Budget impact analysis of darolutamide for treatment of nonmetastatic castration-resistant prostate cancer.

BACKGROUND: Darolutamide, a structurally distinct androgen receptor inhibitor approved for the treatment of men with nonmetastatic castration-resistant prostate cancer (nmCRPC), has been shown to increase metastasis-free survival among men with nmCRPC compared with placebo. This treatment has a novel chemical structure that may also have safety, tolerability, and efficacy advantages for men with nmCRPC. OBJECTIVE: To estimate the projected budget impact of including darolutamide on a U.S. payer formulary as a treatment option for men with nmCRPC. METHODS: A budget impact model was developed to evaluate darolutamide for nmCRPC for a hypothetical 1-million-member plan over a 5-year period. Costs (drug acquisition, drug administration, and treatment-related adverse events [AEs]) were estimated for 2 scenarios: with and without darolutamide treatment for nmCRPC. The budget impact of darolutamide was calculated as the difference in costs for these 2 scenarios. An analysis for high-risk nmCRPC also was conducted. The model included treatments recommended by the National Comprehensive Cancer Network (e.g., apalutamide and enzalutamide) and potential comparators that are used but are not specifically indicated for nmCRPC. All treatments were assumed to be administered in combination with a weighted average androgen deprivation therapy comparator (consisting of luteinizing hormone-releasing hormone [LHRH] agonists, LHRH antagonists, and first-generation antiandrogens). Market share estimates were derived from interviews with physicians treating men with nmCRPC. The model includes grade 3-4 AEs, and the rates were obtained from clinical trial data. Costs were taken from publicly available sources and varied in a one-way sensitivity analysis. RESULTS: For a plan with 1 million lives, there were approximately 90 incident cases of nmCRPC (46 high risk) each year, with 332 (109 high risk) treatment-eligible cases by year 5. Darolutamide's market share increased from 3.6% in year 1 to 18% in year 5. Given the utilization of other agents, introducing darolutamide along with other targeted therapies was predicted to increase the total budget by $158,640 ($0.0132 per member per month [PMPM]) in year 1, which decreased over time to a cost savings of $149,240 ($0.0124 PMPM) by year 5. The scenario with darolutamide showed reduced AE costs each year. Similar results were observed for the high-risk nmCRPC population. CONCLUSIONS: Adding darolutamide to a U.S. payer formulary for the treatment of nmCRPC can result in a manageable increase in the budget that is partly offset by AE costs in the first 4 years, followed by a cost savings by year 5. DISCLOSURES: This study was conducted by RTI Health Solutions under the direction of Bayer U.S. and was funded by Bayer U.S., which was involved in the design of the study; collection, analysis, and interpretation of the data; writing of the report; and the decision to submit the report for publication. Miles and Purser (and/or their institutions) are employees of RTI Health Solutions and received research funding from Bayer U.S. to develop the budget impact model. Appukkuttan and Farej are employees of Bayer U.S. Wen was an employee of Bayer U.S. at the time of the study. This study was presented as a poster at the AMCP Virtual Learning Event, April 20-24, 2020.

Medication utilization evaluation of androgen deprivation therapy for prostate cancer in Taiwan.

Prostate cancer is one of the most common cancer in males. Both the incidence and the mortality rates of prostate cancer show an increasing trend. Androgen deprivation therapy (ADT) is the standard treatment for metastatic prostate cancer. The aim of our study was to show the epidemiology of prostate cancer and the proportion of patients utilizing ADT.This study used Taiwan's National Health Insurance Research Database (NHIRD) and identified the patients who had been diagnosed with prostate cancer (International Classification of Disease (ICD)-10: C61) and followed up between Jan 1, 2008 and Dec 31, 2015. The ADT drugs used by prostate cancer patients were recorded: Gonadotropin-releasing hormone (GnRH) agonists; GnRH antagonist; estrogen analogs and androgen receptor antagonist.A total of 25,233 patients with newly diagnosed prostate cancer in 2008-2014 were enrolled. The utilization of ADT increased from more than 7,000 person-time in 2008 to more than 50,000 person-time in 2014. Cyproterone acetate was the most commonly used drug in 2008-2015, but its proportion of utilization, which was the highest in stage 2 cancer, dropped from 43% in 2008 to 15% in 2015. Bicalutamide was the second most used drug from 2008 to 2015, but its utilization was not different for different stages.The incidence rate of prostate cancer increased in the study period and medical expenditure also increased in ADT treatment. Health insurance benefits for various ADT drugs should be further evaluated.

