Cost-Effectiveness of the 21-Gene Breast Cancer Assay in Mexico
The 21-gene breast cancer assay (Oncotype DX®; Genomic Health, Inc.) is a validated diagnostic test that predicts the likelihood of adjuvant chemotherapy benefit and 10-year risk of distant recurrence in patients with hormone-receptor-positive, human epidermal growth receptor 2-negative, 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 Mexico.
A Markov model was developed to make long-term projections of distant recurrence, survival, and direct costs in scenarios using conventional diagnostic procedures or the 21-gene assay to inform adjuvant chemotherapy recommendations. Transition probabilities and risk adjustment were taken from published landmark trials. Costs [2011 Mexican Pesos (MXN)] were estimated from an Instituto Mexicano del Seguro Social perspective. Costs and clinical benefits were discounted at 5% annually.
Following assay testing, approximately 66% of patients previously receiving chemotherapy were recommended to receive hormone therapy only after consideration of assay results. Furthermore, approximately 10% of those previously allocated hormone therapy alone had their recommendation changed to add chemotherapy. This optimized therapy allocation led to improved mean life expectancy by 0.068 years per patient and increased direct costs by MXN 1707 [2011 United States Dollars (USD) 129] per patient versus usual care. This is equated to an incremental cost-effectiveness ratio (ICER) of MXN 25,244 (USD 1914) per life-year gained.
In early-stage breast cancer patients in Mexico, guiding decision making on adjuvant therapy using the 21-gene assay was projected to improve life expectancy in comparison with the current standard of care, with an ICER of MXN 25,244 (USD 1914) per life-year gained, which is within the range generally considered cost-effective.
KeywordsBreast cancer Cost Cost-effectiveness Gene expression profiling Mexico Oncology Oncotype DX
Breast cancer is a major health concern worldwide, but particularly in the low- and middle-income countries, where approximately 45% of the 1 million new cases occur each year . It is difficult to accurately quantify the prevalence and incidence of breast cancer in Mexico as no cancer registry exists to systematically collect data, but estimates from 2000 suggested that the burden is growing and projected approximately 16,500 new cases annually from 2020 . The clinical impact of breast cancer is large, since it is the leading cause of cancer death in Mexico, and represents the second most common cause of death for women aged 30–54 years (behind diabetes mellitus) . Data on the total economic burden of breast cancer in Mexico are currently lacking. However, a recent cohort study based in Mexico calculated the mean per patient annual cost of breast cancer treatment to be MXN (Mexican Pesos) 110,459 [approximately USD (United States Dollars) 8375], with costs increasing with delayed diagnosis .
Breast cancer is a heterogeneous disease. Patients survival and recurrence rates vary widely and are influenced by a number of factors including disease stage at diagnosis (based on tumor size, lymph node involvement and distant metastases), presence of particular molecular markers including, in particular, the estrogen and progesterone receptors (ER and PR, respectively) and the human epidermal growth factor receptor 2 (HER2). Only a small proportion of patients with early-stage ER-positive and HER2-negative invasive breast cancer derive a benefit from adjuvant chemotherapy, as shown in the NSABP B-20 trial where a 4.4% absolute benefit from addition of chemotherapy to tamoxifen at 10 years was observed across the entire population, but the 25% of patients at high risk showed a 28% absolute benefit from chemotherapy. This indicates the heterogeneity of the disease and shows that not all patients benefit equally from chemotherapy. However, a meta-analysis of adjuvant therapy recommendations recently suggested that approximately 45% of patients receive chemotherapy in usual care [5, 6, 7, 8].
