Generic antiepileptic drugs and associated medical resource utilization in the United States.

OBJECTIVE: To evaluate whether generic substitution was associated with any difference in medical resource utilization for 5 widely used antiepileptic drugs (AEDs) in the United States. METHODS: Health insurance claims from PharMetrics Database, representing over 90 health plans between January 2000 and October 2007, were analyzed. Adult patients with epilepsy, continuously treated with carbamazepine, gabapentin, phenytoin, primidone, or zonisamide, were selected. An open-cohort design was used to classify patients into mutually exclusive periods of brand vs generic use of AEDs. Pharmacy and medical utilization were compared between the 2 periods with multivariate regression analyses. Results were stratified into epilepsy-related medical services, and stable (< or = 2 outpatient visits per year and no emergency room visit) vs unstable epilepsy. Time-to-event analyses were also performed for all services and epilepsy-related endpoints. RESULTS: A total of 18,125 patients were observed in the stable group and 15,500 patients in the unstable group. After adjustment of covariates, periods of generic AED treatment were associated with increased use of all prescription drugs (incidence rate ratio [IRR] [95% confidence interval (CI)] = 1.13 [1.13-1.14]) and higher epilepsy-related medical utilization rates (hospitalizations: IRR [95% CI] = 1.24 [1.19-1.30]; outpatient visits: IRR [95% CI] = 1.14 [1.13-1.16]; lengths of hospital stays: IRR [95% CI] = 1.29 [1.27-1.32]). Generic-use periods were associated with increased utilization rates in stable and unstable patients and with 20% increased risk of injury, compared to periods with brand use of AEDs. CONCLUSIONS: Generic antiepileptic drug use was associated with significantly greater medical utilization and risk of epilepsy-related medical events, compared to brand use. This relationship was observed even in patients characterized as stable. AED = antiepileptic drug; CI = confidence interval; ER = emergency room; HR = hazard ratio; ICD = International Classification of Diseases; IRR = incidence rate ratio.

Economic impact of switching from valsartan to other angiotensin receptor blockers in patients with hypertension.

BACKGROUND: The approaching availability of lower-cost generic angiotensin receptor blockers (ARBs) may affect formulary policies for patients maintained on the ARB valsartan. OBJECTIVE: Estimate the economic impact of switching from valsartan (including valsartan-based single-pill combinations) to other ARBs without apparent medical reasons. RESEARCH DESIGN AND METHODS: Patients with essential hypertension and at least 6 months of continuous valsartan treatment free of hospitalization, cardiovascular events, renal events or ARB-associated adverse events were identified from the MarketScan administrative claims database from January 1, 2004 to March 31, 2008. Those who subsequently switched to a different ARB with at least a 5% copayment decrease (switchers) were matched to those who did not switch (maintainers) according to propensity score quintiles and selected baseline characteristics. Refills were not required after the index fill for the switched-to ARB or maintained valsartan. Matched switchers and maintainers were compared in terms of medication discontinuation, healthcare resource use and costs during the 6 months following the index fill. RESULTS: A total of 99,926 valsartan maintainers and 2150 switchers (with a mean copayment decrease of $16.5 per month) were identified and matched. After matching, switching from versus maintaining valsartan was associated with an 8% higher risk of medication discontinuation (p < 0.008), 19.1 additional outpatient visits/100 patients (p = 0.002) and 9.3 additional hypertension-related inpatient days/100 patients (p = 0.030). Concurrently, switching from versus maintaining valsartan was associated with higher total medical costs by $748/patient (p < 0.001), driven largely by higher costs for hypertension-related medical services by $492/patient (p = 0.004). LIMITATIONS: Exact reasons for switching were not available and the study assessed only the short-term impacts of switching. CONCLUSIONS: Hypertension patients maintained on valsartan who switched to a different ARB with a lower copayment experienced substantial increases in medication discontinuation, healthcare resource use and costs compared to those who maintained valsartan treatment.

The risks and costs of multiple-generic substitution of topiramate.

OBJECTIVE: To investigate clinical and economic consequences following generic substitution of one vs multiple generics of topiramate (Topamax; Ortho-McNeil Neurologics, Titusville, NJ). METHODS: Medical and pharmacy claims data of Régie de l'Assurance-Maladie du Québec from January 2006 to October 2007 were used. Patients with epilepsy treated with topiramate were selected. An open-cohort design was used to classify the observation period into periods of brand, single-generic, and multiple-generic use. One-year generic-switch and switchback-to-brand rates were estimated using Kaplan-Meier methodology. Medical resource utilization and costs were compared among the three periods using multivariate regression analysis. RESULTS: In total, 948 patients were observed during 1,105 person-years of brand use, 233 person-years of single-generic use, and 92 person-years of multiple-generic use. A total of 23% of generic users received at least two different generic versions. Compared to brand use, multiple-generic use was associated with higher utilization of other prescription drugs (incidence rate ratio [IRR] = 1.27, 95% confidence interval [CI] = 1.24-1.31), higher hospitalization rates (0.48 vs 0.83 visit/person-year, IRR = 1.65, 95% CI = 1.28-2.13), and longer hospital stays (2.6 vs 3.9 days/person-year, IRR = 1.43, 95% CI = 1.27-1.60), but the effect was less pronounced in single-generic use (hospitalization: IRR = 1.08, 95% CI = 0.88-1.34, length of stay: IRR = 1.12, 95% CI = 1.03-1.23). The risk of head injury or fracture was nearly three times higher (hazard ratio = 2.84, 95% CI = 1.24-6.48) following a generic-to-generic switch compared to brand use. The total annualized health care cost per patient was higher in the multiple-generic than brand periods by C$1,716 (cost ratio = 1.21, p = 0.0420). CONCLUSION: Multiple-generic substitution of topiramate was significantly associated with negative outcomes, such as hospitalizations and injuries, and increased health care costs.