Pharmacoeconomic issues in bisphosphonate treatment of metastatic bone disease.

Bisphosphonates provide a supportive benefit to patients with bone metastases from cancer by reducing skeletal complications, such as bone pain, pathologic fractures, and hypercalcemia. Although bisphosphonates have important therapeutic effects, such as significant improvements in the quality of remaining life, they do not, as yet, significantly improve the overall survival of affected patients. Furthermore, as with all new innovations, they exert a major impact on drug budgets dedicated for cancer care. Further research is warranted to identify clinical predictors of the optimum time in the course of the disease to start and stop therapy, to integrate use of bisphosphonates with other therapies, to identify their role in the adjuvant setting, and to determine their cost-benefit consequences. Current cost-effectiveness assessments have shown that the incremental costs per skeletal-related event are particularly sensitive to the unit price of the bisphosphonate modeled. Therefore, pharmacoeconomic evaluations should be combined with clinical trials to predict accurately the true costs (total resource usage) of this health care intervention and to ultimately assess the rational broad use of these agents.

Burden of illness associated with metastatic melanoma: an audit of 100 consecutive referral center cases.

BACKGROUND: Although long-term survival in patients with metastatic melanoma (MM) is infrequent, response to a variety of cytotoxic and immunotherapies occurs and survival varies based on the site of metastases. Because different patterns of care of MM are likely to vary substantially in their intensity and resource use, the authors audited care at a regional referral center. METHODS: The records of 100 consecutive new patients with MM who presented at the University of Pittsburgh Cancer Institute (UPCI) after January 1997 were audited. Demographics, disease sites, and treatment prior to presentation at UPCI as well as the diagnostic and therapeutic methods undertaken at UPCI were tracked monthly with regard to inpatient and outpatient activity. RESULTS: The median age of the patient cohort was 51 years was a median 2.2 years after the time of initial diagnosis. Eighty-two percent of the patients had died and only 8% had been lost to long-term follow-up. Eighty-seven percent of patients had been referred to UPCI and 28% had received some treatment prior to presenting at UPCI. The median survival was 9.0 months. The lung was the most common symptomatic site and 38% of patients developed central nervous system (CNS) metastases. Eighty-four percent of patients initially were treated on a research protocol 30% of whom were part of a Phase III study. Twenty-nine percent of the patients were never hospitalized. The most common reason for hospitalization was elective treatment with high-dose interleukin-2. Lifetime hospital days averaged only 7.3 days. Therapeutic actions (if ever given) by category type were surgery in 23% of patients, radiation therapy in 44%, immunotherapy in 75%, and chemotherapy in 51%. Using assigned values for the identified resources used, the approximate cost per patient averaged $59,400. CONCLUSIONS: The current audit of MM patients demonstrated that lung and CNS metastases dominate a broad variety of complications, that clinical trial participation was the norm, that hospitalizations occurred relatively infrequently, and that the direct health care costs of current treatment patterns are among the highest for all malignancies. Medical auditing of contemporary American cancer care provides meaningful insights into its patterns of care.

Cost-effectiveness analysis of exemestane compared with megestrol in patients with advanced breast carcinoma.

BACKGROUND: The objective of this study was to determine the potential economic implications resulting from using exemestane (EXE), a new steroidal, irreversible aromatase inactivator, compared with megestrol acetate (MA) in patients with advanced breast carcinoma. METHODS: The model used the clinical results from the manufacturer-sponsored, international, randomized, controlled, double-blind trial of patients with postmenopausal, tamoxifen-refractory advanced breast carcinoma. Seven hundred sixty-nine women were randomized to EXE 25 mg per day or MA 40 mg four times daily EXE was well tolerated, significantly delayed tumor progression (relative risk [RR], 0.82; 95% confidence interval [95% CI], 0.70-0.97), and prolonged survival (RR, 0.77; 95% CI, 0.59-0.99). Lifetime effectiveness projections were made using the trial efficacy results to the U.S. market using a 1000-day ( approximately 3-year) time frame. Because the median survival of patients who received EXE was not reached, it was projected from the Cox model. There were no differences in the rate of hospitalization. The average wholesale prices for EXE and MA were used. RESULTS: Patients who received EXE were projected to have a mean survival benefit of 53.5 days (estimated 95% CI, 2-100 days) and to incur at an additional cost of $1559 per patient (estimated 95% CI, 880-2075 dollars). The incremental cost effectiveness (CE) ratio using EXE was 10,600 dollars per life year gained (estimated 95% CI, 6200-209,000 dollars). If MA had no costs, then the CE ratio increased to 12,200 dollars per life year. Using a 5-year projection, the CE ratio for EXE was 5900 dollars per life year. The projected survival at 1000 days was 53.9% in the EXE cohort compared with 44.8% in the MA cohort. CONCLUSIONS: EXE, compared with MA, is projected to increase survival at a modest added cost. If treatment with EXE delays or defers initiating more costly therapies, then it may even be cost saving.

