Patterns of use of sildenafil among commercially insured adults in the United States: 1998-2002.

Sildenafil is increasingly being marketed to younger healthcare consumers. The purpose of this study was to profile sildenafil use in commercially insured, adult beneficiaries. Annual ambulatory prescription claims data from 1998 to 2002, for a nationwide, random sample of over 5 million life-years of commercially insured adults (aged > or =18 y), were examined retrospectively. The overall prevalence of sildenafil use increased from 0.8% (1998) to 1.4% (2002), an 84% increase. While the growth in use slowed in older males, use became more pronounced in younger males and females and decreased in older females. The fastest growing segment of users was found to be males aged 18-45 y. The proportion of users who had two or more claims for a medication that is suspected of inducing erectile dysfunction (ED) and/or a marker for a suspected ED-inducing disease decreased over the study period. Our findings suggest that use may increase among younger male and female patients and those without an underlying etiologic reason for use.

Helicobacter pylori eradication in clinical practice: retreatment rates and costs of competing regimens.

OBJECTIVE: To measure outcomes for eradication regimens for Helicobacter pylori infection in routine clinical practice. DESIGN: Retrospective analysis of an integrated medical and pharmacy claims database identified patients treated from June 1, 1995 through May 31, 1996, and followed the patients' claims until December 31, 1996. SETTING: The database represented multiple health plans throughout the US. PATIENTS: Patients were > or = 16 years old, continuously enrolled from April 1, 1995, to December 31, 1996, and met clinical (diagnostic or procedural) criteria. INTERVENTION: Patient cohorts were treated with bismuth-based triple (n = 98), proton-pump inhibitor (PPI)-based triple (n = 180), or PPI-based dual (n = 337) regimens. OUTCOME MEASURES: Retreatment; monthly postregimen medical expense, controlling for preregimen expense; and drug cost per successfully treated patient. Cox regression (retreatment analysis) and ANCOVA (postregimen expense analysis) adjusted for age, gender, diagnostic/procedural criteria met by patient, and specialty physician use. RESULTS: Retreatment rates were higher (p < 0.05) for PPI-based dual than bismuth-based or PPI-based triple-therapy cohorts. Retreatment rates for bismuth- and PPI-based triple-therapy cohorts were not significantly different. Total and follow-up (excluding the first 2 wk of treatment) expenses were higher for retreated than nonretreated patients (p < 0.01). Total expenses were higher for the PPI-dual cohort (p < 0.05) than for triple cohorts. Drug costs per successfully treated patient were $30 for bismuth-based, $172 for PPI-based triple, and $208 for PPI-based dual-therapy regimens. CONCLUSIONS: PPI-based dual-therapy regimens are not cost-effective in H. pylori treatment. Further study should compare more costly (PPI-based) versus less costly (bismuth-based) triple-therapy regimens.

Compliance with and dosing of angiotensin-converting-enzyme inhibitors before and after hospitalization.

Compliance with and dosing of angiotensin-converting-enzyme (ACE) inhibitors as they occur before and after hospitalization for heart failure were studied, and factors predictive of compliance with and dosing of ACE inhibitors after hospitalization were identified. Two hundred thirty-six patients hospitalized with heart failure between October 1, 1995, and April 30, 1996, were identified. Compliance with and use and dosing of ACE inhibitors were examined over the 180-day period before admission and the 180-day period after discharge using an integrated pharmacy and medical claims database. Use of an ACE inhibitor was defined as at least one claim for an ACE inhibitor over the period examined, and dosing was assessed by calculating the mean percentage of an adequate daily dose dispensed. Before hospitalization 109 patients (46.2%) used ACE inhibitors, and after hospitalization 148 (62.7%) used them--a significant increase. ACE inhibitor use before hospitalization was a predictor of postdischarge use. Younger patients were more likely to take ACE inhibitors after hospitalization than older ones, and men had better compliance after hospitalization than women. Additional analyses revealed that, among hospitalized patients, compliance was lower in individuals who also took an antidepressant. Dosing increased from 72% to 85% of an adequate daily dose after hospitalization among patients who took ACE inhibitors during both prehospitalization and posthospitalization periods. However, almost one third of hospitalized patients stopped taking their ACE inhibitor within six months of hospital discharge. The study found few significant predictors of patient compliance after hospitalization. Dosing of ACE inhibitors before and after hospitalization needs to be improved.

Angiotensin-converting enzyme inhibitor compliance and dosing among patients with heart failure.

