The impact of proton pump inhibitor compliance on health-care resource utilization and costs in patients with gastroesophageal reflux disease.

OBJECTIVE: Standard pharmacotherapy for patients with gastroesophageal reflux disease (GERD) includes treatment with proton pump inhibitors (PPIs). This study examined the effect of GERD patients' compliance with PPI therapy on health-care resource utilization and costs. METHODS: This was a retrospective study of more than 25 million managed care lives in the United States from January 2000 through February 2005. Administrative claims data were obtained from the National Managed Care Benchmarks database, developed by Integrated Health Care Information Solutions. GERD-diagnosed patients who had at least two PPI dispensings were extracted and grouped into two treatment categories based on their PPI medication possession ratio (MPR): compliant (MPR > 0.8) and noncompliant. A regression-based difference-in-differences approach was used to estimate the effect of compliance on the frequency and costs of inpatient and outpatient visits and pharmacy costs. Statistical controls included health plan type, patient age, baseline use of nonsteroidal antiinflammatory drugs, and comorbidities. RESULTS: Of the total 41,837 patients studied, 68% were compliant. On an annual, per-patient basis, PPI compliance resulted in 0.47 fewer outpatient visits (P = 0.040), 0.03 fewer inpatient visits (P = 0.015), and 0.47 fewer hospitalization days (P = 0.001) from the pre-PPI use period, compared to noncompliance. PPI therapy increased pharmacy costs for both groups, but the total annual health-care costs were reduced for both groups. Compliant patients experienced a greater decline in total cost from the pre-PPI period compared to noncompliant patients (declines of $3261 vs. $2406 per patient per year, P = 0.012). CONCLUSIONS: Both health-care resource use and costs were reduced after initiation of PPI therapy. Additional reductions from the pre-PPI period were further observed by compliance with PPI therapy.

Impact of compliance with proton pump inhibitors on NSAID treatment.

OBJECTIVE: To assess the impact of patient compliance with proton pump inhibitor (PPI) therapy on nonsteroidal anti-inflammatory drug (NSAID) treatment duration and upper-gastrointestinal (GI) complications in patients with gastroesophageal reflux disease (GERD). STUDY DESIGN: Retrospective cohort study. METHODS: Study subjects were GERD patients receiving cotherapy with a PPI and a cyclooxygenase-2-selective (COX-2-selective) or nonselective NSAID. Patients compliant and noncompliant with PPI therapy were compared on NSAID treatment duration and incidence of upper-GI events. Kaplan-Meier analysis and a multivariate Cox proportional hazards model were used to compare durations of NSAID treatment, controlling for baseline characteristics. The incidences of GI events were compared using incidence rate and Poisson regression models. The analyses were conducted separately for patients taking COX-2-selective NSAIDs and those taking nonselective NSAIDs. RESULTS: In both patient groups taking a COX-2-selective agent (n = 12,562; 70.9% compliant) and nonselective NSAID (n = 17,487; 69.9% compliant), mean NSAID treatment duration was significantly longer (84.0 days and 20.8 days longer, respectively) in PPI-compliant patients than in noncompliant patients. Compliance with PPI therapy was associated with a greater reduction in the incidence of GI events than noncompliance in both patients taking a COX-2-selective NSAID (6-fold vs 5-fold; P = .026) and patients taking a nonselective NSAID (8-fold vs 6-fold; P = .002). CONCLUSIONS: In GERD patients receiving NSAIDs, those who were compliant with PPI therapy had a longer NSAID treatment duration and better GI tolerability than those who were noncompliant.

Compulsory generic switching of antiepileptic drugs: high switchback rates to branded compounds compared with other drug classes.

PURPOSE: Compulsory generic substitution of antiepileptic drugs (AEDs) may lead to adverse effects in epilepsy patients because of seizure recurrence or increased toxicity. The study objectives were (a) to quantify and compare the switchback rates from generic to brand-name AEDs versus non-AEDs, and (b) to assess clinical implications of switching from branded Lamictal to generic lamotrigine (LTG) and whether signals exist suggesting outcome worsening. METHODS: By using a public-payer pharmacy-claims database from Ontario, Canada, switchback rates from generic to branded AEDs [Lamictal, Frisium (clobazam; CLB), and Depakene (VPA; divalproex)] were calculated and compared with non-AED long-term therapies, antihyperlipidemics and antidepressants, in January 2002 through March 2006. We then assessed pharmacy utilization and AED dosage among LTG patients switching back to branded Lamictal compared with those staying on generic formulation. RESULTS: The 1,354 patients (403 monotherapy, 951 polytherapy) were prescribed generic LTG, of whom 12.9% switched back to Lamictal (11.7% monotherapy, 13.4% polytherapy). Switchback rates of other AEDs were approximately 20% for CLB and VPA. The switchback rates for AEDs were substantially higher than for non-AEDs (1.5-2.9%). Significant increases in LTG doses were observed after generic substitution for those who did not switch back (6.2%; p<0.0001). The average number of codispensed AEDs and non-AED drugs significantly increased (p<0.0001) after LTG generic entry, especially in the generic group. CONCLUSIONS: These results reflect poor acceptance of switching AEDs to generic compounds. They may also indicate increased toxicity and/or loss of seizure control associated with generic AED use.

