Show Me the Money: Patients' Perspectives on a Decision Aid for Sacubitril/Valsartan Addressing Out-of-Pocket Cost.

BACKGROUND: Out-of-pocket medication costs for patients who have heart failure with reduced ejection fraction may be an important part of shared decision-making, but cost has generally been excluded from clinical discussions. This study reports patients' perspectives on a decision aid for sacubitril/valsartan that explicitly addresses out-of-pocket costs. METHODS: Structured, in-depth interviews were conducted with 20 patients with heart failure with reduced ejection fraction from 2 medical centers to elicit their views on a publicly available decision aid for sacubitril/valsartan that explicitly incorporates considerations related to out-of-pocket costs. Qualitative descriptive analysis was conducted. RESULTS: Key themes identified were general enthusiasm for decision aids for medication decisions, openness on the part of patients to incorporation of cost into decision-making and the decision aid, requests for greater specificity regarding patient-specific cost, and challenges communicating evidence of benefit in a way that allows patients to make cost-benefit analyses for themselves. Patients also raised questions regarding logistical challenges of incorporating a decision aid into the normal clinical and decision-making workflow. CONCLUSIONS: Patients were receptive to the inclusion of out-of-pocket cost as relevant in a decision aid for sacubitril/valsartan. Key challenges to effective integration of cost in these decisions include developing mechanisms for acquiring reliable patient-specific cost estimates and addressing patients' difficulties (and sometimes skepticism) applying trial evidence to their own situation. In addition, implementation strategies are important to develop to facilitate decision aid integration for routine medical decisions into clinic workflow.

Conflicting Perspectives on the Value of Neprilysin Inhibition in Heart Failure Revealed During Development of a Decision Aid Focusing on Patient Costs for Sacubitril/Valsartan.

BACKGROUND: Despite concerns about rising costs in health care, cost is rarely an issue discussed by patients and clinicians when making treatment decisions in a clinical setting. This study aimed to understand stakeholder perspectives on a patient decision aid (PtDA) meant to help patients with heart failure choose between a generic and relatively low-cost heart failure medication (ACE [angiotensin-converting enzyme] inhibitor or angiotensin II receptor blocker) and a newer, but more expensive, heart failure medication (angiotensin II receptor blocker neprilysin inhibitor). METHODS AND RESULTS: Feedback on the PtDA was solicited from 26 stakeholders including patients, clinicians, and the manufacturer. Feedback was recorded and discussed among development team members until consensus regarding both the interpretation of the data and the appropriate changes to the PtDA was reached. Stakeholders found the PtDA sufficient in clarifying the different treatment options for heart failure. However, patients, physicians, and the manufacturer had different opinions on the importance of highlighting cost in a PtDA. Patients indicated issues of cost were crucial to the decision while physicians and manufacturers expressed that the cost issue was secondary and should be de-emphasized. CONCLUSIONS: The stratified perspectives on the role of cost in medical decision-making expressed by our participants underscore the importance and challenge of having clear, frank discussions during clinic visits about treatment cost and perceived value.

Fabrication of Ultra-Pure Anisotropic Zinc Oxide Nanoparticles via Simple and Cost-Effective Route: Implications for UTI and EAC Medications.

The purposes of this work are to evaluate the antimicrobial, antibiofilm, anticancer, and antioxidant abilities of anisotropic zinc oxide nanoparticles (ZnO NPs) synthesized by a cost-effective and eco-friendly sol-gel method. The synthesized ZnO NPs were entirely characterized by UV-Vis, XRD, FTIR, HRTEM, zeta potential, SEM mapping, BET surface analyzer, and EDX elemental analysis. Antimicrobial and antibiofilm activities of ZnO NPs were investigated against multidrug-resistant (MDR) bacteria and yeast causing serious diseases like urinary tract infection (UTI). The anticancer activity was performed against Ehrlich ascites carcinoma (EAC). Additionally, antioxidant scavenging activity against 2,2-diphenyl-1-picrylhydrazyl (DPPH) was observed. The synthesized ZnO NPs exhibited an absorption peak at 385.0 nm characteristic to the surface plasmon resonance (SPR). Data obtained from HRTEM, SEM, and XRD confirmed the anisotropic crystalline nature of the prepared ZnO NPs with an average particle size of 68.2 nm. The calculated surface area of the prepared ZnO NPs was 10.62 m2/g and the porosity was 13.16%, while pore volume was calculated to be 0.013 cm3/g and the average pore size was about 3.10 nm. The prepared ZnO NPs showed promising antimicrobial activity against all tested UTI-causing pathogens. It showed a prominent antimicrobial capability against Candida tropicalis with a zone of inhibition (ZOI) reaching 22.4 mm, 13 mm ZOI for Bacillus subtilis, and 12.5 mm ZOI for Pseudomonas aeruginosa. Additionally, the prepared ZnO NPs showed enhanced biofilm repression of about 79.33%, 72.94%, and 33.68% against B. subtilis, C. tropicalis, and P. aeruginosa, respectively. Moreover, the prepared ZnO NPs had a powerful antioxidant property with 33.0% scavenging ability after applied DPPH assay. Surprisingly, upon ZnO NPs treatment, cancer cell viability reduced from 100 to 58.5% after only 24 h due to their unique antitumor activity. Therefore, according to these outstanding properties, this study could give insights for solving serious industrial, pharmaceutical, and medical challenges, particularly in the EAC and UTI medications.

