Development of an interactive model of the burden of future coronary heart disease from an employer perspective.

OBJECTIVE: To create a computer-based model for employers to better understand the burden of coronary heart disease (CHD) to their organizations. METHODS: A user-friendly model was developed to allow employers to evaluate the burden of CHD. Inputs include the demographic distribution by age and sex, prevalence of CHD and CHD risk factors, direct and indirect medical costs of CHD events, and discount and inflation rates. The model contains prediction equations derived from National Health and Nutrition Examination Survey data and Framingham Heart Study equations, used with employer inputs to predict future CHD events and expenditures. RESULTS: Interactive graphs are presented for the employer's covered population alongside regional benchmarks. The time horizon and population may be adjusted. CONCLUSIONS: This interactive model illustrates how pragmatic outcomes research can be converted into a transparent model addressing health care budget issues that is readily understood by corporate managers.

Direct medical costs for patients seeking emergency care for losses of epilepsy control in a U.S. managed care setting.

The objective of this retrospective claims database study was to compare the costs of care from a U.S. payer perspective before and after epilepsy treatment in emergent care settings and, secondarily, to describe the frequency of toxic effects and physical injuries occurring on the date of the emergent care. Nine and four-tenths percent of patients receiving emergent care for epilepsy (114/1213) had an injury or adverse antiepileptic drug effect on the same date. The majority of incidents were superficial injuries and contusions (28%), fractures (21%), open wounds or injury to blood vessels (19%), intracranial injury (10%), and/or medication toxicity (10%). Both non-epilepsy-related (US$12,745.56) and epilepsy-related (US$2013.62) direct medical costs of care pre-index were significantly different from those post-index (US$15,274.95 and US$7087.53, respectively). The cost of care for possible reestablishment of epilepsy control and treatment of co-occurring injuries is significant when compared with that for the period prior to seizure.

Case-control analysis of ambulance, emergency room, or inpatient hospital events for epilepsy and antiepileptic drug formulation changes.

PURPOSE: Although antiepileptic drugs (AEDs) with multisource generic alternatives are becoming more prevalent, no case-control studies have been published examining multisource medication use and epilepsy-related outcomes. This study evaluated the association between inpatient/emergency epilepsy care and the occurrence of a recent switch in AED formulation. METHODS: A case-control analysis was conducted utilizing the Ingenix LabRx Database. Eligible patients were 12-64 years of age, received >or=145 days of AEDs in the preindex period, had continuous eligibility for 6 months preindex, and no prior inpatient/emergency care. Cases received care between 7/1/2006 and 12/31/2006 in an ambulance, emergency room, or inpatient hospital with a primary epilepsy diagnosis. Controls had a primary epilepsy diagnosis in a physician's office during the same period. The index date was the earliest occurrence of care in each respective setting. Cases and controls were matched 1:3 by epilepsy diagnosis and age. Odds of a switch between "A-rated" AEDs within 6 months prior to index were calculated. RESULTS: Cases (n = 416) had 81% greater odds of having had an A-rated AED formulation switch [odds ratio (OR) = 1.81; 95% confidence interval (CI) = 1.25 to 2.63] relative to controls (n = 1248). There were no significant differences between groups regarding demographics or diagnosis. Significant differences were found with regard to medical coverage type (case Medicaid = 4.6%, control Medicaid = 1.8%, p = 0.002). Post hoc analysis results excluding Medicaid recipients remained significant and concordant with the original analysis. DISCUSSION: This analysis found an association between patients receiving epilepsy care in an emergency or inpatient setting and the recent occurrence of AED formulation switching involving A-rated generics.

Risk of treatment-emergent diabetes mellitus in patients receiving antipsychotics.

BACKGROUND: Type 2 diabetes mellitus has been reported during antipsychotic treatment. OBJECTIVE: To quantify the potential risk of treatment-emergent diabetes mellitus among patients receiving antipsychotic medications. METHODS: The MEDLINE and Psychinfo databases were searched using the key words antipsychotic (including individual drug names), diabetes, risk, and incidence for all English-language articles published between 1966 and 2005. Risk calculations were performed using data obtained from pharmacoepidemiologic studies that met the following criteria: (1) cohort design, (2) determination of preexisting diabetes, (3) inclusion of antipsychotic monotherapy as an exposure variable, and (4) comparison with exposure to first-generation antipsychotics. Studies meeting these criteria were used to calculate incidence, attributable risk between agents, and number needed to harm. RESULTS: A total of 25 observational pharmacoepidemiologic studies were found comparing antipsychotics on the outcome of diabetes mellitus. Sufficient information was provided in 15 of the reports to be able to estimate attributable risk. Attributable risk for individual second-generation antipsychotics relative to first-generation antipsychotics ranged from 53 more to 46 fewer new cases of diabetes per 1000 patients. Little observable difference was noted between the individual second-generation antipsychotics versus first-generation antipsychotics on this outcome. However, few of the studies controlled for body weight, race or ethnicity, or the presence of diabetogenic medications. None adjusted for familial history of diabetes, levels of physical activity, or diet, as this information is not usually available in the databases used in pharmacoepidemiologic studies. CONCLUSIONS: Based on the published pharmacoepidemiologic reports reviewed, the avoidance of diabetes as an outcome cannot be predictably achieved with precision by choice of a second-versus a first-generation antipsychotic. Risk management for new-onset diabetes requires the assessment of established risk factors such as family history, advancing age, non-white ethnicity, diet, central obesity, and level of physical activity.