Dosing patterns and treatment costs of erythropoietic agents in elderly patients with pre-dialysis chronic kidney disease in managed care organisations.

OBJECTIVES: To investigate dosing patterns and drug costs of erythropoietic agents and assess the frequency of outpatient nephrologist visits in an elderly population with pre-dialysis chronic kidney disease (pCKD) newly initiated on epoetin alfa (EPO) or darbepoetin alfa (DARB). METHODS: An analysis of medical claims from more than 30 healthcare plans covering all census regions of the US in the period July 2002 through February 2005 was conducted. Patients were included if they were > or = 65 years of age, had at least one claim for CKD within 90 days prior to the initiation of any erythropoietic agent, were newly commenced on either EPO or DARB, and had received at least two treatment doses. If a patient received renal dialysis, data were censored 30 days prior to the first date of dialysis. Patients diagnosed with cancer or those who had undergone chemotherapy were excluded from the analysis. The average dosing interval for both EPO and DARB was calculated and classified as once weekly (qw), every 2 weeks (q2w) or every 3 weeks or less frequently (> or = q3w). Weighted average weekly doses were scaled based on treatment duration. The frequency of outpatient nephrologist visits was analysed. Average weekly treatment costs were calculated and presented using the May 2005 Wholesale Acquisition Costs. RESULTS: A total of 293 EPO and 102 DARB patients met the inclusion criteria. The two groups of patients had similar mean age (74.4 years for EPO vs 74.3 years for DARB) and gender distribution (47.4% female for EPO vs 51.0% for DARB). Extended dosing (every 2 weeks or less frequently: > or = q2w) during treatment was observed in both groups (EPO: qw 49.8%, q2w 31.7%, > or = q3w 18.4%; DARB: qw 19.6%, q2w 52.9%, > or = q3w 27.5%). The average dosing interval between injections was 13.6 days for the EPO group and 17.3 days for the DARB group. The weighted average weekly dose was 12,748 units for EPO and 43.5 microg for DARB. The average weekly erythropoietic treatment cost was significantly greater for DARB compared with EPO (190 US dollars vs 155 US dollars per week [2005 values]; p = 0.028). After controlling for covariates, the cost difference between the two groups was more pronounced and remained statistically significant (adjusted cost difference 41 US dollars/week higher for DARB patients; p = 0.013). The frequency of outpatient nephrologist visits during treatment was similar between the two groups (EPO 3.4 vs DARB 3.0 visits). CONCLUSIONS: Based on this analysis of claims data from more than 30 US healthcare plans, extended dosing (> or = q2w) of EPO and DARB was common in elderly pCKD patients treated with erythropoietic agents, with significantly higher weekly drug costs observed in the DARB group compared with the EPO group. The number of outpatient nephrologist visits was not significantly different between EPO and DARB patients. This study was the first to evaluate the dosing patterns of EPO and DARB in elderly pCKD patients in a large managed care population.

Drug administration frequency and provider office visit patterns for oncology patients during treatment with erythropoietic agents: an analysis of four observational studies.

BACKGROUND: Several drug administration regimens of epoetin alfa (EPO) and darbepoetin alfa (DARB) are used for the management of anemia in cancer patients in the clinical practice setting. OBJECTIVE: The purpose of the present analysis was to assess whether drug administration regimens were associated with differences in the number of provider office visits and hemoglobin assessments during treatment with these agents. METHODS: Data from 4 observational studies that examined treatment patterns of EPO and DARE and health care resource utilization were analyzed. These studies, selected based on the availability of office visit and/or hemoglobin determination data during the course of treatment, included a retrospective chart review, 2 retrospective claims analyses, and an ongoing prospective patient registry. The treatment patterns and oncology-related provider visits and/or the frequency of hemoglobin evaluations among the studies were reported. RESULTS: Data from 15,845 cancer patients were included in the analysis. The patient demographic and baseline characteristics were similar across all 4 studies; patients were predominantly women (62%-71%) with a mean age range of 56 to 63 years. Mean treatment duration ranged from 7.1 to 8.4 weeks without significant differences between EPO and DARE in any study. Weekly and extended (at least every 2 weeks [> or =Q2W]) drug administration frequencies were observed in both treatment groups. The most frequent drug administration schedule for EPO was once weekly (53%-75% of patients), and for DARE Q2W (67%-73%). Despite the difference in erythropoietic agent administration frequency, no significant differences were observed between EPO and DARB for either the number of oncology-related provider visits or the number of hemoglobin assessments. CONCLUSIONS: The frequency of oncology-related provider visits and hemoglobin assessments appears to be independent of the EPO and DARB administration frequency. These findings might provide useful information for health care providers and oncology patients in understanding patterns of care during treatment with erythropoietic agents.

