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.

Cost Effectiveness of Treatment Sequences in Advanced Renal Cell Carcinoma.

BACKGROUND: The treatment landscape for metastatic renal cell carcinoma (mRCC) has significantly evolved in recent years. Without direct comparator trials, factors such as cost effectiveness (CE) are important to guide decision-making. OBJECTIVE: To assess the CE of guideline-recommended approved first- and second-line treatment regimens. DESIGN, SETTING, AND PARTICIPANTS: A comprehensive Markov model was developed to analyze the CE of the five current National Comprehensive Cancer Network-recommended first-line therapies with appropriate second-line therapy for patient cohorts with International Metastatic RCC Database Consortium favorable and intermediate/poor risk. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Life years, quality-adjusted life years (QALYs), and total accumulated costs were estimated using a willingness-to-pay threshold of $150 000 per QALY. One-way and probabilistic sensitivity analyses were performed. RESULTS AND LIMITATIONS: In patients with favorable risk, pembrolizumab + lenvatinib followed by cabozantinib added $32 935 in costs and yielded 0.28 QALYs, resulting in an incremental CE ratio (ICER) of $117 625 per QALY in comparison to pembrolizumab + axitinib followed by cabozantinib. In patients with intermediate/poor risk, nivolumab + ipilimumab followed by cabozantinib added $2252 in costs and yielded 0.60 QALYs compared to cabozantinib followed by nivolumab, yielding an ICER of $4184. Limitations include differences in median follow-up duration between treatments. CONCLUSIONS: Pembrolizumab + lenvatinib followed by cabozantinib, and pembrolizumab + axitinib followed by cabozantinib were cost-effective treatment sequences for patients with favorable-risk mRCC. Nivolumab +ipilimumab followed by cabozantinib was the most cost-effective treatment sequence for patients with intermediate-/poor-risk mRCC, dominating all preferred treatments. PATIENT SUMMARY: Because new treatments for kidney cancer have not been compared head to head, comparison of their cost and efficacy can help in making decisions about the best treatments to use first. Our model showed that patients with a favorable risk profile are most likely to benefit from pembrolizumab and lenvatinib or axitinib followed by cabozantinib, while patients with an intermediate or poor risk profile will probably benefit most from nivolumab and ipilimumab followed by cabozantinib.

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.

Trends in Insurance Status during Initial Presentation of Testicular Carcinoma: Examining Health Outcomes and Implications of Health Reform for Young Adults in the United States.

INTRODUCTION: We evaluated trends in insurance status, and assessed socioeconomic factors associated with clinically metastatic testicular cancer presentation and potential barriers to treatment in the United States. METHODS: The National Cancer Database was queried for patients with testicular germ cell tumors diagnosed from 2004 to 2014. Temporal trends and forecast of insurance status were examined in the years before and after the ACA (Affordable Care Act) was enacted. Multivariable logistic regression was used to assess predictors of clinically metastatic presentation. RESULTS: A total of 58,348 patients were identified with 37.95% presenting with clinically metastatic disease. The uninsured rate remained relatively unchanged during the years before and after the ACA was enacted (11.7% vs 11.9%, respectively). Predictors for clinically metastatic presentation were Medicaid (OR 2.12, 95% CI 1.80-2.50), Medicare (OR 1.35, 95% CI 1.13-1.60) and uninsured status (OR 1.41, 95% CI 1.22-1.64) compared to privately insured patients. A forecast model revealed no significant changes in the uninsured rate (11.58% to 11.60%) for 2015 through 2017. CONCLUSIONS: Socioeconomic disparities continue to be barriers for young adults presenting with testicular cancer in the United States. Longer prospective followup will be required to assess the impact of payer status with the reportedly increased health coverage fostered by the ACA.

Does Implementing an Enhanced Recovery After Surgery Protocol Increase Hospital Charges? Comparisons From a Radical Cystectomy Program at a Specialty Cancer Center.

