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Background Outcomes data among patients with heart failure (HF) with reduced ejection fraction treated with sacubitril/valsartan ( SAC / VAL ) are largely limited to clinical trial results. We compared hospitalization and healthcare costs among real‐world patients with HF with reduced ejection fraction treated with SAC / VAL versus angiotensin‐converting enzyme inhibitor or angiotensin‐receptor blocker ( ACEI / ARB ). Methods and Results Using retrospective administrative claims data, stable patients with HF with reduced ejection fraction treated with SAC / VAL or ACEI / ARB from October 2015 to June 2016 were identified. Postindex hospitalization and healthcare costs were assessed in propensity‐matched cohorts using robust variance estimation. Time to first hospitalization was modeled using unadjusted Kaplan–Meier estimates and multivariable models. Postindex all‐cause healthcare costs were modeled using an adjusted multivariable model. Among 279 patients per matched cohort, postindex hospitalization risk was lower for SAC / VAL compared with ACEI / ARB using Kaplan–Meier estimation and unadjusted Cox models. For HF hospitalization, the hazard ratio (95% CI) was 0.56 (0.33–0.94; P =0.030). Adjusted results were similar to unadjusted. Mean ( SD ) monthly healthcare costs were lower for SAC / VAL versus ACEI / ARB for all categories except pharmacy, with hospital costs being particularly disparate between cohorts: for HF hospitalization, $248 ($1588) for SAC / VAL versus $1122 ($7290) for ACEI / ARB . The adjusted risk of incurring increased all‐cause postindex costs was lower for SAC / VAL versus ACEI / ARB (cost ratio [95% CI] 0.74 [0.59–0.94]; P =0.013). Conclusions In clinical practice, patients with HF with reduced ejection fraction treated with SAC / VAL were less likely to be hospitalized than matched patients treated with ACEI / ARB . Despite higher pharmacy costs, SAC / VAL –treated patients incurred lower monthly medical and total healthcare costs.

Introduction: Among patients with HFrEF, treatment with sacubitril/valsartan (SAC/VAL) was shown in PARADIGM-HF to reduce risks of CV death and HF hospitalization compared with enalapril; however, scarce data exist regarding the impact of SAC/VAL on real-world healthcare resource utilization (HCRU) compared to ACEI or ARB. Objective: To compare HCRU among patients with HFrEF treated with SAC/VAL vs. ACEI or ARB. Methods: Using managed care claims data, we identified stable adults with claims-based proxy for HFrEF and ≥1 claim for SAC/VAL (identified first), ACEI or ARB during Oct 2015 to Jun 2016. We required ≥80% proportion of days covered with SAC/VAL or ACE/ARB for first 3 months post index claim. SAC/VAL and ACEI/ARB cohorts were propensity score matched on demographics, baseline characteristics and length of follow-up. Per patient per month (PPPM) HCRU (ambulatory visit, ER visit and hospitalization) and timing of first hospitalization (including estimated failure probabilities) were calculated during a variable follow-up period (3-12 months). HF hospitalization was identified based on first-listed diagnosis code of HF on a hospital facility claim. Robust variance estimation was used to compare PPPM HCRU between matched cohorts and proportional hazards models (no covariate adjustment) were used to evaluate risk of first hospitalization. Results: With mean (SD) follow-up of 185.0 (70.1) days, 279 patients were identified in each of the SAC/VAL cohort and matched ACEI/ARB cohort (mean [SD] age, 67.9 [12.6] years; 73.5% Medicare Advantage enrollee; 26.5% commercial enrollee; 68.1% male; 56.1% diabetes; 46.1% AF; 46.6% hospitalization in 1 year pre index claim). Patients in the SAC/VAL cohort, compared with the ACEI/ARB cohort, experienced lower mean (SD) PPPM all-cause ER visits (0.10 vs. 0.19, p Conclusions: Based on a real-world sample of patients with HFrEF, those initiated with SAC/VAL ≤12 months following US market approval experienced fewer monthly hospitalizations and ER visits compared to ACEI/ARB, and no difference in ambulatory visits. Lower risk of hospitalization after initiating SAC/VAL, rather than using ACEI/ARB, is important since HF hospitalization was previously associated with higher 30-60 day mortality and readmission rate.

