Cost-utility of Initial Management of High-grade T1 Bladder Cancer With Intravesical BCG vs Immediate Radical Cystectomy.

OBJECTIVE: To compare the cost-utility of initial management of high-grade T1 non-muscle invasive bladder cancer (HGT1 NMIBC) with intravesical BCG vs immediate radical cystectomy. High-risk NMIBC patients may climb a costly ladder of treatments, culminating in radical cystectomy for oncologic or symptomatic benefit in up to one-third. This high healthcare resource utilization presents a challenging dilemma in balancing sufficiently aggressive management with cost, toxicity, and quality-of-life. METHODS: Cost-utility of initially managing HGT1 with intravesical BCG and early radical cystectomy with ileal conduit urinary diversion was compared using decision-analytic Markov models. Five-year oncologic outcomes, adverse event rates, and published utility values were extracted from literature. Costs were calculated from a US Medicare perspective in 2021 US dollars. Sensitivity analysis identified drivers of cost and break-even points for recurrence and progression. RESULTS: Mean costs were $26,093 for intravesical BCG and $39,720 for immediate radical cystectomy, though cystectomy generated a gain of 2.2 quality-adjusted life years (QALYs) compared to intravesical BCG. Immediate cystectomy was a more cost-effective management strategy for HGT1 NMIBC with an incremental CE ratios (ICER) of $7120/QALY. The costs associated with cystectomy, TURBT, and BCG toxicity had the greatest impact on ICER. One-way sensitivity analysis demonstrated that intravesical BCG became a cost-effective management strategy if the 5-year recurrence rate of HG T1 was less than 56% or the 5-year progression rate to MIBC was less than 4%. CONCLUSION: At current prices, treatment of high-grade T1 NMIBC with early radical cystectomy is more cost-effective management strategy than initial treatment with intravesical BCG.

Three-port approach vs standard laparoscopic radical cystectomy with an ileal conduit: a single-centre retrospective study.

BACKGROUND: This study aimed to evaluate the effect of the three-port approach and conventional five-port laparoscopic radical cystectomy (LRC) with an ileal conduit. METHODS: Eighty-four patients, who were diagnosed with high-risk non-muscle-invasive and muscle-invasive bladder carcinoma and underwent LRC with an ileal conduit between January 2018 and April 2020, were retrospectively evaluated. Thirty and fifty-four patients respectively underwent the three-port approach and five-port LRC. Clinical characteristics, pathological data, perioperative outcomes, and follow-up data were analysed. RESULTS: There were no differences in perioperatively surgical outcome, including pathology type, prostate adenocarcinoma incidence, tumour staging, and postoperative creatinine levels between the two groups. The operative time (271.3 ± 24.03 vs. 279.57 ± 48.47 min, P = 0.299), estimated blood loss (65 vs. 90 mL, P = 0.352), time to passage of flatus (8 vs. 10 days, P = 0.084), and duration of hospitalisation post-surgery (11 vs. 12 days, P = 0.922) were no clear difference between both groups. Compared with the five-port group, the three-port LRC group was related to lower inpatient costs (12 453 vs. 14 134 $, P = 0.021). Our follow-up results indicated that the rate of postoperative complications, 90-day mortality, and the oncological outcome did not show meaningful differences between these two groups. CONCLUSIONS: Three-port LRC with an ileal conduit is technically safe and feasible for the treatment of bladder cancer. On comparing the three-port LRC with the five-port LRC, our technique does not increase the rate of short-term and long-term complications and tumour recurrence, but the treatment costs of the former were reduced.

Retrospective German claims data study on initial treatment of bladder carcinoma (BCa) by transurethral bladder resection (TURB): a comparative analysis of costs using standard white light- (WL-) vs. blue light- (BL-) TURB.

