Cost-Effectiveness Modeling of Surgery Plus Adjuvant Endocrine Therapy Versus Primary Endocrine Therapy Alone in UK Women Aged 70 and Over With Early Breast Cancer.

OBJECTIVES: Approximately 20% of UK women aged 70+ with early breast cancer receive primary endocrine therapy (PET) instead of surgery. PET reduces surgical morbidity but with some survival decrement. To complement and utilize a treatment dependent prognostic model, we investigated the cost-effectiveness of surgery plus adjuvant therapies versus PET for women with varying health and fitness, identifying subgroups for which each treatment is cost-effective. METHODS: Survival outcomes from a statistical model, and published data on recurrence, were combined with data from a large, multicenter, prospective cohort study of over 3400 UK women aged 70+ with early breast cancer and median 52-month follow-up, to populate a probabilistic economic model. This model evaluated the cost-effectiveness of surgery plus adjuvant therapies relative to PET for 24 illustrative subgroups: Age {70, 80, 90} × Nodal status {FALSE (F), TRUE (T)} × Comorbidity score {0, 1, 2, 3+}. RESULTS: For a 70-year-old with no lymph node involvement and no comorbidities (70, F, 0), surgery plus adjuvant therapies was cheaper and more effective than PET. For other subgroups, surgery plus adjuvant therapies was more effective but more expensive. Surgery plus adjuvant therapies was not cost-effective for 4 of the 24 subgroups: (90, F, 2), (90, F, 3), (90, T, 2), (90, T, 3). CONCLUSION: From a UK perspective, surgery plus adjuvant therapies is clinically effective and cost-effective for most women aged 70+ with early breast cancer. Cost-effectiveness reduces with age and comorbidities, and for women over 90 with multiple comorbidities, there is little cost benefit and a negative impact on quality of life.

Cost sharing for breast cancer hormone therapy: How do dual eligible patients' copayment impact adherence.

OBJECTIVE: To examine the different levels of copayment assistance and treatment adherence among Medicare and Medicaid dual eligible beneficiaries with breast cancer in the U.S. RESEARCH DESIGN: Propensity Score methodology was adopted to minimize potential selection bias from the nonrandom allocation of the treatment group (i.e., full Medicaid beneficiaries) and control group (i.e., Medicare Savings Programs [MSPs] beneficiaries). Longitudinal hierarchical model and Cox proportional-hazard model were adopted to examine patients' adherence over their full five-year course of adjuvant hormone therapy. RESULTS: Our study cohort consisted of 1,133 dual eligible beneficiaries diagnosed with hormone receptor-positive early stage breast cancer in years 2007 -mid 2009. About 80.5% of them received MSPs benefits, while the rest received full Medicaid benefits. On average for a standardized 30-day hormone therapy medication, full Medicaid beneficiaries spent $0.5-$2.0 and MSP beneficiaries spent $1.4-$4.8 in copayment. After adjusting for other factors, this copayment reduction wasn't associated with a significantly better adherence. However, when the catastrophic coverage threshold was reached (copayments reduced to zero), significant improvement in adherence was found in both groups. CONCLUSIONS: Our study found that small amount of cost-sharing reduction did not affect Medicare and Medicaid dual eligible patients' medication treatment adherence, however, the elimination of cost-sharing (even a minimal amount) was associated with improved adherence. Future legislative and advocacy efforts should be paid on eliminating cost sharing for dual eligibles, and possibly even a broader group of financially vulnerable patients.

First-line Treatment with Ribociclib plus Endocrine Therapy for Premenopausal Women with Hormone-receptor-positive Advanced Breast Cancer: A Cost-effectiveness Analysis.

