Objectives. We sought to estimate the association between sedative hypnotic use and motor vehicle crash risk. Methods. We conducted a new user cohort study of 409 171 adults in an integrated health care system. Health plan data were linked to driver license and collision records. Participants were aged 21 years or older, licensed to drive in Washington State, had at least 1 year of continuous enrollment between 2003 and 2008, and were followed until death, disenrollment, or study end. We used proportional hazards regression to estimate the risk of crash associated with 3 sedatives. Results. We found 5.8% of patients received new sedative prescriptions, with 11 197 person-years of exposure. New users of sedatives were associated with an increased risk of crash relative to nonuse: temazepam hazard ratio (HR) = 1.27 (95% confidence interval [CI] = 0.85, 1.91), trazodone HR = 1.91 (95% CI = 1.62, 2.25), and zolpidem HR = 2.20 (95% CI = 1.64, 2.95). These risk estimates are equivalent to blood alcohol concentration levels between 0.06% and 0.11%. Conclusions. New use of sedative hypnotics is associated with increased motor vehicle crash risk. Clinicians initiating sedative hypnotic treatment should consider length of treatment and counseling on driving risk.

Introduction Recovery from orthopedic surgery is oriented towards restoring functional health outcomes while reducing hospital length of stay (LOS) and medical expenditures. Optimal pain management is a key to reaching these objectives. We sought to compare orthopedic surgery patients who received combination intravenous (IV) acetaminophen and IV opioid analgesia to those who received IV opioids alone and compared the two groups on LOS and hospitalization costs. Methods We performed a retrospective analysis of the Premier Database (Premier, Inc.; between January 2009 and June 2015) comparing orthopedic surgery patients who received post-operative pain management with combination IV acetaminophen and IV opioids to those who received only IV opioids starting on the day of surgery and continuing up to the second post-operative day. The quarterly rate of IV acetaminophen use for all hospitalizations by hospital served as the instrumental variable in two-stage least squares regressions controlling for patient and hospital covariates to compare the LOS and hospitalization costs of IV acetaminophen recipients to opioid monotherapy patients. Results We identified 4,85,895 orthopedic surgery patients with 1,74,805 (36%) who had received IV acetaminophen. Study subjects averaged 64 years of age and were predominantly non-Hispanic Caucasians (78%) and female (58%). The mean unadjusted LOS for IV acetaminophen patients was 3.2 days [standard deviation (SD) 2.6] compared to 3.9 days (SD 3.9) with only IV opioids (P < 0.0001). Average unadjusted hospitalization costs were $19,024.9 (SD $13,113.7) for IV acetaminophen patients and $19,927.6 (SD $19,578.8) for IV opioid patients (P < 0.0001). These differences remained statistically significant in our instrumental variable models, with IV acetaminophen associated with 0.51 days shorter hospitalization [95% confidence interval (CI) −0.58 to −0.44, P < 0.0001] and $634.8 lower hospitalization costs (95% CI −$1032.5 to −$237.1, P = 0.0018). Conclusion Compared to opioids alone, managing post-orthopedic surgery pain with the addition of IV acetaminophen is associated with shorter LOS and decreased hospitalization costs. Funding Mallinckrodt Pharmaceuticals.

Background: To evaluate the value of new therapies for non-small cell lung cancer (NSCLC), it is necessary to understand overall survival (OS) rates associated with previous standard therapies and how these rates have evolved over time. Methods: We retrospectively analyzed data from patients enrolled in the Surveillance, Epidemiology, and End Results (SEER) cancer registry. Adults with unresectable, stage III NSCLC treated with chemoradiotherapy were grouped by diagnosis year (2000–2002; 2003–2005; 2006–2008; 2009–2011; 2012–2013). The primary endpoint was OS (data cut-off, December 31, 2014), estimated using the Kaplan–Meier estimator. Temporal survival-trend significance was tested using a two-sided log-rank trend test. Results: Of 12,865 eligible patients, 59.1% were male, 59.9% had stage IIIB disease, and 62.7% had non-squamous histology. Median age at diagnosis was 67 years. Overall, 10,899 (84.7%) patients died and 1966 (15.3%) were censored/lost to follow-up. Median follow-up (95% confidence interval [CI]) was 80 (77–82) months; median OS (95% CI) was 15 (15–16) months; 1- and 3-year survival probabilities (95% CI) were 57.7% (56.9–58.6) and 24.1% (23.3–24.8), respectively. Stratification by diagnosis year showed consistent improvements in survival over time (p < 0.0001 for trend). Median OS was 12, 14, 15, 18, and 19 months in successive cohorts. Conclusions: OS in patients diagnosed with unresectable, stage III NSCLC between 2003 and 2013 was consistent with that from clinical studies of sequential/concurrent chemoradiotherapy. Despite improvement over time, median OS was < 2 years and mortality remained high during the first year post-diagnosis.

