Shah, Nilay D.

Background: The US Food and Drug Administration approved the use of sacubitril/valsartan in patients with heart failure with reduced ejection fraction in July 2015. We aimed to assess the adoption and prescription drug costs of sacubitril/valsartan in its first 18 months after Food and Drug Administration approval. Methods and Results: Using a large US insurance database, we identified privately insured and Medicare Advantage beneficiaries who filled a first prescription for sacubitril/valsartan between July 1, 2015, and December 31, 2016. We compared them to patients treated with an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker. Outcomes included adoption, prescription drug costs, and 180-day adherence, defined as a proportion of days covered ≥80%. A total of 2244 patients initiated sacubitril/valsartan. Although the number of users increased over time, the proportion of heart failure with reduced ejection fraction patients taking sacubitril/valsartan remained low (<3%). Patients prescribed sacubitril/valsartan were younger, more often male, with less comorbidity than those taking an angiotensin-converting enzyme inhibitor/angiotensin receptor blocker. Although a majority of prescription costs were covered by the health plan (mean, $328.37; median, $362.44 per 30-day prescription), out-of-pocket costs were still high (mean, $71.16; median, $40.27). By comparison, median out-of-pocket costs were $2 to $3 for lisinopril, losartan, carvedilol, and spironolactone. Overall, 59.1% of patients were adherent to sacubitril/valsartan. Refill patterns suggested that nearly half of nonadherent patients discontinued sacubitril/valsartan within 180 days of starting. Conclusions: Adoption of sacubitril/valsartan after Food and Drug Administration approval has been slow and may be associated with the high cost.

Goals: To determine patient preference for the Barrett esophagus (BE) screening techniques. Background: Sedated esophagogastroduodenoscopy (sEGD) and unsedated transnasal endoscopy (uTNE) are both potential techniques for BE screening. However, systematic assessment of patient preference for these 2 techniques is lacking. As part of a comparative effectiveness randomized trial of BE screening modalities, we measured short-term patient preferences for the following approaches: in-clinic uTNE (huTNE), mobile-based uTNE (muTNE), and sEGD using a novel assessment instrument. Study: Consenting community patients without known BE were randomly assigned to receive huTNE, muTNE, or sEGD, followed by a telephone administered preference and tolerability assessment instrument 24 hours after study procedures. Patient preference was measured by the waiting trade-off method. Results: In total, 201 patients completed screening with huTNE (n=71), muTNE (n=71), or sEGD (n=59), and a telephone interview. Patients’ preferences for sEGD and uTNE using the waiting trade-off method were comparable (P=0.51). Although tolerability scores were superior for sEGD (P<0.001) compared with uTNE, scores for uTNE examinations were acceptable. Conclusions: Patient preference is comparable between sEGD and uTNE for diagnostic examinations conducted in an endoscopy suite or in a mobile setting. Given acceptable tolerability, uTNE may be a viable alternative to sEGD for BE screening.

89 Background: Lymph node counts have been proposed as a quality metric for patients undergoing radical prostatectomy (RP) and pelvic lymph node dissection (PLND). It is unclear whether surgical approach and hospital characteristics independently determine the number of lymph nodes removed at PLND. Therefore, we assessed the variation in lymph node counts from a population-based cohort of patients undergoing surgery for intermediate and high-risk prostate cancer. Methods: Using the National Cancer Database, we identified all surgically treated patients diagnosed with pre-treatment intermediate or high-risk prostate cancer from 2010 to 2011. The primary outcome was the number of lymph nodes retrieved at the time of RP. Generalized estimating equations were used to assess for differences in the adjusted number of lymph nodes retrieved after accounting for patient and hospital characteristics and surgical approach. Results: Overall, 35,876 patients were diagnosed with intermediate (61.2%) and high-risk (38.8%) prostate cancer and underwent RP and PLND. On multivariable analysis, open radical prostatectomy (ORP) and high volume and academic hospitals were independently associated with greater lymph node counts compared to robotic-assisted radical prostatectomy (RARP) and medium/low and community hospitals, respectively (all p<0.001). After adjusting for patient and hospital variables, higher adjusted lymph nodes counts were observed for ORP compared to RARP (7.1 vs. 6.1; p<0.001). Adjusted counts were also higher for high volume compared to medium/low volume hospitals (7.8 vs. 5.9; p<0.001), and academic compared to community hospitals (7.3 vs. 5.6; p<0.001). Conclusions: Among patients with aggressive prostate cancer treated with RP and PLND, lymph node counts varied by surgical approach and hospital characteristics.