Economic evaluation of irbesartan in combination with hydrochlorothiazide in the treatment of hypertension in Greece.

OBJECTIVES: Hypertension is a major risk factor for cardiovascular disease and a leading cause of morbidity and mortality. This study evaluates irbesartan in relation to commonly used alternative hypertension therapies losartan and valsartan given in combination with hydrochlorothiazide (HCTZ) in the general hypertensive population in Greece. METHODS: A Markov model with eight states of health was constructed: hypertension, myocardial infarction (MI), post-MI, angina, stroke, poststroke, heart failure, and death. The model has an annual cycle and estimates mean quality-adjusted survival and treatment cost, which reflect the hypertension treatment and managing cardiovascular events. Risk functions were used to conduct extrapolations. Data on treatment effectiveness, quality of life (QOL) and epidemiology were obtained from published clinical trials and studies. The database of the main Greek National Social Insurance Institute (IKA) was analyzed to estimate the cost of events. The analysis was done from a payer perspective. All outcomes were discounted, and prices correspond to 2008. RESULTS: The estimated patient cost per annum was stable angina euro 2,252, unstable angina euro 2,572, myocardial infarction euro 2,473, post-MI euro 1,677, stroke euro 12,233, poststroke euro 1,240, heart failure euro 2,655, coronary angiography euro 1,544, percutaneous transluminal coronary angioplasty euro 6,511, and coronary artery bypass graft surgery euro 11,514. For the baseline group (age 57 years, systolic blood pressure 147 mmHg, cholesterol 6.00 mmol/L, body mass index 29) of men with mild to moderate hypertension, for irbesartan, the total treatment cost was euro 15,146, for losartan euro 15,696 and for valsartan euro 15,613; the quality-adjusted life years (QALYs) were irbesartan 12.67, losartan 12.63 and valsartan 12.64. For the baseline group of women with mild to moderate hypertension, the total treatment cost was euro 12,945 for irbesartan, euro 13,424 for losartan and euro 13,379 for valsartan; QALYs were 14.29 for irbesartan, 14.27 for losartan and 14.27 for valsartan. For men with severe hypertension, for irbesartan and losartan, the total treatment cost was euro 18,679 and euro 21,488 and QALYs 12.47 and 12.37, respectively. For women, the total treatment cost was euro 16,202 and euro 19,099 and QALYs 14.16 and 14.09, respectively. Similar results were obtained in relation to other treatment groups in various sensitivity analysis scenarios. CONCLUSIONS: Based on efficacy data from clinical trials and lower attainment costs in various hypertensive patient populations, irbesartan in combination with HCTZ compares favorably with losartan and valsartan in combination with HCTZ in the Greek setting.

Cost-effectiveness of irbesartan 300 mg given early versus late in patients with hypertension and a history of type 2 diabetes and renal disease: a Canadian perspective.

BACKGROUND: The Irbesartan in Reduction of Microalbuminuria trial and the Irbesartan in Diabetic Nephropathy Trial found that irbesartan is renoprotective in patients having hypertension with type 2 diabetes. OBJECTIVE: The objective of this study was to assess whether treatment with irbesartan is cost-effective in Canada relative to conventional care in this patient population and whether it is more cost-effective to treat patients early rather than later in the development of renal disease from the perspective of the Canadian health and social care system. METHODS: The analysis compared 3 alternative strategies for the management of hypertension in patients with type 2 diabetes and early renal disease: (1) conventional hypertensive treatment excluding the use of angiotensin II receptor antagonists (AIIRAs); (2) the early addition of irbesartan (an AIIRA) to conventional treatment; and (3) the late addition of irbesartan to conventional treatment. A Markov model was used to simulate the progression of renal disease (microalbuminuria to death) in hypertensive patients with type 2 diabetes over a 25-year time horizon. Transition probabilities were derived from the 2 randomized controlled trials. A cost-effectiveness analysis was conducted with outcome measured in life-years gained (LYGs). RESULTS: The early addition of irbesartan during microalbuminuria was cost-saving and more effective than both delaying irbesartan treatment until advanced overt nephropathy (AON) (0.45 LYG, Can $54,100 saved) and conventional antihypertensive use (0.62 LYG, $68,400 saved). This was due to the increased drug costs associated with the use of irbesartan being offset by savings arising from delays in the development of overt nephropathy and the subsequent delay to end-stage renal disease (ESRD). Sensitivity analyses confirmed the robustness of the study results. CONCLUSIONS: The early use of irbesartan for patients with hypertension and type 2 diabetes who have yet to develop overt nephropathy is both more effective and less costly than delaying irbesartan treatment until AON and conventional antihypertensive use. Analysis suggests that the earlier irbesartan is added to conventional antihypertensive treatment, the greater the delays in the onset of ESRD and the overall savings in health care resource utilization from the perspective of the Canadian health and social care system.