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Purpose: Genomic tests can guide the decision to administer adjuvant chemotherapy in women with hormone receptor (HR)-positive, Human Epidermal growth Factor 2 (HER2)-negative breast cancer (BC) at intermediate risk of recurrence. We assessed the decision-making and economic impact of the Prosigna test in a real-life setting., Methods: Retrospective cohort study of HR + , HER2- BC patients managed from 2016 to 2020, potential candidates for adjuvant chemotherapy, at intermediate risk of recurrence, in whom a Prosigna test was performed according to contemporary guidelines. The additional cost of chemotherapy over one year in terms of direct medical and non-medical costs was estimated in this study to be €9,737 (derived from a previous study, NCT02813317). The cost of the Prosigna test, as defined by the reimbursement system, was €1,849., Results: Among the 809 patients included in this study, 2.3 Prosigna tests had to be performed to avoid adjuvant chemotherapy for one patient. The number of tests that had to be performed to avoid chemotherapy for one patient was higher for patients with grade 3 tumors and pN1mic axillary node involvement and lower for grade 1 tumors or in the absence of axillary node involvement (pN0), but did not vary according to the 10-year overall survival gain predicted by the Predict online test. The cost saving related to withholding of adjuvant chemotherapy for one patient on the basis of the Prosigna test results was €5,485., Conclusion: We present one of the largest cohorts of HR + , HER2- BC patients at intermediate risk of recurrence, in whom a Prosigna test was used to guide the adjuvant therapy decision in a real-life setting, resulting in a 44% decrease in the indication for chemotherapy.

Purpose: Achieving a pathologic complete response (pCR) with neoadjuvant therapy for HER2-positive breast cancer is associated with less recurrence and improved clinical outcomes compared to having residual cancer at surgery. However, recent data have demonstrated favorable outcomes for patients with residual HER2-positive cancer who received adjuvant trastuzumab emtansine (TDM-1). Therefore, we sought to determine the optimal chemotherapy/anti-HER2 treatment strategy., Methods: We created a decision-analytic model for patients with stage II-III HER2-positive cancer that incorporated utilities based on toxicity and recurrence. We separately modeled hormone receptor-negative (HR-) and positive (HR+) disease and calculated quality-adjusted life years (QALYs) and costs through 5 years. Simulated patients received one of the following neoadjuvant treatments: three 'intensive' regimens (TCHP: docetaxel, carboplatin, trastuzumab, pertuzumab; THP + AC: taxol, trastuzumab, pertuzumab then doxorubicin and cyclophosphamide; THP: taxol, trastuzumab, pertuzumab) and two 'de-escalated' regimens (TH: taxol, trastuzumab; TDM-1) followed by adjuvant treatment based on pathologic response., Results: Among 'intensive' neoadjuvant strategies, treatment with THP was more effective and less costly than TCHP or THP + AC. When 'de-escalated' strategies were included, TH became the most cost-effective. For HR-negative cancer, TH had 0.003 fewer quality-adjusted life years (QALYs) than THP but was less costly by $55,831, resulting in an incremental cost-effectiveness ratio of over $18M/QALY for THP, well above any threshold. For HR-positive cancer, neoadjuvant TH dominated the THP strategy., Conclusion: An adaptive-treatment strategy beginning with neoadjuvant THP or TH followed by tailoring post-operative therapy reduces treatment costs, and spares toxicity compared to more intensive chemotherapy regimens for women with HER2-positive breast cancer.