Cost-effectiveness analysis of simvastatin and lovastatin/extended- release niacin to achieve LDL and HDL goal using NHANES data.

OBJECTIVE: The Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults, Adult Treatment Panel III (ATP III) encouraged reduced low-density lipoprotein (LDL) cholesterol levels for a greater number of patients and reemphasized the benefits of high-density lipoprotein (HDL) cholesterol. The purpose of this study was to compare 2 regimens achieving simultaneous LDL and HDL goals. METHODS: A decision-analytic model compared the cost-effectiveness of simvastatin and lovastatin/extended-release niacin. The perspective of the analysis was that of a health system. Product labeling was used to determine changes in cholesterol concentrations and frequencies of clinically important adverse events. The Third National Health and Nutrition Examination Survey (NHANES III) adult data were used for baseline cholesterol levels. Each product was titrated to achieve LDL and HDL goals unless an adverse effect occurred. Direct medical costs were determined for each treatment to determine cost-effectiveness. RESULTS: For both the 130 mg/dL and 100 mg/dL LDL goal analyses (and HDL e40 mg/dL), lovastatin/extended-release niacin had higher success rates and lower estimated direct-medical costs than simvastatin. Simvastatin had the highest success rate in achieving LDL level <160 mg/dL and HDL e40 mg/dL; however, its estimated direct-medical cost was approximately twice that of lovastatin/extended-release niacin (665 US dollars versus 333 US dollars). CONCLUSION: For the LDL goals <130 mg/dL and <100 mg/dL (and HDL e40 mg/dL) required of the majority of U.S. residents, lovastatin/extended-release niacin was both more successful and less costly than simvastatin.

Angiotensin-converting enzyme inhibitor therapy in patients with heart failure enrolled in a managed care organization: effect on costs and probability of hospitalization.

STUDY OBJECTIVE: To evaluate the effect of angiotensin-converting enzyme (ACE) inhibitor therapy on risk of hospitalization and resource utilization in patients with heart failure enrolled in a managed care organization. DESIGN: Retrospective medical and pharmacy claims analysis. PATIENTS: One thousand five hundred seventy-three patients with heart failure enrolled in a managed care organization. MEASUREMENTS AND MAIN RESULTS: Medical and pharmacy claims from January 1, 1997-December 31, 1999, from a managed care organization covering approximately 350,000 individuals were analyzed. Patients aged 35 years or older with a diagnostic code for heart failure and 18 months of continuous eligibility were selected. From this group (1573 patients), two cohorts were selected based on exposure to an ACE inhibitor. Dependent variables of interest were all-cause hospitalization and total direct medical costs during the 12-month study period. A logistic regression model and an ordinary least-squares model adjusting for patient demographics, comorbidities, and concomitant drug therapy were used to analyze the risk of all-cause hospitalization and total direct medical costs, respectively. Therapy with an ACE inhibitor for 180 days was associated with a decreased risk of all-cause hospitalization (odds ratio 0.65, p<0.0001) and lower total costs (mean dollars 2397, p<0.001) compared with no ACE inhibitor therapy. CONCLUSION: In patients with a diagnosis of heart failure, exposure to ACE inhibitor therapy is associated with fewer hospitalizations and lower total costs than no ACE inhibitor exposure.

Clinicians' responses to direct-to-consumer advertising of prescription medications.

BACKGROUND: The direct-to-consumer advertising (DTCA) of prescription medications is proliferating in the United States. The relationship between patient exposure to DTCA and the response of clinicians is not well understood. METHODS: A randomized postal survey of Arizona primary care provider physicians (n = 1080) and physician assistants (n = 704) was conducted. A questionnaire was created using a hypothetical patient scenario that varied according to the diagnosis of the patient (ie, hypertension, hypercholesterolemia, seasonal allergies, or obesity) and the type of informational exposure generating the patient's questions (ie, DTCA vs drug references such as Physicians' Desk Reference). Clinicians were randomly assigned 1 of 8 forms of the scenario and were asked standardized questions related to their responses when faced with the patient scenario. RESULTS: The response rate was 44% (40.5% of physicians and 49.3% of physician assistants). No statistically significant differences were found between the early and late responders or between responders and nonresponders. Relative to clinicians who received the "drug reference book" patient scenario, clinicians who received the DTCA patient scenario were more likely to become annoyed with a patient for asking for more information about medications (P =.003); less likely to answer the patient's questions (P =.03) or provide additional written information (P =.007); more likely to become frustrated (P =.003) and annoyed (P<.001) with the patient for asking to try a specific medication; and less likely to provide samples (P =.001) or a prescription (P<.001) for a specific medication. CONCLUSION: Clinicians are amenable to patients asking for drug information and medications, but they are less receptive to questions arising from DTCA.

