Citations

Objective The aim of this study was to perform a cost-effectiveness analysis comparing the management for ongoing voiding dysfunction after midurethral sling placement, including early sling loosening and delayed sling lysis. Methods A Markov model was created to compare the cost-effectiveness of early sling loosening (2 weeks) versus delayed sling lysis (6 weeks) for the management of persisting voiding dysfunction/retention after midurethral sling placement. A literature review provided rates of resolution of voiding dysfunction with conservative management, complications, recurrent stress urinary incontinence, or ongoing retention, as well as quality-adjusted life years (QALYs). Costs were based on 2020 Medicare reimbursement rates. Incremental cost-effectiveness ratios were compared using a willingness-to-pay threshold of $100,000/QALY. One-way and probabilistic sensitivity analyses were performed. Results At 1 year, early sling loosening resulted in increased costs ($3,575 vs $1,836) and higher QALYs (0.948 vs 0.925) compared with delayed sling lysis. This translated to early sling loosening being the most cost-effective strategy, with an incremental cost-effectiveness ratio of $74,382/QALY. The model was sensitive to multiple variables on our 1-way sensitivity analysis. For example, delayed sling lysis became cost-effective if the rate of voiding dysfunction resolution with conservative management was greater than or equal to 57% or recurrent stress urinary incontinence after early loosening was greater than or equal to 9.6%. At a willingness-to-pay threshold of 100,000/QALY, early sling loosening was cost-effective in 82% of microsimulations in probabilistic sensitivity analysis. Conclusions Early sling loosening represents a more cost-effective management method in resolving ongoing voiding dysfunction after sling placement. These findings may favor early clinical management in patients with voiding dysfunction after midurethral sling placement.

321 Background: KEYNOTE-564 demonstrated that adjuvant pembrolizumab after nephrectomy for high-risk clear cell renal cell carcinoma (RCC) decreased the risk of disease progression and – albeit with immature follow-up (2 years) – found a signal of improved overall survival as well. Herein, we used extrapolations from a Markov-model, accounting for the costs and toxicities of pembrolizumab relative to its efficacy, to investigate its utility at a population level. Methods: A decision-analytic Markov Model was used to conduct a cost-utility analysis of adjuvant pembrolizumab versus placebo after nephrectomy for high risk RCC, using data from KEYNOTE-564 to inform model probabilities. Transition probabilities not found in KEYNOTE-564, in addition to utility values, were extracted from the literature. Base case analyses were conducted with 5-year and 15-year time horizons (using extrapolations from 2-year outcomes), and 3-week time cycles. Primary outcomes were Quality-adjusted life years (QALYs), 2021 US Medicare costs, and Incremental cost-effectiveness ratios (ICERs). The willingness-to-pay threshold was set at $100,000/QALY. One-way sensitivity analyses were used to identify cost-effectiveness thresholds of individual parameters while probabilistic sensitivity analyses with 100,000 Monte-Carlo simulations were used to simultaneously vary all model inputs. Results: Pembrolizumab was associated with higher QALYs and costs relative to placebo (Table). Pembrolizumab was not cost-effective at a 5-year time horizon but was cost-effective at 15 years and beyond. One-way sensitivity analysis noted that pembrolizumab became cost-effective at 5-years if: 1) its administration cost was less than $5,064 (base = $10,278) or 2) if the 5-year risk of progression was 18.8% higher in placebo vs pembrolizumab (base = 9%). Using pembrolizumab’s reported hazard ratio of 0.68 for progression from KEYNOTE-564, we estimated that pembrolizumab would be cost-effective at 5-years for all patients with a Mayo Progression Free Survival Score of 10 or higher. Probabilistic sensitivity analysis found that pembrolizumab was cost-effective for 29% and 58% of microsimulations at 5 and 15 years, respectively. Conclusions: At current prices, adjuvant pembrolizumab was not cost-effective for all trial patients at a population level at 5-years after treatment but may be cost-effective for time horizons over 15 years. Instead, adjuvant pembrolizumab was found to be cost-effective only for the highest risk subsets of RCC at 5-years. Longer term trial data of progression-free survival and overall survival are necessary to confirm these extrapolations.[Table: see text]

