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Purpose: In recent years, the treatment options for metastatic hormone-sensitive prostate cancer (mHSPC) have expanded significantly. In addition to androgen deprivation therapy, the systemic treatments now include docetaxel, abiraterone, enzalutamide, and apalutamide. Radiation to the primary is also an option for select low-volume patients., Methods: We conducted a review of the pivotal trials that have changed the practice of mHSPC., Results: We describe an overview of the trials that investigated docetaxel (CHAARTED and STAMPEDE-Docetaxel), abiraterone (LATTITUDE and STAMPEDE-Abiraterone), enzalutamide (ARCHES, ENZAMET), apalutamide (TITAN), and radiation to the primary (STAMPEDE-Radiation)., Discussion: The treatment of mHSPC is a complex topic, and treatment choice should be individualized. Patient preferences, cost, volume of disease, and side effect profiles are important in determining which option is the best for an individual patient.

Objective: To determine how out-of-pocket costs for adjuvant endocrine therapy (AET) medication affects adherence among newly diagnosed breast cancer survivors with private health insurance who initiate therapy., Materials and Methods: We examined medical and pharmacy claims for the 1-year period after initiating AET using the Truven Health Analytics MarketScan database. Adherence was defined as ≥80% proportion of days covered. Mean out-of-pocket costs for AET fill were measured as the sum of copayments, coinsurance, and deductibles and adjusted to 30-day amounts. Using a multivariable logistic regression model we calculated adjusted risk ratios controlling for age, comorbidities, type of surgery, use of chemotherapy and/or radiation therapy, average out-of-pocket costs for other services, and pharmacy use characteristics., Results: Of the 6863 women 64 years and younger who were diagnosed with breast cancer and initiated AET, 73.9% were adherent (proportion of days covered≥80%). A total of 19% of patients had <$5 monthly out-of-pocket costs for AET, 30% had $5 to $9.99, 17% had $10 to $14.99, 10% had $15 to $19.99, and 25% had $20 or greater. Patients with out-of-pocket costs for AET between $10 and $14.99, $15 and $19.99, and >$20 were 6% to 8% less likely to be adherent compared with patients paying <$5.00, after controlling for covariates (P<0.05). Out-of-pocket costs for inpatient, outpatient, and other pharmacy services were not associated with adherence., Conclusions: A substantial proportion of privately insured patients are nonadherent to AET and out-of-pocket costs for AET medication are significantly associated with a greater likelihood of nonadherence.

Background: In cost-effectiveness analysis (CEA), the effects of health-care interventions on multiple health dimensions typically require consideration of both quantity and quality of life., Objectives: To explore the impact of alternative approaches to quality-of-life adjustment using patient preferences (utilities) on the outcome of a CEA on use of tamoxifen for breast cancer risk reduction., Research Design: A state transition Markov model tracked hypothetical cohorts of women who did or did not take 5 years of tamoxifen for breast cancer risk reduction. Incremental quality-adjusted effectiveness and cost-effectiveness ratios (ICERs) for models including and excluding a utility adjustment for menopausal symptoms were compared with each other and to a global utility model., Subjects: Two hundred fifty-five women aged 50 and over with estimated 5-year breast cancer risk >or=1.67% participated in utility assessment interviews., Measures: Standard gamble utilities were assessed for specified tamoxifen-related health outcomes, current health, and for a global assessment of possible outcomes of tamoxifen use., Results: Inclusion of a utility for menopausal symptoms in the outcome-specific models substantially increased the ICER; at the threshold 5-year breast cancer risk of 1.67%, tamoxifen was dominated. When a global utility for tamoxifen was used in place of outcome-specific utilities, tamoxifen was dominated under all circumstances., Conclusions: CEAs may be profoundly affected by the types of outcomes considered for quality-of-life adjustment and how these outcomes are grouped for utility assessment. Comparisons of ICERs across analyses must consider effects of different approaches to using utilities for quality-of-life adjustment.