Health economic impact of a biopsy-based cell cycle gene expression assay in localized prostate cancer.

Background: Prior studies have established that broader incorporation of active surveillance, guided by additional prognostic tools, may mitigate the growing economic burden of localized prostate cancer in the USA. This study sought to further explore the potential of a particular gene expression-based prognostic tool to address this unmet need. Materials & methods: A deterministic, decision-analytic model was developed to estimate the economic impact of the Prolaris® test on a US commercial health plan. Results & conclusion: When adopted in patients classified by the American Urological Association as low or intermediate risk, the assay was projected to reduce costs by $1894 and $2129 per patient over 3 and 10 years, respectively, largely through the increased use of active surveillance.

Comparative study of surgical orchidectomy and medical castration in treatment efficacy, adverse effects and cost based on a large prospective metastatic prostate cancer registry.

INTRODUCTION: Androgen deprivation therapy (ADT) remains the mainstay of treatment for metastatic prostate cancer (mPCa) but is associated with significant morbidities. Comparisons of medical castration (MC) and surgical orchidectomy (SO) have yielded varied results. We aimed to evaluate the oncological outcomes, adverse effect (AE) profiles and costs of MC and SO in patients with mPCa. METHODS AND MATERIALS: We reviewed 523 patients who presented with de novo mPCa from a prospectively maintained prostate cancer database over 15 years (2001-2015). All patients received ADT (either MC or SO) within 3 months of diagnosis. The data were analyzed with chi-square, binary and logistics regression models. RESULTS: One hundred and fifty one (28.9%) patients received SO while 372 (71.1%) patients had MC. The median age of presentation was 73 [67 -79] years old. The median prostate-specific antigen (PSA) was 280ng/ml [82.4-958]. Three hundred and thirty one patients (66.3%) had high volume bone metastasis and 57 patients (10.9%) had visceral metastasis. Clinical demographics and clinicopathological were similar across both groups. Similar oncological outcomes were observed in both groups. The proportion of PSA response (PSA <1ng/ml) was 65.6% for SO and 67.2% for MC (P = 0.212). Both therapies achieve >95% of effective androgen suppression (testosterone <50ng/dL). Time to castrate-resistance was similar (18 vs 16 months, P = 0.097), with comparative overall survival (42 vs. 38.5 months, P = 0.058) and prostate cancer mortality (80.1 vs. 75.9%, P = 0.328). Similarly, no difference was observed for the 4 AE profiles between SO and MC respectively; change in Haemoglobin (-0.75 vs. -1.0g/dL, P = 0.302), newly diagnosed Diabetes mellitus (4.6 vs. 2.9%, P = 0.281), control measured by HbA1c (0.2 vs. 0.25%, P = 0.769), coronary artery disease events (9.9 vs. 12.9%, P = 0.376) and skeletal-related fractures (9.3 vs. 7.3%, P = 0.476). After adjusting for varying governmental subsidies and inflation rates, the median cost of SO was $5275, compared to MC of $9185.80. CONCLUSION: Both SO and MC have similar oncological outcomes and AE profiles. However, SO remains a much more cost-effective form of ADT for the long-term treatment of mPCa patients.

Budget Impact of Enzalutamide for Nonmetastatic Castration-Resistant Prostate Cancer.