Purpose: The objective of this study is to understand an impact of financial burden on the adjuvant hormonal therapy (AHT) adherence and persistence for insured women aged 18-64 with early breast cancer in Texas., Methods: We conducted a retrospective cohort study using claims data for population insured by Blue Cross Blue Shield of Texas from the year 2008 to 2013. Outcomes include adherence to adjuvant hormonal therapy, which was measured by medication possession ratio and persistence on AHT, which is the duration of time from initiation to discontinuation of therapy. Multivariate logistic regression models with repeated regional-level adjustments were used to explore the odds of AHT adherence. Cox proportional hazards model was conducted to assess time to the first 90+-day gap for persistence and a Kaplan-Meier curve were used to estimate probabilities to calculate the percentages of women who experienced 90+-day gaps in AHT., Results: Of the 938 women in the cohort, 627 (66.8%) initiated the treatment. By year 1, 66.9% of women were adherent to the therapy, and by year 5, only 29% of those were adherent. The percentage of women with no gap in therapy greater than 90 days was 80.8%. Both higher out-of-pocket costs spent on all prescription drugs except AHT and AHT-specific out-of-pocket costs were negatively associated with adherence to AHT as well as continuing AHT as recommended., Conclusions: Financial burdens including both non-AHT medication and AHT-specific out-of-pocket costs were significantly associated with adherence and persistence to the therapy.

Purpose: Evidence suggests substantial disparities in breast cancer survival by socioeconomic status (SES). We examine the extent to which receipt of newer, less invasive, or more effective treatments-a plausible source of disparities in survival-varies by SES among elderly women with early-stage breast cancer., Methods: Multivariate regression analyses applied to 11,368 women (age 66-90 years) identified from SEER-Medicare as having invasive breast cancer diagnosed in 2006-2009. Socioeconomic status was defined based on Medicaid enrollment and level of poverty of the census tract of residence. All analyses controlled for demographic, clinical health status, spatial, and healthcare system characteristics., Results: Poor and near-poor women were less likely than high SES women to receive sentinel lymph node biopsy and radiation after breast-conserving surgery (BCS). Poor women were also less likely than near-poor or high SES women to receive any axillary surgery and adjuvant chemotherapy. There were no significant differences in use of aromatase inhibitors (AI) between poor and high SES women. However, near-poor women who initiated hormonal therapy were more likely to rely exclusively on tamoxifen, and less likely to use the more expensive but more effective AI when compared to both poor and high SES women., Conclusions: Our results indicate that SES disparities in the receipt of treatments for incident breast cancer are both pervasive and substantial. These disparities remained despite women's geographic area of residence and extent of disease, suggesting important gaps in access to effective breast cancer care.

5-fluorouracil, epirubicin, cyclophosphamide → docetaxel (FEC-D) has been associated with higher-than-expected rates of febrile neutropenia (FN) that meet the current guideline threshold of 20 % for primary prophylaxis (PP) with granulocyte colony-stimulating factor (G-CSF). We examined the cost-effectiveness of FEC-D with varying strategies of G-CSF prophylaxis from the perspective of the public payer in Ontario, Canada. A state-transition model was developed to compare three strategies: FEC-D with secondary prophylaxis (SP) only, PP starting with the first cycle of D, and PP starting with the first cycle of FEC. Analysis was conducted for a hypothetical cohort of 50-year-old early-stage breast cancer patients undergoing adjuvant chemotherapy, at a 10-year horizon. Results were expressed in quality-adjusted life-years (QALYs) and 2013 Canadian dollars. Costs and benefits were discounted at 5 %. Event rates, costs, and utilities were derived from the literature. One-way and probabilistic sensitivity analyses were conducted. Using filgrastim, the incremental cost-effectiveness ratios (ICERs) for starting PP with the first cycle of D and starting PP with the first cycle of FEC, compared to using SP only, were $57,886/QALY and $116,186/QALY, respectively. With pegfilgrastim, the ICERs for the same strategies were $90,735/QALY and $149,483/QALY. Compared to using filgrastim SP only, starting PP with D had a 24 % chance of being cost-effective at a willingness-to-pay (WTP) threshold of $50,000/QALY, and a 99 % chance at a WTP threshold of $100,000/QALY. Results were sensitive to FN-related parameters, such as the risk of FN per cycle with D and the associated mortality, but were robust to uncertainty in parameters related to breast cancer, such as the utilities and hazard of relapse. FEC-D with PP starting with the first cycle of D is most likely to be cost-effective, especially with increased risk of FN and mortality from FN.