BACKGROUND: We conducted a cost-effectiveness analysis incorporating recent phase III clinical trial (MONALEESA-7) data to evaluate the cost-effectiveness of ribociclib (RIB) as a first-line treatment for premenopausal women with hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (ABC) from the United States healthcare payer perspective. In addition, because RIB has not been marketed in China, we identified the range of drug costs for which RIB could be considered cost effective from a Chinese healthcare system perspective. PATIENTS AND METHODS: A Markov model was developed to evaluate the cost-effectiveness of adding RIB to endocrine therapy over a lifetime. The clinical outcomes and utility data were obtained from published literature. Costs data were obtained from United States and Chinese official websites, and we determined the potential price for RIB in China based on its price in the United States. The main outcomes of this study were the incremental cost-effectiveness ratio (ICER) and quality-adjusted life-years (QALYs). RESULTS: The model projected that mean outcome was better with RIB and endocrine combined (3.83366 QALYs) than with endocrine therapy alone (2.71203 QALYs). In the United States, RIB and endocrine therapy cost an additional $604,960.06, resulting in an ICER of $539,357.95/QALY compared with endocrine monotherapy. Subgroup analyses indicated that, in China, the projected mean outcomes were better for RIB and endocrine therapy (6.37 QALYs) than for endocrine monotherapy (2.71 QALYs). The corresponding incremental costs were $224,731.88943. Thus, the ICER comparing RIB and endocrine therapy with endocrine therapy alone represented a $61,454.96/QALY gain. CONCLUSION: Additional use of RIB is estimated to not be cost effective as a first-line treatment for premenopausal women with HR-positive, HER2-negative ABC in the United States. A value-based price for the cost of RIB is less than $31.74/200 mg for China.

Cost-effectiveness of ribociclib plus endocrine therapy versus placebo plus endocrine therapy in HR-positive, HER2-negative breast cancer.

BACKGROUND: The 2015 American Society of Clinical Oncology guidelines recommend first-line treatment of hormone receptor (HR)-positive breast cancer with endocrine therapy plus or minus palbociclib, a selective cyclin-dependent kinase (CDK)4/6 inhibitor. In 2018, the U.S. Food and Drug Administration approved ribociclib, a new orally available selective CDK4/6 inhibitor. While gains in progression-free survival (PFS) and overall survival (OS) from ribociclib are important for clinical and treatment outcomes, trade-offs in adverse events (AEs) and additional costs necessitate cost-effectiveness analysis (CEA) to assist consideration by third-party payer systems, physicians, and patients. OBJECTIVES: To (a) develop a Markov model and (b) determine the cost-effectiveness of ribociclib plus endocrine therapy versus endocrine therapy alone as treatment for premenopausal and perimenopausal patients with HR-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. METHODS: A lifetime 3-state Markov model ("stable," "progressed," and "dead" health states) was developed using a U.S. payer perspective. Transition probabilities were calculated based on OS and PFS outcomes from the randomized controlled phase 3 trial MONALEESA-7. These Kaplan-Meier curves were extended to lifetime by estimating best-fit distributions using loglogistic distribution for ribociclib curves and Weibull distribution for placebo curves. Costs were obtained from national data sources using 2019 U.S. dollars (USD) and discounted by 3%. Utilities were obtained via published breast cancer literature and were included for each health state and for time spent with each AE. Results were expressed as an incremental cost-effectiveness ratio (ICER) expressed as USD per quality-adjusted life-year (QALY) saved. Treatments were assumed to be cost-effective based on a willingness-to-pay (WTP) threshold of $150,000 per QALY gained. Base-case, 1-way sensitivity tornado diagrams and probabilistic sensitivity analyses demonstrated changes in the ICER and were driven by the cost of ribociclib and the utility of remaining in the stable health state. RESULTS: Ribociclib plus endocrine therapy was cost-effective at an ICER of $124,513 per QALY when compared with endocrine therapy alone at a WTP threshold of $150,000. The ribociclib plus endocrine therapy arm had an effectiveness of 5.28 QALYs and a total cost of $385,112, while placebo plus endocrine therapy provided only 2.46 QALYs at a lower total cost of $67.246. The model was sensitive to the cost of ribociclib and the utility of time spent in the stable health state. Probabilistic sensitivity analysis demonstrated that endocrine therapy alone was cost-effective until a WTP of $125,000 and was cost-effective 72% of the time at the WTP threshold. CONCLUSIONS: Ribociclib plus endocrine therapy is more cost-effective than endocrine therapy alone. Professionals in managed care settings should consider the pharmacoeconomic benefits of ribociclib for the treatment of HR-positive, HER2-negative breast cancer as they make value-based formulary decisions. Further CEAs should be considered as direct treatment comparison trials between CDK4/6 inhibitors are completed in the future. DISCLOSURES: No outside funding supported this study. The authors have nothing to disclose.