The 21-gene breast cancer signature (Oncotype DX® Breast Cancer Assay, Genomic Health Inc., Redwood City, CA, USA) is a validated assay that has been shown to successfully predict the likelihood of chemotherapy benefit, as well as distant recurrence 10 years after diagnosis in patients with early-stage, node-negative and node-positive ER-positive breast cancer. The assay uses real-time reverse-transcriptase polymerase chain reaction (RT-PCR) to quantitatively examine the expression profile of 21 genes (16 cancer-related genes and 5 reference genes). The gene expression results are then combined to provide a single Recurrence Score value between 0 and 100, which corresponds to a point estimate (with 95% confidence intervals) of the 10-year risk of distant recurrence at an individual patient level [9, 10, 11, 12]. The ability to predict whether a patient is likely to benefit from chemotherapy can support physicians making individualized treatment decisions, thereby improving patient outcomes and minimizing unnecessary exposure to chemotherapy and associated adverse events in patients who are not likely to benefit from treatment. This in turn has implications in terms of reducing the economic and humanistic burden associated with breast cancer.
The use of the 21-gene assay is recommended as a decision tool to guide adjuvant chemotherapy decision making in a number of published guidelines, including the European Society for Medical Oncology (ESMO), American Society of Clinical Oncology (ASCO), and the National Comprehensive Cancer Network (NCCN) [13, 14, 15]. In addition, St. Gallen’s International Expert Consensus Panel on the primary treatment of early breast cancer in 2009 advised the use of multi-gene assays (including the 21-gene assay) if there is doubt about the indication for adjuvant chemotherapy . At the St. Gallen meeting in 2011, 84% of the panel agreed that the 21-gene assay may also be used to predict chemotherapy responsiveness in an endocrine responsive cohort where uncertainty remains after consideration of other tests . The IMPAKT 2012 Working Group stated that the analytical and clinical validity of the 21-gene assay had been demonstrated, but remained cautious as to the clinical utility of the test .
A recent systematic review of cost-effectiveness studies of multi-gene assays in breast cancer identified 18 studies evaluating the cost-effectiveness of the 21-gene assay . Of these analyses, the majority were conducted in economically developed countries (five in the USA, three in Canada, two in the UK, two in Japan, two in Singapore, one in Australia, and one in Ireland) and none were conducted in Latin America. The aim of the present study was to evaluate the cost-effectiveness of using this assay in patients with early-stage breast cancer in Mexico, from the perspective of the Instituto Mexicano del Seguro Social (IMSS), the governmental organization with responsibility for funding healthcare in Mexico.
A time horizon of 40 years in the base case was chosen, to allow all recurrence events over patient lifetimes to be captured. Future costs and clinical benefits were discounted at 5% per annum in line with published guidance for Mexico . Half-cycle correction was applied to avoid systematic over- or underestimation of survival in the model.
Patients in the model were assigned adjuvant therapy based either on the conventional approach in Mexico (usual care) or based on their Recurrence Score. There were three states in the model: recurrence-free (in which all patients start the simulation), recurrence (following a distant recurrence event after which patients were exposed to the risk of breast cancer mortality in each subsequent year of the simulation) and dead (following a mortality event). All patients started the simulation in the recurrence-free state. In each 1-year cycle of the simulation, patients were exposed to the risk of competing mortality and recurrence. Patients who had a mortality event transitioned to the dead state (absorbing state). Patients who experienced a distant recurrence event transitioned to the recurrence state, where they were exposed to the risk of breast cancer mortality in each subsequent year of the simulation.
Incremental cost-effectiveness ratios (ICERs) were calculated by dividing the difference in costs between the 21-gene assay arm and the usual care arm by the difference in life expectancy between the 21-gene assay arm and the usual care arm. Calculation of an ICER identifies whether a treatment is considered good value for money, and allows comparison across a range of therapy areas to allow healthcare payers to make informed decisions to optimize healthcare with a finite budget.
Values used to parameterize the model are outlined below, and all inputs used in the modeling analysis can be found in the online electronic supplementary material.
