Clinical outcomes of patients after nipple-sparing mastectomy and reconstruction based on the expander/implant technique.

Advances in multi-modality treatments incorporating systemic chemotherapy, endocrine therapy, and radiotherapy for the management of breast cancer have resulted in a surgical-management paradigm change toward less-aggressive surgery that combines the use of breast-conserving or -reconstruction therapy as a new standard of care with a higher emphasis on cosmesis. The implementation of skin-sparing and nipple-sparing mastectomies (SSM, NSM) has been shown to be oncologically safe, and breast reconstructive surgery is being performed increasingly for patients with breast cancer. NSM and breast reconstruction can also be performed as prophylactic or risk-reduction surgery for women with BRCA gene mutations. Compared with conventional breast construction followed by total mastectomy (TM), NSM preserving the nipple-areolar complex (NAC) with breast reconstruction provides psychosocial and aesthetic benefits, thereby improving patients' cosmetic appearance and body image. Implant-based breast reconstruction (IBBR) has been used worldwide following mastectomy as a safe and cost-effective method of breast reconstruction. We review the clinical evidence about immediate (one-stage) and delayed (two-stage) IBBR after NSM. Our results suggest that the postoperative complication rate may be higher after NSM followed by IBBR than after TM or SSM followed by IBBR.

The relationship between contralateral prophylactic mastectomy and breast reconstruction, complications, breast-related procedures, and costs: A population-based study of health insurance data.

BACKGROUND: Increasingly, women are undergoing contralateral prophylactic mastectomy for the treatment of unilateral breast cancer. The relationship between contralateral prophylactic mastectomy and breast reconstruction, postsurgical complications, additional breast-related procedures, and cost has not received the attention it deserves. METHODS: Data from the New York comprehensive, all-age, all-payer, Statewide Planning and Research Cooperative System were queried to identify patients undergoing unilateral mastectomy or contralateral prophylactic mastectomy from 2008 to 2010. We identified the complications and breast-related procedures within a 2-y follow-up period. Costs of the index operation and subsequent follow-up were estimated. Univariate and multivariate analyses were conducted. RESULTS: Of 12,959 women identified, 10.7% underwent contralateral prophylactic mastectomy. On univariate analysis, contralateral prophylactic mastectomy was positively associated with breast reconstruction, complications, and additional breast-related procedures. Rates of complications were greater for women who had contralateral prophylactic mastectomy (29.5% vs 20.8% for unilateral mastectomy group; P < .001), but not after stratifying by breast reconstruction. Additional breast-related procedures were more common in the contralateral prophylactic mastectomy group than in the unilateral mastectomy group, but only for those who underwent breast reconstruction (82.8% vs 72.1%; P < .001). Unadjusted costs were greater for women with contralateral prophylactic mastectomy than with unilateral mastectomy but did not differ between the groups after adjusting for breast reconstruction and additional breast-related procedures. CONCLUSION: Women who elected contralateral prophylactic mastectomy in this population-based study were more likely to have both breast reconstruction and additional breast-related procedures than women with unilateral mastectomy. The greater rates of complications and costs associated with contralateral prophylactic mastectomy were explained by breast reconstruction and additional breast-related procedures. Surgeons should counsel patients regarding the increased cost and likelihood of undergoing additional, non-complication-related procedures after contralateral prophylactic mastectomy with breast reconstruction.

Socioeconomic Factors Associated with the Receipt of Contralateral Prophylactic Mastectomy in Women with Breast Cancer.