Half-dose fulvestrant plus anastrozole as a first-line treatment for hormone receptor-positive metastatic breast cancer: a cost-effectiveness analysis.

OBJECTIVE: The S0226 trial demonstrated that the combination of half-dose fulvestrant (FUL) and anastrozole (ANA) (F&A) caused a significant improvement in overall survival (OS) versus ANA monotherapy for first-line treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer (PMW-MBC (HR+)). The objective of this study was to evaluate the cost-effectiveness of F&A in the first-line treatment for PMW-MBC (HR+) in China. DESIGN: We constructed a Markov model over a life-time horizon. The clinical outcomes and utility data were obtained from published literature. Cost data were obtained from official Chinese websites. Sensitivity analyses were performed to test result uncertainty. SETTING: Chinese healthcare system perspective. POPULATION: A hypothetical cohort of adult patients presenting with PMW-MBC (HR+). INTERVENTIONS: F&A compared with full-dose FUL and ANAmonotherapy. MAIN OUTCOME MEASURES: The main outcome of this study was the incremental cost-effectiveness ratio (ICER) and quality-adjusted life-years (QALY). RESULTS: ANA was estimated to have the lowest cost and minimum life-years. The ICER of F&A versus ANA was US$15 665.891/QALY with incremental cost and QALY of US$12 401.120 and 0.792, respectively, which was less than the willingness-to-pay of US$29 383/QALY. Compared with F&A, FUL yielded a higher cost and a shorter lifetime; hence, it was identified as a dominated strategy. The univariate sensitivity analysis indicated the price of FUL was the most influential factor in our study. The probability that F&A was cost-effective at a threshold of US$29 383/QALY in China was 86.5%. CONCLUSION: F&A is a cost-effective alternative to FUL and ANA monotherapy for the first-line treatment of PMW-MBC (HR+) in China. F&A is a promising first-line treatment for PMW-MBC (HR+), and more research is needed to evaluate the economy of using F&A in other countries.

Economic Outcomes in Patients with Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer Treated with Enzalutamide or Abiraterone Acetate Plus Prednisone.

INTRODUCTION: Prostate cancer (PC) is the second leading cause of cancer death among US men and accounts for considerable healthcare expenditures. We evaluated economic outcomes in men with chemotherapy-naïve metastatic castration-resistant PC (mCRPC) treated with enzalutamide or abiraterone acetate plus prednisone (abiraterone). METHODS: We performed a retrospective analysis on 3174 men (18 years or older) utilizing the Veterans Health Administration (VHA) database from 1 April 2014 to 31 March 2018. Men with mCRPC were included if they had at least one pharmacy claim for enzalutamide or abiraterone (first claim date = index date) following surgical or medical castration, had no chemotherapy treatment within 12 months prior to the index date, and had continuous VHA enrollment for at least 12 months pre- and post-index date. Men were followed until death, disenrollment, or end of study and were 1:1 propensity score matched (PSM). All-cause and PC-related resource use and costs per patient per month (PPPM) in the 12 months post index were compared between matched cohorts. RESULTS: We identified 1229 men with mCRPC prescribed enzalutamide and 1945 prescribed abiraterone with mean ages of 74 and 73 years, respectively. After PSM, each cohort had 1160 patients. The enzalutamide cohort had fewer all-cause (2.51 vs 2.86; p < 0.0001) and PC-related outpatient visits (0.86 vs 1.03; p < 0.0001), with corresponding lower all-cause ($2588 vs $3115; p < 0.0001) and PC-related ($1356 vs $1775; p < 0.0001) PPPM outpatient costs compared with the abiraterone cohort. All-cause total costs (medical and pharmacy) PPPM ($8085 vs $9092; p = 0.0002) and PC-related total costs PPPM ($6321 vs $7280; p < 0.0001) were significantly lower in the enzalutamide cohort compared with the abiraterone cohort. CONCLUSIONS: Enzalutamide-treated men with chemotherapy-naïve mCRPC had significantly lower resource utilization and healthcare costs compared with abiraterone-treated men.

