Current and Future Use of HEOR Data in Healthcare Decision-Making in the United States and in Emerging Markets.

BACKGROUND: Health economics and outcomes research (HEOR) is a growing field that provides important information for making healthcare coverage and access decisions. However, there is no standard process for incorporating HEOR into the decision-making process, and the current use of HEOR by healthcare payers remains unknown. OBJECTIVES: To examine how HEOR data are being used by healthcare payers, including managed care organizations today, and how the use of such data is expected to change in the future in relation to access and reimbursement decision-making. METHODS: The Managed Care Survey (MCS) and the Pharmacy & Therapeutics (P&T) Committee Survey (PTS) were distributed to decision makers in the United States. A total of 72 managed care decision makers responded to the MCS and 30 P&T Committee members responded to the PTS from US healthcare organizations that cover from tens of thousands to millions of lives. The goal of these surveys was to understand the current use of HEOR data, perceived barriers and limitations in the use of HEOR, and the expectations for future use, and how these and other factors affect formulary decisions. An international perspective was gained by modifying the MCS based on feedback received at a European conference, and a pilot version was given to individuals in emerging markets across Asia, Latin America, and the Middle East and Africa. RESULTS: The majority of US respondents to the MCS (74%; N = 53) and to the PTS (77%; N = 23) indicate that HEOR is currently being used in their decision-making process; but the majority of respondents to the MCS (66%; N = 48) also state that quality assessment is limited (quality assessment was not addressed in the PTS). In addition, the majority of respondents to the MCS (82%; N = 59) expect the use of HEOR to increase in the future. Safety and efficacy were reported in the PTS to be the most important factors in the P&T Committee decision-making process, followed by head-to-head comparisons, and cost. The current use of HEOR in Asia, Latin America, and the Middle East and Africa varied widely across respondents. CONCLUSION: This study provides an important benchmark of HEOR use in the United States before the implementation of healthcare reform. Between the years 2010 and 2011, HEOR data were used to varying extents across global regions, but their use in the future is likely to increase in relation to access and reimbursement decisions.

Prevalence of peripheral neuropathy and painful peripheral neuropathy in Turkish diabetic patients.

The aim of this study was to determine the prevalence of diabetic peripheral neuropathy (DPN) and neuropathic pain in diabetic patients attending university outpatient clinics in Turkey. In this multicenter cross-sectional study, neurologic examinations and nerve conduction studies along with clinical diabetic neuropathy score, and Leeds Assessment of Neuropathic Symptoms and Signs pain scale were performed on 1,113 patients (46.2% male) from 14 centers. Prevalence of DPN determined only by clinical examination was 40.4% and increased to 62.2%, by combining nerve conduction studies with clinical examination. According to Leeds Assessment of Neuropathic Symptoms and Signs scores, neuropathic pain prevalence was 16.0% in those who reported pain. Poor glycemic control, retinopathy, microalbuminuria, hyperlipidemia, diabetic foot, and foot amputation were more commonly observed in patients with DPN. Clinical DPN affected 40.4% of diabetic patients, and neuropathic pain prevalence in diabetic patient population was 14.0%. Clinical examinations and nerve conduction studies are important components for early detection and accurate diagnosis of DPN and painful DPN.

Adherence with multiple-combination antihypertensive pharmacotherapies in a US managed care database.

OBJECTIVE: The aim of this analysis was to assess the impact of multiple combination therapies on medication possession ratios (MPRs) in an antihypertensive naive population. METHODS: Data were collected using the Integrated Healthcare Information Solution's National Benchmark Database (January 1997 to June 2004). Data from patients who received 2-pill pharmacotherapy with valsartan or valsartan/hydrochlorothiazide (HCTZ) in a fixed-dose combination (FDC) + amlodipine were compared with those from patients who received 3-pill therapy with valsartan + HCTZ + amlodipine as 3 free-drug components. MPR was calculated by dividing the total days' supply for the lower value in the case of individual drug components, or the number of days' supply in the case of FDC, by 365 (the number of days during the 1-year study period the medication regimen was prescribed). A general linear regression was then performed to determine the effect of treatment group on MPR, controlling for the demographic and clinical characteristics. RESULTS: Data from 908 patients were included (527 women, 381 men; mean age, 53.9 years; 2-pill treatment with valsartan + amlodipine, 224 patients; 2-pill treatment with valsartan/HCTZ + amlodipine, 619; and 3-pill therapy with valsartan + HCTZ + amlodipine, 65). The MPR values were 75.4%, 73.1%, and 60.5%, respectively (P = 0.005). MPR improved with age (69.6% in the subset aged 18-<36 years vs 75.2% in the subset aged >or=64 years; P = 0.023). CONCLUSIONS: In these antihypertensive-naive patients with hypertension, MPR decreased with the increase in tablets per regimen, and improved MPR was correlated with increasing age. These findings suggest patient compliance improves with simplified pharmacotherapeutic approaches.