BACKGROUND: Prostate cancer is the most common cancer and second-leading cause of cancer death among men in the United States. Prostate cancer poses a large economic burden, which increases with progression from localized to metastatic disease. Newly approved treatments for non-metastatic castration-resistant prostate cancer (nmCRPC) delay disease progression and reduce the risk of metastatic disease. Quantifying the potential budget impact of these new treatments is of interest to health care decision makers. OBJECTIVE: To estimate the budget impact of enzalutamide for the treatment of patients with nmCRPC in the United States over a 3-year time horizon. METHODS: An Excel-based model was developed to estimate the budget impact to a U.S. health plan of enzalutamide, a second-generation antiandrogen, as an add-on to androgen deprivation therapy (ADT) for the treatment of high-risk nmCRPC patients (prostate-specific antigen doubling time of ≤ 10 months). Comparators include apalutamide + ADT, bicalutamide + ADT, and ADT only. The analysis includes treatment costs for nmCRPC and for treatment after progression to metastatic castration-resistant prostate cancer (mCRPC). The treated population size was estimated from epidemiological data and literature. Dosing, duration of therapy, and adverse event rates were based on package inserts and pivotal studies. RED BOOK, Centers for Medicare & Medicaid Services fee schedules, and literature were used to obtain costs of drugs, adverse events, and health care visits. Market shares were estimated for each comparator before and after enzalutamide adoption. A 1-way sensitivity analysis was performed to quantify the impact of parameter uncertainty. RESULTS: In a hypothetical 1-million-member plan with 3% annual growth, it was estimated that there would be approximately 19 eligible incident nmCRPC patients in year 1, increasing to 20 eligible incident patients in year 3. With an assumed market share of approximately 6% for enzalutamide in year 1, the budget impact would be $106,074 ($0.009 per member per month [PMPM]). With a 26% enzalutamide share in year 3, the budget impact would be $632,729 ($0.048 PMPM). Cumulative budget impact to the health plan over 3 years is estimated to be $1,082,095 ($0.028 PMPM). The increased cost of the treatment regimen is partly offset by reduced postprogression costs. CONCLUSIONS: Treatment of nmCRPC patients with enzalutamide has a modest budget impact that is partly offset by delaying progression to mCRPC. DISCLOSURES: This research was sponsored by Astellas Pharma and Pfizer, the codevelopers of enzalutamide. All authors contributed to the development of the manuscript and maintained control over the final content. Schultz is employed by Astellas Pharma and owns stock in Gilead Sciences and Shire. O'Day and Sugarman are employees of Xcenda, which received consultancy fees from Astellas Pharma. Ramaswamy is employed by Pfizer. A synopsis of the current study was presented in poster format at the AMCP Managed Care & Specialty Pharmacy Annual Meeting 2019, in San Diego, CA, on March 25-28, 2019.

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.

Total cost of care for castration-resistant prostate cancer in a commercially insured population and a medicare supplemental insured population.

Background: The total cost of healthcare for patients with castration-resistant prostate cancer (CRPC) is an important component for assessing value of treatment options. The need for real-world evidence has increased with the introduction of oral targeted therapies for metastatic and nonmetastatic disease. In this study, we examined patient healthcare costs during periods of nonmetastatic CRPC (nmCRPC) and metastatic CRPC (mCRPC).Methods: This retrospective cohort study captured data from claims in the Truven Health MarketScan Commercial and Medicare Supplemental (Medigap) databases (1/1/2012-12/31/2016). Male patients (≥18 years) with ≥1 prostate cancer diagnosis, a subsequent metastatic diagnosis, and prescription claim for an mCRPC-indicated therapy (index date) were included. Patients were considered to have nmCRPC during the 12-month period prior to mCRPC if they had ≥1 claim for androgen deprivation therapy. Unadjusted all-cause healthcare resource utilization (HRU) and associated costs in 2016 USD per patient per year (PPPY) were determined for nmCRPC and mCRPC periods.Results: Patients included from the Commercial database (N = 449) had an average age of 59.4 ± 4.5 (standard deviation) years and a mean Quan Charlson Comorbidity Index (QCI) score of 2.8 ± 1.6. Among patients included from the Medigap database (N = 1,173), the mean age was 78.6 ± 7.2 years and mean QCI score was 3.3 ± 2.0. Across all healthcare resource types, HRU was approximately 1.5-2.5 times greater after a diagnosis of metastasis for both study populations. For commercially insured patients, total all-cause healthcare costs increased 6.2-fold from the nmCRPC to mCRPC periods ($29,192 to $182,156 PPPY). Likewise, among Medigap patients, total all-cause healthcare costs increased 5.1-fold from the nmCRPC to mCRPC periods ($27,549 to $139,847).Conclusions: In this study, the cost of care during 2012-2016 was substantially higher for mCRPC than nmCRPC, underscoring the value of interventions that may delay progression to metastases in high-risk individuals.