PURPOSE: Photodynamic diagnosis using hexaminolevulinate (HAL)-guided BL-TURB may reduce the recurrence risk in non-muscle invasive BCa compared to standard WL-TURB due to more sensitive tumor detection. The impact of the initial use of WL- vs. BL-TURB on follow-up costs was evaluated in this real-world data analysis. METHODS: Anonymous claims data of German statutory health insurances (GKV) from 2011 to 2016 were analyzed in a primary and adjusted study population. Selection criteria included five quarters before enrolment, one index quarter (InQ) of initial TURB and BCa diagnosis, either within two years for the primary analysis or within four years for the adjusted analysis, and a follow-up period (FU) of either eleven or three quarters, respectively. RESULTS: In the primary analysis (n = 2331), cystectomy was identified as an important cost driver masking potential differences between cohorts. Therefore, patients undergoing cystectomy (InQ + FU) were excluded from the adjusted study population of n = 4541 patients (WL: 79%; BL: 21%). Mean total costs of BL-TURB were initially comparable to WL-TURB (WL: EUR 4534 vs. BL: EUR 4543) and tended to be lower compared to WL-TURB in the first two quarters of FU. After one year (3rd FU quarter), costs equalized. Considering total FU, mean costs of BL-TURB were significantly lower compared to WL-TURB (WL: EUR 7073 vs BL: EUR 6431; p = 0.045). CONCLUSION: This retrospective analysis of healthcare claims data highlights the comparability of costs between BL-TURB and WL-TURB.

Utilizing time-driven activity-based costing to determine open radical cystectomy and ileal conduit surgical episode cost drivers.

OBJECTIVES: Patients undergoing radical cystectomy represent a particularly resource-intensive patient population. Time-driven activity based costing (TDABC) assigns time to events and then costs are based on the people involved in providing care for specific events. To determine the major cost drivers of radical cystectomy care we used a TDABC analysis for the cystectomy care pathway. SUBJECTS AND METHODS: We retrospectively reviewed a random sample of 100 patients out of 717 eligible patients undergoing open radical cystectomy and ileal conduit for bladder cancer at our institution between 2012 and 2015. We defined the cycle of care as beginning at the preoperative clinic visit and ending with the 90-day postoperative clinic visit. TDABC was carried out with construction of detailed process maps. Capacity cost rates were calculated and the care cycle was divided into 3 phases: surgical, inpatient, and readmissions. Costs were normalized to the lowest cost driver within the cohort. RESULTS: The mean length of stay was 6.9 days. Total inpatient care was the main driver of cost for radical cystectomy making up 32% of the total costs. Inpatient costs were mainly driven by inpatient staff care (76%). Readmissions were responsible for 29% of costs. Surgery was 31% of the costs, with the majority derived from operating room staff costs (65%). CONCLUSION: The major driver of cost in a radical cystectomy pathway is the inpatient stay, closely followed by operating room costs. Surgical costs, inpatient care and readmissions all remain significant sources of expense for cystectomy and efforts to reduce cystectomy costs should be focused in these areas.

The natural history of muscle-invasive bladder cancer in geriatric patients undergoing transurethral resection only: Outcome and cost.

PURPOSE: Bladder cancer is predominant in the elderly. Up to 70% of geriatric patients with muscle-invasive bladder cancer do not receive curative treatment. We analyzed the outcome of patients managed only by transurethral resection of bladder tumor (TURBT) without chemo- or radio-therapy, and performed a cost analysis of the cumulative inpatient interventions throughout the course of the disease. METHODS: From 2010 to 2016 81 patients ≥75 years with de novo muscle-invasive bladder cancer who were not eligible for curative treatment options were analyzed retrospectively. All patients were treated only with TURBT. Overall survival (OS) was measured by Kaplan-Meier plots (log-rank test) and clinical parameters predicting OS by a multivariate analysis. The cost analysis was based on actual billing from the hospital provider and referenced standardized pricing in Germany for bladder cancer treatment. RESULTS: The median age was 83 years. The OS was 11 months, the 1-year OS was 42%. In the multivariate model Charlson Comorbidity Index <8 (P = 0.016), tumor size ≤3 cm (P = 0.011), complete (T0) tumor resection (P = 0.003), normal C-reactive protein level (P = 0.010), and initial elective surgery (P = 0.035) were shown to be independent predictors of longer OS in palliative TURBT regimes. Median treatment cost for the TURBT regimen was $16,175 vs. $16,467 for a salvage radical cystectomy in this cohort. CONCLUSIONS: In a TURBT-only concept elective surgery, tumor size, Charlson Comorbidity Index, C-reactive protein level and complete TURBT are independent predictors of OS. The treatment-related cumulative cost appears to be higher in patients not managed by cystectomy.

Comparing Costs of Radical Versus Partial Cystectomy for Patients Diagnosed With Localized Muscle-Invasive Bladder Cancer: Understanding the Value of Surgical Care.