Assessment of adherence, persistence, and costs among valsartan and hydrochlorothiazide retrospective cohorts in free-and fixed-dose combinations.

OBJECTIVES: To assess medication adherence, persistence, and costs between cohorts of patients in managed care settings using a fixed-dose combination (FDC) or individual components (IC) of valsartan and hydrochlorothiazide in an insurance claims database. METHODS: Medical and prescription claims for hypertensive patients using a combination of valsartan and HCTZ were identified from the IHCIS National Managed Care Benchmark Database via a retrospective cohort analysis. Study subjects had at least 110 days prior to start of study medications during which no other antihypertensive medications were prescribed, and were followed for 12 months. Claims for 8711 adult patients were analyzed for adherence, persistence and costs. General linear regression was conducted to detect differences in adherence among groups. Covariates included age, gender, persistence, number on concomitant cardiovascular drugs, and number of cardiovascular diagnoses. RESULTS: Most subjects used an FDC product (N=8150, 93.6%) vs. the IC (N=561, 6.4%). The FDC group had a larger portion of males and less concomitant cardiovascular medications or disease. A random sample of 1628 of the FDC subjects had improved values for medication adherence compared to the IC group (62.1 vs. 53.0%, p<0.001) and persistence values were improved at both 180 days (73 vs. 28%, p<0.001) and 365 days (54 vs. 19%, p<0.001). Both prescription drug costs ($1587 vs. $2050, p<0.001) and medical costs ($3343 vs. $3817, p<0.001) were lower in the FDC cohorts. CONCLUSIONS: The use of fixed-dose therapy in hypertension may lead to increased adherence and persistence with a positive financial impact on both prescription and total medical costs. As with any retrospective claims database analysis, unobserved systematic differences between the two medication groups may exist.

Public health value of fixed-dose combinations in hypertension.

It is well documented that reducing blood pressure (BP) in hypertensive individuals reduces the risk of cardiovascular (CV) events. Despite this, many patients with hypertension remain untreated or inadequately treated, and fail to reach the recommended BP goals. Suboptimal BP control, whilst arising from multiple causes, is often due to poor patient compliance and/or persistence, and results in a significant health and economic burden on society. The use of fixed-dose combinations (FDCs) for the treatment of hypertension has the potential to increase patient compliance and persistence. When compared with antihypertensive monotherapies, FDCs may also offer equivalent or better efficacy, and the same or improved tolerability. As a result, FDCs have the potential to reduce both the CV event rates and the non-drug healthcare costs associated with hypertension. When FDCs are adopted for the treatment of hypertension, issues relating to copayment, formulary restrictions and therapeutic reference pricing must be addressed.

Effectiveness of add-on therapy with amlodipine in hypertensive patients receiving valsartan.

OBJECTIVE: To describe the real-world effectiveness of amlodipine add-on therapy for hypertensive patients receiving valsartan. METHODS: Retrospective cohort study based on USA electronic medical records. The study population included hypertensive patients who, between January 1998 and December 2005, were receiving valsartan and subsequently initiated add-on therapy with amlodipine. Change in systolic blood pressure (SBP)/diastolic blood pressure (DBP), and attainment of goal SBP/DBP (i.e. < 140/90 mmHg), were examined based on last available reading prior to day 180 following initiation of amlodipine. RESULTS: Mean (+/- SD) baseline SBP/DBP of study subjects (n=155) was 152.5 (+/- 21.1)/84.0 (+/- 13.5) mmHg. Add-on therapy with amlodipine reduced SBP by 13.3 mmHg (95% CI 9.4-17.1) and DBP by 6.1 mmHg (95% CI 4.2-8.1). Among patients with baseline SBP/DBP > or = 160/100 mmHg (n=69), corresponding reductions were 28.8 mmHg (95% CI 23.4-34.2) and 11.4 mmHg (95% CI 8.4-14.3). Goal SBP/DBP was achieved by 46% (95% CI 37.7-55.6) of subjects; rates of goal attainment were similar for patients with and without diabetes or chronic kidney disease, and those aged > or = 65 years versus younger. CONCLUSIONS: Adding amlodipine to valsartan for treatment of hypertension results in clinically meaningful reductions in blood pressure, on an overall basis and in high-risk subgroups who may benefit the most from blood pressure control.