The Cost-Utility of Sequential Adjuvant Trastuzumab in Women with Her2/Neu-Positive Breast Cancer: An Analysis Based On Updated Results from the HERA Trial

Skedgel, Chris; Rayson, Daniel; Younis, Tallal

doi:10.1111/j.1524-4733.2009.00511.x

Cited by 32 publications

(39 citation statements)

References 38 publications

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“…Relapses post-chemotherapy was computed from event rates in NSABP B20 and SWOG 8814 [9,10]. Disease-free (DFS) and overall survival (OS) were derived from breast cancer relapse risk combined with the general mortality (death without recurrence) for women with a median age of 50 [28], as per our previous study [30,[35][36][37]. Chemo-associated adverse events were based on FEC-100 (5-fluorouracil 500 mg/m 2 , epirubicin 100 mg/m 2 , cyclophosphamide 500 mg/m 2 q 3 weekly for 6 cycles) and FEC-D (FEC-100 q 3 weekly for 3 cycles followed by docetaxel 100 mg/m 2 q 3 weekly for 3 cycles) regimens commonly employed in Canada for N-and N?…”

Section: Markov Modelmentioning

confidence: 99%

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Cost-utility of the 21-gene recurrence score assay in node-negative and node-positive breast cancer

Lamond

Skedgel

Rayson

et al. 2012

Breast Cancer Res Treat

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The 21-gene recurrence score (Oncotype DX: RS) appears to augment clinico-pathologic prognostication and is predictive of adjuvant chemotherapy benefit in node-negative (N-) and node-positive (N+), endocrine-sensitive breast cancer. RS is a costly assay that is associated with good 'value for money' in N- disease, while economic evaluations in N+ disease based on most recent data have not been conducted. We examined the cost-utility (CU) of a RS-guided adjuvant strategy, compared to current practice without RS in N- and N+, endocrine-sensitive, breast cancer from a Canadian health care system perspective. A generic state-transition model was developed to compute cumulative costs and quality-adjusted life years (QALYs) over a 25-year horizon. Patient outcomes with and without chemotherapy in RS-untested cohorts and in those with low, intermediate and high RS were examined based on the reported prognostic and predictive impact of RS in N- and N+ disease. Chemotherapy utilization (current vs. RS-guided), unit costs and utilities were derived from a Nova Scotia Canadian population-based cohort, local unit costs and the literature. Costs and outcomes were discounted at 3% annually, and costs were reported in 2011 Canadian dollars ($). Probabilistic and one-way sensitivity analyses were conducted for key model parameters. Compared to a non-RS-guided strategy, RS-guided adjuvant therapy was associated with $2,585 and $864 incremental costs, 0.27 and 0.06 QALY gains, and resultant CUs of $9,591 and $14,844 per QALY gained for N- and N+ disease, respectively. CU estimates were robust to key model parameters, and were most sensitive to chemo utilization proportions. RS-guided adjuvant therapy appears to be a cost-effective strategy in both N- and N+, endocrine-sensitive breast cancer with resultant CU ratios well below commonly quoted thresholds.

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Section: Markov Modelmentioning

confidence: 99%

“…Costs were adjusted to 2011 Canadian dollars ($) using the Consumer Price Index (health care component) [51]. Utility weights ( Table 2) were derived from a published database [37,41].…”

Section: Costs and Utilitiesmentioning

confidence: 99%

Cost-utility of the 21-gene recurrence score assay in node-negative and node-positive breast cancer

Lamond

Skedgel

Rayson

et al. 2012

Breast Cancer Res Treat

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“…Most studies evaluated direct cost from a third party payer perspective [47,51,54,55]. This decision likely reflected access to data, details of resource use and reimbursements by third party payers being generally more readily available than details of out of pocket expenditures or where costs relate to absenteeism or presenteeism.…”

Section: Study Perspectivementioning

confidence: 99%

“…How models are populated also varies though the relatively small number of trials relating to use of Trastuzumab in early stage breast cancer has served to limit heterogeneity here. Data from the HERceptin Adjuvant (HERA) [53,54,65,66] trial has become the most commonly used source for evaluations of treatment in an early stage setting. Differences regarding DFS rates (disease-free state), duration of treatment effect, disease recurrence, cardiac toxicity, mortality, transition probability between trials will lead to significant differences in model parameters and choices in which outcomes to focus on can influence estimated ICERs even when these are derived from the same trial.…”

