Online Tools to Decrease Out-of-Pocket Prescription Costs for Patients: A Practical Guide for Urologists.

INTRODUCTION: Patients who seek urologic care have recently reported a high degree of financial toxicity from prescription medications, including management for nephrolithiasis, urinary incontinence, and urological oncology. Estimating out-of-pocket costs can be challenging for urologists in the US because of variable insurance coverage, local pharmacy distributions, and complicated prescription pricing schemes. This article discusses resources that urologists can adopt into their practice and share with patients to help lower out-of-pocket spending for prescription medications. METHODS: We identify 4 online tools that are designed to direct patients toward more affordable prescription medication options: the Medicare Part D Plan Finder, GoodRx, Amazon, and the Mark Cuban Cost Plus Drug Company. A brief historical overview and summary for patients and clinicians are provided for each online resource. A patient-centered framework is provided to help navigate these 4 available tools in clinic. RESULTS: Among the 4 tools we identify, there are multiples tradeoffs to consider as financial savings and features can vary. First, patients insured by Medicare should explore the Part D Plan Finder each year to compare drug plans. Second, patients who need to urgently refill a prescription at a local pharmacy should visit GoodRx. Third, patients who are prescribed recurrent generic prescriptions for chronic conditions can utilize the Mark Cuban Cost Plus Drug Company. Finally, patients who are prescribed 3 or more chronic medications can benefit from subscribing to Amazon RxPass. CONCLUSIONS: Prescription medications for urologic conditions can be expensive. This article includes 4 online resources that can help patients access medications at their most affordable costs. Urologists can provide this framework to their patients to help support lowering out-of-pocket drug costs.

What is cancer? A focus on Grade Group 1 prostate cancer.

Since the widespread adoption of prostate-specific antigen-based screening for prostate cancer, the prevalence of Grade Group 1 (GG1) prostate cancer has risen. Historically, these patients were subjected to overtreatment of this otherwise indolent disease process, leading to significant quality-of-life detriments. Active surveillance as a primary management strategy has allowed for a focus on early detection while minimising morbidity from unnecessary intervention. Here we provide a comprehensive overview of the characteristics of GG1 prostatic adenocarcinoma, including its histological features, genomic differentiators, clinical progression, and implications for treatment guidelines, all supporting the movement to reclassify GG1 disease as a non-cancerous entity.

Functional Outcomes After Localized Prostate Cancer Treatment.

Importance: Adverse outcomes associated with treatments for localized prostate cancer remain unclear. Objective: To compare rates of adverse functional outcomes between specific treatments for localized prostate cancer. Design, Setting, and Participants: An observational cohort study using data from 5 US Surveillance, Epidemiology, and End Results Program registries. Participants were treated for localized prostate cancer between 2011 and 2012. At baseline, 1877 had favorable-prognosis prostate cancer (defined as cT1-cT2bN0M0, prostate-specific antigen level <20 ng/mL, and grade group 1-2) and 568 had unfavorable-prognosis prostate cancer (defined as cT2cN0M0, prostate-specific antigen level of 20-50 ng/mL, or grade group 3-5). Follow-up data were collected by questionnaire through February 1, 2022. Exposures: Radical prostatectomy (n = 1043), external beam radiotherapy (n = 359), brachytherapy (n = 96), or active surveillance (n = 379) for favorable-prognosis disease and radical prostatectomy (n = 362) or external beam radiotherapy with androgen deprivation therapy (n = 206) for unfavorable-prognosis disease. Main Outcomes and Measures: Outcomes were patient-reported sexual, urinary, bowel, and hormone function measured using the 26-item Expanded Prostate Cancer Index Composite (range, 0-100; 100 = best). Associations of specific therapies with each outcome were estimated and compared at 10 years after treatment, adjusting for corresponding baseline scores, and patient and tumor characteristics. Minimum clinically important differences were 10 to 12 for sexual function, 6 to 9 for urinary incontinence, 5 to 7 for urinary irritation, and 4 to 6 for bowel and hormone function. Results: A total of 2445 patients with localized prostate cancer (median age, 64 years; 14% Black, 8% Hispanic) were included and followed up for a median of 9.5 years. Among 1877 patients with favorable prognosis, radical prostatectomy was associated with worse urinary incontinence (adjusted mean difference, -12.1 [95% CI, -16.2 to -8.0]), but not worse sexual function (adjusted mean difference, -7.2 [95% CI, -12.3 to -2.0]), compared with active surveillance. Among 568 patients with unfavorable prognosis, radical prostatectomy was associated with worse urinary incontinence (adjusted mean difference, -26.6 [95% CI, -35.0 to -18.2]), but not worse sexual function (adjusted mean difference, -1.4 [95% CI, -11.1 to 8.3), compared with external beam radiotherapy with androgen deprivation therapy. Among patients with unfavorable prognosis, external beam radiotherapy with androgen deprivation therapy was associated with worse bowel (adjusted mean difference, -4.9 [95% CI, -9.2 to -0.7]) and hormone (adjusted mean difference, -4.9 [95% CI, -9.5 to -0.3]) function compared with radical prostatectomy. Conclusions and Relevance: Among patients treated for localized prostate cancer, radical prostatectomy was associated with worse urinary incontinence but not worse sexual function at 10-year follow-up compared with radiotherapy or surveillance among people with more favorable prognosis and compared with radiotherapy for those with unfavorable prognosis. Among men with unfavorable-prognosis disease, external beam radiotherapy with androgen deprivation therapy was associated with worse bowel and hormone function at 10-year follow-up compared with radical prostatectomy.