Prostate cancer (PC) is the second leading cause of death among men with cancer in the USA. Healthcare costs associated with PC, including hospitalizations, outpatient visits, and medications prescribed to treat adverse effects, depend on the severity of the disease and intensity of treatment, but are generally very high. Enzalutamide and abiraterone acetate with prednisone (abiraterone) are both approved treatments for men with PC that does not respond to treatments that reduce the male hormone testosterone, known as castration-resistant PC (CRPC). These drugs are associated with varying treatment duration and different adverse effects, and therefore could result in differences in the use of healthcare resources and overall cost of treatment. Here we evaluated the healthcare resource utilization (HCRU), which was calculated as the average number of healthcare encounters, including inpatient stays, outpatient visits, and pharmacy visits, and length of inpatient stays, and treatment costs associated with use of enzalutamide or abiraterone by men with metastatic CRPC (mCRPC), who had not received prior chemotherapy in the Veterans Health Administration. We found that men with chemotherapy-naïve mCRPC treated with enzalutamide used less healthcare resources and incurred lower total healthcare costs than men treated with abiraterone. On average, all-cause total healthcare costs were $1007 per patient per month lower and PC-related total healthcare costs were $959 per patient per month lower for patients treated with enzalutamide than those treated with abiraterone. These results support the hypothesis that the long-term HCRU and costs of enzalutamide may be lower compared with abiraterone.

Effects of Previous Medication Regimen Factors and Bipolar and Psychotic Disorders on Breast Cancer Endocrine Therapy Adherence.

BACKGROUND: Endocrine therapy adherence remains a barrier to optimal estrogen receptor-positive breast cancer outcomes. We theorized that experience navigating difficult medication regimen factors, such as route of administration complexity, might improve subsequent adherence after stressful cancer diagnoses but not for patients with bipolar and psychotic disorders at risk of poor access and nonadherence. MATERIALS AND METHODS: We included 21,894 women aged ≥ 68 years at their first surgically treated stage I-IV estrogen receptor-positive breast cancer (2007-2013) from the Surveillance, Epidemiology, and End Results-Medicare data set, of whom 5.8% had bipolar or psychotic disorders. We required continuous fee-for-service Medicare (parts A and B) data for ≥ 36 months before and 18 months after the cancer diagnosis. The medication regimen factors in the part D claims for 4 months before included the number of all medications used, pharmacy visits, and administration complexity (medication regimen complexity index subscale). Cox regression analysis was used to model the time to initiation and discontinuation, with longitudinal linear regression for adherence to endocrine therapy. RESULTS: Women with more frequent previous medication use and pharmacy visits were more likely to initiate, 4+ medications and 2+ visits versus no medication (hazard ratio [HR], 1.47; 95% confidence interval [CI], 1.33-1.63), to adhere (6.0%; 95% CI, 4.3-7.6), and to continuously use their endocrine therapy (discontinuation HR, 0.48; 95% CI, 0.39-0.59). Medication administration complexity had modest effects. Difficult medication regimens were more common for patients with bipolar and psychotic disorders but had no statistically significant effects. CONCLUSIONS: Experience with frequent previous medication use and pharmacy visits might increase the likelihood of endocrine therapy use for most patients but not for those with bipolar and psychotic disorders.

Metastatic Hormone-Sensitive Prostate Cancer: A Review of the Current Treatment Landscape.

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.

Utilization and Outcomes of Surgical Castration in Comparison to Medical Castration in Metastatic Prostate Cancer.