395 Background: Patients with BCG-unresponsive carcinoma in situ (CIS) are treated with radical cystectomy (RCx) or salvage intravesical chemotherapy (SIC). Recently, the FDA approved pembrolizumab for BCG-unresponsive CIS +/- papillary tumors. Given the costs and toxicities of pembrolizumab, it remains unclear whether its benefits are sufficient to warrant widespread use for BCG-unresponsive CIS. To that end, we conducted a cost-effectiveness analysis comparing pembrolizumab with RCx and SIC (using gemcitabine-docetaxel as the prototypical regimen) for patients with BCG-unresponsive CIS. Methods: A decision-analytic Markov model compared pembrolizumab, SIC (with gemcitabine-docetaxel), and RCx for patients with BCG-unresponsive CIS +/- papillary tumors who are RCx candidates (index patient 1) or are unwilling/unable to undergo RCx (index patient 2). Each treatment option was a Markov node containing distinct variations of the following health states: surveillance, recurrence, progression to MIBC, progression to metastasis, treatment toxicity, and death. Incremental Cost-Effectiveness Ratios (ICERs) were compared using a willingness-to-pay threshold of $100,000/Quality-adjusted life year (QALY). The model used a US Medicare perspective with a 5-year time horizon for the base case. One-way and probabilistic sensitivity analyses were performed for all model parameters. Results: For index patient 1, pembrolizumab was not cost-effective vs. RCx (ICER $1,403,008) or SIC (ICER $2,011,923). One-way sensitivity analysis revealed that pembrolizumab only became cost-effective relative to RCx with a > 93% price reduction. Relative to RCx, SIC was cost-effective for time horizons < 5 years and nearly cost-effective at 5 years (ICER $118,324). One-way sensitivity analysis revealed that SIC became cost-effective relative to RCx if its risk of recurrence or metastasis at 2 years was less than 55% or 5.9%, respectively. For index patient 2, pembrolizumab required > 90% price reduction to be cost-effective vs. RCx (ICER $1,073,240). Probabilistic sensitivity analyses revealed that pembrolizumab was unlikely to be cost-effective even at high willingness-to-pay thresholds. Further sensitivity analyses found that no two-way combination of extrapolated values resulted in pembrolizumab being favored over RCx or SIC for either index patient. Conclusions: Based on decision-analytic Markov modeling of treatment options for patients with BCG-unresponsive CIS, pembrolizumab was unlikely to be cost-effective without a > 90% price reduction. While both RCx and SIC were more cost-effective than pembrolizumab, further studies may validate the cost-effectiveness of gemcitabine-docetaxel relative to RCx if the recurrence and metastasis thresholds are met. Overall, our model supports the preferential use of RCx and SIC over pembrolizumab for BCG-unresponsive CIS.

Objective: The aim of this study was to develop a risk score utilizing C-reactive protein (CRP) and procalcitonin to better predict a clinical infection for patients with obstructive urolithiasis. Methods: A retrospective review was performed of patients presenting to the emergency room from December 2017 to February 2019 and who underwent upper urinary tract decompression due to concern for infection in the setting of obstructing urolithiasis. Over 30 clinical parameters were assessed and a composite risk score was created. Univariate and multivariate, forward, stepwise regression analyses were performed to identify predictors of true urinary tract infection (UTI). Results: Ninety-eight patients met inclusion criteria, of which a true UTI was identified in 50 (51%). The standard model of serum white blood cells >15 or temperature >38°C had an area under curve (AUC) of only 0.67 to predict UTI. A multivariable regression-based 4-point risk score (1 point for each of the following: positive urinary Gram stain, perinephric fat stranding on CT, serum CRP >21.95, and serum procalcitonin >0.36) had an AUC of 0.91 to predict UTI. Individually, these components had an AUC of 0.68, 0.68, 0.80, and 0.77, respectively. The chances of confirmed UTI were 8%, 11%, 68%, and 100% for risk scores of 0, 1, 2, and 3 to 4, respectively ( p < 0.001). Conclusions: Only 50% of patients with a suspected UTI and an obstructing stone were ultimately confirmed to have a UTI. A risk score consisting of Gram stain, perinephric fat stranding, CRP, and procalcitonin can improve UTI prediction and warrants further study.