Cost effectiveness of interventions to improve adherence to statin therapy in ASCVD patients in the United States.

INTRODUCTION: Cardiovascular disease (CVD) is the leading cause of death in the United States, and high cholesterol is a leading risk factor for CVD. While statins are effective at reducing cholesterol, they are frequently underused in patients at highest risk of CVD. The objective of this study was to identify interventions which may improve adherence to statins and to assess their cost effectiveness within the US Medicare population. METHODS: A literature review was undertaken to identify interventions to improve adherence in patients with CVD at highest risk of a recurrent event and to quantify non-adherence and the consequences of non-adherence to statins in this population. A Markov cost-utility model was developed to assess the cost effectiveness of these interventions. RESULTS: Ten adherence interventions were identified in the literature, with 6 demonstrating statistically significant improvement in adherence. The six interventions were disease management, interactive voice response, nurse counselling, discharge letter, nurse/dietician counselling and electronic pill bottle with feedback. The model found the cost effectiveness of an intervention was highly dependent on its effectiveness and costs. Incremental cost effectiveness ratios ranged from $27,545/QALY for discharge letter with large adherence gain to $130,399/QALY for disease management program with small adherence gain. CONCLUSION: Some interventions to improve adherence have been shown to be effective, but little attention has been paid to the costs. Further studies on adherence interventions should include economic evaluations.

Temporal changes in statin prescription and intensity at discharge and impact on outcomes in patients with newly diagnosed atherosclerotic cardiovascular disease-Real-world experience within a large integrated health care system: The IMPRES study.

BACKGROUND: Statins are indicated for secondary atherosclerotic cardiovascular disease (ASCVD) prevention; however, multiple surveys have found treatment gaps in clinical application. OBJECTIVE: To determine trends over 15 years in the prevalence and impact of a statin prescription and dose intensity at discharge after a first ASCVD event. METHODS: The Intermountain Enterprise Data Warehouse was searched to identify all adults with a first encounter for ASCVD between January 1, 1999 and December 31, 2013, including coronary artery disease, cerebrovascular disease, and peripheral arterial disease, who survived the index event and were followed for ≥3 years or until death. Major adverse cardiovascular events (MACE) were assessed overall and in 5-year increments. RESULTS: A total of 62,070 patients met inclusion criteria. Mean age was 65.9 ± 13.7 years, and most of them were male (64.7%). Increases in any statin (59.3% to 72.6% to 80.8%) and high-intensity prescription (3.1% to 14.2% to 28.1%) occurred over consecutive 5-year intervals and were greatest in coronary artery disease patients. Statin therapy was associated with a reduced risk of 3-year MACE (multivariable hazard ratio = 0.75 [0.72, 0.78], P < .0001), with a significant linear trend across dose intensities. CONCLUSION: In a real-world experience within a large, integrated health care system, significant reductions in MACE were found in association with both any and high-intensity statin prescriptions following an ASCVD event. Temporal trends indicated progressive improvement in guideline-recommended prescriptions. However, treatment gaps remain in receipt of both any statin and, especially, a high-intensity statin prescription, and these represent prime opportunities for further improvement in secondary ASCVD prevention.

Efficacy and Safety of Oritavancin Relative to Vancomycin for Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) in the Outpatient Setting: Results From the SOLO Clinical Trials.

BACKGROUND: The objective of this analysis was to evaluate the efficacy and safety of oritavancin compared with vancomycin for patients with acute bacterial skin and skin structure infections (ABSSSIs) who received treatment in the outpatient setting in the Phase 3 SOLO clinical trials. METHODS: SOLO I and SOLO II were 2 identically designed comparative, multicenter, double-blind, randomized studies to evaluate the efficacy and safety of a single 1200-mg dose of intravenous (IV) oritavancin versus 7-10 days of twice-daily IV vancomycin for the treatment of ABSSSI. Protocols were amended to allow enrolled patients to complete their entire course of antimicrobial therapy in an outpatient setting. The primary efficacy outcome was a composite endpoint (cessation of spread or reduction in size of the baseline lesion, absence of fever, and no rescue antibiotic at early clinical evaluation [ECE]) (48 to 72 hours). Key secondary endpoints included investigator-assessed clinical cure 7 to 14 days after end of treatment (posttherapy evaluation [PTE]) and 20% or greater reduction in lesion area at ECE. Safety was assessed until day 60. RESULTS: Seven hundred ninety-two patients (oritavancin, 392; vancomycin, 400) received entire course of treatment in the outpatient setting. Efficacy response rates at ECE and PTE were similar (primary composite endpoint at ECE: 80.4% vs 77.5% for oritavancin and vancomycin, respectively) as was incidence of adverse events. Five patients (1.3%) who received oritavancin and 9 (2.3%) vancomycin patients were subsequently admitted to a hospital. CONCLUSIONS: Oritavancin provides a single-dose alternative to multidose vancomycin for treatment of ABSSSI in the outpatient setting.