OBJECTIVE: To compare costs associated with radical versus partial cystectomy. Prior studies noted substantial costs associated with radical cystectomy, however, they lack surgical comparison to partial cystectomy. METHODS: A total of 2305 patients aged 66-85 years diagnosed with clinical stage T2-4a muscle-invasive bladder cancer from January 1, 2002 to December 31, 2011 were included. Total Medicare costs within 1 year of diagnosis following radical versus partial cystectomy were compared using inverse probability of treatment-weighted propensity score models. Cox regression and competing risks analysis were used to determine overall and cancer-specific survival, respectively. RESULTS: Median total costs were not significantly different for radical than partial cystectomy in 90 days ($73,907 vs $65,721; median difference $16,796, 95% CI $10,038-$23,558), 180 days ($113,288 vs $82,840; median difference $36,369, 95% CI $25,744-$47,392), and 365 days ($143,831 vs $107,359; median difference $34,628, 95% CI $17,819-$53,558), respectively. Hospitalization, surgery, pathology/laboratory, pharmacy, and skilled nursing facility costs contributed largely to costs associated with either treatment. Patients who underwent partial cystectomy had similar overall survival but had worse cancer-specific survival (Hazard Ratio 1.45, 95% Confidence Interval, 1.34-1.58, P < .001) than patients who underwent radical cystectomy. CONCLUSION: While treatments for bladder cancer are associated with substantial costs, we showed radical cystectomy had comparable total costs when compared to partial cystectomy among patients with muscle-invasive bladder cancer. However, partial cystectomy resulted in worse cancer-specific survival further supporting radical cystectomy as a high-value surgical procedure for muscle-invasive bladder cancer.

The cost of obesity in radical cystectomy.

INTRODUCTION: The prevalence of obesity is on the rise in the Unites States, and obesity has been associated with increased complications and costs in a variety of complex surgeries. However, the contribution of obesity to the overall costs of radical cystectomy has not been studied in detail using contemporary data. Our objective is to assess the variation in healthcare costs due to obesity on the index hospitalization for radical cystectomy in the United States between 2003 and 2015. MATERIALS AND METHODS: This was a retrospective cohort study, using the Premier Healthcare Database, of 1,242 patients who underwent radical cystectomy and were either overweight (25  ≤  body mass index [BMI] < 30), obese (30  ≤  BMI < 40), or morbidly obese (BMI ≥ 40). The primary outcome costs of the index hospitalization for each BMI category. Multivariable median regression was used to identify drivers of increased costs. RESULTS: The cost of the index hospitalization for cystectomy was $24,596 (95% confidence interval [CI], $22,599-$26,592) for overweight patients. The costs for obese and morbidly obese patients were $2,158 (95% CI, -$80 to $4,395, P = 0.059) and $5,308 (95% CI, $2,652-$7,964, P < 0.001) higher compared to overweight patients, respectively. After adjustment for operative time or length of stay in the multivariable models, there were no longer any differences in cost. Operative time was prolonged as BMI increased (median operative time for overweight, obese, and morbidly obese: 346, 391, and 420 minutes, respectively P = 0.0001). Median length of stay was 1 day shorter for overweight vs. morbidly obese patients (P = 0.0030), with each additional day costing $1,738 (95% CI, $1,654 to $1,821, P < 0.0001) on multivariable analysis. CONCLUSIONS: The cost of radical cystectomy is greater for obese and morbidly obese patients compared to overweight patients. The increased financial cost is driven by increased operative times and longer length of stay.

Reframing Financial Incentives Around Reducing Readmission After Radical Cystectomy.

OBJECTIVE: To better understand the financial implications of readmission after radical cystectomy, an expensive surgery coupled with a high readmission rate. Currently, whether hospitals benefit financially from readmissions after radical cystectomy remains unclear, and potentially obscures incentives to invest in readmission reduction efforts. MATERIALS AND METHODS: Using a 20% sample of national Medicare beneficiaries, we identified 3544 patients undergoing radical cystectomy from January 2010 to November 2014. We compared price-standardized Medicare payments for index admissions and readmissions after surgery. We also examined the variable financial impact of length of stay and the proportion of Medicare payments coming from readmissions based on overall readmission rate. RESULTS: Medicare patients readmitted after cystectomy had higher index hospitalization payments ($19,164 readmitted vs $18,146 non-readmitted, P = .03) and an average readmission payment of $7356. Adjusted average Medicare readmission payments and length of stay varied significantly across hospitals, ranging from $2854 to $15,605, and 2.0 to 17.1 days, respectively (both P <.01), with longer length of stay associated with increased payments. After hospitals were divided into quartiles based on overall readmission rates, the percent of payments coming from readmissions ranged from 5% to 13%. CONCLUSION: Readmissions following radical cystectomy were associated with increased Medicare payments for the index hospitalization, and the readmission payment, potentially limiting incentives for readmission reduction programs. Our findings highlight opportunities to reframe efforts to support patients, caregivers, and providers through improving the discharge and readmission processes to create a patient-centered experience, rather than for fear of financial penalties.