BACKGROUND: The efficacy of angiotensin-converting enzyme (ACE) inhibitors in treating heart failure is well established, but there is concern that these agents are underutilized. Proper treatment is contingent both on appropriate medication dosing by the physician and on patient compliance with therapy. This study examined dosing and compliance with ACE inhibitors in routine clinical practice. METHODS AND RESULTS: Data were integrated medical and pharmacy claims from 869 patients with heart failure. Compliance and dosing of ACE inhibitors was examined for each patient over a 10- to 17-month period. Patients had ACE inhibitors available on 71% of the days assessed. At 180 days after their index prescription, 86% of patients continued to take an ACE inhibitor. The mean percentage of an adequate daily dose of ACE inhibitors dispensed per prescription was 79%, but only 34% of patients were dispensed >/=100% of an adequate daily dose. A number of variables were found to independently predict compliance and dosing levels in the multivariate analyses. CONCLUSIONS: Both physician-dependent and patient-dependent factors contributed significantly to ACE inhibitor underutilization. Each of these factors must be addressed to improve compliance and dosing of ACE inhibitors in routine clinical care.

The effect of a copay increase on pharmaceutical utilization, expenditures, and treatment continuation.

OBJECTIVE: No research has evaluated the impact of an increase to a copay that is reflective of today's healthcare market. This study examined the effect of an increase from a $10 to $15 copay for brand drugs on key pharmaceutical utilization measures, including participation rates, treatment continuation, and expenditures, in an adult population. STUDY DESIGN: A quasi-experimental, pre-post design with control group was used. PATIENTS AND METHODS: Two different employer plans implemented an increase from $10 to $15 for brand copays in January of 1997. The utilization and expenditures of these plans were compared with those of a control group with a constant brand copay of $10 for 6 months preceding and 6 months following the copay increase. RESULTS: When other predictor variables were controlled for, the copay increase was not associated with a statistically significant difference in overall utilization compared with the control group, although brand utilization was significantly lower in the copay group. Savings to the payer were substantial, and resulted primarily from cost-shifting, reduction in brand utilization, and an increase in the generic fill rate. The rates of continuation with chronic medications in the 6 months following the copay increase were not reduced in the copay group compared with the control group. CONCLUSION: A copay increase can provide substantial savings to a payer without being a major deterrent to overall utilization or resulting in discontinuation of chronic medications.

The effect of a closed formulary on prescription drug use and costs.

This study examines the effect of a closed formulary on pharmaceutical use and spending. We compared an employer plan that implemented a closed formulary in July 1997 to a control group with an open formulary, for the nine months preceding and following implementation of the formulary. When controlling for age, gender, and chronic disease score, the closed formulary was associated with significantly lower increases in utilization and expenditures, a higher prior authorization rate, and a reduced rate of continuation with chronic medications in the nine months following its implementation. These findings have implications for the design of prescription drug benefits.

Patient education programs and continuance with estrogen replacement therapy: evaluation of the women's health exchange.

OBJECTIVE: This study examined the impact of the Women's Health Exchange (WHE), a program aimed at educating women about menopause and estrogen replacement therapy, on patient continuance with Estraderm, a transdermal estrogen replacement medication. DESIGN: The prescription database of Express Scripts, Inc., a pharmacy benefits management company serving a large, nationwide insured population, was used for the study. All study subjects had one or more claims for Estraderm between 2/1/95 and 8/31/95. The intervention group consisted of 299 WHE enrollees, and the control group comprised a random sample of 1,513 patients who had not enrolled in WHE. RESULTS: A multivariate Cox regression model found that older age, longer prior length of Estraderm use, progestin use, and patronage of a mail-order pharmacy were associated with increased continuance. Controlling for these factors and for HMO enrollment and copay amount, the likelihood of discontinuing Estraderm was significantly lower for WHE enrollees compared to non-WHE enrollees. Sensitivity analyses tested the effects of preexisting differences between the WHE and control group subjects on study findings. Even when WHE enrollees were compared with control subjects having similar medication costs, disease severity, or continuance with chronic medications, WHE enrollment was associated with an increased length of Estraderm therapy. CONCLUSIONS: These findings suggest that patient education programs may improve continuance with transdermal hormone replacement therapy for patients with a prescription benefit.

The use of claims databases for outcomes research: rationale, challenges, and strategies.

Health care payers and policy makers need information about the cost and effectiveness of medical treatments. While randomized controlled trials historically are the primary source of medical information, they are expensive and labor-intensive, and often have limited utility for answering questions about "real-world" patient populations. These problems have led to an increasing reliance on claims database research in making policy decisions about treatment options. However, both researchers and decision makers should recognize the limitations and unique features of claims databases. Recommendations for avoiding or minimizing threats to internal validity, construct validity, and external validity are: (1) use of a study design that includes comparisons; (2) ensuring that the study design and conclusions are consistent with the database; (3) a priori conceptual modeling of the research question; (4) use of appropriate constructs; (5) explicit examination of alternative explanations for study findings; (6) sensitivity analyses of key assumptions; (7) awareness of the distinction between statistical and practical significance of findings; (8) generalization only when appropriate; and (9) reporting of relevant information. Given that any study design or data source has limitations, we hope that this paper will encourage a philosophy of methodological pluralism in outcomes research. Awareness and accurate reporting of validity issues will strengthen and extend the information resources currently available to decision makers.