Clinical Parameters and Variables in the Base Case Analysis
Allocation of chemotherapy in early-stage breast cancer patients, with and without 21-gene assay testing
Recurrence Score group
After 21-gene assay testing
Hormone therapy only (%)
Hormone therapy and chemotherapy (%)
Hormone therapy only (%)
Hormone therapy and chemotherapy (%)
In each cycle of the model, the risk of recurrence was evaluated for each simulated patient based on their Recurrence Score defined category of low, intermediate or high risk as reported by Paik et al.  for the NSABP B-20 cohort. For patients with low, intermediate and high Recurrence Scores, the 10-year risk of recurrence was 3.2%, 9.1%, and 39.5%, respectively. Risk of recurrence was adjusted based on whether patients were receiving chemotherapy as per the initial recommendations (in the standard care arm) and based on the Recurrence Score (in the 21-gene assay arm). The relative benefits of chemotherapy, in terms of distant recurrence for patients with low Recurrence Score (<18), intermediate Recurrence Score (18–30) and high Recurrence Score (≥31) results were 1.31 [95% confidence interval (CI) 0.46–3.78], 0.61 (95% CI 0.24–1.59) and 0.28 (95% CI 0.13–0.53), respectively . Based on these data, the modeling analysis captured a relative risk reduction associated with chemotherapy of 74% in patients with high Recurrence Scores only (as the 95% CI of relative risk in the low and intermediate groups spanned 1).
Non-breast cancer death was captured as a competing risk in the model, based on Mexican life tables . For patients experiencing distant recurrence, mean survival was 3.3 years based on a retrospective analysis of recurrence data from real-life clinical practice . Baseline age was 55.5 years, based on mean age of onset of breast cancer in Mexico taken from data collected by the Instituto Nacional de Cancerología (INCan) .
Costs in the Base Case Analysis
Costs were accounted from an IMSS perspective, with only direct medical costs included. Costs were identified from published sources on the basis of a literature review [24, 25]. Searches of the PubMed database and gray literature based on selected key words (breast, cancer, cost and Mexico) were performed, limited to articles published in Spanish or English between 2002 and 2012. The searches produced a total of 39 hits, of which 7 articles were selected for full text review.
All costs were expressed in 2011 Mexican Pesos (MXN) and mid-point averages between fluorouracil (5FU), epirubicin and cyclophosphamide (FEC), and cyclophosphamide, methotrexate and 5FU (CMF) regimen costs were used in the analysis, resulting in an average cost of chemotherapy of MXN 154,133 (USD 11,685) in the first year, based on six cycles of chemotherapy [25, 26]. The annual costs of endocrine therapy were assumed to be MXN 5972 (USD 453) based on data from the INCan and were accrued for 8 years per patient . The one-off cost of the 21-gene assay was MXN 42,871 based on the current list price (converted from USD 3250 at a rate of USD 1 = MXN 13.191), with this exchange rate used for all other currency conversions. Distant recurrence was calculated to cost MXN 404,907 (USD 30,696) per patient based on data from the INCan .
Sensitivity Analysis and Secondary Analysis
A series of one-way sensitivity analyses were performed to identify key drivers of model outcomes. Where possible sensitivity analyses were based on alternative data sources, but in a number of cases a lack of evidence to inform alternative values resulted in varying input values symmetrically to evaluate sensitivity (rather than uncertainty). This approach is in line with health economic guidance . The cost discount rate was varied between 3% and 7%, with outcome discount rate varied between 0% and 7%, in line with pharmacoeconomic guidance for Mexico . The time horizon was varied to 10, 20, and 30 years (compared to 40 years in the base case). The total cost of chemotherapy (including adverse event costs) was varied ±20%. The cohort age was varied to 45, 50 and 60 years, (55.5 years in the base case). To investigate the impact of survival following distant recurrence, post-recurrence survival was set to 1.5 years, based on data reported by Remák and Brazil . To assess the importance of chemotherapy benefit, the relative risk reduction with chemotherapy in the low and intermediate Recurrence Score groups was set to 1.1% and 39%, respectively, in two sensitivity analyses, based on data reported by Paik et al. . The impact of risk of distant recurrence was investigated by setting the 10-year risk of recurrence to 4.43%, 13.24%, and 27.26% in low, intermediate and high Recurrence Score groups, respectively, based on data from postmenopausal, node-negative patients in the UK (converted from annual rates) . In addition to the one-way sensitivity analyses, two multi-way sensitivity analyses representing best and worst case scenarios for the 21-gene assay were performed. In the optimistic scenario, the cost of chemotherapy was increased by 20% and post-recurrence survival was set to 1.5 years. In the pessimistic scenario, the cost of chemotherapy was decreased by 20% and post-recurrence survival was set to 4.8 years.