Alvimopan Is Associated With a Reduction in Length of Stay and Hospital Costs for Patients Undergoing Radical Cystectomy.

OBJECTIVE: To evaluate the impact of alvimopan in patient undergoing radical cystectomy (RC) for bladder cancer. We hypothesize that alvimopan can decrease cost for RC by reducing length of stay (LOS). METHODS: We identified patients who underwent elective RC for bladder cancer from 2009 to 2015 in the Premier Healthcare Database, a nationwide, all-payer hospital-based database, and compared patients who received and did not receive alvimopan in the perioperative period. Hospitals that had no record of administering alvimopan for patients undergoing RC were excluded. The primary outcomes were LOS and the direct hospital costs. The secondary outcomes were 90-day readmission for ileus and major complications. RESULTS: After applying the inclusion criteria, the study cohort consisted of 1087 patients with 511 patients receiving perioperative alvimopan. Alvimopan was associated with a reduction in hospital costs by -$2709 (95% confidence interval: -$4507 to -$912, P = .003), decreased median LOS (7 vs 8 days, P < .001), and lower likelihood of readmission for ileus (adjusted odds ratio: 0.63, P = .041). While alvimopan use led to higher pharmacy costs, this was outweighed by lower room and board costs due to the reduced LOS. There was no significant difference between 2 groups regarding major complications. These results were robust across multiple adjusted regression models. CONCLUSION: Our data show that alvimopan is associated with a substantial cost-saving in patients undergoing RC, and suggest that routine use of alvimopan may be a potential cost-effective strategy to reduce the overall financial burden of bladder cancer.

Cost-Effectiveness of Robot-assisted Radical Cystectomy Using a Propensity-matched Cohort.

BACKGROUND: Health-related quality of life is important for patients undergoing radical cystectomy (RC). OBJECTIVE: To determine the cost-effectiveness of robotic-assisted RC (RARC) compared to open cystectomy (OC) for bladder cancer and factors that contribute to cost-effectiveness. DESIGN, SETTING, AND PARTICIPANTS: A decision analytic model was used to compare health-related quality of life and medical costs for RARCs with intracorporeal urinary diversion and OCs performed between 2007 and 2015. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Propensity matching was performed among 1322 cases to yield a final cohort of 100 RARC and 96 ORC cases. Probabilities were obtained from the clinical study data, while quality-adjusted life years (QALYs) and health utility values were derived from the literature. A complication, readmission, or transfusion was included in the 90-d time horizon model. RESULTS AND LIMITATIONS: There were no differences between the groups in patient demographics, pathologic staging, or length of stay. Multivariable analysis revealed that the RARC group had fewer transfusions and complications compared to the OC group. The incremental cost-effectiveness ratio was $2969. RARC cost $2969 less per QALY when compared to OC. While RARC was $17000 more expensive, it also associated with an increase of 0.32 QALYs. One-way sensitivity analysis identified RARC as the preferred strategy if a complication can be prevented 74% of the time. RARC is preferred as long as it is 70% effective in preventing a transfusion. Two-way sensitivity analysis showed that as long as RARC can prevent complications and transfusions, it is the preferred cost-effective treatment when compared to OC. The study is limited by the omission of a societal perspective and the lack of health utility values for RC. CONCLUSIONS: RARC is cost-effective compared to OC when the rates of complications and transfusions are significantly lower. PATIENT SUMMARY: Bladder removal via a robotic approach is more expensive, but it improves health-related quality of life. Robotic surgery is cost-effective compared to an open approach for bladder removal if there are low rates of complications and blood transfusion.

Outcomes for urologic oncology procedures: are there differences between academic and community hospitals?

