Lenalidomide performance in the real world: patterns of use and effectiveness in a Medicare population with myelodysplastic syndromes.

BACKGROUND: Lenalidomide is approved for the treatment of anemia with transfusion dependence (TD) in patients with lower-risk myelodysplastic syndrome (MDS) with 5q deletion (del5q-MDS), but its "real-life" use and effect on transfusion needs are unclear. In the current study, the authors examined its use in the Medicare population. METHODS: Patients with MDS who were enrolled in Medicare Parts A, B, and D were identified using International Classification of Diseases 9-Clinical Modification (ICD-9) codes from 100% Medicare claims from 2006 through 2008. Patients were followed until the end of the study or death. Claims were used to determine time to initiation of lenalidomide, daily dose, duration, and other MDS therapies. Transfusion status was defined each week based on transfusion use in rolling 8-week period: TD, required transfusions during 2 weeks, separated by ≥ 3 weeks; transfusion user (TU), 1 transfusion; and transfusion independence (TI), no transfusions. RESULTS: A total of 753 of 23,855 patients (3.2%) received lenalidomide, including 31% of 470 patients with del5q-MDS. At the time of lenalidomide initiation, 33% of patients were TD, 31% were TU, and 36% were TI. The median time to lenalidomide initiation was shorter for patients with del5q-MDS than for other lower-risk patients (8 weeks vs 20 weeks; P < .01). The percentage of patients with del5q-MDS receiving lenalidomide increased over time. Lenalidomide initiation was found to be negatively associated with older age and baseline diabetes, stroke, and renal disease. During the observation period, 44% of TU/TD patients (53% of the patients with del5q-MDS) achieved reductions in transfusion use; among TD patients receiving ≥ 3 cycles, 77% reduced their transfusion use and 40% achieved TI. CONCLUSIONS: To the authors' knowledge, the current study is the first report of lenalidomide use in a large Medicare-enrolled population with MDS. Reductions in transfusion rates were overall consistent with data from clinical trials. Response rates were higher when ≥ 3 lenalidomide cycles were received.

Prevalence of thyrotoxicosis, antithyroid medication use, and complications among pregnant women in the United States.

BACKGROUND: Population-based estimates of the prevalence of thyrotoxicosis (TTX), the frequency of antithyroid drug (ATD) use, and risk of adverse events in pregnant women and their infants are lacking. Therefore, our objective was to obtain epidemiologic estimates of these parameters within a large population-based sample of pregnant women with TTX. METHODS: A retrospective claims analysis was performed from the MarketScan Commercial Claims and Encounters health insurance database for the period 2005-2009. Women aged 15-44 years, enrolled for at least 2 years, and who had a pregnancy during the study period were included. Diagnosis of TTX was based on International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes using narrow (TTX-1=ICD 242.0) and broad (TTX-2=ICD 242.0 or 242.9) definitions. ATD use was based on prescriptions filled for propylthiouracil (PTU) or methimazole (MMI). Adverse events in mothers and infants were determined from the ICD-9-CM diagnosis codes recorded on submitted claims. RESULTS: The database contained 904,497 eligible women. The average yearly prevalence per 1000 pregnant women was 2.46 for TTX-1 and 5.88 for TTX-2. Thirty-nine percent used ATD at any time during the study period. Compared to women without a TTX diagnosis, there was more than a twofold increase for liver disease among women with TTX (odds ratio [OR]=2.08, p<0.001) and a 13% increased risk for congenital anomalies (OR=1.13, p=0.014), but no association was observed with ATD use. The rates of congenital defects (per 1000 infants) associated with ATD use were 55.6 for MMI, 72.1 for PTU, and 65.8 for untreated women with TTX, compared to 58.8 among women without TTX. CONCLUSIONS: There was some indication of an elevated risk of liver disease and congenital anomalies in women with TTX, but the risk did not appear to be related to the ATD use. There seems to be a higher pregnancy termination rate for women with TTX on MMI, which likely reflects elective pregnancy terminations.

Patient and physician characteristics associated with erythropoiesis-stimulating agent use in patients with myelodysplastic syndromes.

Patient and physician characteristics associated with use of erythropoiesis-stimulating agents in myelodysplastic syndrome patients have not yet been described. Myelodysplastic syndrome patients diagnosed from 2001 to 2005 were identified from the Surveillance Epidemiology and End Results-Medicare database. Multivariate regressions examined the association between patient and physician characteristics and the probability of receiving any erythropoiesis-stimulating agents, and of receiving therapeutic-length (≥ 8 week) treatment episodes. Among the 6,588 myelodysplastic syndrome patients studied, 65% received erythropoiesis-stimulating agents. Use of erythropoiesis-stimulating agents was lower for blacks compared to whites (OR 0.78; 95% CI:0.61-0.99), single persons compared to married (OR 0.77; 95% CI:0.62-0.97), Medicaid recipients (OR 0.66; 95% CI:0.55-0.79), and those living in census tracts with lower educational attainment. Patients who did not consult a hematology-oncology specialist were less likely to receive erythropoiesis-stimulating agents. Specialist access, financial resources and mobility are key determinants of receipt of erythropoiesis-stimulating agents among myelodysplastic syndrome patients.

Evaluation of a physician-focused educational intervention on medicaid children with asthma.

BACKGROUND: The 1990 Omnibus Budget Reconciliation Act mandated drug utilization review in response to inappropriate drug use. In the Pennsylvania Medicaid program, pediatric asthma is associated with high healthcare utilization and cost. OBJECTIVE: To determine the effects of a physician-focused educational intervention on asthma drug use and healthcare utilization. METHODS: Pre- and postintervention comparison design was used in children 5-18 years of age who were enrolled in the Pennsylvania Medicaid fee-for-service program from July 1, 1998, to March 31, 1999 (preintervention), and July 1, 1999, to March 31, 2000 (postintervention). The intervention packet included patients' drug profiles, medical history, monograph with national asthma management guidelines, and patient education materials to physicians. Main outcome measures are changes in asthma drug utilization among high-users of short-acting beta(2)-agonists (SAB). RESULTS: The intervention focused on 2 asthma drug use criteria: (1) high-use of quick-relief medication and (2) use of salmeterol without the availability of a quick-relief medication. The intervention reduced quick-relief medication use by 26% among patients with higher use without significant changes in long-term control drugs. In addition, 82% of the recipients evaluated had a positive change in salmeterol utilization as either having an SAB inhaler added after the intervention or salmeterol discontinued after the intervention. There was no significant change in asthma-related emergency department visits or hospitalizations. CONCLUSIONS: Although the physician responders agreed on the usefulness of the educational materials, the results suggest that the intervention had limited success in improving the pharmacologic management and no effect on the health outcomes. We believe that mailed educational materials to physicians can be effective to change prescribing behavior; however, a more multifaceted intervention may be necessary to improve health outcomes.