Background: Contralateral prophylactic mastectomy (CPM) treatments have been on the rise among white women with early stage unilateral breast cancer who have a higher socioeconomic status (SES) and private insurance. Low income and uninsured women are not choosing CPM at the same rate. The purpose of this study was to evaluate the socioeconomic factors related to the choice of surgical treatment in women diagnosed with unilateral breast cancer in the state of New Jersey. Materials and Methods: This retrospective study of 10 years of breast cancer data abstracted from the New Jersey State Cancer Registry utilized bivariate analyses and two multivariate logistic regression models to analyze the effect of socioeconomics on choice of surgical treatment. Results: In New Jersey, 52,529 women were treated for breast cancer from 2004 to 2014. CPM rates increased gradually over time from 3.72% in 2004 to 10.82% in 2014 with women more likely to choose CPM if they were younger, white, and had private insurance (p < 0.001). The single factor that was most predictive of choosing CPM was access to immediate reconstruction (odds ratio 2.36, confidence interval 2.160-2.551). Women with low SES were much less likely to choose CPM. Conclusions: Results of this study may provide incentive for researchers to assess the impact of culture, race/ethnicity, and socioeconomics on a woman's interactions with health care providers so as to allow all women regardless of SES to express their needs, concerns, and wishes when confronted with a breast cancer diagnosis.

The budgetary impact of genetic testing for hereditary breast cancer for the statutory health insurance.

Objectives: Potential opportunities and challenges of predictive genetic risk classification of healthy persons are currently discussed. However, the budgetary impact of rising demand is uncertain. This project aims to evaluate budgetary consequences of predictive genetic risk classification for statutory health insurance in Germany.Methods: A Markov model was developed in the form of a cohort simulation. It analyzes a population of female relatives of hereditary breast cancer patients. Mutation carriers are offered intensified screening, women with a BRCA1 or BRCA2 mutation can decide on prophylactic mastectomy and/or ovarectomy. The model considers the following scenarios: (a) steady demand for predictive genetic testing, and (b) rising demand. Most input parameters are based on data of the German Consortium for Hereditary Breast and Ovarian Cancer. The model contains 49 health states, starts in 2015, and runs for 10 years. Prices were evaluated from the perspective of statutory health insurance.Results: Steady demand leads to an expenditure of €49.8 million during the 10-year period. Rising demands lead to additional expenses of €125.5 million. The model reveals the genetic analysis to be the main cost driver while cost savings in treatment costs of breast and ovarian cancer are indicated.Conclusions: The results contribute to close the knowledge gap concerning the budgetary consequences due to genetic risk classification. A rising demand leads to additional costs especially due to costs for genetic analysis. The model indicates budget shifts with cost savings due to breast and ovarian cancer treatment in the scenario of rising demands.

Impact of anticipated financial burden on patient decision to undergo contralateral prophylactic mastectomy.

BACKGROUND: We sought to determine whether patients undergoing contralateral, prophylactic mastectomy have greater anticipated and actual costs and financial burden than patients undergoing unilateral mastectomy, whether these financial considerations influence surgical decision making, and whether this affects satisfaction with surgical decision and overall quality of life. METHODS: Female patients with unilateral breast cancer who underwent mastectomy at a large academic institution were surveyed regarding their financial experience surrounding the decision whether to undergo contralateral, prophylactic mastectomy. RESULTS: Of 109 patients approached, 101 completed the survey (response rate: 93%); 55 patients (55%) had contralateral, prophylactic mastectomy. Of the respondents, 16% reported that their decision was at least somewhat affected by anticipated costs. More patients opting for contralateral, prophylactic mastectomy had a "very large" anticipated financial burden than unilateral mastectomy patients (26% vs 9%, P = .037), but actual out-of-pocket costs and financial burden were similar between the two groups. Contralateral, prophylactic mastectomy patients, however, did not differ from unilateral mastectomy patients in their satisfaction with their decision nor quality of life, regardless of out-of-pocket costs or financial burden (P > .05). CONCLUSION: Although contralateral, prophylactic mastectomy patients are more likely to anticipate a "very large" financial burden compared with unilateral mastectomy patients, this does not seem to deter them from the contralateral procedure.

The effect of contralateral prophylactic mastectomy on breast-related charges: A 5-year analysis.

