Analyzing Access and Costs of Oral Medications for Overactive Bladder: Uncovering Disparities.

OBJECTIVE: To report out-of-pocket costs associated with overactive bladder (OAB) medications among Medicare beneficiaries and the uninsured. METHODS: We performed a cross-sectional analysis of the Centers for Medicare & Medicaid Services Prescription Drug Plan Formulary Data (Q1-2022). FDA-approved medications for OAB were identified. We calculated out-of-pocket costs for Medicare beneficiaries in each Part D prescription benefit phase, average retail price, total yearly costs and discounted prices through cash-pay discount coupons (GoodRx) or online pharmacies like Mark Cuban Cost Plus Drug Company (MCCPDC). We also report plan utilization management requirements. RESULTS: We analyzed 5721 plan formularies for 18 medications. Mirabegron was the only beta-3 agonist (B3). Only Vesicare oral solution (14.3% of plans) and Mirabegron (0.1%) required prior authorization. Many plans required step therapy for selective generic anticholinergics (ACH) (12.4%-43.3%), while the B3 rarely required step therapy (0.6%). Monthly costs varied by coverage phase and averaged $59 for ACHs in the initial coverage phase ($14 in catastrophic; $72 in coverage gap). The monthly cost for the B3 averaged $47 in the initial coverage phase ($26 in catastrophic; $129 in coverage gap). The total yearly cost for generic ACHs ranged from $494 (oxybutynin IR) to $1452 (darifenacin) and the yearly cost for brand-name ACHs ranged from $1175 (Toviaz ER) to $2198 (Oxytrol). The total yearly cost for the B3 was $1283. CONCLUSION: We evaluated coverage, out-of-pocket costs, total yearly costs, and utilization management for OAB medications to make pricing more transparent. While selective medications may be "covered," coverage does not translate into affordable drug prices.

The PSR13, a tool for evaluating patient-perceived recovery after vaginal prolapse repair surgery.

INTRODUCTION AND HYPOTHESIS: Surgical recovery is the return to preoperative functional, psychologic, and social activity, or a return to normalcy. To date, little is known about the global post-surgical recovery experience from the patients' perspective. The aim of this study was to validate the Post-Discharge Surgical Recovery scale 13 (PSR13) in women undergoing vaginal prolapse repair procedures and evaluate the patient-perceived postoperative recovery experience over a 12-week period. METHODS: Fifty women undergoing vaginal prolapse repairs completed the PSR13 and global surgical recovery scale (GSR) at 1, 2, 4, 6, and 12 weeks post-surgery. Validity, the minimal clinically important difference (MCID), and responsiveness to change over time of the PSR13 was evaluated using descriptive statistics and linear regression models. The proportion of patients deemed fully recovered at each time point (defined as PSR13 score ≥ 80) was also assessed. RESULTS: The PSR13 correlated significantly (p < 0.001) with the single-item recovery scale and showed excellent internal consistency reliability (Cronbach α = 0.91, range 0.77 to 0.93). The MCID was estimated at 7.0 points. The PSR13 scores improved at varying rates over time, with the greatest amount of patient-perceived recovery occurring between 4 and 6 weeks after surgery. The proportion of patients deemed fully recovered at 6- and 12- weeks postoperatively was 37% and 56%, respectively. CONCLUSIONS: The PSR13 is a useful instrument to assess overall return to normalcy from the patient's perspective and can be applied to evaluate the recovery experience among women undergoing vaginal prolapse repairs, in both the research and clinical setting.

Rethinking Second-Line Therapy for Overactive Bladder to Improve Patient Access to Treatment Options.

Idiopathic overactive bladder (OAB) is a chronic condition that negatively affects quality of life, and oral medications are an important component of the OAB treatment algorithm. Recent literature has shown that anticholinergics, the most commonly prescribed oral medication for the treatment of OAB, are associated with cognitive side effects including dementia. ß3-adrenoceptor agonists, the only alternative oral treatment for OAB, are similar in efficacy to anticholinergics with a more favorable side effect profile without the same cognitive effects. However, there are marked cost variations and barriers to access for OAB medications, resulting in expensive copays and medication trial requirements that ultimately limit access to ß3-adrenoceptor agonists and more advanced procedural therapies. This contributes to and perpetuates health care inequality by burdening the patients with the least resources with a greater risk of dementia. When prescribing these medications, health care professionals are caught in a delicate balancing act between cost and patient safety. Through multilevel collaboration, we can help disrupt health care inequalities and provide better care for patients with OAB.