Comparative clinical effects and cost-effectiveness of maximum androgen blockade, docetaxel with androgen deprivation therapy and ADT alone for the treatment of mHSPC in China.

Aim: To compare the clinical effects and cost-effectiveness of maximum androgen blockade (MAB), docetaxel to androgen deprivation therapy (Doc-ADT) and ADT alone for the treatment of patients with metastatic hormone-sensitive prostate cancer in China. Methods: A network meta-analysis and a Markov model were adopted for effectiveness and economic evaluation. Results: The hazard ratios of overall survival and progression-free survival were 0.782 and 0.628 for Doc-ADT versus ADT alone; 0.897 and 0.824 for MAB versus ADT alone. Doc-ADT was cost-effective compared with MAB and ADT alone, with an incremental cost-effectiveness ratio of CNY 96,848 and CNY 67,758 per quality-adjusted life year, respectively. MAB was cost-effective compared with ADT alone, with an incremental cost-effectiveness ratio of CNY 137,487 per quality-adjusted life year. Conclusion: Doc-ADT is likely the optimal option from the perspective of both clinical outcomes and economic considerations.

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.

Cost-Effectiveness of Adding Androgen Deprivation Therapy to Radiation Therapy for Men with Advanced Prostate Cancer from a U.S. Payer's Perspective.

BACKGROUND: No study has investigated the cost and effectiveness of androgen deprivation therapy (ADT) and other curative treatment therapies among the Medicare population, and no study has taken into consideration the long-term side effects associated with ADT. OBJECTIVE: To examine if adding ADT was cost-effective when accounting for ADT-related long-term side effects in men with prostate cancer. METHODS: For this cost-utility analysis, we used the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database to estimate and compare patient survival, costs from a health payer's perspective, and cost-effectiveness of 3 treatment modalities for advanced prostate cancer patients, including radiation therapy, radiation plus ADT, and active surveillance. We also estimated quality-adjusted life-years (QALYs) by assigning appropriate health state utility values obtained from the literature for each phase of care and for long-term side effects. Propensity score matching was used to control for bias and confounding that were inherent to the observational study design. RESULTS: Adding ADT to radiation therapy increased median patient survival by 0.71 years. The incremental cost-effectiveness ratio (ICER) for radiation plus ADT versus radiation alone was $63,049 and $295,995 per mean life-year gained for radiation compared with active surveillance, respectively. Treatment-associated adverse side effects substantially reduced QALYs gained. Compared with radiation only, the incremental cost of radiation plus ADT was $127,900 per mean QALY and was nearly 80% cost-effective at a willingness-to-pay threshold of $210,000 per QALY. CONCLUSIONS: Despite ADT-associated costs and long-term side effects, compared with radiation alone, radiation plus ADT was cost-effective at $127,900 per QALY. DISCLOSURES: This research was supported in part by the Cancer Prevention Research Institute of Texas (grant nos. RP130051 and RP170668). The authors declare that there are no conflicts of interest.

Health Technology Assessment and Health Care Utilisation in the Management of Early Prostate Cancer.