BACKGROUND: Androgen deprivation therapy (ADT) is the gold standard for metastatic prostate cancer, which can be achieved either by surgical or medical castration. In this study, we evaluated the trends of utilization of surgical castration and also assess the survival differences of patients who underwent surgical castration when compared with those who underwent medical castration. MATERIALS AND METHODS: The National Cancer Database was used to identify patients with metastatic prostate cancer from 2004 to 2014. Cochran-Armitage tests were used to assess temporal trends in the proportion of patients receiving surgical castration relative to medical castration. Logistic and Cox regression models were utilized to estimate the odds of utilization of surgical castration and the effect of castration on overall survival (OS). RESULTS: A total of 33,585 patients with metastatic prostate cancer were identified; 31,600 (94.1%) had medical castration, and 1985 (5.9%) underwent surgical castration. There was significant decline in the trend of utilization of surgical castration from 8.6% in 2004 to 3.1% in 2014. On multivariable analysis, being of a non-Caucasian race, having lower median income levels, having non-private insurance, and earlier years of diagnosis were found to be associated with increased odds of choosing surgical castration over medical castration. Notably, the odds of surgical castration were lower at academic centers. On univariable analysis, a survival difference between castration modality was evidenced (P < .01); 5-year OS for medical castration and surgical castration were 24.3% and 18.2%, respectively. However, on multivariable analysis, there was no OS difference between surgical castration and medical castration (P = .13). CONCLUSIONS: In this large contemporary analysis, the utilization of surgical castration has declined over time, with no OS difference when compared with medical castration. Increasing the utilization of surgical castration could help reduce health care expenditures. With rising health care costs, patients and physicians need to be aware of treatment options and their financial implications.

First-line fulvestrant plus anastrozole for hormone-receptor-positive metastatic breast cancer in postmenopausal women: a cost-effectiveness analysis.

PURPOSE: In a recent randomized, open-label trial (S0226), the addition of fulvestrant to anastrozole therapy decreased the risk of progression and death in patients with hormone-receptor-positive metastatic breast cancer. However, the cost-effectiveness of incorporating fulvestrant into the first-line setting is unknown. METHODS: We developed a Markov model to assess the costs and clinical outcomes of fulvestrant plus anastrozole compared with anastrozole as a first-line therapy in a cohort of patients with advanced hormone-receptor-positive breast cancer. The transition probabilities were estimated from the fitted survival curves in the S0226 trial. Health care costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) were calculated for fulvestrant plus anastrozole compared with anastrozole from US payer's perspective. RESULTS: Fulvestrant plus anastrozole led to an improvement of 0.11 QALYs compared with treatment with anastrozole alone. However, incorporating fulvestrant into the first-line therapy produced significantly higher health care costs ($72,496 vs. $38,959 for all eligible patients, and $73,728 vs. $37,239 for patients with no previous hormonal adjuvant therapy), resulting in ICERs of $300,564 and $194,450/QALY, respectively. Two-way sensitivity analysis showed that when the cost of fulvestrant decreased to $1.5/mg for all eligible patients or $3.5/mg for patients with no previous hormonal adjuvant therapy, at the perfect health in progression-free status, the ICER became $141,320 and $145,543 per QALY. CONCLUSION: Substituting fulvestrant as a first-line therapy for hormone-receptor-positive metastatic breast cancer is not cost-effective compared with anastrozole based on the willing-to-pay threshold of $150,000 per QALY.

CDK4/6 inhibition in low burden and extensive metastatic breast cancer: summary of an ESMO Open-Cancer Horizons pro and con discussion.

In December 2017, ESMO Open-Cancer Horizons convened a round-table discussion on the background and latest data regarding cyclin-dependent kinase (CDK)4/6 inhibitors with endocrine therapy (ET) in the treatment of endocrine-sensitive breast cancer (BC). A review on this discussion was published in summer 2018 (https://esmoopen.bmj.com/content/3/5/e000368).Endocrine-sensitive BC with non-visceral disease and limited spread of the metastases.Endocrine-sensitive BC with non-life-threatening visceral involvement. Several open questions were identified, which led to a second ESMO Open discussion on CDK4/6 inhibitors, taking place in December 2018 and covered in this article. The panel discussed two important clinical scenarios and the pro and cons of a treatment approach with CDK4/6 inhibitors for each scenario:Endocrine-sensitive BC with non-visceral disease and limited spread of the metastases.Endocrine-sensitive BC with non-life-threatening visceral involvement. Regarding scenario 1, the panel agreed that CDK4/6 inhibitors should be recommended in first-line therapy for most patients if cost and practicality allow. However, the use of single-agent ET with an aromatase inhibitor in the first-line treatment of these patients is still a possibility for a small group of patients with very limited disease, such as one or two bone lesions or limited lymph node involvement. Regarding scenario 2, chemotherapy is the first approach for patients with endocrine-sensitive metastatic BC with life-threatening visceral involvement because of the need for a faster response. The therapeutic approaches for patients with non-life-threatening visceral involvement are still under debate. Nevertheless, CDK4/6 inhibitors are currently the treatment of choice for most patients with a close follow-up of tumour response. A treatment algorithm has been suggested at the round table.