Five years of Tamoxifen (Standard TAM) is a common treatment option for early-stage, hormone receptor positive (HR+) breast cancer (BC). Extending Standard TAM by 5 additional years (Extended TAM) can improve survival and BC recurrences. In postmenopausal women, the use of extended aromatase inhibitors (Extended AI) after Standard TAM is an alternative to Extended TAM. This study examines the cost-effectiveness (CE) of extending Standard TAM with Extended TAM vs. Extended AI in postmenopausal HR+ early-stage BC patients. Three treatments were assessed: (1) Standard TAM; (2) Extended TAM; (3) Extended AI through a Markov model using a Canadian health system perspective, lifetime time-horizon, quality adjusted life years (QALYs), and a 5 % discount rate for future costs and utilities. Incremental cost-effectiveness ratios (ICERs) were calculated, and the impact of parameter uncertainty was assessed through probabilistic sensitivity analyses (SA) using conventional CE thresholds. The estimated total per person costs in 2012 Canadian dollars [$1.00 CAD = $0.99 US 2012] were the least for Extended TAM ($8,623 CAD) and most for Extended AI ($9,432 CAD). Extended AI was the most effective regimen, while Standard TAM was the least. Extended AI was cost-effective at conventional thresholds vs. Extended TAM (ICER: $3,402 CAD/QALY) which was robust to the SA. This study suggests that Extended AI and Extended TAM result in improved QALYs and lower healthcare costs vs Standard TAM. Extended AI results in the greatest improvement in QALYs and is the most cost-effective treatment alternative despite its higher drug costs.

Invasion factors uPA/PAI-1 are guideline-recommended (ASCO, AGO) biomarkers for decision support regarding adjuvant chemotherapy (CTX) in women with primary breast cancer. They define a high-risk group with strong benefit from adjuvant CTX and a low-risk group with uncertain benefit and excellent survival without CTX. In a target population (age > 35/N0/G2/HR+/HER2-), administration of adjuvant CTX is not mandatory in Germany and other countries. Based on existing data, this economic model was developed to determine for the first time health economic impact of uPA/PAI-1 testing. Incremental cost-effectiveness ratio (ICER) resulting from uPA/PAI-1 testing was estimated for the target population by Markov modeling and sensitivity analysis. Survival data, CTX-uPA/PAI-1 interactions, and uPA/PAI-1 hazard ratios were derived from the Chemo N0 trial and other evidence. Incremental costs were computed from a payer's perspective appropriate to the German setting. Incremental effectiveness in life years (ly) was estimated taking into account age-adjusted life expectancy, disease-free survival (with/without CTX), and 2 years post-relapse survival. Sensitivity analysis was performed by varying residual adjuvant CTX benefit in the low-risk group, denoted HR&#95;CTX(LR), in range 0.8-0.99. All patients receive adjuvant endocrine therapy. Test is restricted to patients willing to forgo CTX if both markers are below specific cut-off values and to undergo CTX otherwise. For a typical 55-year-old patient, comparing to an "all-CTX" strategy without the test, ICER (all-CTX vs. test) > 50,000 if HR&#95;CTX(LR) > 0.85, with savings of 18,500 per low-risk patient attributable to the test. The cost-effectiveness of forgoing CTX is very high as HR&#95;CTX(LR) approaches one. Conversely, comparing to a "no-CTX" strategy (e.g., patients who initially refuse CTX) without the test, the test is very cost-effective at all ages in the target group if high-risk patients are willing to undergo CTX: ICER (test vs. no-CTX) < 6,000 at age 55 and even better at younger ages, remaining < 25,000 up to age 75. The main determinants of cost utility are age and residual CTX benefit in low-uPA/PAI-1 patients. The uPA/PAI-1 test is cost-effective in the target group compared to either an "all-CTX" or a "no-CTX" scenario. This model thus lends health economic support to current guideline recommendations that uPA/PAI-1 testing is beneficial for BC patients with no lymph node involvement.