BACKGROUND AND OBJECTIVES: The purpose of this study was to determine charges following unilateral mastectomy (UM) and bilateral mastectomy (BM) for patients with unilateral breast cancer (UBC). We hypothesized that BM may be associated with fewer charges over time. METHODS: A retrospective review was conducted of patients with UBC treated between 2006 and 2010 with UM and BM in a large healthcare system. Institutional billing data were investigated for 5 years postoperatively to calculate the immediate and subsequent charges of all inpatient and outpatient breast-related care associated with the initial diagnosis for a subset of patients identified using propensity score matching method. RESULTS: A subset of matched patients (n = 320) undergoing UM (n = 160) or BM (n = 160) were included in this analysis. At 1 year, there was a trend toward lower total charges following UM as compared with BM (median, $125 230 vs $138 467; P = .6075). However, during years 2 to 5, total charges were significantly higher following UM vs BM ($22 128 vs $13 478; P = .0116). CONCLUSIONS: While initially higher, overall charges for BM are lower than UM between 2 and 5 years out from surgery. Further study is necessary to determine if this trend is sustained over the long term. These data can inform patient decision making regarding mastectomy for their breast cancer.

The Cost of Contralateral Prophylactic Mastectomy in Women with Unilateral Breast Cancer.

BACKGROUND: Contralateral prophylactic mastectomy may be unnecessary from an oncologic perspective; therefore, the debate persists about the value of contralateral prophylactic mastectomy in women with early-stage unilateral breast cancer. Given finite health care resources, this study aims to evaluate the cost of contralateral prophylactic mastectomy and breast reconstruction. METHODS: Women with unilateral breast cancer undergoing either unilateral mastectomy or unilateral mastectomy with contralateral prophylactic mastectomy and immediate breast reconstruction were selected from the Truven MarketScan databases between 2009 and 2013. Demographic and treatment data were recorded, and over an 18-month follow-up period, the treatment cost was tallied. A log-transformed linear model was used to compare cost between the groups. RESULTS: A total of 2343 women were identified who met our inclusion criteria, with 1295 undergoing unilateral mastectomy and 1048 undergoing contralateral prophylactic mastectomy. Complication rates within 18 months were similar for women undergoing unilateral mastectomy and contralateral prophylactic mastectomy (39 percent versus 42 percent; p = 0.17). Management with unilateral mastectomy with reconstruction required an adjusted cumulative mean cost of $33,557. Contralateral prophylactic mastectomy with reconstruction was an additional $11,872 in expenditure (p < 0.001). The cost of initial procedures (mean difference, $6467) and secondary procedures (mean difference, $2455) were the greatest contributors to cost. CONCLUSIONS: In women with unilateral breast cancer, contralateral prophylactic mastectomy with reconstruction is more costly. The increased monetary cost of contralateral prophylactic mastectomy may be offset by improved quality of life. However, this financial reality is an important consideration when ongoing efforts toward reimbursement reform may not pay for contralateral prophylactic mastectomy if outcomes data are not presented to justify this procedure.

Cost effectiveness of population based BRCA1 founder mutation testing in Sephardi Jewish women.