BACKGROUND: Pazopanib was noninferior to sunitinib in progression-free survival in a phase III, open-label, randomized clinical trial comparing the efficacy and safety of the 2 drugs for treatment of patients with advanced renal cell carcinoma (RCC). A secondary analysis of this trial conducted on patient-reported health care resource utilization (HCRU) endpoints revealed significantly fewer monthly telephone consultations and emergency department visits among patients treated with pazopanib over the first 6 months of treatment. OBJECTIVES: To (a) compare total costs of HCRU and adverse events (AEs) in patients with advanced RCC receiving first-line pazopanib or sunitinib from the phase III clinical trial and (b) perform a post hoc economic analysis that applied direct medical care and pharmacy unit costs, obtained from the Truven Health MarketScan Databases, to HCRU and AE rates. METHODS: Total HCRU costs included components for provider contacts, diagnostics, hospitalizations, procedures, and study/nons...

Background: Value-based benefit design has been suggested as an effective approach to managing the high cost of pharmaceuticals in health insurance markets. Premera Blue Cross, a large regional health plan, implemented a value-based formulary (VBF) for pharmaceuticals in 2010 that explicitly used cost-effectiveness analysis (CEA) to inform medication copayments. Objective of the Study: The objective of the study was to determine the impact of the VBF. Design: Interrupted time series of employer-sponsored plans from 2006 to 2013. Subjects: Intervention group: 5235 beneficiaries exposed to the VBF. Control group: 11,171 beneficiaries in plans without any changes in pharmacy benefits. Intervention: The VBF-assigned medications with lower value (estimated by CEA) to higher copayment tiers and assigned medications with higher value to lower copayment tiers. Measures: Primary outcome was medication expenditures from member, health plan, and member plus health plan perspectives. Secondary outcomes were medication utilization, emergency department visits, hospitalizations, office visits, and nonmedication expenditures. Results: In the intervention group after VBF implementation, member medication expenditures increased by $2 per member per month (PMPM) [95% confidence interval (CI), $1–$3] or 9%, whereas health plan medication expenditures decreased by $10 PMPM (CI, $18–$2) or 16%, resulting in a net decrease of $8 PMPM (CI, $15–$2) or 10%, which translates to a net savings of $1.1 million. Utilization of medications moved into lower copayment tiers increased by 1.95 days’ supply (CI, 1.29–2.62) or 17%. Total medication utilization, health services utilization, and nonmedication expenditures did not change. Conclusions: Cost-sharing informed by CEA reduced overall medication expenditures without negatively impacting medication utilization, health services utilization, or nonmedication expenditures.

We sought to compare the economic impact of treatment-related adverse events (AEs) in patients with metastatic breast cancer (mBC) using taxane- or capecitabine-based treatment regimens as either first- or second-line (FL or SL) therapy in the US. We used healthcare claims data from the Truven Health Analytics MarketScan® Commercial Databases to conduct a retrospective cohort study comparing the economic impact of AEs amongst taxane- and capecitabine-treated mBC patients in the US. We selected women diagnosed with mBC between 2008–2010 who received a taxane or capecitabine as first- or second-line (FL or SL) chemotherapy. Costs related to hospitalization, outpatient services, emergency department visits, chemotherapy and other medications were tabulated and combined to determine total healthcare costs. The incremental monthly costs associated with the presence of AEs compared to no AEs were estimated using generalized linear models, controlling for age and Charlson Comorbidity Index. We identified 15,443 mBC patients meeting inclusion criteria. Adjusted total monthly costs were significantly higher in those who experienced AEs than in those without AEs in both lines of treatment (FL incremental cost: taxanes $1,142, capecitabine $1,817; SL incremental cost: taxanes $1,448, capecitabine $4,437). Total costs increased with the number of AEs and were primarily driven by increased hospitalization amongst those with AEs. Adverse events in taxane- or capecitabine-treated mBC patients are associated with significant increases in costs. Selecting treatment options associated with fewer AEs may reduce costs and improve outcomes in these patients.