Objective: Given the potential side effects and an uncertain survival benefit, decisions about tamoxifen treatment for the primary prevention of breast cancer remain complex. Primary care providers, including gynecologists, will need to counsel patients regarding this form of preventive care. In this report, we update cost-effectiveness calculations for tamoxifen chemoprevention and establish reasonable parameters for clinicians' use., Methods: We performed a cost-effectiveness analysis that compared women aged 50 years who were treated with tamoxifen for 5 years with an untreated cohort. In the base model, we assumed a 3.4% 5-year breast cancer risk. Quality-of-life estimates for important outcomes (breast cancer, endometrial cancer, deep venous thrombosis, pulmonary embolism, stroke, metastatic cancer, and hot flushes) were obtained from 106 women. Probabilities and costs of outcomes were derived from the Breast Cancer Chemoprevention Trial and other published estimates. Broad sensitivity analyses were performed. Cost per quality-adjusted life-year gained as a result of tamoxifen breast cancer prevention was the main outcome measure., Results: The use of tamoxifen led to a remaining life expectancy of 26.07 quality-adjusted life-years compared with 25.97 without treatment. The cost per quality-adjusted life-year gained was $43,300. Sensitivity analysis revealed that younger age, the absence of the uterus, higher initial risk of breast cancer, increased fear of curable breast cancer, and reduced tamoxifen cost further favored treatment., Conclusion: Tamoxifen chemoprevention is cost-effective for women aged 40-50 years who are at significant breast cancer risk. Whether this holds true for older women depends on the initial breast cancer risk, fear of breast cancer, and presence of the uterus.

Recent randomized clinical trials (RCT) comparing anastrozole (Arimidex) and letrozole (Femara) to tamoxifen in the first-line treatment of postmenopausal women with advanced hormone-sensitive breast cancer have demonstrated that both agents were at least as effective as tamoxifen. In addition, one RCT has revealed significant superiority of letrozole to tamoxifen with regard to tumor response rate and time to progression. Based on the efficacy and toxicity data, anastrozole or letrozole may replace tamoxifen. A cost effectiveness analysis was undertaken to determine whether the new agents are economically acceptable alternatives to tamoxifen. In the absence of a randomized three-arm trial, a decision model was developed to simulate and compare the most common therapeutic outcomes. The clinical data were obtained from a meta analysis of modern (i.e., post-1990) randomized trials. Clinical outcomes data from the various trials were statistically pooled using a random effects model to provide point estimates and 95% confidence intervals. Total hospital resource consumption was collected from the charts of 87 patients with advanced disease who had failed tamoxifen therapy. The model suggested a comparable duration of quality-adjusted progression-free survival between letrozole and anastrozole, both being superior to tamoxifen (179 days vs. 172 days vs. 161 days). Letrozole and anastrozole had overall costs of Can2,883 dollars and 2,847 dollars per patient, respectively, which were marginally higher than tamoxifen at Can2,258 dollars per patient. When the costs and benefits were combined, the data generated an incremental cost per quality-adjusted progression-free year of 12,500 dollars and 19,600 dollars for letrozole and anastrozole, respectively, relative to tamoxifen. Letrozole and anastrozole are both economically acceptable alternatives to tamoxifen in the first-line treatment setting. However, when efficacy and cost effectiveness are considered together, letrozole could be preferentially considered.

Endocrine therapy has become an integral part of the management of breast cancer and its different clinical applications raise different economic issues. The low toxicity, good response and relatively low cost of agents makes endocrine therapy an attractive treatment option for breast cancer patients at different stages of their disease. The method, hypotheses and expectations from economic analysis of endocrine therapy depend on the objectives of treatment (preventive, curative or palliative), the therapies being compared, the population being treated and the clinical benefits expected. The economic and quality of life literature has focused mainly on the analysis of endocrine therapy in the adjuvant setting. As budgets continue to shrink and treatment guidelines become challenged by new therapeutic and preventive approaches, decision analysis in breast cancer management is likely to become more explicit. Economic analysis can be a useful tool to guide clinical decisions in the management of this complex and chronic disease. Ultimately, the positioning of endocrine therapy with respect to other complementary or alternative treatment modalities will depend on the level of expected effectiveness, and on finding the best therapeutic solution to meet the breast cancer patient's clinical situation, expectations and needs.