Radiation Therapy Without Hormone Therapy for Women Age 70 or Above with Low-Risk Early Breast Cancer: A Microsimulation.

PURPOSE: Hormone therapy without radiation therapy is considered appropriate for women age 70 or above with low-risk, hormone-positive breast cancer after partial mastectomy. However, some patients may prefer radiation without hormone therapy, for which there is minimal modern data. We modeled the comparative efficacy of aromatase inhibition alone without radiation versus radiation alone without hormone therapy. METHODS AND MATERIALS: We constructed a patient-level Markov model and compared 5 years of anastrozole to a 15-fraction course of radiation without boost or anastrozole. The relative effectiveness between treatments was based on the National Surgical Adjuvant Breast and Bowel Project B-21 trial, which was further adjusted such that the endocrine-alone arm matched the Cancer and Leukemia Group B 9343 and PRIME II trials. Common or severe side effects were considered. Eight survival metrics were assessed and validated against clinical trial data. The cost-efficacy of each strategy was considered using the quality-adjusted life year and incremental cost-effectiveness ratio (ICER). RESULTS: The model's predicted outcomes matched those demonstrated by modern trials. Aromatase inhibitors were superior in preventing contralateral cancers, with a small impact on the risk of distant metastatic disease. Radiation was superior in preventing ipsilateral breast tumor recurrence with a small impact on regional failure. No clinically significant differences were seen in the other 4 oncologic endpoints. Differences in quality-adjusted life years were small, but radiation therapy was $3809 more expensive over the average lifetime. The ICER suggested anastrozole was cost-effective in 62% of probabilistic simulations. However, the ICER was unstable owing to a denominator that approached zero. CONCLUSIONS: Women age 70 or above with low-risk early breast cancer who are reluctant or unable to pursue adjuvant aromatase inhibition can safely pursue adjuvant radiation alone with limited differences in outcome and a modest increase in costs.

Population-based estimate of the use of intermittent androgen deprivation therapy in prostate cancer patients in Catalonia, Spain.

PURPOSE: To estimate the use of intermittent androgen deprivation (IAD) therapy in patients with prostate cancer (PCa). METHODS: Retrospective, non-interventional study based on electronic pharmacy dispensation data of luteinizing hormone-releasing hormone (LHRH) analogs and anti-androgens in Catalonia (Spain). Intermittency was defined as the percentage of time off treatment (%IAD), which was calculated for the whole sample by dividing the sum of all off-IAD periods by the total time on any LHRH analog regimen. The prevalence of patients on an IAD regimen (PIAD ) was also estimated. A small validation study based on data from clinical records confirmed the excellent sensitivity and specificity of this approach. RESULTS: A total of 515 803 prescriptions for LHRH analog were dispensed over a 5-year period (2008 to 2012) to 35 089 PCa patients. The mean age (±SD) was 77 years (±9). The %IAD in the cohort was 1.7% whereas the 5-year prevalence (PIAD ) was 4.2%. Only 2.5% of patients on IAD were on IAD for >6 months. Of the physicians (n = 1638) who prescribed hormonal treatment, 24% used IAD at least once. Total expenditures for LHRH analogs were 1.2% of total drug expenditure in this population. CONCLUSIONS: This study confirms the validity of the method developed to estimate IAD use based on electronic pharmacy dispensation data. Given the large potential clinical and economic benefits that greater use of IAD could provide, future studies are needed to confirm these findings and to identify new strategies to increase the use of IAD.

Cost-effectiveness analysis of abiraterone, docetaxel or placebo plus androgen deprivation therapy for hormone-sensitive advanced prostate cancer.