As gene expression profile (GEP) testing for breast cancer may provide additional prognostic information to guide the use of adjuvant chemotherapy, we examined the association between GEP testing and use of chemotherapy, serious chemotherapy-related adverse effects, and total charges during the 12 months following diagnosis. Medical record review was conducted for women age 30-64 years, with incident, non-metastatic, invasive breast cancer diagnosed 2006-2008 in a large, national health plan. Of 534 patients, 25.8% received GEP testing, 68.2% received chemotherapy, and 10.5% experienced a serious chemotherapy-related adverse effect. GEP testing was most commonly used in women at moderate clinical risk of recurrence (52.0 vs. 25.0% of low-risk women and 5.5% of high-risk). Controlling for the propensity to receive GEP testing, women who had GEP were less likely to receive chemotherapy (propensity adjusted odds ratio, 95% confidence interval 0.62, 0.39-0.99). Use of GEP was associated with more chemotherapy use among women at low risk based on clinical characteristics (OR = 42.19; CI 2.50-711.82), but less use among women with a high risk based on clinical characteristics (OR = 0.12; CI 0.03-0.47). Use of GEP was not associated with chemotherapy for the moderate risk group. There was no significant relationship between GEP use and either serious chemotherapy-associated adverse effects or total charges. While GEP testing was associated with an overall decrease in adjuvant chemotherapy, we did not find differences in serious chemotherapy-associated adverse events or charges during the 12 months following diagnosis.

The use of taxanes to treat node-positive (N+) breast cancer patients is associated with heterogeneous benefits as well as with morbidity and financial costs. This study aimed to assess the economic impact of using gene expression profiling to guide decision-making about chemotherapy, and to discuss the coverage/reimbursement issues involved. Retrospective data on 246 patients included in a randomised trial (PACS01) were analyzed. Tumours were genotyped using DNA microarrays (189-gene signature), and patients were classified depending on whether or not they were likely to benefit from chemotherapy regimens without taxanes. Standard anthracyclines plus taxane chemotherapy (strategy AT) was compared with the innovative strategy based on genomic testing (GEN). Statistical analyses involved bootstrap methods and sensitivity analyses. The AT and GEN strategies yielded similar 5-year metastasis-free survival rates. In comparison with AT, GEN was cost-effective when genomic testing costs were less than 2,090€. With genomic testing costs higher than 2,919€, AT was cost-effective. Considering a 30% decrease in the price of docetaxel (the patent rights being about to expire), GEN was cost-effective if the cost of genomic testing was in the 0€-1,139€, range; whereas AT was cost-effective if genomic testing costs were higher than 1,891€. The use of gene expression profiling to guide decision-making about chemotherapy for N+ breast cancer patients is potentially cost-effective. Since genomic testing and the drugs targeted in these tests yield greater well-being than the sum of those resulting from separate use, questions arise about how to deal with extra well-being in decision-making about coverage/reimbursement.

Prescribing anastrozole instead of tamoxifen increases initial adjuvant drug costs but there is an eventual saving as fewer patients will relapse. The effect of this saving depends on an accurate understanding of the cost of breast cancer relapse. We identified 232 patients relapsing between March 2000 and 2005. Seventy-seven were randomly selected for analysis of their entire hospital and community management costs from the date of relapse until death, or the end of the evaluation period (01/01/07). The mean cost per patient was 25,186 pounds (95% CI 13,705 pounds- 33,821 pounds). The median survival from time of relapse was 40.07 months (range 0.5-73 months) and median total cost per patient was 31,402.62 pounds. Equating this figure with the difference in relapse rate (4.1%), initial drug cost (4,773 pounds) gives an extra cost of 17,244 pounds/life year saved. This was the first adjuvant cost effectiveness analysis which included the community management activity of a subsequent relapse.