BACKGROUND: Population-based BRCA1/BRCA2 founder-mutation testing has been demonstrated as cost effective compared with family history based testing in Ashkenazi Jewish women. However, only 1 of the 3 Ashkenazi Jewish BRCA1/BRCA2 founder mutations (185delAG[c.68_69delAG]), 5382insC[c.5266dupC]), and 6174delT[c.5946delT]) is found in the Sephardi Jewish population (185delAG[c.68_69delAG]), and the overall prevalence of BRCA mutations in the Sephardi Jewish population is accordingly lower (0.7% compared with 2.5% in the Ashkenazi Jewish population). Cost-effectiveness analyses of BRCA testing have not previously been performed at these lower BRCA prevalence levels seen in the Sephardi Jewish population. Here we present a cost-effectiveness analysis for UK and US populations comparing population testing with clinical criteria/family history-based testing in Sephardi Jewish women. STUDY DESIGN: A Markov model was built comparing the lifetime costs and effects of population-based BRCA1 testing, with testing using family history-based clinical criteria in Sephardi Jewish women aged ≥30 years. BRCA1 carriers identified were offered magnetic resonance imaging/mammograms and risk-reducing surgery. Costs are reported at 2015 prices. Outcomes include breast cancer, ovarian cancer, and excess deaths from heart disease. All costs and outcomes are discounted at 3.5%. The time horizon is lifetime, and perspective is payer. The incremental cost-effectiveness ratio per quality-adjusted life-year was calculated. Parameter uncertainty was evaluated through 1-way and probabilistic sensitivity analysis. RESULTS: Population testing resulted in gain in life expectancy of 12 months (quality-adjusted life-year = 1.00). The baseline discounted incremental cost-effectiveness ratio for UK population-based testing was £67.04/quality-adjusted life-year and for US population was $308.42/quality-adjusted life-year. Results were robust in the 1-way sensitivity analysis. The probabilistic sensitivity analysis showed 100% of simulations were cost effective at £20,000/quality-adjusted life-year UK and the $100,000/quality-adjusted life-year US willingness-to-pay thresholds. Scenario analysis showed that population testing remains cost effective in UK and US populations, even if premenopausal oophorectomy does not reduce breast cancer risk or if hormone replacement therapy compliance is nil. CONCLUSION: Population-based BRCA1 testing is highly cost effective compared with clinical criteria-driven approach in Sephardi Jewish women. This supports changing the paradigm to population-based BRCA testing in the Jewish population, regardless of Ashkenazi/Sephardi ancestry.

Cost-effectiveness Analysis of Contralateral Prophylactic Mastectomy Compared to Unilateral Mastectomy with Routine Surveillance for Unilateral, Sporadic Breast Cancer.

BACKGROUND: Contralateral prophylactic mastectomy (CPM) rates in younger women with unilateral breast cancer have more than doubled. Studies of cost and quality of life of the procedure remain inconclusive. METHODS: A cost-effectiveness analysis using a decision-tree model in TreeAge Pro 2015 was used to compare long-term costs and quality of life following unilateral mastectomy (UM) with routine surveillance versus CPM for sporadic breast cancer in women aged 45 years. A 10-year risk period for contralateral breast cancer (CBC), reconstruction, wound complications, cost of routine surveillance, and treatment for CBC were used to estimate accrued costs. In addition, a societal perspective was used to estimate quality-adjusted life years (QALYs) following either treatment for a period of 30 years. Medical costs were obtained from the 2014 Medicare physician fee schedule and event probabilities were taken from recent literature. RESULTS: The mean cost of UM with surveillance was $14,141 and CPM was $20,319. Treatment with CPM resulted in $6178 more in costs but equivalent QALYs (17.93) compared with UM over 30 years of follow-up. Even with worst-case scenario and varying assumptions, CPM is dominated by UM in terms of cost and quality. CONCLUSIONS: From this refined model, UM with routine surveillance costs less and provides an equivalent quality of life. Patients undergoing CPM may eliminate the anxiety of routine surveillance, but they face the burden of higher lifetime medical costs.

[Entitlement to prophylactic treatment in cases of genetic predisposition for breast cancer : Interdisciplinary perspectives]. / Leistungsanspruch auf prophylaktische Behandlung bei genetischer Prädisposition für Brustkrebs : Interdisziplinäre Perspektiven.

Genetic tests can detect the predisposition to various diseases. The demand for gene diagnostics and corresponding prophylactic measures is increasing steadily. In the German healthcare system, however, legal uncertainties exist as to whether a mere risk of disease is reason enough to bear the costs for prophylactic measures. When medically effective prophylactic measures are available in certain cancer diseases, such as in hereditary breast cancer, the current practice of deciding in individual cases appears to be insufficient.The fact that persons with a high or very increased risk of breast cancer are precluded from a standard care procedure raises questions concerning ethical justification as well as medical plausibility. Moreover, it is remarkable that the statutory healthcare system treats persons at risk differently. In some cases there is a regulated way of reimbursement for preventive measures for persons at risk (factor V Leiden mutation) and in other cases there are only case-by-case decisions. Finally, in light of social regulations for persons at high and very increased risk this article considers the need of optimization regarding the risk communication in the decision-making process and the crucial question of budgetary impact for the German healthcare system.From a medical, ethical and legal perspective, a social regulation for persons at high and very increased risk of disease is inevitable and the consequences should be discussed in advance.