OBJECTIVE: To compare perioperative charges induced at the initial phase of a standardized enhanced recovery after surgery (ERAS) program from a tertiary referral center. METHODS: A multidisciplinary ERAS protocol was implemented in our department on July 2015. During the subsequent year, all patients were treated according to this protocol (ERAS group). The patients were compared in terms of real in-hospital charges per surgical episode with a control group consisting of consecutive patients before the start of ERAS. Individual charges were analyzed per sample population and compared with the Wilcoxon rank-sum test or t test. Additionally, cost variances for each group were evaluated. RESULTS: A total of 257 consecutive patients were evaluated of which the last 112 were ERAS patients. The median length of stay for each group was 6 days (P = .748). ERAS patients incurred higher medication charges ($1939 vs $1729, P = .036). Control patients incurred higher supplies ($861 vs $692), treatment ($90 vs $72), and miscellaneous charges ($537 vs $388) (all, P < .001). The median total charges per patient were $59,539 for the control group and $60,655 for the ERAS group (P = .175). ERAS adoption significantly reduced variance in billed charges (P < .001). CONCLUSION: ERAS implementation did not significantly increase expenditure for cystectomy patients. ERAS showed decreased variance in charges likely due to standardization of care while eliciting savings in supplies, treatment, and miscellaneous costs.

Evaluation of point-of-care PRO assessment in clinic settings: integration, parallel-forms reliability, and patient acceptability of electronic QOL measures during clinic visits.

PURPOSE: Assessment of patient-reported outcomes (PROs), such as health-related quality of life, has become an important component of healthcare that measures the impact of disease and medical treatment on patient health. Collecting PROs during point-of-care assessments and integrating them into the clinical setting, however, remains challenging. The objective of this pilot study was to evaluate the reliability, usability, and acceptability of point-of-care electronic PRO assessments implemented in a prostate cancer clinic. METHODS: Fifty subjects completed paper-pencil and computerized formats of the Expanded Prostate Cancer Index Composite (EPIC), a validated, condition-specific QOL instrument, at separate times before treatment. Parallel-forms reliability was evaluated by comparing mean scores, variations in response distribution, and correlations between administration formats. Correlation coefficients of at least 0.70 were used for reliability testing. Differences between administration forms, indicating potential bias, were compared using the signed-rank test. A 6-item acceptability scale was also used to evaluate patient acceptability and satisfaction with the electronic format. RESULTS: Mean scores and standard deviations were similar between the paper-pencil and electronic forms across all EPIC instrument domains, and no assessment bias was found. Each EPIC domain demonstrated a high reliability between administration formats (correlation coefficients: 0.70-0.98). The majority (>90 %) of respondents found that the computerized QOL format was user friendly and simple to use. CONCLUSIONS: Point-of-care computerized QOL assessments were reliable and acceptable to patients in this study, supporting the feasibility of PRO integration at the point-of-care in clinical settings.

The impact of technology diffusion on treatment for prostate cancer.

BACKGROUND: The use of local therapy for prostate cancer may increase because of the perceived advantages of new technologies such as intensity-modulated radiotherapy (IMRT) and robotic prostatectomy. OBJECTIVE: To examine the association of market-level technological capacity with receipt of local therapy. DESIGN: Retrospective cohort. SUBJECTS: Patients with localized prostate cancer who were diagnosed between 2003 and 2007 (n=59,043) from the Surveillance Epidemiology and End Results-Medicare database. MEASURES: We measured the capacity for delivering treatment with new technology as the number of providers offering robotic prostatectomy or IMRT per population in a market (hospital referral region). The association of this measure with receipt of prostatectomy, radiotherapy, or observation was examined with multinomial logistic regression. RESULTS: For each 1000 patients diagnosed with prostate cancer, 174 underwent prostatectomy, 490 radiotherapy, and 336 were observed. Markets with high robotic prostatectomy capacity had higher use of prostatectomy (146 vs. 118 per 1000 men, P=0.008) but a trend toward decreased use of radiotherapy (574 vs. 601 per 1000 men, P=0.068), resulting in a stable rate of local therapy. High versus low IMRT capacity did not significantly impact the use of prostatectomy (129 vs. 129 per 1000 men, P=0.947) and radiotherapy (594 vs. 585 per 1000 men, P=0.579). CONCLUSIONS: Although there was a small shift from radiotherapy to prostatectomy in markets with high robotic prostatectomy capacity, increased capacity for both robotic prostatectomy and IMRT did not change the overall rate of local therapy. Our findings temper concerns that the new technology spurs additional therapy of prostate cancer.