Health technology assessment (HTA) is a key tool used to allocate health care funding. A critical aspect of HTA is the performance of economic evaluations that compare the costs and outcomes for competing therapies; these typically rely on data from clinical trials. For early prostate cancer, this represents a challenge, as long-term survival and quality-of-life effects-key outcomes in such evaluations-may require a decade or more of follow-up. Thus, identification of early or intermediate measures of benefit is critical. Systematic reviews of economic evaluations in prostate cancer show that understanding the links between intermediate and final outcomes is important for confidence in assessments of what represents value for money. This highlights the importance of efforts to identify and validate intermediate clinical endpoints for use in determining clinical benefit, and hence value for money, in early prostate cancer. PATIENT SUMMARY: As the costs of providing care rise, the challenge is to ensure that we achieve value for money. In this brief review, we note the importance of clinical trial data in understanding what represents value for money and we highlight current efforts to identify measures that can be used to make decisions on treatment funding sooner.

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.

External beam radiotherapy with or without androgen deprivation therapy in elderly patients with high metastatic risk prostate cancer.

OBJECTIVE: Several randomized controlled trials have documented significant overall survival benefit in high metastatic risk prostate cancer (PCa) patients treated with combination of androgen deprivation therapy (ADT) at radiotherapy (RT) relative to RT alone. Unfortunately, elderly patients are either not included or are underrepresented in these trials. In consequence, the survival benefit of combination of ADT at RT in the elderly warrants detailed reassessment, including its cost. METHODS: Between 1991 and 2009 within the Surveillance Epidemiology and End Results (SEER)-Medicare-linked database, we identified 3,692 patients aged 80 years or more with clinical T1-T2 PCa and WHO histological grade 3, or clinical T3-T4 PCa and any histological grade, treated with or without combination of ADT at RT. Competing risks analyses focused on cancer-specific mortality (CSM) and other-cause mortality, after accounting for confounders. All analyses were repeated in patients with no comorbidity and in most contemporary patients, treated between 2001 and 2009. Finally, we assessed median annual cost according to use of combination of ADT at RT, after adjusting for patient and tumor characteristics. RESULTS: In competing-risks multivariable analyses, no statistically significant difference was observed in CSM and other-cause mortality between patients treated with or without combination of ADT at RT. Same results were recorded in subgroup analyses of patients with no comorbidity and in most contemporary patients. The median annual costs of $36,140 and of $47,510 were recorded, respectively in patients treated without and with ADT at RT. CONCLUSION: Our findings failed to confirm that combination of ADT at RT reduces CSM rates in high metastatic risk PCa patients aged 80 years or more. Moreover, combination of ADT at RT resulted in a significant cost increase, relative to RT alone.

Docetaxel in hormone-sensitive advanced prostate cancer; GENESIS-SEFH evaluation reporta.

Prostate cancer (PC) is the most common urogenital malignancy in older men and the second leading cause of death by cancer in men in Europe. Current therapeutic practice considers Androgen Deprivation Therapy (ADT) as first line treatment for clinically localized prostate cancer at high-risk, either locally advanced or metastatic. ADT can be achieved through orchiectomy (surgical castration), luteinizing hormone-releasing hormone (LHRH) agonists, or through complete androgen blockade (LHRH agonist combined with an anti-androgen). Docetaxel in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer. The CHAARTED and STAMPEDE clinical trials studied the effect of bringing forward the use of docetaxel added on to ADT in the context of hormone-sensitive patients. The CHAARTED clinical trial showed a significant increase in a variable with maximum relevance such as Overall Survival (OS), with a difference of 13.6 months between medians. There was also clinical benefit in the secondary variables: median time until castration-resistant disease or until clinical progression. In the STAMPEDE clinical trial, which included 39% of non-metastatic patients, a 10-month difference between medians was demonstrated in OS, and 17 months in the primary co-variable of Progression Free Survival. The most frequent adverse events were: neutropenia, febrile neutropenia, leucopenia, and general disorders such as asthenia, lethargy or fever. According to data from the CHAARTED and STAMPEDE studies, and the incremental cost of € 3 196.98 for adding on docetaxel to standard treatment, the estimated additional cost for each year of life gained is compatible with an incremental cost-effectiveness ratio between € 2 267.36 and € 3 851.78. In view of the efficacy and safety results, the proposed positioning is: to advance the use of docetaxel added to androgen deprivation therapy to first-line metastatic hormone-sensitive prostate cancer, regardless of metastatic volume, in those patients who meet the CHAARTED study criteria.