Post hoc economic analysis of temozolomide versus dacarbazine in the treatment of advanced metastatic melanoma.

PURPOSE: To determine the potential economic implications resulting from oral temozolomide (TEM) compared with intravenous (IV) dacarbazine (DTIC) for metastatic melanoma. PATIENTS AND METHODS: We performed a cost-effectiveness (CE) analysis using hazard ratios (HRs) from the phase III (Schering I95-018) trial comparing TEM 200 mg/m(2)/d orally for 5 days every 28 days with DTIC 250 mg/m(2)/d IV for 5 days every 21 days. Sensitivity analyses assessed a range of TEM's efficacy and costs, direct nonmedical costs, and the DTIC schedule. RESULTS: The trial found an overall survival trend favoring TEM; median survival times of patients treated with DTIC and TEM were 6.4 and 7.7 months, respectively (HR = 1.18; 95% confidence interval [CI], 0.92 to 1.52; intention to treat, P =.20). The mean increase in survival of TEM over DTIC was 1.1 months. The projected average costs per patient were greater with TEM than DTIC ($6,902 v $3,697, respectively). The incremental CE ratio using TEM was $36,990 per life-year or $101 per day of life gained. The CE ratio's 95% CI ranged from -$65,180 (DTIC is more effective) to $18, 670 per year of life gained. The CE ratios decreased 50% if direct nonmedical costs were included and increased 50% if DTIC's efficacy was unchanged if given as a single daily dosage. Sixty percent of simulations found TEM with a CE threshold of less than $50,000 per life-year gained. CONCLUSION: Although the base-case efficacy of TEM compared with DTIC was not statistically significant, its associated incremental CE would be comparable with many interventions. TEM for metastatic melanoma illustrates the tension confronting providers choosing between similar agents that markedly differ in convenience and costs.

Pamidronate in prevention of bone complications in metastatic breast cancer: a cost-effectiveness analysis.

PURPOSE: Pamidronate is effective in reducing bony complications in patients with metastatic breast cancer who have known osteolytic lesions. However, pamidronate does not increase survival and is associated with additional financial costs and inconvenience. We conducted a post-hoc evaluation of the cost-effectiveness of pamidronate using the results of two randomized trials that evaluated pamidronate 90 mg administered intravenously every month versus placebo. PATIENTS AND METHODS: The trials differed only in the initial systemic therapy administered (hormonal or chemotherapy). Total skeletal related events (SREs), including surgery for pathologic fracture, radiation for fracture or pain control, conservatively treated pathologic fracture, spinal cord compression, or hypercalcemia, were taken directly from the trials. Using a societal perspective, direct health care costs were assigned to each SRE. Each group's monthly survival was equal and was projected to decline using observed median survivals. The cost of pamidronate reflected the average wholesale price of the drug plus infusion. The value or disutility of an adverse event per month was evaluated using a zero value (events avoided) or an assigned one (range, 0.2 to 0.8). RESULTS: The cost of pamidronate therapy exceeded the cost savings from prevented adverse events. The difference between the treated and placebo groups was larger with hormonal systemic therapy than with chemotherapy (additional $7,685 compared with $3,968 per woman). The projected net cost per SRE avoided was $3,940 with chemotherapy and $9,390 with hormonal therapy. The cost-effectiveness ratios were $108,200 with chemotherapy and $305, 300 with hormonal therapy per quality-adjusted year. CONCLUSION: Although pamidronate is effective in preventing a feared, common adverse outcome in metastatic breast cancer, its use is associated with high incremental costs per adverse event avoided. The analysis is most sensitive to the costs of pamidronate and pathologic fractures that were asymptomatic or treated conservatively.

Tamoxifen should be cost-effective in reducing breast cancer risk in high-risk women.