OBJECTIVE: To compare the rate of hospital-based outcomes including costs, 30-day readmission, mortality, and length of stay in patients who underwent major urologic oncologic procedures in academic and community hospitals. METHODS: We retrospectively reviewed the Vizient Database (Irving, Texas) from September 2014 to December 2017. Vizient includes ~ 97% of academic hospitals (AH) and more than 60 community hospitals (CH). Patients aged ≥ 18 with urologic malignancies who underwent surgical treatment were included. Chi square and Student t tests were used to compare categorical and continuous variables, respectively. RESULTS: We identified a total of 37,628 cases. There were 33,290 (88%) procedures performed in AH and 4330 (12%) in CH. These included prostatectomy (18,540), radical nephrectomy (rNx) 8059, partial nephrectomy (pNx) (5287), radical cystectomy (4421), radical nephroureterectomy (rNu) (1006), and partial cystectomy (321). There were no significant differences in 30-day readmission rates or mortality for any procedure between academic and community hospitals (Table 1), p > 0.05 for all. Length of stay was significantly lower for radical cystectomy and prostatectomy in AH (p < 0.01 for both) and lower for rNx in CH (p = 0.03). The mean direct cost for index admission was significantly higher in AH for rNx, pNx, rNu, and prostatectomy. Case mix index was similar between the community and academic hospitals. CONCLUSION: Despite academic and community hospitals having similar case complexity, direct costs were lower in community hospitals without an associated increase in readmission rates or deaths. Length of stay was shorter for cystectomy in academic centers.

The effect of multiple recruitment contacts on response rates and patterns of missing data in a survey of bladder cancer survivors 6 months after cystectomy.

PURPOSE: The Bladder Cancer Quality of Life Study collected detailed and sensitive patient-reported outcomes from bladder cancer survivors in the period after bladder removal surgery, when participation in survey research may present a burden. This paper describes the study recruitment methods and examines the response rates and patterns of missing data. METHODS: Detailed surveys focusing on quality of life, healthcare decision-making, and healthcare expenses were mailed to patients 5-7 months after cystectomy. We conducted up to 10 follow-up recruitment calls. We analyzed survey completion rates following each contact in relation to demographic and clinical characteristics, and patterns of missing data across survey content areas. RESULTS: The overall response rate was 71% (n = 269/379). This was consistent across patient clinical characteristics; response rates were significantly higher among patients over age 70 and significantly lower among racial and ethnic minority patients compared to non-Hispanic white patients. Each follow-up contact resulted in marginal survey completion rates of at least 10%. Rates of missing data were low across most content areas, even for potentially sensitive questions. Rates of missing data differed significantly by sex, age, and race/ethnicity. CONCLUSIONS: Despite the effort required to participate in research, this population of cancer survivors showed willingness to share detailed information about quality of life, health care decision-making, and expenses, soon after major cancer surgery. Additional contacts were effective at increasing participation. Response patterns differed by race/ethnicity and other demographic factors. Our data collection methods show that it is feasible to gather detailed patient-reported outcomes during this challenging period.

Patient frailty predicts worse perioperative outcomes and higher cost after radical cystectomy.

BACKGROUND: Relatively few studies investigated the importance of frailty in radical cystectomy (RC) patients. We tested the ability of frailty, using the Johns Hopkins Adjusted Clinical Groups indicator, to predict early perioperative outcomes after RC. METHODS: RC patients were identified within the National Inpatient Sample database (2000-2015). The effect of frailty, age and Charlson Comorbidity Index were tested in five separate multivariable models predicting: (1) complications, (2) failure to rescue (FTR), (3) in-hospital mortality, (4) length of stay (LOS) and (5) total hospital charges (THCs). All models were weighted and adjusted for clustering, as well as all available patient and hospital characteristics. RESULTS: Of 23,967 RC patients, 5833 (24.3%) were frail, 7721 (32.2%) were aged ≥75 years and 2832 (11.8%) had CCI ≥2. Frailty, age ≥75 years and CCI ≥2 were non-overlapping in 86.3% of the cohort. Any two or three of these features were recorded in 12.4 and 1.3%, respectively. Frailty was an independent predictor of all five examined endpoints and the magnitude of its association was stronger or at least equal than that of age ≥75 years and CCI ≥2. CONCLUSION: Frailty, advanced age and comorbidities represent non-overlapping patients' characteristics. Of those, frailty represents the most consistent and strongest predictor of early adverse outcomes after RC. Ideally, all three indicators should be considered in retrospective, as well as prospective analyses. Pre-surgical recognition of frail patients should be ideally incorporate in clinical practice in order to address these patients to multimodal pre-habilitation programs that may potentially improve the perioperative prognosis.

Cost comparison between open radical cystectomy, laparoscopic radical cystectomy, and robot-assisted radical cystectomy for patients with bladder cancer: a systematic review of segmental costs.