The benefits of 21-gene assay testing may be mostly manifested in terms of reducing the level of chemotherapy over-prescribing (chemotherapy sparing). For this reason, while the primary analysis included all early-stage breast cancer patients (representing a conservative cost-effectiveness scenario), a secondary analysis was conducted focusing on the population recommended chemotherapy prior to assay testing. Data for this analysis were taken from a recent decision impact study in Mexico, as this breakdown was not available from Hornberger and Chien [8, 29]. In this population (n = 46), approximately 46% of patients had adjuvant therapy recommendations changed following assay testing. For this analysis, all other clinical and cost parameters were unchanged from the base case analysis.
Compliance with Ethics Guidelines
The analysis in this article is based on previously conducted studies and does not involve any new studies of human or animal subjects performed by any of the authors.
Base Case Analysis of All Early-Stage Breast Cancer Patients
Based on the Hornberger and Chien  meta-analysis of decision impact studies, use of the 21-gene assay was associated with significant reduction in the number of patients receiving chemotherapy. Approximately, 66% of patients previously receiving chemotherapy were recommended to receive hormone therapy only after consideration of assay results. Furthermore, approximately 10% of those previously allocated hormone therapy alone had their recommendation changed to add chemotherapy.
Summary of cost-effectiveness results for the base case analysis of all early-stage breast cancer patients
21-gene assay testing
124,999 (USD 9476)
126,706 (USD 9605)
1707 (USD 129)
Life expectancy (years)
ICER (MXN per life-year gained)
25,244 (USD 1914 per life-year gained)
Summary of sensitivity analysis results for early-stage breast cancer patients in Mexico
ICER (MXN per life-year gained) for 21-gene assay testing versus usual care
ICER (USD per life-year gained) for 21-gene assay testing versus usual care
Costs discounted by 3% per annum, outcomes discounted by 7% per annum
Costs discounted by 7% per annum, outcomes discounted by 0% per annum
Costs discounted by 3% per annum, outcomes discounted by 0% per annum
Costs discounted by 7% per annum, outcomes discounted by 7% per annum
Cost of chemotherapy
Increased by 20%
Decreased by 20%
Incapacity cost not included
Post-recurrence survival set to 1.5 years (Remák and Brazil )
Relative risk reduction with chemotherapy in the low Recurrence Score group set to 1.1%
Relative risk reduction with chemotherapy in the intermediate Recurrence Score group set to 39%
10-year risk of recurrence set to 4.43%, 13.24% and 27.26% in low, intermediate and high Recurrence Score groups, respectively, based on Dowsett et al. 
Optimistic and pessimistic scenarios
Secondary Analysis of Patients Previously Allocated Chemotherapy in Standard Care
Summary of cost-effectiveness results for the secondary analysis of patients allocated chemotherapy in usual care
21-gene assay testing
207,063 (USD 13,588)
179,649 (USD 15,697)
−27,414 (−USD 2078)
Life expectancy (years)
ICER (MXN per life-year gained)
The present long-term modeling study, which represents the first cost-effectiveness evaluation of a molecular diagnostic assay in breast cancer in Latin America, found that use of the 21-gene assay was associated with an ICER of MXN 25,244 (USD 1914) per life-year gained in patients with early-stage breast cancer in Mexico. Decision making around whether a new healthcare intervention is cost-effectives is subjective, depending on the willingness-to-pay for improvements in healthcare, which may be affected by a wide variety of factors. To date, no willingness-to-pay threshold is evident for the Mexican setting. The World Health Organization recommends the use of a willingness-to-pay threshold of three times the gross domestic product per capita per quality-adjusted life-year gained. In the Mexican setting, this would equate to a threshold of MXN 432,000 (USD 32,750) per quality-adjusted life-year gained. However, the present analysis captured only life expectancy, and not quality of life. A conservative approach is to assume that the willingness-to-pay threshold for a life-year is the same as for a quality-adjusted life-year. Based on this approach, while fully acknowledging its assumptions and weaknesses, use of the 21-gene assay is likely to be cost-effective in Mexico for patients with hormone-receptor-positive, HER2-negative, node-negative or up to 3 node-positive early-stage breast cancer.