Purpose: BCIRG 001 demonstrated prolonged disease-free (DFS) and overall survival (OS) but increased toxicity for adjuvant docetaxel, doxorubicin, and cyclophosphamide (TAC) versus 5-fluorouracil, doxorubicin, cyclophosphamide (FAC) in women with node positive breast cancer (BC). This study evaluates quality-adjusted survival and cost-effectiveness of adjuvant TAC versus FAC, taking downstream decisions and events into account, including palliative chemotherapy with taxanes., Methods: We developed a Markov model for a cohort of women with node positive BC eligible for adjuvant anthracyclines. Data input included clinical and resource utilization data collected prospectively from BCIRG 001. Treatment decisions and outcomes with disease recurrence were based on a systematic literature review with validity reviewed by a national panel of Canadian BC oncologists. Direct costs for resource utilization following Canadian practice patterns were included. Unit costs were obtained from provincial cost list and published drug list prices. Utility scores were derived from the literature. An incremental cost-effectiveness ratio (ICER) in cost per quality-adjusted life-years (QALY) gained for TAC versus FAC was calculated., Results: For 1,000 women with node positive BC, the model showed that TAC would lead to a gain of 313 QALY (370 life years) at an additional cost of $5.8 Million Canadian dollars (Cdn) compared to FAC, over a 10-year time horizon. The ICER of TAC versus FAC was $18,505.54 Cdn per QALY gained. Sensitivity analyses supported the robustness of the model. By one-way sensitivity analyses of over 50 model variables, 95% of the cumulative ICER variation was from $6,000 to $28,000 Cdn/QALY. By multivariate Monte Carlo simulation, there was a 70% probability that the ICER would be under $50,000 CdN/QALY., Conclusion: For women with node positive BC, TAC improves DFS and OS compared to FAC and is a cost-effective adjuvant chemotherapy strategy.

Introduction: The use of neoadjuvant chemotherapy in cases of locally advanced breast cancer has been steadily increasing, and is also in wider use for other cancers. As a consequence, a growing number of studies have focused on the question of how best to assess the therapeutic response to various chemotherapy or systemic therapy regimens. Prognostic imaging of response to therapy early in the course of a planned chemotherapy regimen could be of considerable value, particularly if shifting to another therapy regimen would be more effective., Methods: A cost effectiveness analysis was completed, specific to imaging of neoadjuvant chemotherapy response in breast cancer, to determine the dominant parameters that would make imaging systems cost effective. The cost analysis was completed with respect to a system for near infrared spectral imaging, but the costs are not dramatically different for other systems such as PET or MRI. Using a standard metric of $25,000 per discounted life year gained as a measure of a successful system., Results: It is shown that system specificity and patient average life expectancy are not dominant factors. Increases in cure rate and the efficacy of the initial chemotherapy are dominant factors. As long as the initial chemotherapy was less than 90% effective, most imaging systems would be cost effective, and if the cure rate of the disease could be increased as little as 1% through a change to alternate therapy, then the cost effectiveness of the system would be acceptable., Conclusions: Based upon this simple economic analysis, diagnostic imaging of neoadjuvant chemotherapy appears warranted, assuming that it can be shown that the early shift from ineffective neoadjuvant chemotherapy to a more effective one has a measurable benefit in cure rate. This study indicates that the most important issue is to assess the added benefit of individualized chemotherapy in patient management, and clinical trials in this area would then provide the data required to justify analysis of prognostic imaging procedures.