Urologist-level variation in the management of T1a renal cell carcinoma: A population-based cohort study.

OBJECTIVES: Lack of strict indications in current guidelines have led to significant variation in management patterns of small renal masses. The impact of the urologist on the management approach for patients with small renal masses has not been explored previously. MATERIALS AND METHODS: Using the linked Surveillance, Epidemiology, and End Results-Medicare database, patients aged ≥66 years diagnosed with small renal masses from January 1, 2004 to December 31, 2013 were identified and assigned to primary urologists. Mixed-effects logistic models were used to evaluate factors associated with different management approaches, estimate urologist-level probabilities of each approach, assess management variation, and determine urologist impact on choice of approach. RESULTS: A total of 12,402 patients with 2,794 corresponding primary urologists were included in the study. At the individual urologist level, the estimated case-adjusted probability of different approaches varied markedly: nonsurgical management (mean, 12.8%; range, 4.9%-36.1%); thermal ablation (mean, 10.8%; range, 2.4%-66.3%); partial nephrectomy (mean, 30.1%; range, 10.1%-66.6%); and radical nephrectomy (mean, 40.4%; range, 17.7%-71.6%). Compared to patient and tumor characteristics, the primary urologist was a more influential measured factor, accounting for 13.6% (vs. 12.9%), 33.8% (vs. 2.1%), 15.1% (vs. 8.4%), and 13.5% (vs. 4.0%) of the variation in management choice for nonsurgical management, thermal ablation, partial nephrectomy, and radical nephrectomy, respectively. CONCLUSIONS: Significant variation exists in the management of small renal masses and appears to be driven primarily by urologist preference and practice patterns. Our findings emphasize the need for unified guidance regarding management of these masses to reduce unwarranted variation in care.

Estimating the Impact of the Inflation Reduction Act on the Out-of-Pocket Costs for Medicare Beneficiaries With Advanced Prostate Cancer.

INTRODUCTION: Combination systemic therapy for advanced prostate cancer has reduced mortality, but high out-of-pocket costs impose financial barriers for patients. The Inflation Reduction Act's $2,000 out-of-pocket spending cap for Medicare's prescription drug benefit (Part D) can potentially lower out-of-pocket spending for beneficiaries starting in 2025. This study aims to compare out-of-pocket spending for commonly prescribed regimens for advanced prostate cancer before and after implementation of the Inflation Reduction Act. METHODS: Medication regimens constructed to treat metastatic, hormone-sensitive prostate cancer consisted of baseline androgen deprivation therapy with traditional chemotherapy, androgen receptor inhibitors, and androgen biosynthesis inhibitors. Using 2023 Medicare Part B prices and the Medicare Part D plan finder, we estimated annual out-of-pocket costs under current law and under the Inflation Reduction Act's redesigned standard Part D benefit. RESULTS: Under current law, out-of-pocket costs for Part D drugs ranged from $464 to $11,336 per year. Under the Inflation Reduction Act, annual out-of-pocket costs for 2 regimens remained unchanged: androgen deprivation therapy with docetaxel and androgen deprivation therapy with abiraterone and prednisone. However, out-of-pocket costs for regimens using branded novel hormonal therapy were significantly lower under the 2025 law with potential savings estimated to be $9,336 (79.2%) for apalutamide, $9,036 (78.7%) for enzalutamide, and $8,480 (76.5%) for docetaxel and darolutamide. CONCLUSIONS: The $2,000 spending cap introduced by the Inflation Reduction Act may significantly decrease out-of-pocket costs and reduce financial toxicity associated with advanced prostate cancer treatment, impacting an estimated 25,000 Medicare beneficiaries.