PURPOSE: To estimate the cost-effectiveness of tamoxifen in the prevention of breast cancer. PATIENTS AND METHODS: Clinical trial results of National Surgical Adjuvant Breast Program P-1 compared tamoxifen versus placebo in the prevention of breast cancer, and direct medical care costs were estimated from the Agency for Health Care Policy and Research and local sources. The base estimate of effectiveness included all women on the trial. RESULTS: For every 100 women treated for 5 years, 1.665 expected cancers would not be detected. If breast cancer death is fully prevented by this strategy, then the cost-effectiveness of tamoxifen compared with no intervention is $8,479 per additional year of life gained. If lifetime prevention of the risk of death from breast cancer exceeded 17%, then the cost-effectiveness ratio would be less than $50,000 per year of life gained (a common benchmark). CONCLUSIONS: Tamoxifen for breast cancer prevention should be cost-effective under nearly all circumstances. Its use will require additional resources because it is not cost saving, but it fits within accepted guidelines.

Cost-effectiveness of adding an electron-beam boost to tangential radiation therapy in patients with negative margins after conservative surgery for early-stage breast cancer.

PURPOSE: Electron-beam boosts (EBB) are routinely added after conservative surgery and tangential radiation therapy (TRT) for early-stage breast cancer. We performed an incremental cost-utility analysis to evaluate their cost-effectiveness. METHODS: A Markov model examined the impact of adding an EBB to TRT from a societal perspective. Outcomes were measured in quality-adjusted life years (QALYs). On the basis of the Lyon trial, the EBB was assumed to reduce local recurrences by approximately 2% at 10 years but to have no impact on survival. Patients' utilities were used to adjust for quality of life. Given the small absolute benefit of the EBB, baseline utilities were assumed to be the same with or without it, an assumption evaluated by Monte Carlo simulation. Direct medical, time, and travel costs were considered. RESULTS: Adding the EBB led to an additional cost of $2,008, an increase of 0.0065 QALYs and, therefore, an incremental cost-effectiveness ratio of over $300,000/QALY. In a sensitivity analysis, the ratio was moderately sensitive to the efficacy and cost of the EBB and highly sensitive to patients' utilities for treatment without it. Even if patients do value a small risk reduction, the mean cost-effectiveness ratio estimated by the Monte Carlo simulation remains high, at $70,859/QALY (95% confidence interval, $53,141 to $105,182/QALY). CONCLUSION: On the basis of currently available data, the cost-effectiveness ratio for the EBB is well above the commonly cited threshold for cost-effective care ($50,000/QALY). The EBB becomes cost-effective only if patients place an unexpectedly high value on the small absolute reduction in local recurrences achievable with it.

Is the use of radiation therapy after mastectomy cost-effective?

With the publication of two randomized trials showing an improvement in overall survival after the use of postmastectomy radiation therapy, interest in the use of radiation therapy in this setting has been rekindled. These results are in contrast to those reported in the most recent meta-analysis of the Early Breast Cancer Trialists' Collaborative Group, in which a statistically significant survival benefit was not detected. Although evidence of a survival benefit was sufficient in the past for an intervention to gain acceptance, payers are increasingly interested in knowing whether its use is also cost-effective. This article briefly reviews the methods used in performing cost-effectiveness analyses, summarizes the results of one published and a second preliminary cost-effectiveness analysis of postmastectomy radiation therapy, and highlights several areas for future research.

A sociodemographic and economic comparison of breast reconstruction, mastectomy, and conservative surgery.

BACKGROUND: There are a variety of surgical choices for women with early-stage breast cancer, including breast-conserving surgery, mastectomy, or mastectomy plus reconstructive surgery. This report examines some of the factors that affect these choices and the costs of the various treatment options. METHODS: Data from the Virginia Cancer Registry were linked to insurance claims from the Trigon Blue Cross and Blue Shield Company for women with local and regional staged breast cancer from 1989 to 1991 in Virginia. Multivariate analyses and cost studies were performed. RESULTS: There were 592 women who underwent breast-conserving surgery (BCS, 26%), mastectomy (58%), or mastectomy plus reconstruction (16%). Increasing age reduced the use of reconstruction. The choice of reconstruction was not affected by tumor size, nodal status, or race. Sixty percent of women had immediate breast reconstruction at the time of mastectomy; the majority had the implant procedure. The cost of BCS ($21,582) was higher than that of mastectomy ($16,122, P < .01). The costs for BCS and mastectomy were significantly lower than for mastectomy plus reconstruction ($31,047, P < .05). The 2-year cost for immediate reconstruction was $8200 less than for delayed procedures and was similar to the cost of BCS. CONCLUSIONS: Age was the driving force in reconstruction decisions. Clinical factors such as tumor size and nodal status were more important for the choice between BCS and mastectomy. There are significant cost differences between the various procedures. For a similar cosmetic outcome, BCS is less expensive than breast reconstruction. When reconstruction is required, a simultaneous procedure is less expensive.