Recent advances have increased treatment options for, and improved clinical outcomes in, metastatic melanoma (mM). Using a large claims database, this retrospective study compared healthcare and adverse event (AE) costs in a US managed care population of mM patients initiating vemurafenib (VEM), ipilimumab (IPI), dacarbazine (DTIC), paclitaxel (PAC), or temozolomide (TMZ) from July 2009 to September 2012. Treatment episodes were identified from the start of study drugs (index date) to a switch to a different study drug, or a gap greater than 45 days (>112 days for IPI). Grade 3/4 adverse events occurring ≥5% from study drug package inserts were selected for this analysis. All-cause costs for treatment episodes and AEs were normalized as monthly costs. Generalized estimating equation models with log link and gamma distribution provided adjusted monthly treatment episode and AE costs. A total of 809 treatment episodes were identified in 541 mM patients, with a mean (SD) age of 57.5 (11.5) years. The total mean (SD) all-cause cost per treatment episode for VEM was $77 687 ($60 329), for IPI was $153 062 ($134 048), for DTIC was $35 243 ($33 641), for TMZ was $42 870 ($41 384), and for PAC was $58 991 ($81 306). The adjusted mean monthly treatment episode cost for VEM was significantly lower than that for IPI and comparable to that for other drugs. VEM had a significantly lower monthly AE cost than IPI, DTIC, and PAC. In combination with safety and efficacy findings, these results may assist clinicians, patients, policy makers, and payers in the treatment of mM.

Introduction: Heart failure (HF) and reduced ejection fraction (HF r EF) requires timely ACC/AHA guideline recommended treatment (Tx) with multiple pharmacotherapies, including renin-angiotensin system and sympathetic nervous system blockers. The relationship between initial pharmacotherapies (IPT) and treatment modifications ([TM]: add-on or switch to a new class, or discontinuation of IPT) in real world practice is not well understood. Methods: This retrospective cohort study identified Humana Medicare managed care patients (pts) with ≥2 claims for HF from 8/2010-7/2015. The 1st HF claim was the index date. Patients had 1-year (yr) continuous enrollment, no HF diagnosis prior to index, and continuous enrollment 2-yrs post-index or until death. A claims-based algorithm was used to derive HF r EF status. IPT were mono- or combo-use of ACE-inhibitor (ACEI), angiotensin II receptor blocker (ARB), beta blocker (BB), hydralazine-nitrate (HN), and aldosterone antagonist (AA) in 1 yr post-index. No IPT was no drug use, only 1 fill, or st TM in 2 yrs post-index and subsequent therapies were identified. Results: Of 14,359 HF r EF pts, mean (SD) age was 75 (±8) yrs; 45% were female. Post-index, 32% had no IPT after 1 yr, 61% had IPT within 1 month, and 7% initiated IPT after the 1 st month. Of pts with IPT (n=9705), 48% received mono vasodilators (ACEI/ARB or HN), 17% mono BB, 23% vasodilator+BB, and 4% triple therapy [(ACEI/ARB)+BB+(HN or AA)]. Among pts on IPT, 52% had 1 st TM within 2 yrs post-index, with 26% adding a new class, 7% switching to a new class, 9% discontinuing a class of IPT, and 9% discontinuing all IPT. Mean (SD) time from IPT to 1 st TM was 9 (±7) months. For pts with subsequent therapies after 1 st TM, vasodilator+BB was most common (41%), followed by mono vasodilator (15%); then triple therapy (12%). (Table 1) Conclusion: Despite national HF r EF Tx guidelines recommending combo use of vasodilator+BB, nearly 1/3 of pts had no IPT within 1 yr post-index and over ½ received mono Tx as IPT. Of pts on IPT, mean time to 1 st TM was 9 months and few initiated triple therapy. In clinical trials, dual (vasodilator+BB) or triple therapies improved health outcomes. Consequences of HF pharmacotherapy gaps warrant further study.

Background— This study directly compares risk of acute myocardial infarction (AMI), acute heart failure (AHF), or all-cause death among pioglitazone- and rosiglitazone-treated patients in a managed-care population. Methods and Results— Patients ≥18 years of age, newly initiated on rosiglitazone or pioglitazone between January 1, 2001, and December 12, 2005, were included. The date of the first pharmacy claim for rosiglitazone or pioglitazone was defined as index date. Patients were excluded if they had P =0.666) when patients were followed from index date until end of study period, termination of enrollment status, or diagnosis of AMI/AHF/death. Conclusions— In this retrospective cohort study directly comparing rosiglitazone and pioglitazone with a propensity score–matched population that includes mortality data, no significant differences were found in the risk of AMI, AHF or death.