Use of advanced treatment technologies among men at low risk of dying from prostate cancer.

IMPORTANCE: The use of advanced treatment technologies (ie, intensity-modulated radiotherapy [IMRT] and robotic prostatectomy) for prostate cancer is increasing. The extent to which these advanced treatment technologies have disseminated among patients at low risk of dying from prostate cancer is uncertain. OBJECTIVE: To assess the use of advanced treatment technologies, compared with prior standards (ie, traditional external beam radiation treatment [EBRT] and open radical prostatectomy) and observation, among men with a low risk of dying from prostate cancer. DESIGN, SETTING, AND PATIENTS: Using Surveillance, Epidemiology, and End Results (SEER)-Medicare data, we identified a retrospective cohort of men diagnosed with prostate cancer between 2004 and 2009 who underwent IMRT (n = 23,633), EBRT (n = 3926), robotic prostatectomy (n = 5881), open radical prostatectomy (n = 6123), or observation (n = 16,384). Follow-up data were available through December 31, 2010. MAIN OUTCOMES AND MEASURES: The use of advanced treatment technologies among men unlikely to die from prostate cancer, as assessed by low-risk disease (clinical stage ≤T2a, biopsy Gleason score ≤6, and prostate-specific antigen level ≤10 ng/mL), high risk of noncancer mortality (based on the predicted probability of death within 10 years in the absence of a cancer diagnosis), or both. RESULTS: In our cohort, the use of advanced treatment technologies increased from 32% (95% CI, 30%-33%) to 44% (95% CI, 43%-46%) among men with low-risk disease (P < .001) and from 36% (95% CI, 35%-38%) to 57% (95% CI, 55%-59%) among men with high risk of noncancer mortality (P < .001). The use of these advanced treatment technologies among men with both low-risk disease and high risk of noncancer mortality increased from 25% (95% CI, 23%-28%) to 34% (95% CI, 31%-37%) (P < .001). Among all patients diagnosed in SEER, the use of advanced treatment technologies for men unlikely to die from prostate cancer increased from 13% (95% CI, 12%-14%), or 129.2 per 1000 patients diagnosed with prostate cancer, to 24% (95% CI, 24%-25%), or 244.2 per 1000 patients diagnosed with prostate cancer (P < .001). CONCLUSION AND RELEVANCE: Among men diagnosed with prostate cancer between 2004 and 2009 who had low-risk disease, high risk of noncancer mortality, or both, the use of advanced treatment technologies has increased.

Improving bladder cancer patient care: a pharmacoeconomic perspective.

Bladder cancer is the most expensive cancer per capita to treat in the US healthcare system. Substantial costs associated with the diagnosis, management and surveillance of bladder cancer account for the bulk of the expense; yet, for that cost, patients may not receive high-quality care. Herein the authors review the sources of expenditure associated with bladder cancer care, review population-level analyses of the quality of bladder cancer care in the USA, and discuss opportunities for quality improvement that may yield greater value for men and women newly diagnosed with bladder cancer.

Downstream complications following urinary diversion.