Background: Adjuvant 5-flurouracil, epirubicin and cyclophosphamide-docetaxel (FEC-D) has been shown to improve disease-free and overall survival (DFS and OS), compared to FEC 100, for node-positive breast cancer. An economic evaluation was undertaken to examine the cost-utility (CU) of FEC-D relative to FEC 100 given possible differences in cost between the two regimens., Methods: A Markov model was developed to calculate the cumulative costs and quality-adjusted life years (QALY) gained over a 10-year horizon for a hypothetical cohort of 1,000 women with node-positive breast cancer treated with FEC 100 or FEC-D. Event rates, costs, and utilities were derived from the literature. Efficacy outcomes were based primarily on the hazard ratio of DFS for all patients, but separate analyses were also conducted according to age and menopausal status as per the PACS 01 subgroup analysis results. The model took a third-party direct payer perspective and reports results in 2006 Canadian dollars ($). Both costs and benefits were discounted at 3%., Results: FEC-D is associated with 0.156 QALY gain and a $2,280 incremental cost compared to FEC 100, with a CU of $14,612/QALY gained. Results were robust to model assumptions and input parameters in a sensitivity analysis but were marginal in pre-menopausal and younger women., Conclusions: Adjuvant FEC-D is a cost-effective alternative to FEC 100, with a cost-effectiveness ratio well below commonly employed thresholds. The CU according to age and menopausal status should be considered in view of the potential differences in efficacy in these subgroups, if any.

Background: In the primary core analysis of BIG 1-98, a randomized, double-blind trial comparing 5 years of initial adjuvant therapy with letrozole versus tamoxifen in postmenopausal women with hormone receptor-positive (HR+) early breast cancer, letrozole significantly improved disease-free survival by 19% and reduced the risk of breast cancer recurrence by 28% and distant recurrence by 27%., Methods: A Markov model was used to estimate the incremental cost per quality-adjusted life year (QALY) gained with 5 years of initial adjuvant therapy with letrozole versus tamoxifen from a Canadian healthcare system perspective. Probabilities of recurrence and side effects for tamoxifen were based on published results of BIG 1-98 and other published population-based studies. Corresponding probabilities for letrozole were calculated by multiplying probabilities for tamoxifen by estimated relative risks for letrozole versus tamoxifen from BIG 1-98. Other probabilities, costs of breast-cancer care and treatment of side effects, and health-state utilities were obtained from published studies. Costs and QALYs were estimated over the lifetime of a cohort of postmenopausal women with HR+ early breast cancer, aged 60 years at initiation of therapy, and discounted at 5% annually., Results: Compared with tamoxifen, letrozole yields an additional 0.368 life-years (12.453 vs. 12.086) and 0.343 QALYs (11.582 vs. 11.239). These benefits are obtained at an additional cost of Can$ 8,110 (Can$ 30,819 vs. Can$ 22,709). Cost per QALY gained for letrozole versus tamoxifen is Can$ 23,662 (95% CI Can$ 15,667-Can$ 52,014)., Conclusion: In postmenopausal women with HR+ early breast cancer, initial adjuvant treatment with letrozole is cost-effective from the Canadian healthcare system perspective.

Background: This study evaluated the cost-effectiveness of anastrozole versus generic tamoxifen for primary adjuvant treatment of postmenopausal women with hormone receptor-positive (HR+) early breast cancer (EBC), from a US healthcare perspective., Methods: A probabilistic Markov model was developed using the 5-year completed treatment analysis of the ATAC ('Arimidex', Tamoxifen Alone or in Combination) trial (ISRCTN 18233230) to project outcomes for anastrozole and tamoxifen to 25 years. Resource utilization data were obtained primarily from published literature and a physician survey (including expert opinion from ATAC Steering Committee members). Drug costs were taken from published wholesale acquisition costs (anastrozole $6.56/day, generic tamoxifen $1.33/day). Other unit costs ($US 2003-4) were from standard sources. Utility estimates of relevant health states, used to compute quality-adjusted life-years (QALYs), were collected using the standard gamble technique in a cross-sectional sample of 44 patients. Costs and benefits were discounted 3% annually., Results: In a cohort of 1000 postmenopausal women with HR+ EBC, the model showed anastrozole treatment (versus tamoxifen) would lead to 257 QALYs gained (0.26 QALYs gained per patient), at an additional cost of $5.21 million over 25 years ($5,212 per patient). The estimated incremental cost-effectiveness ratio (ICER) of anastrozole compared with tamoxifen was $20,246 per QALY gained ($23,541 per life-year gained). Cost-effectiveness acceptability curves indicated a >90% probability that the cost per QALY gained with anastrozole would be <$50,000. Results were robust in a sensitivity analysis., Conclusion: Anastrozole is a cost-effective alternative to tamoxifen for the primary adjuvant treatment of postmenopausal women with HR+ EBC.