BACKGROUND: Robot-assisted radical cystectomy is becoming a common treatment for bladder carcinoma. However, in comparison with open radical cystectomy, its cost-effectiveness has not been confirmed. Although few published reviews have compared total costs between the two surgical procedures, no study has compared segmental costs and explained their impact on total costs. METHODS: A systematic review was conducted based on studies on the segmental costs of open, laparoscopic, and robot-assisted radical cystectomy using PubMed, Web of Science, and Cochrane Library databases to provide insight into cost-effective management methods for radical cystectomy. The segmental costs included operating, robot-related, complication, and length of stay costs. A sensitivity analysis was conducted to determine the impact of the annual number of cases on the per-case robot-related costs. RESULTS: We identified two studies that compared open and laparoscopic surgeries and nine that compared open and robotic surgeries. Open radical cystectomy costs were higher than those of robotic surgeries in two retrospective single-institution studies, while robot-assisted radical cystectomy costs were higher in 1 retrospective single-institution study, 1 randomized controlled trial, and 4 large database studies. Operating costs were higher for robotic surgery, and accounted for 63.1-70.5% of the total robotic surgery cost. Sensitivity analysis revealed that robot-related costs were not a large proportion of total surgery costs in institutions with a large number of cases but accounted for a large proportion of total costs in centers with a small number of cases. CONCLUSIONS: The results show that robot-assisted radical cystectomy is more expensive than open radical cystectomy. The most effective methods to decrease costs associated with robotic surgery include a decrease in operating time and an increase in the number of cases. Further research is required on the cost-effectiveness of surgeries, including quality measures such as quality of life and quality-adjusted life years.

Definitive BCG immunotherapy versus radical cystectomy in intermediate or high-risk nonmuscle invasive bladder cancer patients: A retrospective study.

At present, intravesical Bacillus Calmette-Guerin (BCG) immunotherapy is recommended for prophylaxis purposes after transurethral resection of bladder tumor, but has chances of recurrence. Radical cystectomy reduces the risk of recurrence in bladder cancer patients, but may have chances of postoperative complications. The objective of the study was to test the hypothesis that radical cystectomy has overtreatment and definitive BCG immunotherapy has undertreatment in intermediate or high-risk nonmuscle invasive bladder cancer patients. Data regarding biopsies, ultrasound, the computed tomography scan, adopted treatment strategy, treatment-emergent adverse effect, and a follow-up period of 312 patients with confirmed nonmuscle invasive bladder cancer (pTa, pTis, or pT1 stage; intermediate or high-risk cancer) were reviewed. Patients who had received definitive intravesical BCG immunotherapy were included in BCG group (n = 210) and those who underwent radical cystectomy were included in RXC group (n = 87). Clinical decision-making for treatment strategies was evaluated for both groups. Cystitis was frequently observed in all patients who received BCG immunotherapy. In RXC group, ileus was frequently observed in all patients in early days after the operation. During 2 years of the follow-up period, biopsies, ultrasound, and the computed tomography scan reported that BCG group had fewer numbers of negative cancer patients after treatment than the RXC group after surgery (P < .0001). Total expenditure for BCG immunotherapy was higher than radical cystectomy (22,945 ±â€Š945 ¥/patient vs 17,985 ±â€Š545 ¥/patient; P < .0001). Definitive BCG immunotherapy had undertreatment and radical cystectomy had overtreatment for intermediate or high-risk invasive bladder cancer patients (level of evidence III).

Photodynamic versus white light-guided treatment of non-muscle invasive bladder cancer: a study protocol for a randomised trial of clinical and cost-effectiveness.

INTRODUCTION: Bladder cancer is the most frequently occurring tumour of the urinary system. Ta, T1 tumours and carcinoma in situ (CIS) are grouped as non-muscle invasive bladder cancer (NMIBC), which can be effectively treated by transurethral resection of bladder tumour (TURBT). There are limitations to the visualisation of tumours with conventional TURBT using white light illumination within the bladder. Incomplete resections occur from the failure to identify satellite lesions or the full extent of the tumour leading to recurrence and potential risk of disease progression. To improve complete resection, photodynamic diagnosis (PDD) has been proposed as a method that can enhance tumour detection and guide resection. The objective of the current research is to determine whether PDD-guided TURBT is better than conventional white light surgery and whether it is cost-effective. METHODS AND ANALYSIS: PHOTO is a pragmatic multicentre randomised controlled trial (open parallel group, non-masked and superiority trial) comparing the intervention of PDD-guided TURBT with standard white light resection in newly diagnosed intermediate and high risk NMIBC within the UK National Health Service setting. Clinical effectiveness is measured with time to recurrence. Cost-effectiveness is assessed within trial via the calculation of incremental cost per recurrence avoided and incremental cost per quality-adjusted life per year gained over 3 years and over long term through a modelling exercise over patients' lifetime. ETHICS AND DISSEMINATION: Formal ethics review was undertaken with a favourable opinion, in line with UK regulatory procedures (REC reference number: 14/NE/1062). If reductions in time to recurrence is associated with long-term patient benefits, the cost-effectiveness evaluation will provide further evidence to inform adoption of the technology. Findings will be shared in lay media such as patient and charity forums and will be presented at key meetings and published in academic literature.Trial registration number ISRCTN84013636.