OBJECTIVE: To evaluate the cost-effectiveness of the addition of chemotherapy or abiraterone to androgen deprivation. METHODS: We developed an analytical model to determine the cost-effectiveness of the addition of docetaxel or abiraterone versus androgen deprivation therapy alone. Direct and indirect costs were included in the model. The effects were expressed in Quality-Adjusted Life Years adjusted for side effects. RESULTS: Compared to androgen deprivation therapy alone, the addition of chemotherapy and of abiraterone generated 0.492 and 0.999, respectively, in Quality-Adjusted Life Years. Abiraterone led to a Quality-Adjusted Life Years gain of 0.506 compared to docetaxel. The incremental costs per Quality-Adjusted Life Years were R$ 133.649,22 for docetaxel, R$ 330.828,70 for abiraterone and R$ 571.379,42 for abiraterone compared to docetaxel, respectively. CONCLUSION: The addition of chemotherapy to androgen deprivation therapy is more cost-effective than the addition of abiraterone to androgen deprivation therapy. However, discounts on abiraterone cost might improve cost-effectiveness.

The impact of state parity laws on copayments for and adherence to oral endocrine therapy for breast cancer.

BACKGROUND: Adherence to endocrine therapy for breast cancer is often inadequate, in part because of out-of-pocket costs for medication. Numerous states have enacted parity laws to limit patient cost-sharing for oral anticancer drugs. The objective of this study was to estimate the impact of these laws on patient copayments for and adherence to oral endocrine therapy for breast cancer. METHODS: Administrative health insurance claims data from 2007 to 2014 derived from a US health care database were used to identify female patients aged 18 to 64 years with invasive cancer or ductal carcinoma in situ of the breast who initiated endocrine therapy and were enrolled in fully insured health plans in states that either enacted parity legislation between 2008 and 2013 or had not yet enacted such legislation by 2015. Differences-in-differences analysis was used to compare copayments for and adherence to endocrine therapy during the 1-year period before and after each year of legislation enactment. RESULTS: In total, 6900 individuals who received 7778 unique drug therapy courses were identified. Parity legislation was associated with significant decreases in the 25th percentile of copayments for anastrozole of $4.39 (95% confidence interval [CI], -$4.52 to -$4.26; P < .001) and for exemestane of $3.08 (95% CI, -$4.80 to -$1.35; P < .001). The median copayment for exemestane decreased by $10.25 (95% CI, -$12.61 to -$7.89; P < .001). A higher median monthly copayment was significantly associated with a greater risk of medication nonadherence (adjusted risk ratio, 1.006 per dollar increase; P < .001). CONCLUSIONS: Parity laws had a modest effect on lowering the cost of anastrozole and exemestane, but more focused efforts to limit out-of-pocket costs for endocrine therapy may have a greater impact on medication adherence.

Cost-effectiveness analysis of abiraterone, docetaxel or placebo plus androgen deprivation therapy for hormone-sensitive advanced prostate cancer / Análise de custo-efetividade da adição de abiraterona ou quimioterapia ao tratamento do câncer de próstata metastático hormônio-sensível

ABSTRACT Objective To evaluate the cost-effectiveness of the addition of chemotherapy or abiraterone to androgen deprivation. Methods We developed an analytical model to determine the cost-effectiveness of the addition of docetaxel or abiraterone versus androgen deprivation therapy alone. Direct and indirect costs were included in the model. The effects were expressed in Quality-Adjusted Life Years adjusted for side effects. Results Compared to androgen deprivation therapy alone, the addition of chemotherapy and of abiraterone generated 0.492 and 0.999, respectively, in Quality-Adjusted Life Years. Abiraterone led to a Quality-Adjusted Life Years gain of 0.506 compared to docetaxel. The incremental costs per Quality-Adjusted Life Years were R$ 133.649,22 for docetaxel, R$ 330.828,70 for abiraterone and R$ 571.379,42 for abiraterone compared to docetaxel, respectively. Conclusion The addition of chemotherapy to androgen deprivation therapy is more cost-effective than the addition of abiraterone to androgen deprivation therapy. However, discounts on abiraterone cost might improve cost-effectiveness.

