Economics of Genomic Testing for Women With Breast Cancer | Page 2
Published Online: December 23, 2013
Robert D. Lieberthal, PhD
Economic modeling studies have focused primarily on the direct costs associated with breast cancer treatment and recurrence, while failing to fully address indirect costs. For patients, these indirect costs play a significant role in treatment decision making. The false-negative cost mainly includes the cost of nonfatal recurrences and mortality during recurrence or chemotherapy, and is estimated at $51,000.16 Medical costs and related nonmedical costs of unnecessary chemotherapy are high: treatment costs varied from $10,000 to $23,000 in a prior study that was included in our side-byside comparison.17 In another study included in our comparison, adverse events related to chemotherapy were found to cost more than $2000 per patient.18 In a third study included in our comparison, Bacchi and colleagues19 stated that the 18% difference in cost between use and nonuse of an assay could be attributed to the cost of medications for prophylaxis and treatment of side effects of chemotherapy.4
There is limited mention of indirect costs (eg, productivity loss) in any of the published studies we reviewed. There have been attempts to estimate the burden of side effects in terms of quality of life or other patient-reported outcome measures. However, there is no systematic study that translates indirect costs into monetary terms. Data used in a payer perspective study that we reviewed focused on the avoidance of costs of long-term adjuvant chemotherapy such as infertility and second primary tumors.20 A study by Hornberger and colleagues21 in 2011 that was included in our comparison also did not translate indirect costs into monetary terms.
The most significant benefit expected from tailoring treatment using genomic testing is a reduction in adverse drug effects for subpopulations that may not benefit from chemotherapy. The adverse effects of chemotherapy include nausea, vomiting, alopecia, fatigue, vasomotor symptoms, pain, and risk of infection.22 McArdle and colleagues23 found that 85% of patients receiving chemotherapy experienced nausea and vomiting and suffered distress, 36% of patients lost their hair, and 39% of patients developed mucosal ulceration. They also reported that depression and anxiety occurred in patients receiving chemotherapy, although psychiatric morbidity was present for some of these patients even prior to invasive surgery.
A major benefit of genomic testing is extended quality-adjusted life-years (QALYs). Hornberger and colleagues24 analyzed the preliminary QALYs for using 6-month chemotherapy treatment for “low-risk” patients. Their analysis, included in our comparison, found that if the utility of chemotherapy was set at 0.5 for 6 months of treatment, then chemotherapy was of no benefit for those low-risk patients, as no gain in QALYs resulted. However, survivors who received chemotherapy tended to have greater preference for undergo ing chemotherapy than survivors who did not receive chemotherapy.24 This and other previous studies have shown there is ambivalence and inconsistency in patients’ reports on how they view the value of chemotherapy. The literature does not clearly provide information on reduction of QALYs for the breast cancer patients who were distant recurrence free after primary surgical and radiation therapy but who were offered chemotherapy according to current breast cancer treatment practice.
COMPARATIVE EFFECTIVENESS ANALYSES
The economic evaluation of genomic testing requires a valuation of whether the benefits of early diagnosis and treatment outweigh the costs of the test. This framework can include comparing direct and indirect costs, as well as clinical, financial, and humanistic benefits. Which costs and benefits are included depends on the study’s perspective. Using decision analysis, one can choose a particular test over other diagnostic steps or interventions.
Modeling-Based Cost-Effectiveness Analysis
For the decision analysis of genomic testing, we included 3 studies that compared clinical and economic outcomes of genomic testing–guided adjuvant treatment versus guidelinebased adjuvant therapy in our comparison.7,17,25 We also included in our comparison 2 studies of different adjuvant treatment strategies: chemotherapy treatment for all patients (or no chemotherapy) or adjuvant therapy strategies guided by genomic testing.24,26
We included 5 cost-effectiveness studies of Oncotype DX, all of which concluded that treatment guided by genomic testing is cost-effective compared with conventional treatment selected according to guidelines. In 1 study, Lyman and colleagues26 examined the incremental cost-effectiveness ratio associated with 3 treatment strategies: tamoxifen alone, chemotherapy followed by tamoxifen, and recurrence score–guided treatment. They found that genomic testing is costeffective relative to the other strategies.26 In another study, Klang and colleagues18 applied recurrence score–guided recommendations to patients of a managed care organization in Israel. They found that treatment pathways were changed from the initial recommendation (according to traditional prognostic pathways) in 40% of patients and that the incremental cost-effectiveness ratio for using Oncotype DX was $10,770 per QALY.18 That is well below the international norms of willingness to pay used in Israel and the threshold of $50,000 per QALY gained commonly used in the United States context (Table).27
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