Contralateral Prophylactic Mastectomy with Immediate Breast Reconstruction Increases Healthcare Utilization and Cost.

BACKGROUND: The rates of contralateral prophylactic mastectomy (CPM) in women with unilateral breast cancer continue to rise, especially in women undergoing immediate breast reconstruction (IBR). METHODS: We utilized administrative claims data from a large US commercial insurance database (OptumLabs) to identify women age 18-64 years who underwent IBR between January 2004 and December 2013. We compared 2-year unadjusted utilization rates and total costs of care between unilateral mastectomy (UM) and bilateral mastectomy (BM) for implant-based and autologous reconstruction. Comparisons were tested using t-test and differences in cost were estimated using the Wilcoxon rank-sum test. RESULTS: Overall, 11,235 women undergoing mastectomy with IBR were identified; 7319 with implant reconstruction [1923 UM (26%) and 5396 BM (74%)] and 3916 with autologous reconstruction [1687 UM (43%) and 2229 BM (57%)]. The overall rate of office visits (2386 vs. 2391 per 100 women, p = 0.42) and hospital readmission rate (29.1 per 100 women vs. 27.4, p = 0.06) were similar between BM + IBR and UM + IBR. Women undergoing BM + IBR had a higher emergency room (ER) visit rate (34.1 per 100 women vs. 29.8, p < 0.0001). The total 2-year cost of care was higher for BM + IBR than UM + IBR for implant reconstruction ($106,711 vs. $97,218, p < 0.0001) and for autologous reconstruction ($114,725 vs. $87,874, p < 0.0001). CONCLUSIONS: BM + IBR (autologous or implant) was associated with increased ER visits and higher total cost of care over 2 years compared with UM + IBR. Patients considering CPM should be counseled on the additional risks and costs associated with BM + IBR.

Cost-effectiveness of population based BRCA testing with varying Ashkenazi Jewish ancestry.

BACKGROUND: Population-based BRCA1/BRCA2 testing has been found to be cost-effective compared with family history-based testing in Ashkenazi-Jewish women were >30 years old with 4 Ashkenazi-Jewish grandparents. However, individuals may have 1, 2, or 3 Ashkenazi-Jewish grandparents, and cost-effectiveness data are lacking at these lower BRCA prevalence estimates. We present an updated cost-effectiveness analysis of population BRCA1/BRCA2 testing for women with 1, 2, and 3 Ashkenazi-Jewish grandparents. STUDY DESIGN: Decision analysis model. METHODS: Lifetime costs and effects of population and family history-based testing were compared with the use of a decision analysis model. 56% BRCA carriers are missed by family history criteria alone. Analyses were conducted for United Kingdom and United States populations. Model parameters were obtained from the Genetic Cancer Prediction through Population Screening trial and published literature. Model parameters and BRCA population prevalence for individuals with 3, 2, or 1 Ashkenazi-Jewish grandparent were adjusted for the relative frequency of BRCA mutations in the Ashkenazi-Jewish and general populations. Incremental cost-effectiveness ratios were calculated for all Ashkenazi-Jewish grandparent scenarios. Costs, along with outcomes, were discounted at 3.5%. The time horizon of the analysis is "life-time," and perspective is "payer." Probabilistic sensitivity analysis evaluated model uncertainty. RESULTS: Population testing for BRCA mutations is cost-saving in Ashkenazi-Jewish women with 2, 3, or 4 grandparents (22-33 days life-gained) in the United Kingdom and 1, 2, 3, or 4 grandparents (12-26 days life-gained) in the United States populations, respectively. It is also extremely cost-effective in women in the United Kingdom with just 1 Ashkenazi-Jewish grandparent with an incremental cost-effectiveness ratio of £863 per quality-adjusted life-years and 15 days life gained. Results show that population-testing remains cost-effective at the £20,000-30000 per quality-adjusted life-years and $100,000 per quality-adjusted life-years willingness-to-pay thresholds for all 4 Ashkenazi-Jewish grandparent scenarios, with ≥95% simulations found to be cost-effective on probabilistic sensitivity analysis. Population-testing remains cost-effective in the absence of reduction in breast cancer risk from oophorectomy and at lower risk-reducing mastectomy (13%) or risk-reducing salpingo-oophorectomy (20%) rates. CONCLUSION: Population testing for BRCA mutations with varying levels of Ashkenazi-Jewish ancestry is cost-effective in the United Kingdom and the United States. These results support population testing in Ashkenazi-Jewish women with 1-4 Ashkenazi-Jewish grandparent ancestry.