RESUMO Objetivo Avaliar a relação custo-efetividade da adição de quimioterapia ou abiraterona à terapia de privação hormonal. Métodos Um modelo analítico foi desenvolvido para determinar a relação custo-efetividade da adição de docetaxel ou abiraterona comparada à terapia de privação hormonal isolada. Custos diretos e indiretos foram incluídos no modelo. Os efeitos foram expressos em Anos de Vida Ajustados para Qualidade corrigidos pelos efeitos colaterais de cada terapia. Resultados A adição de quimioterapia e de abiraterona à terapia de privação hormonal aumentou os Anos de Vida Ajustados para Qualidade em 0,492 e 0,999, respectivamente, em comparação à terapia de privação hormonal isolada. A abiraterona promoveu ganho de Anos de Vida Ajustados para Qualidade de 0,506 em relação ao docetaxel. O custo incremental por Anos de Vida Ajustados para Qualidade foi R$ 133.649,22 para o docetaxel, R$ 330.828,70 para a abiraterona e R$ 571.379,42 para a abiraterona comparada ao docetaxel. Conclusão A adição de quimioterapia à terapia de privação hormonal é mais custo-efetiva que a adição de abiraterona à terapia de privação hormonal. Contudo, descontos no custo da abiraterona poderiam tornar esse tratamento mais custo-efetivo.

Cost-effectiveness of monitoring endoxifen levels in breast cancer patients adjuvantly treated with tamoxifen.

PURPOSE: Breast cancer is the most common malignancy in women worldwide. Recurrence rates in breast cancer are considered to be dependent on the serum concentration of endoxifen, the active metabolite of tamoxifen. The goal of this study is to investigate the cost-effectiveness of periodically monitoring serum concentrations of endoxifen in adjuvant estrogen receptor alfa (ERα) positive breast cancer patients treated with tamoxifen in the Netherlands. METHODS: A Markov model with disease-free survival (DFS), recurrent disease (RD), and death states was constructed. The benefit of drug monitoring was modeled via a difference in the fraction of patients achieving adequate serum concentrations. Robustness of results to changes in model assumptions were tested through deterministic and probabilistic sensitivity analyses. RESULTS: Monitoring of endoxifen added 0.0115 quality-adjusted life-years (QALYs) and saved € 1564 per patient in the base case scenario. Deterministic sensitivity analysis demonstrated a large effect on the incremental cost-effectiveness ratio (ICER) of the differences in costs and utilities between the DFS and RD states. Probabilistic sensitivity analysis showed that the probability of cost-effectiveness at a willingness to pay of € 0 per quality-adjusted life-year (QALY) was 89.8%. CONCLUSIONS: Based on this model, monitoring of endoxifen in adjuvant ERα + breast cancer patients treated with tamoxifen is likely to add QALYs and save costs from a healthcare payer perspective. We advise clinicians to consider integrating serum endoxifen concentration monitoring into standard adjuvant tamoxifen treatment of ERα + breast cancer patients.

Improved cost-effectiveness of short-course radiotherapy in elderly and/or frail patients with glioblastoma.

BACKGROUND AND PURPOSE: Short-course radiotherapy (25 Gy in five fractions) was recently shown in a randomized phase III trial to be non-inferior to 40 Gy in 15 fractions in elderly and/or frail patients with glioblastoma multiforme. This study compared the cost-effectiveness of the two regimens. MATERIAL AND METHODS: The direct unit costs of imaging, radiotherapy (RT), and dexamethasone were collected from the five primary contributing countries to the trial, constituting the data of 88% of all patients. Effectiveness was measured by the restricted mean overall survival (RMOS) and progression free survival (RMPFS). The incremental cost-effectiveness ratio (ICER) was calculated. Indirect costs were also estimated for comparison. RESULTS: The median OSs for the short-course and commonly used RTs were 8.2 (95% confidence interval [CI] 6.1-10.3) and 7.7 (95% CI 5.5-9.9) months, respectively (log rank p = 0.340). Median PFSs were also not different (p = 0.686). The differences in the RMOS and the ICER, however, were +0.11 life-years and -$3062 United States dollars (USD) per life-year gained, respectively. The differences in the RMPFS and the ICER were +0.02 PFS and -$17,693 USD, respectively. CONCLUSION: The ICER of -$3062 per life-year gained and -$17,693 per PFS gained indicates that the short-course RT is less costly compared to the longer RT regimen.

Association between financial burden and adjuvant hormonal therapy adherence and persistent use for privately insured women aged 18-64 years in BCBS of Texas.

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.