Dosing patterns and costs of erythropoietic agents in patients with chronic kidney disease not on dialysis in managed care organizations.

BACKGROUND: Epoetin alfa (EPO) and darbepoetin alfa (DARB) are erythropoietic agents indicated in the United States for the treatment of anemia in chronic kidney disease (CKD). OBJECTIVE: This study investigated dosing patterns and costs associated with the use of erythropoietic-stimulating therapy (EST) in patients with CKD not on dialysis who were newly starting EPO or DARB therapy in managed care organizations. METHODS: This was a retrospective analysis of medical claims data from >30 health plans for the period from July 2002 to February 2005. Patients were included if they were aged > or =18 years, had > or =1 claim for CKD within 90 days before the initiation of treatment, had newly started therapy with EPO or DARB, and had received > or =2 doses of treatment. If a patient was undergoing renal dialysis, data were censored 30 days before the first date of dialysis. Patients with a diagnosis of cancer or who had undergone chemotherapy were excluded from the analysis. The mean dosing interval was determined for both groups. Mean weekly doses and costs (using 2005 wholesale acquisition costs), weighted by the treatment duration, were calculated. The frequency of outpatient nephrologist visits was described and included in cost considerations. RESULTS: The study population consisted of 595 patients who received EPO and 260 who received DARB. The EPO group was significantly older than the DARB group (mean age, 63.5 vs 61.2 years, respectively; P = 0.020). The proportion of women was similar between the 2 groups (51.6% and 50.4%). Use of extended dosing (> or =q2wk) was common in both groups (63.2% and 90.8%). The weighted mean weekly dose was 11,536 U for EPO and 42.5 mug for DARB. The mean number of outpatient nephrologist visits during treatment was similar between the 2 groups (3.9 and 3.5). Mean weekly costs (EST drug cost plus cost of nephrologist visits) were significantly lower for EPO compared with DARB (159 dollars vs 205 dollars; P < 0.001). CONCLUSIONS: The majority of these CKD patients newly started on EST in managed care organizations received extended dosing regimens (> or =q2wk) of EPO or DARB. EPO treatment was associated with significantly lower mean weekly costs compared with DARB. The number of outpatient nephrology visits did not differ significantly between groups.

Dosing patterns, treatment costs, and frequency of physician visits in adults with cancer receiving erythropoietic agents in managed care organizations.

OBJECTIVE: To investigate the dosing patterns and treatment costs of erythropoietic agents in adult (>or= 18 years of age) cancer patients newly initiated on epoetin alfa (EPO) or darbepoetin alfa (DARB) in managed care organizations. METHODS: An analysis of US medical claims (30 million lives in over 35 health plans) in the period July 1, 2002-February 28, 2005 was conducted. Patients with >or= 1 cancer claim within 90 days prior to initiating EPO or DARB, and who received at least two doses of the same erythropoietic agent, were included in this analysis. Weighted average weekly dosing, cumulative treatment dose, associated drug cost, dosing frequency patterns, and the frequency of outpatient visits were evaluated. The EPO:DARB dose ratio, based on average cumulative treatment doses, was assessed. RESULTS: 5639 EPO and 2166 DARB patients met the inclusion and exclusion criteria. The EPO group was older (EPO 59.1 years; DARB 57.6 years; p < 0.001) with a higher proportion of men (EPO 38.1%; DARB 33.1%; p < 0.001). Variable dosing frequency was observed with similar treatment durations for the two groups (days: EPO 55.6; DARB 57.7; p = 0.122). A dose ratio of 236:1 was observed (average cumulative dose: EPO 252 856 U; DARB 1072 mcg). Average drug cost was significantly higher in the DARB group (drug cost: EPO 3077 dollars; DARB 4674 dollars; p < 0.001). The average number of hematology/oncology outpatient visits per patient (visits: EPO 7.4; DARB 7.3; p = 0.676) and outpatient visits for hemoglobin determination (visits: EPO 6.7; DARB 6.4; p = 0.093) during treatment was similar between the two groups. LIMITATIONS: The results were based on medical claims only. The absence of information on actual injection dates in pharmacy claims prevented their incorporation in the analysis. CONCLUSIONS: Based on the average cumulative doses, the EPO:DARB dose ratio was 236:1 (Units EPO: mcg DARB) with 52% greater drug cost in the DARB group. Despite the variable administration frequency observed between the two agents, the number of hematology/oncology outpatient visits was not different.