

Guiding decision-making on adjuvant chemotherapy using the 21-gene assay was projected to improve survival, quality-adjusted life expectancy, and be cost saving vs the current standard of care women with ER+, HER2− early-stage breast cancer.

Keywords::

• Cost
• Cost-effectiveness
• Breast cancer
• Germany
• 21-gene assay

Transparency

Declaration of funding

This study was supported by a grant from Genomic Health International (GHI).

Declaration of finacial relationships

Jens-Uwe Blohmer and William Valentine received grant support from GHI to carry out this study. Jens-Uwe Blohmer, Thorsten Kühn, Kay Friedrichs, and Wolfgang Eiermann have acted as speakers on behalf of GHI. Sherko Kümmel and Jens-Uwe Blohmer have received speakers’ honoraria from GHI. Kay Friedrichs has received sponsorship from Roche. Mahdi Rezai, Thorsten Kühn, Mathias Warm, and Anja Benkow have no relevant financial relationships to disclose.

Acknowledgments

No assistance in the preparation of this article is to be declared.

Notice of Correction The version of this article published online ahead of print on 12 September 2012 contained an error on page 4. An incorrect version of Table 2 was published. This does not affect any of the results of the analysis. The error has been corrected for this version.