Trastuzumab for HER2-Positive Metastatic Breast Cancer: Clinical and Economic Considerations

Trastuzumab is a recombinant humanized monoclonal antibody that selectively targets the extra-cellular domain of the HER2 receptor. It was approved by the FDA in September 1998 as the first targeted therapy for HER2-positive metastatic breast cancer, and has since led to significant improvements in the overall prognosis for patients with HER2-positive metastatic disease. The favourable benefit/risk profile associated with palliative trastuzumab has been demonstrated in a number of clinical trials that examined trastusumab as monotherapy or in combination with chemotherapy, endocrine therapy and other HER2 targeted agents. The clinical benefits of trastuzumab, however should also be examined within the context of its significant drug acquisition costs. This review highlights the significant findings from the landmark clinical trials of trastuzumab for metastatic HER2-positive breast cancer, and the potential “value for money” associated with its use in clinical practice

Cost-utility of adjuvant zoledronic acid in patients with breast cancer and low estrogen levels

BACKGROUND: Adjuvant zoledronic acid (za) appears to improve disease-free survival (dfs) in women with early-stage breast cancer and low levels of estrogen (lle) because of induced or natural menopause. Characterizing the cost-utility (cu) of this therapy could help to determine its role in clinical practice. METHODS: Using the perspective of the Canadian health care system, we examined the cu of adjuvant endocrine therapy with or without za in women with early-stage endocrine-sensitive breast cancer and lle. A Markov model was used to compute the cumulative costs in Canadian dollars and the quality-adjusted life-years (qalys) gained from each adjuvant strategy, discounted at a rate of 5% annually. The model incorporated the dfs and fracture benefits of adjuvant za. Probabilistic and one-way sensitivity analyses were conducted to examine key model parameters. RESULTS: Compared with a no-za strategy, adjuvant za in the induced and natural menopause groups was associated with, respectively, $7,825 and$7,789 in incremental costs and 0.46 and 0.34 in qaly gains for cu ratios of $17,007 and$23,093 per qaly gained. In one-way sensitivity analyses, the results were most sensitive to changes in the za dfs benefit. Probabilistic sensitivity analysis suggested a 100% probability of adjuvant za being a cost-effective strategy at a threshold of $100,000 per qaly gained. CONCLUSIONS: Based on available data, adjuvant za appears to be a cost-effective strategy in women with endocrine-sensitive breast cancer and lle, having cu ratios well below accepted thresholds

Is trastuzumab a cost-effective treatment for breast cancer?

Trastuzumab is a recombinant humanized monoclonal antibody that is currently approved for the treatment of HER2-neu-positive breast cancer. From a clinical perspective, it is an effective treatment with a relatively favorable benefit/risk profile. From an economic perspective, trastuzumab is an expensive treatment that is associated with high drug acquisition cost. Overall, it appears to provide reasonable 'value for money' (i.e., is cost-effective), especially in the adjuvant as opposed to the palliative setting. Trastuzumab's cost-effectiveness appears to be driven primarily by trastuzumab costs and the magnitude of benefit derived. Longer follow-up of clinical trials is, therefore, required to better estimate the long-term benefits associated with adjuvant trastuzumab, and its true cost-effectiveness in the treatment of HER2-neu-positive breast cancer

Evidence in Medicine: Math Versus Biology!

The drive for optimal clinical decisions based on "best" evidence has gained significant momentum in the last few decades. [...

Is the 21-gene recurrence score a cost-effective assay in endocrine-sensitive node-negative breast cancer?

The 21-gene recurrence score (RS) is a gene expression profile assay currently endorsed for use in patients with endocrine-sensitive node-negative breast cancers. The RS has been shown to augment current 'prognostic' and 'predictive' assessments of relapse risk and chemotherapy benefits, respectively, and lead to significant change in oncologists' recommendations for adjuvant chemotherapy, with an overall reduction in chemotherapy utilization. The RS (Oncotype DX) is marketed by Genomic Health Inc. (CA, USA) and currently retails for approximately US$4290 per patient. Like all novel tests/therapies, however, these upfront costs should be examined in the context of all its clinical benefits through cost-effectiveness or cost-utility evaluations. This review highlights the clinical evidence supporting RS testing for patients with endocrine-sensitive node-negative breast cancers, and examines all published economic evaluations that examined its 'value for money' in this setting