Cost effectiveness of left atrial appendage closure with the Watchman device for atrial fibrillation patients with absolute contraindications to warfarin.

AIMS: Atrial fibrillation (AF) patients with contraindications to oral anticoagulation have had few options for stroke prevention. Recently, a novel oral anticoagulant, apixaban, and percutaneous left atrial appendage closure (LAAC) have emerged as safe and effective therapies for stroke risk reduction in these patients. This analysis assessed the cost effectiveness of LAAC with the Watchman device relative to apixaban and aspirin therapy in patients with non-valvular AF and contraindications to warfarin therapy. METHODS AND RESULTS: A cost-effectiveness model was constructed using data from three studies on stroke prevention in patients with contraindications: the ASAP study evaluating the Watchman device, the ACTIVE A trial of aspirin and clopidogrel, and the AVERROES trial evaluating apixaban. The cost-effectiveness analysis was conducted from a German healthcare payer perspective over a 20-year time horizon. Left atrial appendage closure yielded more quality-adjusted life years (QALYs) than aspirin and apixaban by 2 and 4 years, respectively. At 5 years, LAAC was cost effective compared with aspirin with an incremental cost-effectiveness ratio (ICER) of €16 971. Left atrial appendage closure was cost effective compared with apixaban at 7 years with an ICER of €9040. Left atrial appendage closure was cost saving and more effective than aspirin and apixaban at 8 years and remained so throughout the 20-year time horizon. CONCLUSIONS: This analysis demonstrates that LAAC with the Watchman device is a cost-effective and cost-saving solution for stroke risk reduction in patients with non-valvular AF who are at risk for stroke but have contraindications to warfarin.

Time to Cost-Effectiveness Following Stroke Reduction Strategies in AF: Warfarin Versus NOACs Versus LAA Closure.

BACKGROUND: Left atrial appendage closure (LAAC) and nonwarfarin oral anticoagulants (NOACs) have emerged as safe and effective alternatives to warfarin for stroke prophylaxis in patients with nonvalvular atrial fibrillation (AF). OBJECTIVES: This analysis assessed the cost-effectiveness of warfarin, NOACs, and LAAC with the Watchman device (Boston Scientific, Marlborough, Massachusetts) for stroke risk reduction in patients with nonvalvular AF at multiple time points over a lifetime horizon. METHODS: A Markov model was developed to assess the cost-effectiveness of LAAC, NOACs, and warfarin from the perspective of the Centers for Medicare & Medicaid Services over a lifetime (20-year) horizon. Patients were 70 years of age and at moderate risk for stroke and bleeding. Clinical event rates, stroke outcomes, and quality of life information were drawn predominantly from PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) 4-year data and meta-analyses of warfarin and NOACs. Costs for stroke risk reduction therapies, treatment of associated acute events, and long-term care following disabling stroke were presented in 2015 U.S. dollars. RESULTS: Relative to warfarin, LAAC was cost-effective at 7 years ($42,994/quality-adjusted life-years [QALY]), and NOACs were cost-effective at 16 years ($48,446/QALY). LAAC was dominant over NOACs by year 5 and warfarin by year 10. At 10 years, LAAC provided more QALYs than warfarin and NOACs (5.855 vs. 5.601 vs. 5.751, respectively). In sensitivity analyses, LAAC remained cost-effective relative to warfarin ($41,470/QALY at 11 years) and NOACs ($21,964/QALY at 10 years), even if procedure costs were doubled. CONCLUSIONS: Both NOACs and LAAC with the Watchman device were cost-effective relative to warfarin, but LAAC was also found to be cost-effective and to offer better value relative to NOACs. The results of this analysis should be considered when formulating policy and practice guidelines for stroke prevention in AF.

The cost-effectiveness of blue light cystoscopy in bladder cancer detection: United States projections based on clinical data showing 4.5 years of follow up after a single hexaminolevulinate hydrochloride instillation.

INTRODUCTION: Several studies, including the recently published phase III study by Stenzl and colleagues have demonstrated that hexaminolevulinate hydrochloride, when used with blue light fluorescence cystoscopy, improves detection of non-muscle invasive bladder tumors compared to white light cystoscopy and transurethral resection of bladder tumors (TURB) alone. MATERIALS AND METHODS: The objective of this study was to conduct a detailed assessment of the cost-effectiveness of using hexaminolevulinate hydrochloride with blue light cystoscopy as an adjunct to white light versus white light cystoscopy alone at time of initial TURB in the United States. A probabilistic decision tree model, using TreeAge Pro 2011 software, was developed using base case scenario cost and utility estimates. RESULTS: Incorporation of hexaminolevulinate hydrochloride into diagnostic cystoscopy results in lower costs over 5 years ($25,921) as compared to those patients who initially receive white light cystoscopy ($30,581). Those patients who initially receive hexaminolevulinate hydrochloride blue light TURB also experience a lower overall cancer burden. CONCLUSIONS: Hexaminolevulinate hydrochloride may be cost effective when used at first TURB for patients with suspected new or recurrent non-muscle invasive bladder cancer.