Current status and future perspective of robot-assisted radical cystectomy for invasive bladder cancer.

The current status of robot-assisted radical cystectomy was reviewed 16 years after the initial robot-assisted radical cystectomy for the treatment of invasive bladder cancer. Articles associated with robot-assisted radical cystectomy and written in English were selected from the PubMed database from January 2003 to February 2019. The present review article focused on the distribution of robot-assisted radical cystectomy, patient selection, preoperative management, surgical technique, lymph node dissection, urinary diversion, recurrence pattern, oncological outcomes, cost, learning curve, complications and educational programs. A total of 400 articles were divided according to the country of the first author's affiliation. The USA was the most dominant at 198 (50%), whereas the number of articles from the countries belonging to the Urological Association of Asia was 15 (3.8%) for China, 17 (4.3%) for South Korea, 10 (2.5%) for Japan, eight (2%) for Taiwan, eight (2%) for Turkey and one (0.2%) for Iran. The percentage of robot-assisted radical cystectomy carried out is increasing, and intracorporeal urinary diversion and ileal neobladder are also frequently carried out. With a refined technique being performed in high-volume centers, robot-assisted radical cystectomy has contributed to the reduction in transfusion rate, length of stay and severe complications; however, it has not yet shown any cancer-specific survival benefits. Robot-assisted radical cystectomy is not fully spread throughout the Urological Association of Asia. Further investigation with respect to worldwide results is needed to prove the real benefit of robot-assisted radical cystectomy regarding low morbidity, reduced total medical cost, and survival benefit. In the era of precision medicine, appropriate drug and surgery will be given based on each genetic profile.

Comparison of Costs of Radical Cystectomy vs Trimodal Therapy for Patients With Localized Muscle-Invasive Bladder Cancer.

Importance: Earlier studies on the cost of muscle-invasive bladder cancer treatments lack granularity and are limited to 180 days. Objective: To compare the 1-year costs associated with trimodal therapy vs radical cystectomy, accounting for survival and intensity effects on total costs. Design, Setting, and Participants: This population-based cohort study used the US Surveillance, Epidemiology, and End Results-Medicare database and included 2963 patients aged 66 to 85 years who had received a diagnosis of clinical stage T2 to T4a muscle-invasive bladder cancer from January 1, 2002, through December 31, 2011. The data analysis was performed from March 5, 2018, through December 4, 2018. Main Outcomes and Measures: Total Medicare costs within 1 year of diagnosis following radical cystectomy vs trimodal therapy were compared using inverse probability of treatment-weighted propensity score models that included a 2-part estimator to account for intrinsic selection bias. Results: Of 2963 participants, 1030 (34.8%) were women, 2591 (87.4%) were white, 129 (4.4%) were African American, and 98 (3.3%) were Hispanic. Median costs were significantly higher for trimodal therapy than radical cystectomy in 90 days ($83 754 vs $68 692; median difference, $11 805; 95% CI, $7745-$15 864), 180 days ($187 162 vs $109 078; median difference, $62 370; 95% CI, $55 581-$69 160), and 365 days ($289 142 vs $148 757; median difference, $109 027; 95% CI, $98 692-$119 363), respectively. Outpatient care, radiology, medication expenses, and pathology/laboratory costs contributed largely to the higher costs associated with trimodal therapy. On inverse probability of treatment-weighted adjusted analyses, patients undergoing trimodal therapy had $136 935 (95% CI, $122 131-$152 115) higher mean costs compared with radical cystectomy 1 year after diagnosis. Conclusions and Relevance: Compared with radical cystectomy, trimodal therapy was associated with higher costs among patients with muscle-invasive bladder cancer. The differences in costs were largely attributed to medication and radiology expenses associated with trimodal therapy. Extrapolating cost figures resulted in a nationwide excess spending of $468 million for trimodal therapy compared with radical cystectomy for patients who received a diagnosis of bladder cancer in 2017.