Predictors of Medicare costs in elderly beneficiaries with breast, colorectal, lung, or prostate cancer.

BACKGROUND: Determining the apportionment of costs of cancer care and identifying factors that predict costs are important for planning ethical resource allocation for cancer care, especially in markets where managed care has grown. DESIGN: This study linked tumor registry data with Medicare administrative claims to determine the costs of care for breast, colorectal, lung and prostate cancers during the initial year subsequent to diagnosis, and to develop models to identify factors predicting costs. SUBJECTS: Patients with a diagnosis of breast (n = 1,952), colorectal (n = 2,563), lung (n = 3,331) or prostate cancer (n = 3,179) diagnosed from 1985 through 1988. RESULTS: The average costs during the initial treatment period were $12,141 (s.d. = $10,434) for breast cancer, $24,910 (s.d. = $14,870) for colorectal cancer, $21,351 (s.d. = $14,813) for lung cancer, and $14,361 (s.d. = $11,216) for prostate cancer. Using least squares regression analysis, factors significantly associated with cost included comorbidity, hospital length of stay, type of therapy, and ZIP level income for all four cancer sites. Access to health care resources was variably associated with costs of care. Total R2 ranged from 38% (prostate) to 49% (breast). The prediction error for the regression models ranged from < 1% to 4%, by cancer site. CONCLUSIONS: Linking administrative claims with state tumor registry data can accurately predict costs of cancer care during the first year subsequent to diagnosis for cancer patients. Regression models using both data sources may be useful to health plans and providers and in determining appropriate prospective reimbursement for cancer, particularly with increasing HMO penetration and decreased ability to capture complete and accurate utilization and cost data on this population.

Cost-effectiveness assessment of interferon alfa-2b as adjuvant therapy of high-risk resected cutaneous melanoma.

The use of interferon alfa-2b (IFN-alpha 2b) as adjuvant therapy of high-risk resected cutaneous melanoma was recently found to significantly improve relapse-free and overall survival in the Eastern Cooperative Oncology Group trial 1684 (E1684). However, treatment toxicities and costs may limit its widespread use. A cost-effectiveness and cost-utility analysis of this therapy was conducted using a hypothetical cohort of patients as if they had entered E1684. Survival and recurrence rates were calculated at 7 and 35 years for typical 50-year-old melanoma patients based on the clinical results of E1684 and natural history databases. Costs included all treatment-related costs (i.e. drug acquisition and administration, monitoring and treatment-related toxicity) and the costs of treating recurrences. Estimated utility values were assigned based on data from other oncology trials. The model predicted that IFN-alpha 2b provided an extra 0.52 years of life compared with observation at 7 years; however, at 35 years, the survival benefit of IFN-alpha 2b increased almost 4-fold to nearly 2 years. At 7 years, the cost per year of life gained was U.S. $32,600 and the cost per quality-adjusted life-year (QALY) gained was U.S. $43,200. At 35 years, these costs decreased to U.S. $13,700 and $15,200, respectively. These costs are comparable with those of other well-established medical interventions. Although these results require confirmation in a prospective study, it appears that the use of high-dose IFN-alpha 2b for patients with high-risk melanoma is cost-effective.

A comparison of patterns of care of nonsmall cell lung carcinoma patients in a younger and Medigap commercially insured cohort.