Background: Adjuvant Anastrozole (ANA) for 5 years and Tamoxifen followed by Exemestane (TAM-EXE) for 2.5 years each have become acceptable alternatives to 5 years of Tamoxifen (TAM) for post-menopausal women with breast cancer. As these newer options are associated with higher drug costs as well as improved outcomes, an economic evaluation was undertaken to compare the cost-utility of ANA and TAM-EXE relative to TAM alone and to each other in terms of cost per quality-adjusted life year (QALY) gained., Methods: A Markov model was developed to calculate monthly costs and outcomes in a hypothetical cohort of post-menopausal women with early-stage breast cancer. Baseline rates of cancer recurrence and adverse effects with TAM, and hazard ratios associated with ANA and EXE, were derived from the ATAC and IES trials. Patients received hormonal therapy for 5 years and benefit was modeled to persist 5 years beyond treatment. The analysis took a direct payer perspective with a 20-year time horizon. Costs and outcomes were discounted by 3%. Costs are in 2005 Canadian dollars., Results: ANA and TAM-EXE were associated with increased costs and QALYs, though the cost-utility of both relative to TAM alone was strongly favourable (<$50,000/QALY). Based on an indirect comparison of ANA and TAM-EXE, using TAM alone as a common comparator, the cost-utility of ANA relative to TAM-EXE appears unfavourable., Conclusions: Both upfront and sequential AI options were cost-effective alternatives to TAM alone, but TAM-EXE appears to be the economically preferred AI option based on its more favourable cost-utility versus ANA.

Adjuvant tamoxifen therapy for 5 years reduces recurrence in hormone receptor positive, post-menopausal women with early breast cancer, but offers no advantage when prolonged to another 5 years, during which the risk of recurrence remains high. Treating patients, who remain disease-free after 5 years of tamoxifen, with letrozole significantly reduces recurrence, regardless of nodal status. This study evaluated the life-time cost-utility of extended adjuvant letrozole therapy in 62-year-old patients from a third-party payer perspective. A Markov model incorporated locoregional, contralateral, and metastatic recurrences. The comparator was placebo. Event rates were based on published trials. Utility values were taken from a clinical trial and published literature. Costs were obtained from published literature, provincial payment schedules, cancer agencies, and drug plans formularies. Resource use reflected Canadian treatment patterns. Robustness of the model was tested using deterministic and probabilistic sensitivity analyses. Extended adjuvant letrozole therapy of a cohort consisting of 50% node-negative and 50% node-positive patients prolonged their lives on average by 0.466 years or 0.267 quality-adjusted life years (QALYs) at an additional cost of Can$8,031 per patient, yielding an incremental cost-utility ratio (ICUR) of $34,058 per QALY. Letrozole was more cost-effective in node-positive than in node-negative patients (Can$26,553 vs Can$46,049 per QALY). Results were robust to variations in age, healthcare costs, and utilities. The degree of confidence that the cost per QALY would be below Can$50,000 reached 100% for node-positive and 77% for node-negative patients. Extended adjuvant letrozole is cost-effective in both node-negative and node-positive patients having ICURs below Can$50,000/QALY.