PURPOSE: Surveillance following urinary diversion should be tailored to capture complications downstream from the initial reconstruction. Most analyses of the morbidity associated with urinary diversion are restricted to the index admission or the immediate postoperative period. We characterize the long-term medical and surgical complications and burden of health care use after urinary diversion. MATERIALS AND METHODS: Using the 5% Medicare sample from 1998 to 2005 we identified individuals who underwent cutaneous and orthotopic continent urinary diversion, ileal conduit or other types of diversion including enterocystoplasty from physician claims for the index admission. We restricted our sample to subjects with claims 1 year before surgery and at least 2 years after the diversion. We included benign and malignant primary diagnoses, and evaluated the incidence of medical and surgical complications 2 and 5 years after surgery. We stratified complications by diversion type and compared long-term complications after urinary diversion surgery. RESULTS: Of the 1,565 subjects identified 80% underwent ileal conduit urinary diversion, 7% underwent cutaneous or orthotopic continent diversion and 13% underwent other types of reconstruction. Urinary stone formation, wound complications and fistula complications were more common following continent diversion 5 years after surgery, while ureteral obstruction and renal failure/impairment were more common after ileal conduit diversion. Overall we estimated that more than 16% of patients experienced renal failure or impairment after urinary diversion. CONCLUSIONS: Complications are common after urinary diversion and continue to occur through 5 years postoperatively. Urolithiasis and delayed wound complications appear to occur more commonly after continent diversion than after other urinary diversions. A large proportion of patients experience renal deterioration after diversion. These results highlight the need to survey patients for the diversion related complications of cystectomy as rigorously as we monitor for cancer recurrence.

Advanced topics in evidence-based urologic oncology: economic analysis.

Urologists, regardless of whether they practice in the community or in an academic institution, make decisions not only about their individual patients but also about hospital and health care policy by providing input to various committees that influence the adoption of new diagnostic and therapeutic technology. In an era of increasing awareness of healthcare costs, economic analyses that consider not only the potential benefit and harm of a given intervention but also the costs of the intervention, are increasingly important. This review article introduces a framework to critically appraise an economic analysis for its validity, impact, and applicability to patient care using an example from the urologic literature.

Readmissions in the postoperative period following urinary diversion.

PURPOSE: Most analyses of complications after urinary diversion are restricted to the index admission. Given the complexity of these reconstructions, readmissions occur commonly. We sought to characterize the burden and impact of readmissions in the postoperative period following urinary diversion. METHODS: Using 5% Medicare data for the years 1998-2005, we identified patients undergoing ileal conduit, continent, and other urinary diversions for benign and malignant indications. We examined the 90-day rates of readmission and evaluated factors associated with readmission after urinary diversion, either to the primary hospital or to a secondary facility. We assessed 90-day and 2-year mortality after urinary diversion and incorporated readmission status as a covariate in these multivariable models. RESULTS: Our study sample included 1,565 patients, of whom 491 patients (31%) were readmitted within 90 days of their urinary diversion. Patients readmitted after urinary diversion had higher comorbidity count than those not readmitted (59% of those readmitted with comorbidity count at least 1 versus 50% of those not readmitted, P=0.002). Other clinical and demographic characteristics did not differ by readmission status (P>0.12 for age, race, type of urinary diversion, and primary diagnosis). Complication rates were higher in readmitted patients than those not readmitted; 2-year mortality was associated with 90-day readmission status-18.8% of readmitted versus 12.8% of not readmitted patients died within 2 years of surgery (P=0.003). CONCLUSIONS: Readmissions occur commonly after urinary diversion. Many readmitted patients have complications of complex surgery managed at secondary hospitals, which may portend a quality concern that merits further study.

Reimbursement policy and androgen-deprivation therapy for prostate cancer.