El cáncer de próstata (CP) es el tumor maligno urogenital más frecuente en hombres de edad avanzada y la segunda causa de muerte por cáncer en hombres en Europa. La práctica terapéutica actual considera como primera línea la terapia de privación de andrógenos (ADT; androgen deprivation therapy) en el cáncer de próstata clínicamente localizado de alto riesgo, localmente avanzado o metástasico. La ADT se realiza mediante orquiectomía (castración quirúrgica), agonistas de la hormona liberadora de hormona luteinizante (LHRH), o bien mediante el bloqueo androgénico completo (agonista LHRH más antiandrógeno). El docetaxel en combinación con prednisona o prednisolona está indicado para el tratamiento de pacientes con cáncer de próstata hormono-refractariometastásico. Los ensayos clínicos CHAARTED y STAMPEDE analizaron el efecto de adelantar el uso de docetaxel añadido a la ADT en el contexto del paciente hormonosensible. En el ensayo CHAARTED se demostró un aumento significativo en la variable de máxima relevancia como es la supervivencia global (SG), con una diferencia de medianas de 13,6 meses. También se obtuvo beneficio clínico en las variables secundarias mediana de tiempo hasta enfermedad resistente a la castración o hasta progresión clínica. En el ensayo STAMPEDE, en el que se incluyeron un 39% de pacientes no metastásicos, se demostró una diferencia de medianas de 10 meses en la SG y de 17 meses en la covariable principal de supervivencia libre de progresión. Los eventos adversos más frecuentes fueron: neutropenia, neutropenia febril, leucopenia y alteraciones generales tales como astenia, letargia o fiebre. Según los datos del estudio CHAARTED y STAMPEDE y el coste incremental de 3.196,98 € de añadir docetaxel a la terapia de referencia, por cada año de vida ganado el coste adicional estimado es compatible con un coste/eficacia incremental (CEI) entre 2.267,36 € y 3.851,78 €. A la vista de los importantes resultados de eficacia y el perfil manejable de seguridad, el posicionamiento propuesto es adelantar el uso de docetaxel añadido a la ADT a la primera línea del cáncer de próstata metastásico hormonosensible, en aquellos pacientes que cumplan los criterios básicos del estudio CHAARTED.

Cost-effectiveness analysis of additional docetaxel for metastatic hormone-sensitive prostate cancer treated with androgen-deprivation therapy from a Chinese perspective.

The E3805 (CHAARTED) study found that docetaxel combined with androgen-deprivation therapy (ADT) significantly improved overall survival of patients with metastatic hormone-sensitive prostate cancer. This study aims to determine whether docetaxel combined with ADT is a cost-effective strategy for advanced prostate cancer in China. According to the E3805 study, two groups (docetaxel + ADT and ADT alone) and three health states [progression-free survival (PFS), progressive disease (PD) and death] were analysed in a Markov model. All medical costs were calculated from the Chinese societal perspective. Quality-adjusted life year (QALY) and incremental cost-effectiveness ratios (ICERs) were applied as the primary outcome. Overall, the addition of docetaxel was estimated to increase the cost by $12 816.93, with a gain of 0.48 QALY. Additionally, for patients with high-volume disease, the increased cost and effectiveness were $14 627.75 and 0.69 QALYs in docetaxel + ADT group versus the ADT alone group, and the ICER was $21 199.63 per QALY. These ICERs are far more than the commonly accepted willingness-to-pay (WTP) threshold of $20 301 per QALY in China. In spite of longer survival time, docetaxel combined with ADT is not a recommended cost-effective treatment for metastatic hormone-sensitive prostate cancer in the Chinese setting.

Cost of Medications Recommended by Canadian Acne Clinical Practice Guidelines.