Contemporary National Assessment of Robot-Assisted Surgery Rates and Total Hospital Charges for Major Surgical Uro-Oncological Procedures in the United States.

Background: The role of robot assistance is increasingly gaining importance among all major surgical uro-oncological procedures (MSUPs). However, contemporary analyses showed that total hospital charges (THCGs) related to robot-assisted procedures exceed those of open procedures. Based on increasing familiarity with robot-assisted surgery, we postulated that THCGs may have decreased over the past half-decade. Thus, we tested contemporary trends and THCGs related to robot-assisted vs nonrobot-assisted MSUPs. Materials and Methods: Within the National Inpatient Sample database (2009-2015), we identified patients who underwent robot-assisted vs nonrobot-assisted (open or laparoscopic) MSUPs, which included radical prostatectomy (RP), radical nephrectomy (RN), partial nephrectomy (PN), and radical cystectomy (RC). Rates of robot-assisted MSUPs were evaluated using estimated annual percentage changes (EAPCs) analyses. The t-test was used to examine statistically significant differences between mean THCGs according to either robot-assisted or nonrobot-assisted approach. Finally, linear regression analyses were tested for annual variation in the mean THCGs. Results: Of 128,367 MSUPs, 47.7% were robot-assisted. Overall, robot-assisted surgery rates among MSUPs increased from 40.3% to 57.6% (EAPC: +6.3%, p < 0.001) between 2009 and 2015. The mean THCGs for robot-assisted RP, RN, PN, and RC were $13,799, $18,789, $16,574, and $33,575, respectively. The observed mean THCGs differences between robot-assisted and nonrobot-assisted MSUPs were +$1594, +$1592, and +$1829 for RP, RN, and RC, respectively (all p < 0.05). Conversely, no statistically significant difference in the mean THCGs was reported between robot-assisted and nonrobot-assisted PN (+$367, p > 0.05). Finally, the annual observed mean THCGs linearly decreased for all robot-assisted MSUPs during the study period. Conclusions: Rates of robot-assisted MSUPs exponentially increased between 2009 and 2015. Although the mean THCGs decreased in a significant manner during the study period for all MSUPs, THCGs of robot-assisted RP, RN, and RC still exceed those of their respective nonrobot-assisted counterparts. Conversely, no differences in the mean THCGs were reported between robot-assisted vs nonrobot-assisted PN.

A cost-effectiveness modeling study of robot-assisted (RARC) versus open radical cystectomy (ORC) for bladder cancer to inform future research.

BACKGROUND: Open radical cystectomy (ORC) is regarded the standard treatment for muscle-invasive bladder cancer, but robot-assisted radical cystectomy (RARC) is increasingly used in practice. However, it is unclear whether RARC provides value for money. OBJECTIVE: To identify the main evidence gaps and main drivers of cost-effectiveness, comparing RARC to ORC. DESIGN, SETTING, AND PARTICIPANTS: A decision analytical model was developed to study the 30d and 90d postoperative complications with RARC versus ORC and their related cost in bladder cancer patients. Input data were derived from systematic literature searches, meta-analyses, internal databases and expert opinion. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Cost per saved complication (in Clavien-Dindo grading) was determined. Deterministic sensitivity analyses was performed to search for threshold values for RARC to become cost saving. Uncertainty was addressed using probabilistic sensitivity analyses. RESULTS: The expected 30d and 90d risk for a minor complication was lower for RARC than ORC (37% vs. 45% and 32% vs. 36%). The expected 30d and 90d risk of RARC versus ORC for a major complication was 18% vs. 23% and 16% vs. 25%. The 30d and 90d extra costs needed to prevent one major complication were €62,582 and €37,007, respectively. Data on the impact of complications on quality of life were lacking. Three scenarios resulted in cost savings for RARC: operating time (threshold: ≤175min), length of stay (≤4d), and RARC equipment (≤€281). CONCLUSION: Current evidence suggests that it is unlikely that RARC will become less expensive than ORC. However, RARC might result in fewer complications. To determine value for money, research is needed into the consequences of these complications in terms of quality of life. PATIENT SUMMARY: Economic modeling showed that RARC might result in fewer complications, but is more expensive than ORC. Future research should focus on the impact on quality of life.