BACKGROUND: The objective of this study was to examine and compare lifetime treatment patterns and hospitalization of incident nonsmall cell lung carcinoma (NSCLC) between pre-Medicare eligible (age < 65 years) and supplemental Medigap (age > or = 65 years) enrollees in a commercially insured cohort using insurance claims. METHODS: Claims from Virginia Blue Cross and Blue Shield beneficiaries with NSCLC submitted between 1989-1991 were merged with records from the Virginia Cancer Registry (VCR). Data from the VCR identified incident cases, disease stage, and type of tumor. Initial treatment categories were stratified using Physicians' Current Procedural Terminology codes. RESULTS: There were 1706 incident NSCLC patients; 349 were age < or = 64 years ("younger") and 1212 were age > or = 65 years ("elderly"). Having commercial insurance was not associated with any survival advantage compared with national averages at 2 years. In comparison with elderly patients, younger patients more often were treated with surgery for local disease (80.2% vs. 54.8%) and surgery alone or in combination with radiation for regional disease (51.9% vs. 32.0%). Radiation was used more often in elderly patients compared with younger patients with local disease (30.5% vs. 14.0%) but less often in patients with distant disease (76.2% vs. 54.9%). Compared with elderly patients, younger patients presenting with distant disease received more chemotherapy (18.8% vs. 5.1%; P <0.001); late palliative use of chemotherapy or radiation occurred in only 4-8% of younger patients. Compared with elderly patients, younger patients with regional or distant disease spent more days in the hospital (compared with national averages at 2 years: regional disease, 30.0 vs. 23.9 days; distant disease, 33.0 vs. 21.4 days; P <0.0001). CONCLUSIONS: The results of this study show that more comprehensive health insurance is not associated with better outcomes in patients with NSCLC. Age specific trends for greater use of surgery, radiation, and total hospitalization in younger patients is consistent with other reports. Commercial health care claims supplemented by clinical staging from cancer registries can address long term practice patterns in patients with cancer.

Costs of care associated with non-small-cell lung cancer in a commercially insured cohort.

PURPOSE: To examine the cost of incident cases of non-small-cell lung cancer (NSCLC) in a commercially insured cohort. METHODS: Claims from Virginia Blue Cross and Blue Shield (BCBS) beneficiaries with lung cancer from 1989 to 1991 were merged with records from the Virginia Cancer Registry (VCR). Data from the VCR identified incident cases, stage, and type of cancer at diagnosis. Costs for all medical care included insurance payment, copayments, and deductibles for 2 years after diagnosis or until death. RESULTS: Three hundred forty-nine incident NSCLC patients were evaluated. The mean 2-year cost for each patient after diagnosis or until death was $47,941 (95% confidence interval, $43,758 to $52,124). Total average costs and hospital days were significantly lower for local disease ($37,514, 21.2 days), but were similar for regional ($52,797, 30.0 days) and distant ($49,382, 33.0 days) disease. Hospital days accounted for 48% and hospital-based claims for 70% of costs. Initial treatments, which included radiation, unadjusted for stage, had the lowest survival rates and the highest costs, and were associated with the most hospital days. Initial stage, race, gender, and age were not predictors of total 2-year costs. The independent predictors of total 2-year costs were type of treatment: any radiation therapy, any surgery, or any chemotherapy (all, P < .001). Inpatient hospital days was only a modest predictor of costs after adjusting for type of treatment. Patients who survived less than 1 year spent 30.5 days in hospital and had an average cost of $47,280. CONCLUSION: The direct health care costs of younger NSCLC patients care are substantial. These results should serve as a benchmark for future comparisons as the United States market shifts to managed care.

Overview of economic analysis of Le Chevalier Vinorelbine Study.

The costs and relative cost-effectiveness of different treatments for common illnesses are an increasing concern. New treatments for advanced non-small-cell lung cancer are having an impact. However, these treatments vary markedly in their direct financial costs, toxicity, and quality-of-life profiles. Direct comparisons between most combination regimens are not yet completed. Vinorelbine (Navelbine) is the first new agent approved in the United States for the treatment of metastatic non-small-cell lung cancer in more than a decade. We previously reported results of a post-hoc economic analysis that compared the anticipated cost-effectiveness of three regimens used to treat non-small-cell lung cancer (vinorelbine alone versus vinorelbine plus cisplatin [Platinol] versus vindesine plus cisplatin, the assumed standard treatment in Europe). Results showed that vinorelbine plus cisplatin was the most effective regimen. Using vinorelbine alone as a baseline, vinorelbine plus cisplatin added 56 days of life at an additional cost of $2,700, resulting in a cost-effectiveness ratio of $17,700 per year of life gained. Similarly, vindesine plus cisplatin added 19 days of life at a cost of $1,150, or $22,100 per year of life gained. Compared to vindesine plus cisplatin, vinorelbine plus cisplatin added 37 days of life at a cost of $1,570, or $15,500 per year of life gained. We conclude that the incremental cost-effectiveness of the vinorelbine plus cisplatin regimen was less than most commonly accepted medical interventions. If vinorelbine is preferred because of its favorable toxicity profile, the additional effectiveness of cisplatin added substantial efficacy at an acceptable cost.

