Good Research Practices for Measuring Drug Costs in Cost-Effectiveness Analyses: Medicare, Medicaid and Other US Government Payers Perspectives: The ISPOR Drug Cost Task Force Report—Part IV

Objectives Public programs finance a large share of the US pharmaceutical expenditures. To date, there are not guidelines for estimating the cost of drugs financed by US public programs. The objective of this study was to provide standards for estimating the cost of drugs financed by US public programs for utilization in pharmacoeconomic evaluations. Methods This report was prepared by the ISPOR Task Force on Good Research Practices—Use of Drug Costs for Cost-Effectiveness Analysis Medicare, Medicaid, and other US Government Payers Subgroup. The Subgroup was convened to assess the methodological and practical issues confronted by researchers when estimating the cost of drugs financed by US public programs, and to propose standards for more transparent, accurate and consistent costing methods. Results The Subgroup proposed these recommendations: 1) researchers must consider regulation requirements that affect the drug cost paid by public programs; 2) drug cost must represent the actual acquisition cost, incorporating any rebates or discounts; 3) transparency with respect to cost inputs must be ensured; 4) inclusion of the public program\u27s perspective is recommended; 5) high cost drugs require special attention, particularly when drugs represent a significant proportion of health-care expenditures for a specific disease; and 6) because of variations across public programs, sensitivity analyses for actual acquisition cost, real-world adherence, and generics availability are warranted. Specific recommendations also were proposed for the Medicare and Medicaid programs. Conclusions As pharmacoeconomic evaluations for coverage decisions made by US public programs grows, the need for precise and consistent estimation of drug costs is warranted. Application of the proposed recommendations will allow researchers to include accurate and unbiased cost estimates in pharmacoeconomic evaluations

Understanding the adoption of self -management behavior based on patients\u27 stage of change profiles in chronically ill populations

This study involved application of the transtheoretical (TTM) readiness stages of change model to self-management behavior (in the Andersen-Newman Behavioral framework of Health Care Utilization) primarily to understand patients\u27 self-management behavior adoption in chronic medical conditions. The four objectives were to determine the: (1) distribution of self-management readiness stages (TTMSM), its association with chronic medical conditions, and its significance in identifying patient\u27s risk status, and relationship of TTMSM with (2) socio-demographic, and psychosocial (coping, stress, self-efficacy, goal setting) factors, (3) self-management behavior and (4) perceived health outcomes (health status and patient satisfaction). A prospective, cross-sectional random mail survey of 4,040 low-risk and 700 high-risk patient enrollees from an Indiana-based managed care database, was undertaken. The inclusion criteria were patients 18 years and older with asthma, diabetes, hyperlipidemia, or hypertension. The usable net survey response rate was 13 percent. The patients (n = 609) (mean: two chronic conditions, mean disease duration: 14 years, majority wanting self-management advice) distributed across all five TTMSM-stages (pre-contemplation, contemplation, preparation, action, or maintenance) for the three self-management domains of participation with doctor, general, and lifestyle management, but not for the medical care domain. More patients (36.1 percent) were in pre-contemplation and contemplation for general self-management than other self-management behaviors. A significance level of 0.05 was used in statistical analyses. The TTMSM readiness stage for lifestyle management and participation with doctor were significant in classifying a patient as low-risk utilizer. Age, high school and above education, goal setting, self-management behavior, satisfaction with care, and mental health status were significant for patient self-management readiness (adjusted R-square-41.3 percent) while type of chronic medical condition was not. The TTMSM readiness stage for the four self-management domains, were significant for self-management behavior after controlling for clinical (total number and maximum duration of the four medical conditions of interest), psychosocial, and health status (adjusted R-square-48.2 percent) variables. Patient self-management readiness had significant positive association with self-management behavior, which had positive significant association with patient perceived health status. In conclusion, independent of chronic conditions, the TTMSM-readiness stage appears to influence health status through patient self-management behavior. For effective and coordinated delivery in targeting self-management education programs, health providers need to consider patients\u27 TTMSM readiness stage as an independent factor, in addition to their chronic conditions

Antipsychotic Use at Adult Ambulatory Care Visits by Patients With Mental Health Disorders in the United States, 1996-2003: National Estimates and Associated Factors

Objectives: This retrospective analysis was conducted to derive national estimates of typical, atypical, and combination (typical-atypical) antipsychotic use and to examine factors associated with their use at adult (age ≫-18 years) ambulatory care visits by patients with mental health disorders in the United States. Methods: Data on adult visits with an International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code for a mental health disorder were extracted from the office-based National Ambulatory Medical Care Survey and the outpatient facilitybased National Hospital Ambulatory Medical Care Survey from 1996 through 2003. The visits were categorized according to whether use of a typical, atypical, or combination antipsychotic was mentioned (either prescribed, supplied, administered, ordered, or continued at the visits). Total weighted visit estimates, weighted visit percentages, and 95% CIs were calculated across the 3 types of visit groups. Bivariate analysis was performed on the association between selected characteristics and the 3 visit groups. Multivariate logistic regression was performed on factors associated with atypical versus typical antipsychotic use. Results: During the 8-year period, there were an estimated 47.7 million adult ambulatory care visits involving a mental health disorder and mention of an antipsychotic (weighted percent: 0.83%; 95% CI, 0.73-0.93). From 1996/1997 to 2002/2003, visits involving atypical and combination antipsychotics increased by 195% and 149%, respectively, and visits involving typical antipsychotics decreased by 71%. Men, blacks, and those with public insurance made more visits in which combination antipsychotics rather than typical or atypical antipsychotics were mentioned. Relative to typical or combination antipsychotic visits, more atypical antipsychotic visits involved antide-pressants (weighted percent: 61.23% atypical, 37.29% typical, and 38.32% combination). Fewer atypical antipsychotic visits compared with typical or combination antipsychotic visits involved psychotic disorders (weighted percent: 32.94%, 51.23%, and 69.93%, respectively) and medications for extrapyramidal symptoms (weighted percent: 6.69%, 29.95%, and 36.64%). In multivariate analyses controlling for sex, race, diagnosis of schizophrenia, region, diagnosis of anxiety, and recent years, atypical versus typical antipsychotic use was significantly less likely at visits by those aged 41 to 64 years compared with those aged 18 to 40 years (adjusted odds ratio [OR] = 0.63; 95% CI, 0.47-0.84; P = 0.002); significantly less likely at visits by those with public compared with private insurance (Medicare OR = 0.59 [95% CI, 0.40-0.88], P = 0.010; Medicaid OR = 0.44 [95% CI, 0.28-0.69], P \u3c 0.001); and significantly more likely at visits associated with depression compared with those not associated with depression (OR = 1.92; 95% CI, 1.26-2.93; P = 0.003) and those associated with bipolar disorder compared with those not associated with bipolar disorder (OR = 2.10; 95% CI, 1.32-3.36; P = 0.002). Conclusions: This retrospective analysis found more atypical than typical or combination antipsychotic use at US ambulatory care visits by adults with mental health disorders other than schizophrenia or psychoses in the period studied. Atypical versus typical antipsychotic use was significantly less likely at visits by adults aged 41 to 64 years and those with public insurance, but significantly more likely at visits by those with depression or bipolar disorder