A 3-stage model for assessing the probable economic effects of direct-to-consumer advertising of pharmaceuticals.

BACKGROUND: The pharmaceutical industry employs a variety of marketing strategies that have previously been directed primarily toward physicians. However, mass media direct-to-consumer (DTC) advertising of prescription drugs has emerged as a ubiquitous promotional strategy. OBJECTIVE: This article explores the economics of DTC advertising in greater depth than has been done in the past by using a 3-stage economic model to assess the pertinent literature and to show the probable effects of DTC advertising in the United States. METHODS: Economics literature on the subject was searched using the Journal of Economic Literature. Health services literature was searched using computer callback devices. RESULTS: Spending on DTC advertising in the United States increased from $17 million in 1985 to $2.5 billion in 2000. Proponents of DTC advertising claim that it provides valuable product-related information to health care professionals and patients, may contribute to better use of medications, and helps patients take charge of their own health care. Opponents argue that DTC advertising provides misleading messages rather than well-balanced, evidence-based information. The literature is replete with opinions about the effects of prescription drug advertising on pharmaceutical drug prices and physician-prescribing patterns, but few studies have addressed the issues beyond opinion surveys. The economic literature on advertising effects in other markets, however, may provide insight. CONCLUSION: DTC advertising indirectly affects the price and the quantity of production of pharmaceuticals via its effect on changes in consumer demand.

Relationship between direct-to-consumer advertising and physician diagnosing and prescribing.

The relationships between direct-to-consumer advertising expenditures and the monthly frequencies of diagnoses and prescriptions written associated with the products advertised are examined. The analyses utilized quasi-experimental time-series techniques. Data from the National Ambulatory Medical Care Survey and Competitive Media Reporting were used to calculate monthly levels of the dependent and independent variables. The dependent variables included monthly frequencies of diagnoses for the products' FDA-approved indications, medications prescribed within the advertised pharmaceutical class, and medications prescribed for the specific advertised agent. The independent variables included monthly expenditures for advertising each pharmaceutical class and each specific agent. Several significant monthly relationships were found. The diagnoses of hyperlipidemia (p = 0.008) and the number of prescriptions written for antilipemics (p = 0.003) were positively associated with the advertising expenditure for antilipemics. The number of prescriptions written for Claritin (p = 0.004) and Zocor (p < 0.001) was positively related to the advertising expenditure for their respective pharmaceutical classes; the amount of prescriptions written for Hismanal (p = 0.007), Seldane (p < 0.001), and Zantac (p = 0.004) was negatively related to the advertising expenditure for their respective pharmaceutical classes. The number of prescriptions written for Claritin (p = 0.005) and Zocor (p < 0.001) was positively related to the advertising expenditure for each specific product; the amount of prescriptions written for Hismanal (p = 0.049) was negatively associated with the amount of money spent specifically advertising the agent. No significant associations were found in antihypertensive drugs and drugs to treat benign prostatic hypertrophy. The results of the analyses suggest that the direct-to-consumer advertising expenditure is associated with physician diagnosing and physician prescribing for certain drugs and drug classes.

Health care professionals' perceptions of the role of pharmacogenomic data.

OBJECTIVE: To explore the perceptions of health care professionals in examining the uses of pharmacogenomic data. METHODS: A mailed questionnaire elicited respondent perceptions of how the use of pharmacogenomic information would impact the provision of health-related services (7-point scale: 7=strongly increase to 1=strongly decrease). Respondents were also asked to describe their level of agreement to statements related to how pharmacogenomic information should be used (7-point scale: 7=strongly agree to 1=strongly disagree). One-sample t tests were used to investigate significant differences from the midpoint value of each scale. Survey participants were attendees of a policy conference entitled.Pharmacogenomics: Implications for Patients, Providers, and Payers. sponsored by the university college of pharmacy. RESULTS: Respondents believed the use of pharmacogenomic information would affect several areas of health care, including the cost of insurance premiums (P<0.001), the use of confidential medical information (P=0.024), patient access to therapy (P=0.005), and the impact of physician/patient preferences in selecting treatment choices (P<0.001). Furthermore, respondents felt it should be used to help treat patients (P<0.001), help patients/physicians make therapy choices (P<0.001), create treatment guidelines (P<0.001), conduct research (P<0.001), justify refusals of therapy (P=0.014), and budget for future expenditures (P<0.001). Respondents also believed the information should not be used for setting copay amounts (P=0.002), determining insurance premiums (P<0.001), or in the negotiation of insurance contracts (P<0.001). CONCLUSION: The respondents to this survey appeared optimistic about the use of pharmacogenomic information, and their responses provided a proactive framework to discuss the potential use and misuse of this technology.