Cost-effectiveness of routine radiation therapy following conservative surgery for early-stage breast cancer.

PURPOSE: To examine the cost-effectiveness of radiation therapy following conservative surgery for early-stage breast cancer. METHODS: Using a Markov model, a cost-utility analysis was performed to compare a strategy of radiation therapy versus no radiation therapy in a hypothetical cohort of 60-year-old women following conservative surgery. Local recurrence, distant recurrence, and survival rates used in the model were derived from randomized trial data. Utilities for the nonmetastatic health states were collected from actual patients. Direct medical costs were estimated using data from a single institution. Transportation and time costs were also estimated. Years of life, quality-adjusted life-years (QALYs), costs, and incremental cost/QALY over a 10-year time horizon were calculated by the model for each strategy. RESULTS: The addition of radiation therapy results in a cost increase of $9,800 per patient, no change in life expectancy, and an increase of 0.35 QALYs per patient, which leads to an incremental cost-effectiveness ratio of $28,000/QALY, which is well below $50,000/QALY, a commonly cited threshold for cost-effective care. Sensitivity analysis shows the ratio to be heavily influenced by the cost of radiation therapy and the quality-of-life benefit that results from decreased risk of local recurrence. CONCLUSION: Radiation therapy following conservative surgery is cost-effective compared with other accepted medical interventions. This study illustrates the importance of considering an intervention's effect on quality of life, as well as survival in defining cost-effectiveness.

Review of cost-effectiveness assessments of chemotherapy in adjuvant and advanced breast cancer.

Economic assessments of treatment alternatives in breast cancer have been predominantly ones addressing the role and type of adjuvant therapy. These assessments have shown that the effectiveness of the intervention drives the cost-effectiveness results. Other key factors were the relative risk of recurrence, the time frame considered and only minimally the costs of the intervention. Assessments in advanced breast cancer are few in parallel with the limited number of phase III trials. Future assessments should address neoadjuvant therapy, high-dose adjuvant therapy and agents that alter disease associated complications agents such as biphosphonates.

Decision analysis: MIBI imaging of nonpalpable breast abnormalities.

UNLABELLED: Scintimammography using sestamibi has provided exciting preliminary results in evaluating suspicious breast lesions. A computer simulation was performed using projected test characteristics to guide future studies and to evaluate the clinical and financial consequences of the anticipated use of noninvasive breast evaluation strategies. METHODS: A decision analysis model compared sestamibi breast imaging, stereotaxic core biopsy and surgical biopsy as breast evaluation strategies for hypothetical cohorts of 1000 women with nonpalpable breast lesions. All women with a negative original procedure would have a 6-mo follow-up. Sensitivity and specificity were estimated from the literature and from a recent multicenter assessment for sestamibi. Probabilities of 10% for both invasive cancer and in situ cancer were based on mammographic features. Costs were based on the costs incurred by patients who were evaluated at our institution and the costs of sestamibi projections. RESULTS: Per 1000 women, core biopsy was projected to miss about seven invasive and 10 in situ cancers more than would surgery. Sestamibi imaging was projected to miss an additional 16 invasive cancers and 12 in situ cancers, compared to core biopsy. Most misses would be detected at 6-mo follow-up. Compared to immediate surgery, the cost would be reduced by 20% with the core biopsy and 39% with the sestamibi strategy. Sixty-five percent of women having sestamibi imaging would avoid any invasive biopsy. The projected cost savings of core biopsy or sestamibi imaging, compared to surgery, ranged fom $17,700 to $77,500 per delayed cancer diagnosis. CONCLUSION: If sestamibi imaging has similar test characteristics outside the research setting, then sestamibi imaging or sterotaxic core biopsy will lead to substantial cost savings compared to surgery with a slight compromise in the rate of early cancer detection. A decision analysis simulation can aid in designing clinical trials and exploring new strategies. The adopting of nonsurgical biopsy techniques will likely depend on confirming or establishing their test characteristics in lower-risk lesions, the natural history of cancers whose diagnosis is delayed and patient preferences of the value on avoiding any form of breast biopsy.