A limitation of the present analysis is that quality of life is not captured in the results. Therefore, only life expectancy gains associated with identifying patients at high risk of distant recurrence not receiving beneficial chemotherapy in usual care are captured. While undertreatment is a key issue, as it denies patients treatment that would substantially reduce the high risk of distant recurrence, overtreatment is more prevalent in adjuvant breast cancer care, as shown by the meta-analysis by Hornberger and Chien , where 66% of patients originally recommended chemotherapy (29.5% of the total population) received endocrine therapy only following 21-gene assay testing. The impact of chemotherapy on health-related quality of life is substantial, with both short- and long-term adverse events playing a significant role [30, 31, 32]. This detrimental effect in patients who will not experience any benefit from chemotherapy can be avoided when the assay is used to guide adjuvant decision making. This is of particular note in patients who are allocated chemotherapy in usual care, as in the secondary analysis, where 46% of the total population had chemotherapy removed from their treatment regimen. While life expectancy was not found to increase in the analysis of patients previously allocated chemotherapy, inclusion of utilities to capture quality of life changes associated with chemotherapy treatment and its adverse event profile is highly likely to be associated with an improvement in quality-adjusted life expectancy. ICERs calculated based on quality-adjusted life expectancy are likely to be lower than those calculated on life expectancy.
A further potential limitation of the analysis is the reliance on clinical data collected from outside Mexico. The risk of recurrence data and relative risk reduction with chemotherapy were taken from a USA-based study, while survival post-recurrence was estimated from a UK-based study [5, 23]. This data represents the best available evidence to parameterize the model, as clinical data specific to the Mexican setting is not currently available. However, it may not be generalizable to current care in Mexico. In high-income countries such, as the USA and the UK, the majority of breast cancer cases are identified in the early stages, but in Mexico only 10% of breast cancer cases are identified at the lymph node-negative or one lymph node-positive stage of progression . Improved patient outcomes are associated with early detection, and the 21-gene assay is validated in early-stage breast cancer patients. However, detection is likely to become earlier in Mexico in the future, with evidence showing that the proportion of women screened for breast cancer is increasing, with the most substantial increase in the population aged over 45 years . As detection of breast cancer occurs earlier in Mexico, the full utility of the 21-gene assay may be realized.
The Paik et al.  study assessed the 10-year risk of recurrence in patients receiving tamoxifen monotherapy as hormone therapy, while more modern regimens rely on an aromatase inhibitor. However, data from the transATAC study have demonstrated that Recurrence Score results are validated in patients treated with either tamoxifen or an aromatase inhibitor . Moreover, patients in the Paik et al.  study received CMF or MF (methotrexate and 5-FU), rather than CMF or FEC as assumed in our analysis. It is not clear how variation in chemotherapy regimens is likely to impact on the risk of distant recurrence and therefore cost-effectiveness of the 21-gene assay.
