Diana I. Brixner

Toward a Consensus on the QALY

Earlier versions of the other articles in this Value in Health Special Issue, Moving the QALY Forward: Building a Pragmatic Road (articles 2–6) were presented at an ISPOR Development Workshop on “Moving the QALY Forward: Building a Pragmatic Road” held in Philadelphia from November 6–8, 2007. After the discussion of the articles, a workshop consensus group was formed, including representation from the groups producing the other articles. It fell to the consensus group to identify common ground on key issues. Given the diversity of views expressed at this workshop, as evidenced in the articles presented, it was clear that it would not be possible to reach agreement on specifics, such as how QALYs should be measured, or which instrument(s) should be used. Rather, the group felt that the best way forward was to reach agreement on several high-level principles and to express disagreements as a set of issues for further research. In all, eight general statements were agreed upon, which were then put to all the workshop participants for discussion. These statements are outlined as follows, along with the main points arising in the discussion.

Results of a retrospective, observational pilot study using electronic medical records to assess the prevalence and characteristics of patients with resistant hypertension in an ambulatory care setting

BACKGROUND Resistant hypertension, or failure to attain blood pressure (BP) goals while treated with > or = 3 antihypertensives (including a diuretic), occurred in 15% to 18% of patients in prospective cohort trials. OBJECTIVES The aims of this work were to identify the prevalence of resistant hypertension in an ambulatory care setting and to describe the characteristics of patients with resistant hypertension. METHODS Adults with hypertension were retrospectively identified in a US electronic medical record from November 1, 2002, through November 30, 2005. Antihypertensive treatment and BP values were assessed to identify those with BP > or = 140/90 mm Hg (>130/80 mm Hg for those with diabetes mellitus or kidney disease). Patients treated with > or = 3 agents (including a thiazide) who had > or = 1 BP level above target were classified as having resistant hypertension. Baseline characteristics were compared between those with and those without resistant hypertension. RESULTS Of 29,474 study patients aged > or = 18 years, 21,460 (72.8%) had > or = 1 prescription order for an antihypertensive and 19,202 (65.1%) had a follow-up BP level above target. The analysis found that 2670 patients (9.1% overall or 12.4% of those who were treated) were classified as having resistant hypertension. Relative to those without resistant hypertension, a greater proportion of those with resistant hypertension were female (65.6% vs 60.5%), were older (66.2 vs 63.0 years), had a higher body mass index (31.6 vs 30.4 kg/m(2)), had higher baseline BP levels (148/81 vs 138/80 mm Hg), and had higher rates of diabetes mellitus (35.2% vs 20.1%) or kidney disease (4.9% vs 2.7%) than those without resistant hypertension (all comparisons, P < 0.001). CONCLUSIONS This retrospective, observational pilot study of usual community practice supports the findings from prospective trials that resistant hypertension is an important clinical problem. More effective management is needed to enable patients with, or at risk for, resistant hypertension to achieve BP goals.

The economic consequences of noncompliance in cardiovascular disease and related conditions: A literature review

Objectives:  To review studies on the cost consequences of compliance and/or persistence in cardiovascular disease (CVD) and related conditions (hypertension, dyslipidaemia, diabetes and heart failure) published since 1995, and to evaluate the effects of noncompliance on healthcare expenditure and the cost‐effectiveness of pharmaceutical interventions.

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

ABSTRACT 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 (

Incidence and Economic Implications of Heparin-Induced Thrombocytopenia in Medical Patients Receiving Prophylaxis for Venous Thromboembolism

1587 vs.

The economic impact of GERD and PUD: examination of direct and indirect costs using a large integrated employer claims database

2050, p < 0.001) and medical costs (

Patterns of antihypertensive use among patients in the US Department of Defense database initially prescribed an angiotensin-converting enzyme inhibitor or calcium channel blocker

3343 vs.

Moving the QALY Forward: Rationale for Change

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.

Naturalistic Impact of Second-Generation Antipsychotics on Weight Gain

Study Objectives. To determine the incidence of heparin‐induced thrombocytopenia (HIT) in patients admitted to a medical service who were given unfractionated heparin (UFH) or low‐molecular‐weight heparin (LMWH) to prevent venous thromboembolism, the incremental cost of developing HIT, and the cost consequences of using LMWH to prevent venous thromboembolism in medical patients.

Clinical Risk Factors for Fracture in Postmenopausal Osteoporotic Women: A Review of the Recent Literature

ABSTRACT Objective: The objective of this study was to examine the relationship of work loss associated with gastro-esophageal reflux disease (GERD) and peptic ulcer disease (PUD) in a large population of employed individuals in the United States (US) and quantify the economic impact of these diseases to the employer. Methods: A proprietary database that contained workplace absence, disability and workers’ compensation data in addition to prescription drug and medical claims was used to answer the objectives. Employees with a medical claim with an ICD-9 code for GERD or PUD were identified from 1 January 1997 to 31 December 2000. A cohort of controls was identified for the same time period using the method of frequency matching on age, gender, industry type, occupational status, and employment status. Work absence rates and health care costs were compared between the groups after adjusting for demographic, and employment differences using analysis of covariance models. Results: There were significantly lower ( p < 0.05) prescription, and outpatient costs in the controls compared to the disease groups, although the eta-square values were very low. The mean work absence attributed to sick days was 2.8 (± 2.3) for controls, 3.4 (± 2.5) for GERD, 3.2 (± 2.6) for PUD, and 3.2 (± 2.3) days for GERD + PUD. For work loss, a significantly higher ( p < 0.05) rate of adjusted all-cause absenteeism and sickness-related absenteeism were observed between the disease groups versus the controls. In particular, controls had an average of 1.2 to 1.6 days and 0.4 to 0.6 lower all-cause and sickness-related absenteeism compared to the disease groups. The incremental economic impact projected to a hypothetical employed population was estimated to be