Utilizing RENAL nephrometry in pediatric patients undergoing nephron-sparing surgery for renal tumors: A single-institutional cohort.

INTRODUCTION: RENAL Nephrometry is a complexity score validated in adults with renal tumors and describes the likelihood of complication after partial nephrectomy (PN). Utilization in pediatrics has been limited. Thus, our goal is to quantify inter-rater agreement as well as determine how scores correlate with outcomes. We hypothesize that the RENAL Nephrometry Score is reproducible in children with renal tumors and is related to perioperative and post-operative complications. METHODS: All pediatric patients who underwent PN for a renal mass from 2006 to 2019 were identified. Patient data, operative details, and outcomes were aggregated. Pre-operative CT/MR imaging was anonymized and scored by 2 pediatric radiologists and 2 pediatric urologists using RENAL Nephrometry metrics. Statistical analysis utilized Fleiss' kappa and the intraclass correlation coefficient (ICC). Comparative analyses were performed based on Nephrometry Score <9 and ≥ 9. RESULTS: 28 patients undergoing 33 PN were identified. Median age at surgery was 3.2 years (IQR 1.8-4.0). There is moderate-good agreement across scorers on the domains of RENAL Nephrometry Score, with the lowest agreement noted for anterior vs posterior tumors. Comparing patients with scores <9 and ≥ 9, there was increased operative time (357 vs 267 min, p = 0.003) and LOS for those with a higher score, but no difference in the incidence of 30-day complications. CONCLUSION: RENAL Nephrometry Score is an easily reproducible complexity score for renal tumors in pediatric patients. Higher scores are associated with increased length of stay and estimated blood loss but not complications. Reporting of nephrometry scores in future publications on pediatric renal tumors should become standard in the literature.

Projected Savings for Generic Oncology Drugs Purchased via Mark Cuban Cost Plus Drug Company Versus in Medicare.

PURPOSE: Self-administered oncology drugs contribute disproportionately to Medicare Part D spending; prices often remain high even after generic entry. Outlets for low-cost drugs such as Mark Cuban Cost Plus Drug Company (MCCPDC) offer opportunities for decreased Medicare, Part D, and beneficiary spending. We estimate potential savings if Part D plans obtained prices such as those offered under the MCCPDC for seven generic oncology drugs. METHODS: Using the 2020 Medicare Part D Spending dashboard, Q3-2022 Part D formulary prices, and Q3-2022 MCCPDC prices for seven self-administered generic oncology drugs, we estimated Medicare savings by replacing Q3-2022 Part D unit costs with costs under the MCCPDC plan. RESULTS: We estimate potential savings of $661.8 million (M) US dollars (USD; 78.8%) for the seven oncology drugs studied. Total savings ranged from $228.1M USD (56.1%) to $2,154.5M USD (92.4%) compared with 25th and 75th percentiles of Part D plan unit prices. The median savings replacing Part D plan prices were abiraterone $338.0M USD, anastrozole $1.2M USD, imatinib 100 mg $15.6M USD, imatinib 400 mg $212.0M USD, letrozole $1.9M USD, methotrexate $26.7M USD, raloxifene $63.8M USD, and tamoxifen $2.6M USD. All 30-day prescription drug prices offered by MCCPDC generated cost savings except for three drugs offered at the 25th percentile Part D formulary pricing: anastrozole, letrozole, and tamoxifen. CONCLUSION: Replacing current Part D median formulary prices with MCCPDC pricing could yield significant savings for seven generic oncology drugs. Individual beneficiaries could save nearly $25,200 USD per year for abiraterone or between $17,500 USD and $20,500 USD for imatinib. Notably, Part D cash-pay prices for abiraterone and imatinib under the catastrophic phase of coverage were still more expensive than baseline MCCPDC prices.

Clinicians' Perspectives on Proactive Patient Safety Behaviors in the Perioperative Environment.