The data to inform standard care without the 21-gene assay and the decision impact of the use of the test were taken from a meta-analysis of decision impact studies . This took data from a number of settings worldwide and represents the most comprehensive assessment of the effect of use of the 21-gene assay on clinical practice (the total number of included patients was 1154). Therefore, this was considered the most appropriate data source to inform the base case analysis. A potential weakness of the present base case analysis is that this data is not specific to the Mexican setting. More recently, a decision impact study has been conducted in the Mexican setting and this study has been used in a secondary analysis . A key aspect to be considered is how the impact of 21-gene assay may vary in Mexico compared to other settings. The proportion of patients identified at low, intermediate and high Recurrence Scores was similar in the Mexican setting and in the meta-analysis. Chemotherapy allocation at baseline was also similar, but a greater proportion of the high Recurrence Score patients received chemotherapy in standard care in Mexico. Since a greater proportion of patients with high Recurrence Scores were already receiving chemotherapy in the Mexican study, fewer patients were switched to receive chemotherapy. Furthermore, fewer patients with low or intermediate Recurrence Scores were switched from chemotherapy plus hormone therapy to hormone therapy only in the Mexican decision impact study compared to the meta-analysis, despite similar treatment allocation without use of the test. It is likely that as use of the 21-gene assay becomes more prevalent and accepted in the Mexican setting that patients with low or intermediate Recurrence Scores will be switched to receive hormone therapy only. Therefore, the results of the meta-analysis used to inform the base case analysis will become more applicable to the Mexican setting as use of the 21-gene assay increases.
The results of the present analysis concur with previous cost-effectiveness evaluations of the 21-gene assay, conducted in a variety of countries, including the UK (using the model adapted for this study), Australia, USA, Hungary, Israel, Japan and Singapore [20, 34, 35, 36, 37, 38]. In all of these studies, the assay has been projected to improve clinical outcomes, in terms of life expectancy and quality-adjusted life expectancy, versus conventional care. In countries where chemotherapy use is very high in standard care, such as USA, use of the assay was associated with reductions in direct costs, as the savings due to chemotherapy sparing offset the cost of the test. In countries where chemotherapy use is less prevalent in standard care, the assay was associated with increased direct costs, but was still considered cost-effective in all settings.
A key aspect of the present study is the transferability to other low-income countries. In countries with a low income, resources available for healthcare expenditure are generally very restricted. Therefore, the cost savings as a result of avoided chemotherapy following 21-gene assay testing can be very significant, as it allows resources to be spent on other areas of healthcare which would otherwise not have received funding. Use of the 21-gene assay can also lead to substantial improvements in clinical outcomes. This may be particularly important for healthcare systems aiming to maximize health outcomes with a low budget. In countries where undertreatment of patients at high risk of recurrence is prevalent, the 21-gene assay can be used to target chemotherapy to those who are likely to experience a life expectancy benefit. Furthermore, chemotherapy sparing for patients who will not experience a benefit will lead to an increase in quality of life (although duration will not be affected).
The use of the 21-gene assay has a considerable influence on chemotherapy treatment recommendations in patients with hormone-receptor-positive, HER2-negative, node-negative or up to 3 node-positive early-stage breast cancer . It is associated with substantial chemotherapy sparing in patients likely to derive little or no benefit from treatment and assists in the identification of patients currently considered at low risk who will in fact benefit from chemotherapy. Based on this modeling study, guiding decision making on adjuvant therapy using the 21-gene assay was projected to improve life expectancy in comparison with the current standard of care in Mexico, with an ICER of MXN 25,244 (USD 1914) per life-year gained, which is within the range generally considered cost-effective.
Sponsorship and article processing charges for this study were funded by Genomic Health, Inc. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval for the version to be published. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis.
Conflict of interest
Juliette Plun-Favreau is an employee of Genomic Health International. William Valentine is an employee of Ossian Health Economics and Communications. Barnaby Hunt is an employee of Ossian Health Economics and Communications. Ossian received funding from Genomic Health International to support the present study. Juan Enrique Bargalló-Rocha, Fernando Lara-Medina, Victor Pérez-Sánchez, Rafael Vázquez-Romo, Cynthia Villarreal-Garza, Hector Martínez-Said, Robin J Shaw-Dulin, and Alejandro Mohar-Betancourt have no conflicts of interest to declare.
Compliance with ethics guidelines
The analysis in this article is based on previously conducted studies and does not involve any new studies of human or animal subjects performed by any of the authors.
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