Background: Node (+) breast cancer represents over 40% of cases in older women and currently there is a debate whether adjuvant therapy for all older women is cost-effective., Purpose: To evaluate if adjuvant treatment for early-stage (Stage I-IIIa) node (+) breast cancer with hormone therapy, chemotherapy, or combination therapy is cost-effective in older patients., Design: A decision-analysis model for 65, 75, and 85 year-old female breast cancer patients using life tables integrated the cost of treatment in dollars and impact in length and quality of life. Both estrogen receptor (ER) (-) and (+) patients were considered. The primary data sources were meta-analysis from the Early Breast Cancer Trialists' Collaborative Group and the Red Book Average Wholesale Price for drugs. The cost of treatment in dollars and impact of quality of life was examined. Scenarios were used when treatment benefit was uncertain. The incremental cost-effectiveness of different treatment strategies were then compared and mapped graphically., Results: Adjuvant therapy is cost-effective in 65 year-old women with early breast cancer. In a 75 year-old ER (+) patient, hormone therapy is cost-effective, $10,965/quality-adjusted life years (QALY), but chemotherapy was more cost-effective, $27,406/QALY, if one assumed it was as efficacious as in a 65 year-old woman. In a 75 year-old ER (-) patient, chemotherapy was cost-effective at $42,605 with the same assumption. In an 85 year-old ER (+) patient, hormone therapy was cost-effective, $26,463/QALY, if efficacy is not age-sensitive, but chemotherapy was not as cost-effective for either ER (+) or ER (-) patients., Conclusion: Treatment decisions for older breast cancer patients suffer from the lack of sufficient clinical trial data. Decision-analytic models can help policy makers who are faced with decisions about whether to support adjuvant therapy in older breast cancer patients and also outline the important parameters that need to be considered in such a decision.

Objectives: In 1999, California was considering legislation to fund breast cancer treatment for its uninsured. We sought to define the most cost-effective breast cancer benefits package in order to inform this debate., Methods: We use cost-effectiveness analysis to calculate the additional costs and benefits of various adjuvant therapy strategies, radiation after breast conserving surgery, and reconstruction compared to those of surgery alone in order to define the most cost-effective breast cancer benefits package for uninsured women., Results: Using cost-effectiveness analysis, we define a Minimum Breast Cancer Benefits Package that includes only the most cost-effective life-saving breast cancer treatments. To provide these benefits for an estimated 550 breast cancer patients will cost $10,200,000. We present two options that each cost an additional $1,700,000 - to expand the benefits to these patients to include post-mastectomy radiation and breast reconstruction; or to provide the Minimum Package to an additional 93 uninsured women., Conclusions: California legislators must decide whether to offer comprehensive benefits to a limited number of breast cancer patients or to provide only the most life-saving treatments to a greater number of women.

Background: We have developed a decision analysis model that uses the results of available randomized controlled trials to model the natural history of early breast cancer and assess the potential clinical and financial effects of using adjuvant therapies., Patients and Methods: The original model was used to assess the impact of chemotherapy in hypothetical groups of 45-year-old and 60-year-old node-negative, estrogen receptor-negative women. Using the 1992 Early Breast Cancer Trialists' Collaborative Group report, we have expanded and revised the model to assess: 1) the role of tamoxifen alone, chemotherapy alone, or combined therapy in pre-menopausal women, and 2) chemotherapy in elderly women with node-negative, estrogen receptor-negative cancer., Results: For pre-menopausal women, we found that chemotherapy increases quality adjusted life expectancy and survival by a substantial amount at a cost less than most accepted medical interventions. Combined therapy is beneficial and cost-effective in estrogen receptor-positive cancer. For the elderly, chemotherapy prolongs survival but to a lesser extent compared to younger women. The cost of this benefit is high but within the range of commonly reimbursed procedures for women under age 75 without other co-existing conditions., Conclusions: For most patients some form of adjuvant therapy is beneficial and cost-effective. The model builds upon the data derived from collaborative efforts assessing the effectiveness of adjuvant therapies. The model highlights the need for an equal commitment to assessing the economic and quality of life impacts of breast cancer treatments.