Importance: The perioperative environment is hazardous, but patients remain safe with a successful outcome during their care due to staff adaptability and resiliency. The behaviors that support this adaptability and resilience have yet to be defined or analyzed. One Safe Act (OSA), a tool and activity developed to capture self-reported proactive safety behaviors that staff use in their daily practice to promote individual and team-based safe patient care, may allow for improved definition and analysis of these behaviors. Objective: To thematically analyze staff behaviors using OSA to understand what may serve as the basis for proactive safety in the perioperative environment. Design, Setting, and Participants: This qualitative thematic analysis included a convenience sample of perioperative staff at a single-center, tertiary care academic medical center who participated in an OSA activity during a 6-month period in 2021. All perioperative staff were eligible for inclusion. A combined deductive approach, based on a human factor analysis and classification framework, as well as an inductive approach was used to develop themes and analyze the self-reported staff safety behaviors. Exposures: Those selected to participate were asked to join an OSA activity, which was conducted in-person by a facilitator. Participants were to self-reflect about their OSA (proactive safety behavior) and record their experience as free text in an online survey tool. Main Outcome and Measures: The primary outcome was the development and application of a set of themes to describe proactive safety behaviors in the perioperative environment. Results: A total of 140 participants (33 nurses [23.6%] and 18 trainee physicians [12.9%]), which represented 21.3% of the 657 total perioperative department full-time staff, described 147 behaviors. A total of 8 non-mutually exclusive themes emerged with the following categories and frequency of behaviors: (1) routine-based adaptations (46 responses [31%]); (2) resource availability and assessment adaptations (31 responses [21%]); (3) communication and coordination adaptation (23 responses [16%]); (4) environmental ergonomics adaptation (17 responses [12%]); (5) situational awareness adaptation (12 responses [8%]); (6) personal or team readiness adaptation (8 responses [5%]); (7) education adaptation (5 responses [3%]); and (8) social awareness adaptation (5 responses [3%]). Conclusions and Relevance: The OSA activity elicited and captured proactive safety behaviors performed by staff. A set of behavioral themes were identified that may serve as the basis for individual practices of resilience and adaptability that promote patient safety.

Proactive Patient Safety: Focusing on What Goes Right in the Perioperative Environment.

OBJECTIVE: Adverse events in the perioperative environment, a potential risk to patients, may be mitigated by nurturing staff adaptability and resiliency. An activity called "One Safe Act" (OSA) was developed to capture and highlight proactive safety behaviors that staff use in their daily practice to promote safe patient care. METHODS: One Safe Act is conducted in-person in the perioperative environment by a facilitator. The facilitator gathers an ad hoc group of perioperative staff in the work unit. The activity is run as follows: staff introductions, purpose/instructions of the activity, participants self-reflect about their OSA (proactive safety behavior) and record it as free text in an online survey tool, the group debriefs with each person sharing their OSA, and the activity is concluded by summarizing behavioral themes. Each participant completed an attitudinal assessment to understand changes in safety culture perception. RESULTS: From December 2020 to July 2021, a total of 140 perioperative staff participated (21%, 140/657) over 28 OSA sessions with 136 (97%, 140/136) completing the attitudinal assessment. A total of 82% (112/136), 88% (120/136), and 90% (122/136) agreed that this activity would change their practices related to patient safety, improve their work unit's ability to deliver safe care, and demonstrated their colleagues' commitment to patient safety, respectively. CONCLUSIONS: The OSA activity is participatory and collaborative to build shared, new knowledge, and community practices focused on proactive safety behaviors. The OSA activity achieved this goal with a near universal acceptance of the activity in promoting an intent to change personal practice and increasing engagement and commitment to safety culture.

Financial toxicity in prostate cancer survivors: A national cross-sectional assessment of subjective financial burden.

BACKGROUND: In prostate cancer (CaP) survivorship, subjective financial burden (SFB), an aspect of financial toxicity, has not been studied using a national sample. Our goal was to explore and identify factors associated with patient-reported SFB in CaP survivors. MATERIALS AND METHODS: We conducted a retrospective, cross-sectional study of 264 adult individuals with a history of CaP that completed the AHRQ - Medical Expenditures Panel Survey - Household Component and Cancer Self-Administered Questionnaire Supplement in 2016 or 2017. Primary outcomes were the presence of cancer-related SFB and the severity of this burden. Multivariable ordinal logistic regression and logistic regression models were used to identify factors associated with the severity of SFB and different domains of burden. RESULTS: Most participants were non-Hispanic white, had 3 or more comorbidities and had a median age of 72 years. 62.1% of survivors indicated SFB associated with their CaP care and long-term effects. 49.2% of CaP survivors indicated coping SFB, 27.7% psychological, and 29.2% material. Older (OR: 0.95, 95%CI 0.92-0.98) was associated with less SFB. Low-income level (OR: 2.1, 95%CI 1.01-4.36) was associated with higher SFB. Hispanic survivors (OR: 2.8 95%CI 1.1-7.4) indicated more psychologic SFB. Presence of a caregiver was noted as a predictor of material (OR 2.6, 95%CI 1.45-4.49) and psychological (OR: 2.2, 95%CI 1.13-3.91) SFB. CONCLUSIONS: Many CaP survivors experience SFB and associated factors differ in domain of financial burden. This provides evidence and groundwork for understanding financial burden and improving the quality of counseling and care for this population.