Section: Modellingmentioning

confidence: 99%

“…In studies adopting a societal perspectives, many included this as part of an analysis undertaken from the payer's perspective [40,56,57]. From the payer's perspective, most studies included as costs HER-2 testing, drug acquisition and drug administration costs, as well as supportive medications [47,54,55], cardiac monitoring [47,55], costs of palliative Trastuzumab [51,54,55], cost of local and distant cancer recurrences [47,51,54,55] as well as the cost of different chemotherapy-related adverse events [47]. In studies reporting from a societal perspective studies reported productivity losses [51,[56][57][58], transportation costs [56,57], out-of-pocket payments [43].…”

Section: Study Perspectivementioning

confidence: 99%

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A Critical Review of Economic Evaluations of Trastuzumab in the Treatment of Early Stage HER2 Positive Breast Cancer

Nguyen¹,

Nguyen²,

O'Neill³

2017

Pharmacoeconomics

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Eleven years after Trastuzumab was approved for use in the treatment of early stage human epidermal growth factor receptor positive breast cancer (HER2+) its clinical benefit has been demonstrated in short and long term follow up studies. The cost-effectiveness of the therapy in this context remains the subject of debate with a wide range of Incremental Cost Effectiveness Ratios (ICERs) reported in the literature. While several reviews of the literature have been undertaken these have not provided a critical analysis of the factors that might underlie this heterogeneity. In this review we provide a critical overview of the literature and discuss potential sources of heterogeneity in reported ICERs. We identify gaps in the current literature and provide a rationale for filling these gaps.

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Trade-offs associated with axillary lymph node dissection with breast irradiation versus breast irradiation alone in patients with a positive sentinel node in relation to the risk of non-sentinel node involvement: implications of ACOSOG Z0011

Krishnan

Recht

Bellon

et al. 2013

Breast Cancer Res Treat

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Recent data suggest that axillary lymph node dissection (ALND) may be unnecessary for patients with positive sentinel lymph node biopsy (SLNB) receiving whole-breast irradiation (ACOSOG Z0011). The purpose of this study was to use decision analysis with simulated patients to determine subgroups with positive SLNB who may still benefit from ALND. We performed a decision analysis simulating axillary recurrence (ALR) risk, lymphedema, and quality of life following breast-conserving surgery (BCS) with positive SLNB and either completion ALND and whole-breast radiation (ALND + BRT) or breast radiation (BRT) alone. Simulated patients were divided into two risk groups based on the likelihood of disease in non-sentinel axillary nodes after positive SLNB: those with risk 30-60 % ("high-risk") and those with risk under 30 % ("low-risk," similar to average Z0011 patients). In simulated patients aged 55, BRT alone resulted in 1 month of additional QALE in the low-risk group versus ALND + BRT, while ALND + BRT resulted in 9.7 months of additional QALE in the high-risk group versus BRT alone. Overall survival was similar at 5 years in this simulation with either treatment in both groups, but ALND + BRT was superior to BRT alone at 20 years in the high-risk group (42 vs. 38 %). In the low-risk group, BRT alone is preferable unless ALR risk with BRT is greater than 1.6 % or lymphedema risk with ALND is under 10 %. Patients eligible for Z0011 but at a higher risk of residual nodal disease following BCS and positive SLNB may benefit from ALND + BRT, rather than BRT alone.

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The Cost-Utility of Sequential Adjuvant Trastuzumab in Women with Her2/Neu-Positive Breast Cancer: An Analysis Based On Updated Results from the HERA Trial

Abstract: The CU of sequential aTZ is primarily dependent on the magnitude and duration of benefit. Further clinical research is required to establish the optimum sequence and duration of aTZ therapy and clarify the magnitude and duration of treatment benefit.

Cited by 32 publications

References 38 publications

Cost-utility of the 21-gene recurrence score assay in node-negative and node-positive breast cancer

Cost-utility of the 21-gene recurrence score assay in node-negative and node-positive breast cancer

A Critical Review of Economic Evaluations of Trastuzumab in the Treatment of Early Stage HER2 Positive Breast Cancer

Trade-offs associated with axillary lymph node dissection with breast irradiation versus breast irradiation alone in patients with a positive sentinel node in relation to the risk of non-sentinel node involvement: implications of ACOSOG Z0011

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