BACKGROUND: Acne affects a large proportion of the Canadian population and has psychosocial and financial consequences. OBJECTIVE: We provide cost information for treatments recommended by the Canadian acne guidelines. METHODS: Highest level recommendations were selected for 3-month usage cost. RESULTS: Three-month estimated treatment costs were as follows: topical retinoids ($14.40-$73.80), benzoyl peroxide (BPO; $6.75), fixed-dose BPO-clindamycin ($40.95-$44.10) and BPO-adapalene ($73.80), oral antibiotics ($25.20 for tetracycline 250 mg qid; $52.20 and $52.74 for doxycycline 50 mg bid and 100 mg od, respectively), and hormonal therapy ($26.46-$37.80 for ethinyl estradiol [EE] 0.030 mg/drospirenone 3mg and $75.60-108.99 for EE 0.035 mg/cyproterone acetate 2 mg). Oral isotretinoin 3-month costs ranged from $393.96 to $478.80. CONCLUSIONS: Awareness of costs of recommended treatments may facilitate improved outcomes by increasing procurement and adherence.

Changing Patterns of Primary Treatment in Korean Men with Prostate Cancer Over 10 Years: A Nationwide Population Based Study.

PURPOSE: We investigated changing patterns of primary treatment in Korean men with prostate cancer (PC) and impact of sociodemographic factors on treatment choice from a nationwide cohort over 10 years. MATERIALS AND METHODS: We conducted a cohort study of a 2% nationwide random sample of Korean National Health Insurance. A total of 1,382 patients who had undergone active treatments for newly diagnosed PC between 2003 and 2013 were included. Time trends in primary treatment of PC, including radical surgery, radiation therapy (RT), and androgen deprivation therapy (ADT) were analyzed. RESULTS: Total number of patients undergoing active treatments increased significantly (162%). Surgery cases showed the most significant increase, from 22.4% in 2003 to 45.4% in 2013, while the relative proportion of ADT showed a tendency to decrease from 60.3% in 2003 to 45.4% in 2013, and the relative proportion of RT was variable over 10 years (from 7.2% to 18.4%). While treatment patterns differed significantly according to age (p < 0.001) and income classes (p=0.014), there were differences in primary treatment according to residential area. In multinomial logistic regression analysis, older patients showed significant association with ADT or RT compared to surgery, while patients with higher income showed significant association with surgery. CONCLUSION: Treatment pattern in Korean PC patients has changed remarkably over the last 10 years. Sociodemographic factors do affect the primary treatment choice. Our results will be valuable in overviewing changing patterns of primary treatment in Korean PC patients and planning future health policy for PC.

Reimbursement cuts and changes in urologist use of androgen deprivation therapy for prostate cancer.

BACKGROUND: We examined the impact of urologist academic affiliation on use of androgen deprivation therapy (ADT) for prostate cancer before and after major reimbursement cuts for ADT in hopes of better understanding the influence of financial incentives on its use. In particular, we hypothesized that if financial incentive was the predominant factor driving use, we should see a narrowing in the previously documented gap of ADT use between non-academic and academic urologists following the reimbursement cuts. METHODS: With the Surveillance, Epidemiology and End-Results (SEER)-Medicare linked database we examined use of ADT for potentially inappropriate indications (primary therapy of localized, lower risk tumors) among patients of 2214 urologists over the period 2000-2002 and 2004-2007, representing eras before and after reimbursement cuts. Multi-level logistic regression models were used to estimate the likelihood of ADT use adjusted for patient, tumor and urologist characteristics (academic affiliation, board certification, years in practice and patient panel size). RESULTS: Overall, ADT use peaked in 2002 at 46.6% of patients, but dropped dramatically in 2005, with a slow continued decrease through 2007 to 31.1%. A similar pattern was evident within most strata of urologist characteristics, including academic affiliation. In the multilevel model, patients of non-academic urologists had a 30% higher odds of receiving ADT than those of academic urologists in both the eras before and after the reimbursement cuts. CONCLUSION: A similar proportionate drop in use of ADT among both academic and non-academic urologists following reimbursement cuts suggests that factors other than financial incentives may have played a role.