Longitudinal Changes in Quality of Life After Ureteroscopy for Nephrolithiasis.

OBJECTIVE: To assess alterations in health-related quality of life (HRQOL) in patients with nephrolithiasis, given the limited prospective data on patient reported outcomes following surgical intervention with ureteroscopy. METHODS: Adults with either a renal or ureteral calculus who underwent ureteroscopy (URS) were recruited prospectively from 2017-2020. Participants completed the PROMIS-29 profile which measures the dimensions of physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance at enrollment, 1-, 6-, and 12-months. Scores are reported as T-scores (normalized to US-population) and were compared at each time point against the mean for the US-population (50) using one-sample Welch's t'test and between each pairwise time point comparison using a Wilcoxon signed rank test. RESULTS: At enrollment, a total of 69 participants completed the PROMIS-29 survey. As compared to the US-population mean, participants at enrollment had significantly different scores in physical function, fatigue, pain interference, depressive symptoms, anxiety, and sleep disturbance (all P<.05), but not ability to participate in social roles and activities. In pairwise comparisons, improvement was only observed from enrollment to 1-month in pain interference (P<.01) and fatigue (P = .03). However, there was improvement at a longer interval from enrollment to 12-months in all dimensions (pairwise comparisons, all P<.05) except depressive symptoms. CONCLUSION: The PROMIS-29 profile is responsive to changes in HRQOL for patients with nephrolithiasis undergoing URS, with improvement of PROMIS scores up to 12-months. This information can be utilized for patient counseling to guide expectations during the recovery period.

Race/Ethnicity and Insurance's Impact on Delays to Kidney Stone Surgery Scheduling.

OBJECTIVE: To evaluate the association between ethnicity/insurance status and time to kidney stone surgery. METHODS: We retrospectively assessed all patients with evaluation of nephrolithiasis in the emergency room (ED), followed by definitive stone surgery (ureteroscopy/percutaneous nephrolithotomy/ESWL) at our major academic health system consisting of 3 hospitals in a dense, urban center. RESULTS: A total of 682 patients were included. A total of 2.8% (n = 19) were uninsured, 19.3% (n = 132) were enrolled in Medicaid, 23.3% (n = 159) were enrolled in Medicare and 54.5% (n = 372) had commercial insurance. Uninsured patients had a short median time to surgery of only 21 days (IQR 6-49), while Medicare patients had a longer time at 39 days, (IQR 17-64), although these were not significantly different (P =.12). Black race was associated with a higher percentage of uninsured and Medicaid patients (P ≤.001). There was no difference in clinical or patient reported characteristics between the insurance groups (all P >.05) 6.9%, 17.7%, 26.7%, and 48.6% of patients self-identified as Hispanic, Other, Black, and White, respectively. Hispanic patients had the shortest median time to surgery of 28 days (IQR 10-48), while Black patients the longest with a median of 38.5 days (18-72) (P =.007). Clinical variables at presentation including nausea/vomiting, hydronephrosis and sepsis were not statistically significant between the patient groups (all P >.05). CONCLUSION: Our study illustrates persistent delays in surgery scheduling for Black patients regardless of insurance status. This should inform practice patterns for urology providers, highlighting our need to enact institutional safety nets to promote expedient follow up for a vulnerable population.

Naming the Problem: Publishing Trends within in Urology on Race, Health Disparities and Structural Racism.

OBJECTIVES: To assess publishing trends regarding the contribution of societal systems on health disparities within the urology literature. METHODS: We performed a bibliometric analysis of the top 15 urology journals for titles and abstracts with the term race or ethnicity between 2000-2021. Articles were graded by the presence of (1) race, (2) disparities secondary to race, or (3) racial disparities secondary to structural biases. Frequencies were tabulated and logistic regression was used to determine odds of disparities publishing. RESULTS: Our query returned 934 articles for review. In 484 (52%) articles, race was mentioned as a demographic/covariate. 110 (12%) abstracts noted a racial health disparity and only 2 articles implicated racism. Rates of more direct language varied significantly by journal and year of publication. Discussion of disparities increased over time, ranging from 0% in 2002 to 25% in 2020 (P-trend <.001). Logistic regression demonstrated an 11% annual increase in the likelihood of disparity publishing (OR=1.11, 95%CI=1.08-1.14; P<.001). CONCLUSIONS: While it is widely acknowledged that race is a determinant of health, often "race" itself is ascribed the risk when societal inequities are largely at fault. Despite the frequent use of race as a key covariate within the urologic literature, health-disparities relating to structural racism are rarely explicitly named. In order to address the systemic biases that underpin these inequities, increased awareness through clear language in publishing is needed.