Cost-effectiveness of risk-reducing surgeries in preventing hereditary breast and ovarian cancer.

OBJECTIVES: Risk-reducing surgeries are a feasible option for mitigating the risk in individuals with inherited susceptibility to cancer, but are the procedures cost-effective in the current health-care system in Germany? This study compared the health-care costs for bilateral risk-reducing mastectomy (BRRM) and risk-reducing (bilateral) salpingo-oophorectomy (RRSO) with cancer treatment costs that could potentially be prevented. PATIENTS AND METHODS: The analysis is based on interdisciplinary consultations with individuals with a high familial risk for breast and ovarian cancer at the University Breast Center for Franconia (Germany) between 2009 and 2013 (370 consultations; 44 patients with BRCA1 mutations and 26 with BRCA2 mutations). Health-care costs for risk-reducing surgeries in BRCA mutation carriers were calculated as reimbursements in the German diagnosis-related groups (DRG) hospital pricing system. These costs for the health-care system were compared with the potential cancer treatment costs that could possibly be prevented by risk-reducing surgeries. RESULTS: Long-term health-care costs can be reduced by risk-reducing surgeries after genetic testing in BRCA mutation carriers. The health-care system in Germany would have saved € 136,295 if BRRM had been performed and € 791,653 if RRSO had been performed before the development of cancer in only 50% of the 70 mutation carriers seen in our center. Moreover, in patients with combined RRSO and BRRM (without breast reconstruction), one further life-year for a 40-year-old BRCA mutation carrier would cost € 2,183. CONCLUSION: Intensive care, including risk-reducing surgeries in BRCA mutation carriers, is cost-effective from the point of view of the health-care system in Germany.

[Latest international guidelines for screening, prevention and treatment of familial breast cancer - implications for the relevant practice in Hungary]. / Az örökletes emlorák szurésének, megelozésének és kezelésének új nemzetközi irányvonalai - hazai vonatkozásokkal.

INTRODUCTION: Screening, prevention and treatment of familial breast cancer require a multidisciplinary approach. New guidelines were published in the United Kingdom for the management of familial breast cancer. AIM: The authors summarise these new guidelines and analyse the relevant practice in Hungary. METHOD: Relevant guidelines of the National Institute for Health and Care Excellence and Familial Breast Cancer Report (NHS Scotland) are described. RESULTS: New guidelines will increase the number of genetic tests as well as genetic counselling. An increase in the number of breast magnetic resonance imaging is expected, too. Chemoprevention can be offered for individuals with medium risk and above. Promising trials are underway with platinum based chemotherapy and polyADP-ribose polimerase inhibitors for the systemic treatment of familial breast cancer. The increase in the number of genetic tests, counselling, and breast magnetic resonance imaging may have a significant impact on health care budget. CONCLUSIONS: These guidelines will change some aspects of the current management of familial breast cancer. Orv. Hetil., 2016, 157(28), 1117-1125.