BACKGROUND: The Medicare Modernization Act led to moderate reductions in reimbursement for androgen-deprivation therapy (ADT) for prostate cancer, starting in 2004 and followed by substantial changes in 2005. We hypothesized that these reductions would lead to decreases in the use of ADT for indications that were not evidence based. METHODS: Using the Surveillance, Epidemiology, and End Results (SEER) Medicare database, we identified 54,925 men who received a diagnosis of incident prostate cancer from 2003 through 2005. We divided these men into groups according to the strength of the indication for ADT use. The use of ADT was deemed to be inappropriate as primary therapy for men with localized cancers of a low-to-moderate grade (for whom a survival benefit of such therapy was improbable), appropriate as adjuvant therapy with radiation therapy for men with locally advanced cancers (for whom a survival benefit was established), and discretionary for men receiving either primary or adjuvant therapy for localized but high-grade tumors. The proportion of men receiving ADT was calculated according to the year of diagnosis for each group. We used modified Poisson regression models to calculate the effect of the year of diagnosis on the use of ADT. RESULTS: The rate of inappropriate use of ADT declined substantially during the study period, from 38.7% in 2003 to 30.6% in 2004 to 25.7% in 2005 (odds ratio for ADT use in 2005 vs. 2003, 0.72; 95% confidence interval [CI], 0.65 to 0.79). There was no decrease in the appropriate use of adjuvant ADT (odds ratio, 1.01; 95% CI, 0.86 to 1.19). In cases involving discretionary use, there was a significant decline in use in 2005 but not in 2004. CONCLUSIONS: Changes in the Medicare reimbursement policy in 2004 and 2005 were associated with reductions in ADT use, particularly among men for whom the benefits of such therapy were unclear. (Funded by the American Cancer Society.).

Participation of older patients with prostate cancer in Medicare eligible trials.

PURPOSE: On June 7, 2000 President Clinton issued an executive memorandum directing Medicare payment for routine patient care in qualifying clinical trials. We estimated the proportion of older patients with prostate cancer who were examined as part of a qualifying clinical trial, and the association between participation and patient characteristics. MATERIALS AND METHODS: We performed an observational study using the Surveillance, Epidemiology and End Results Medicare database to determine participation in qualifying clinical trials in a sample of 37,216 men 66 years old or older who were enrolled in Medicare and diagnosed with prostate cancer between September 2000 and December 2002. RESULTS: Within 3 years of diagnosis 211 men (0.567%) received routine patient care in a qualifying clinical trial. These participants were more likely to be younger than 70 years (OR 1.687, 95% CI 1.27-2.24) and less likely to be less educated and reside in low income, metropolitan neighborhoods. White men were more likely to participate in clinical trials than nonwhite men but this association was not statistically significant (OR 1.426, CI 0.97-2.09). Participation varied significantly by registry site (0% to 1.2%) but not by tumor grade or stage, or prostate specific antigen status. CONCLUSIONS: Few older patients with prostate cancer participated in qualifying trials between 2000 and 2002. Those who participated were not representative of the general population of older patients with prostate cancer. Greater efforts are required to expand trial enrollment and decrease disparities in research participation.

Understanding the relationship between health care quality and the renal mass.

Quality is increasingly important to all stakeholders of the U.S. health care system. Endeavors to measure and improve quality have moved forward in cardiovascular disease, diabetes care, and surgical wound infections. However, in urology, such efforts have lagged. As a specialty, we are now faced with pressures, exerted primarily by payors, to roll out performance measures, or quality indicators, in the absence of science to support them. In this review, we discuss the broad concepts of health care quality and describe their relationships with small renal tumors.

The evolving role of partial nephrectomy in the management of renal cell carcinoma.

The surgical management of renal cell carcinoma has undergone critical review over the past decade. Initially treated with radical nephrectomy, renal cell carcinoma is now approached with nephron-sparing surgical techniques. Improved imaging modalities have substantially increased the number of incidental renal tumors detected, and with the increasing number of incidentally detected kidney tumors, a size and stage migration has occurred in renal cell carcinoma. Early studies showed that disease-free survival rates were similar between cancers treated with radical and partial nephrectomy. The standard now is to offer partial nephrectomy as a surgical option to all patients with renal lesions measuring 4.0 cm or smaller in the setting of a normal contralateral kidney. More recent issues regarding partial nephrectomy concern complication rates and management, renal cell carcinoma multifocality, margin status and distance to normal renal parenchyma, cost analysis, and the development of laparoscopic techniques that duplicate open partial nephrectomy. The purpose of this review is to outline and analyze these more recent concerns regarding partial nephrectomy.