Purpose To determine the association between the number of patients with multiple myeloma (MM) treated annually at a treatment facility (volume) and all-cause mortality (outcome). Methods Using the National Cancer Database, we identified patients diagnosed with MM between 2003 and 2011. We classified the facilities by quartiles (Q; mean patients with MM treated per year): Q1: < 3.6; Q2: 3.6 to 6.1, Q3: 6.1 to 10.3, and Q4: > 10.3. We used random intercepts to account for clustering of patients within facilities and Cox regression to determine the volume-outcome relationship, adjusting for demographic (sex, age, race, ethnicity), socioeconomic (income, education, insurance type), geographic (area of residence, treatment facility location, travel distance), and comorbid (Charlson-Deyo score) factors and year of diagnosis. Results There were 94,722 patients with MM treated at 1,333 facilities. The median age at diagnosis was 67 years, and 54.7% were men. The median annual facility volume was 6.1 patients per year (range, 0.2 to 109.9). The distribution of patients according to facility volume was: Q1: 5.2%, Q2: 12.6%, Q3: 21.9%, and Q4: 60.3%. The unadjusted median overall survival by facility volume was: Q1: 26.9 months, Q2: 29.1 months, Q3: 31.9 months, and Q4: 49.1 months ( P < .001). Multivariable analysis showed that facility volume was independently associated with all-cause mortality. Compared with patients treated at Q4 facilities, patients treated at lower-quartile facilities had a higher risk of death (Q3 hazard ratio [HR], 1.12 [95% CI, 1.08 to 1.16]; Q2 HR, 1.17 [95% CI, 1.12 to 1.21]; Q1 HR, 1.22 [95% CI, 1.17 to 1.28]). Conclusion Patients who were treated for MM at higher-volume facilities had a lower risk of mortality compared with those who were treated at lower-volume facilities.

Objective To assess recommendations for prostate‐specific antigen ( PSA ) screening in a national survey of radiation oncologists and urologists following the recent USA P reventive S ervices T ask F orce ( USPSTF ) grade D recommendation. Methods A random sample of 1366 radiation oncologists and urologists were identified from the A merican M edical A ssociation P hysician M asterfile. From N ovember 2011 to A pril 2012, a mail survey was sent to query PSA screening recommendations for men at average risk of prostate cancer for the following age groups: 40–49, 50–59, 60–69, 70–74, 75–79 and ≥80 years. Multivariable logistic regression was used to test for differences in PSA ‐based screening recommendations by physician characteristics. Results Response rates were similar at 52% for radiation oncologists and urologists ( P = 0.92). Overall, 51.5% of respondents recommended PSA ‐based screening for men aged 40–49 years, while nearly all endorsed it for those aged 50–74 years (96.1% for 50–59, 97.3% for 60–69, and 87.7% for 70–74 years). However, screening recommendations decreased to 43.9% and 12.8% for men aged 75–79 and ≥80 years, respectively. On multivariable analysis, urologists were more likely to recommend screening for men aged 40–49 (odds ratio [ OR ] 3.09; P < 0.001) and 50–59 years ( OR 3.81; P = 0.01), but less likely for men aged 75–79 ( OR 0.66; P = 0.01) and ≥80 years ( OR 0.45; P = 0.002) compared with radiation oncologists. Conclusion While radiation oncologists and urologists recommended PSA screening for men aged 50–69 years, there was less agreement about screening for younger (40–49 years old) and older (≥70 years) men at average risk for prostate cancer.

AbstractObjectivesCompare healthcare resource utilization (HCRU) and costs between patients prescribed opioids (RxOP) and those who were not (NoRxOP) during an emergency department (ED) or inpatient visit.MethodsRetrospective cohort analysis was performed (January 2006 to September 2010). Continuously eligible RxOP patients in ED/inpatient settings (January 2007 to September 2009) were included if age was ≥ 12 years by initial prescription date (or random date between first ED/inpatient admission and September 30, 2009 [NoRxOP patients]).Healthcare resource utilization and costs for 12 months after initial prescription were compared. Univariate descriptive analyses were performed for baseline and outcome variables and compared using appropriate tests. Risk adjustment compared HCRU between RxOP and NoRxOP cohorts for the postindex period.ResultsOf 27,599 eligible patients, RxOP patients (n = 18,819) were younger, less likely to be male, more likely to reside in southern United States and to have Preferred Provider Organization health plans, and had lower comorbidity index scores, compared with NoRxOP patients (n = 8,780). RxOP patients were less likely to have nonpain‐related comorbidities and more frequently diagnosed with pain‐related comorbidities.Unmatched and propensity‐matched RxOP patients experienced higher HCRU and costs in all subcategories (total, inpatient, outpatient ED, physician, pharmacy, other outpatient settings). Opioid abuse frequency was low in patients with common diagnoses/procedures within 3 months before initial prescription (0.48%). Average time to abuse was < 1 year (201 days).ConclusionMost patients were prescribed opioids initially during ED/inpatient visits and incurred higher HCRU than those not prescribed opioids. Among those with diagnosed opioid abuse after initiating opioids, time to diagnosis was rapid (range: 14 to 260 days) for patients with common diseases and procedures.