The impact of concomitant mid-urethral sling surgery on patients undergoing vaginal prolapse repair.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to assess whether mid-urethral sling (MUS) placement at the time of vaginal prolapse repair compared to vaginal prolapse repair alone is associated with an increase in 30-day postoperative complications. METHODS: Using the American College of Surgeons National Surgical Quality Improvement Database, Current Procedural Terminology codes were used to identify cases of vaginal prolapse repair with and without concomitant MUS from 2012 to 2017. Student's t-test and chi-square test were used to compare differences between the groups. RESULTS: A total of 1469 cases of vaginal prolapse repair with sling were compared to 4566 cases without sling. There was no difference between prolapse repair with sling compared to without sling in mean hospital length of stay (LOS) (1.42 versus 1.32 days, p = 0.65), postoperative urinary tract infection (UTI) (6.1% versus 5.8%, p = 0.670), perioperative blood transfusion (1.1% versus 1.2%, p = 0.673), readmission (2.7% versus 2.6%, p = 0.884) and postoperative wound infection (0.5% versus 0.7%, p = 0.51). There was a higher rate of reoperation (2.2% versus 1.5%, p = 0.049) and venous thromboembolism (VTE) (0.4% versus 0.1%, p = 0.030) in patients undergoing concomitant MUS compared to those undergoing prolapse repair alone. CONCLUSIONS: Compared to prolapse repair alone, the addition of a sling did not increase hospital LOS, UTI, perioperative blood transfusions, readmission or postoperative wound infections. However, concomitant sling was found to be associated with a higher risk of reoperation and VTE.

Venous thromboembolism prophylaxis in vaginal surgery for pelvic organ prolapse: Predictors of high risk in a low-risk population.

AIM: Venous thromboembolism (VTE) rates in vaginal pelvic organ prolapse (POP) repair are low. Our aim is to evaluate specific risk factors for VTE in patients undergoing vaginal POP repair. METHODS: This is a cross-sectional study using the American College of Surgeons NSQIP database. Using CPT codes, cases of vaginal POP repair between 2014 and 2017 were identified. Patient and operative characteristics were collected. VTE was defined as pulmonary embolism (PE) or deep vein thrombosis (DVT) within 30 days from surgery. Univariate analyses were performed using the Student t test for continuous and χ2  tests for categorical variables. Multivariate logistic regression was performed to identify factors independently associated with VTE. RESULTS: Of 44 207 women who underwent vaginal POP repair, there were 69 cases of VTE (0.16%). VTE rates for obliterative (0.15%) and functional (0.16%) vaginal POP repair, as well as for repairs with hysterectomy (0.17%) and without hysterectomy (0.12%) were not significantly different (p = .616 and .216, respectively). Multivariate analysis demonstrated predictors for postoperative VTE to be ASA physical status classification ≥ 3 (aOR, 1.99; p = .014), length of stay >75th percentile (aOR, 2.01; p = .007), operative time >3 h (aOR, 2.24; p = .007), and dyspnea (aOR, 3.26, p = .004). CONCLUSION: Despite the low incidence of VTE after vaginal POP repair, patients with ASA physical status classification ≥ 3, length of stay >75th percentile, operative time >3 h, and dyspnea were at higher risk for VTE. Vaginal POP repair may have independent VTE risk factors not captured in standard risk assessment tools.

Non-adherence to labor guidelines in cesarean sections done for failed induction and arrest of dilation.

OBJECTIVES: In 2014, the American College of Obstetrics and Gynecology published guidelines for diagnosing failed induction of labor (FIOL) and arrest of dilation (AOD) to prevent cesarean delivery (CD). The objectives of this study were to determine the rate of adherence to these guidelines and to compare the association of guideline adherence with physician CD rates and obstetric/neonatal outcomes. METHODS: Retrospective cohort review of singleton primary cesarean deliveries for FIOL and AOD at a single academic institution from 2014 to 2016. Univariate and multivariate analyses were used to compare adherence to the guidelines with physician CD rates and obstetric/neonatal outcomes. RESULTS: Of the 591 cesarean deliveries in the study, 263 were for failed induction, 328 for AOD and 79% (468/591) were not adherent to the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine (ACOG/SMFM) guidelines. Of the failed inductions, 82% (215/263) and of the AODs 77% (253/328) were not adherent. There was no difference between adherent and non-adherent CDs with regard to maternal characteristics, or obstetric/neonatal outcomes. Duration of oxytocin use after rupture of membranes, dilation at time of CD, and birth weight were statistically higher in adherent CDs. On multivariate linear regression, physician CD rates were inversely correlated with adherence to ACOG/SMFM guidelines (p<0.0001), gestational age (p=0.007), and parity (p=0.003). CONCLUSIONS: Our study shows that physician non-compliance with ACOG guidelines was high. Adherence to these guidelines was associated with lower physician CD rates, without an increase in obstetric or neonatal complications.