Risk of hepatotoxicity-related hospitalizations among patients treated with opioid/acetaminophen combination prescription pain medications.

OBJECTIVE: This study determined the risk of serious hepatotoxicity resulting in hospitalizations among patients prescribed opioid/acetaminophen combinations. METHODS: A retrospective cohort study using an insurance claims database was conducted. Adult patients with ≥1 claim for oxycodone/acetaminophen or hydrocodone/acetaminophen combinations were included (N = 1,228,356). A pre-post design was employed to compare serious hepatotoxicity risk before versus after initiation of opioid/acetaminophen combination. Serious hepatotoxicity risk between the opioid/acetaminophen group and a control group of opioid-alone users (N = 11,809) was also examined. Within the opioid/acetaminophen group, risk of hepatotoxicity-related hospitalizations pre- versus post-opioid/acetaminophen treatment was compared using the normal approximation with the binomial distribution. The incidence rate of hepatotoxicity-related hospitalizations for the opioid/acetaminophen group was compared with the opioid-alone group using multivariate Poisson regression adjusting for baseline differences between groups. RESULTS: Of the opioid/acetaminophen cohort, hepatotoxicity-related hospitalization risk in the 6-month post-opioid/acetaminophen period was lower than that in the pre-period with a risk reduction of 1.2 per 10,000 (pre-period = 0.12%; 95% confidence interval [CI], 0.12 to 0.13; post-period = 0.11%; 95% CI, 0.11 to 0.12). In the 12-month period, risk increased in the post-period by 2.4 per 10,000 (pre-period = 0.14%; 95% CI, 0.14 to 0.15; post-period = 0.17%; 95% CI, 0.16 to 0.18). After adjusting for confounders, the opioid-alone group did not demonstrate a lower rate of hepatotoxicity-related hospitalizations than the opioid/acetaminophen group (incidence rate ratio of opioid-alone over opioid/acetaminophen = 2.9; 95% CI, 1.8 to 4.7). CONCLUSIONS: There is no population data-based evidence supporting elevated risk of hepatotoxicity-related hospitalization associated with opioid/acetaminophen combinations.

Treatment of transfusional iron overload in patients with myelodysplastic syndrome or severe anemia: data from multicenter clinical practices.

BACKGROUND: Patients with myelodysplastic syndrome (MDS) or severe anemia requiring repeated red blood cell (RBC) transfusions risk developing transfusional iron overload, which can reduce survival. Iron chelation therapy (ICT) has been shown to improve survival and quality of life in patients; however, ICT utilization in clinical practices is not well understood. STUDY DESIGN AND METHODS: Medical records of patients diagnosed with MDS or severe anemia at least 6 months before data extraction, aged at least 21 years at diagnosis, and who received at least one RBC transfusion were reviewed. ICT eligibility was defined as at least 20 units of RBCs transfused or at least two serum ferritin levels exceeding 1000 microg/L. Study endpoint was ICT treatment rate among ICT-eligible patients with lower-risk MDS (International Prognostic Scoring System [low or intermediate-1]; World Health Organization [refractory anemia {RA}, refractory anemia with ringed sideroblasts {RARS}, refractory cytopenia with multilineage dysplasia {RCMD}, refractory cytopenia with multilineage dysplasia and ringed sideroblasts, or 5q]; French-American-British [RA/RARS]). RESULTS: Among 78 ICT-eligible patients with lower-risk MDS, 32 (41%) received ICT. At ICT initiation, treated patients received on average 13.3 transfusions (27.6 units) and mean first post-ICT initiation serum ferritin was twice the MDS Foundation recommendation at 1949 microg/L. Median overall survival for all ICT-eligible patients was significantly longer for those ICT-treated patients than untreated patients (8.7 years vs. 4.7 years, log-rank p = 0.02; multivariate hazard ratio 0.372, p = 0.03). CONCLUSION: This study finds only 41% of ICT-eligible patients with lower-risk MDS received ICT in clinical practice, and treatment was initiated later than recommended. Receipt of ICT was associated with significantly longer survival.

Cost implications of IV versus oral anti-angiogenesis therapies in patients with advanced renal cell carcinoma: retrospective claims database analysis.

OBJECTIVE: Angiogenesis inhibitors (AI) are promising novel treatments for patients with renal cell carcinoma (RCC). However, IV therapy may impose infection risk from IV catheters, and will include increased costs due to administration and transportation costs. This study evaluated the incremental costs associated with IV administration of selected AI therapies (bevacizumab off-label) compared to oral therapies (sunitinib or sorafenib) for the treatment of RCC. METHODS: Patients with > or =2 RCC claims (ICD-9: 189.0, 198.0) were identified from a US commercial health insurance claims database from 1/2004 to 12/2007. Patients receiving bevacizumab (n = 109) were matched 1:1 to patients receiving sorafenib or sunitinib, and observed from their first AI therapy claim until the last treatment date. AI, inpatient, outpatient and pharmacy costs were calculated on a per-patient per-month (PPPM) basis over the treatment period. Costs were compared between the IV AI group and each separate oral AI group using multivariate Tobit regressions for each category separately, adjusting for demographic and baseline clinical characteristics. This study assessed costs of treatment and did not evaluate the cost-effectiveness of AIs. RESULTS: Mean total medical costs were $13,351, $6998, and $8213 PPPM for bevacizumab, sorafenib, and sunitinib, respectively (p <0.05 for equality). Adjusted incremental total cost for the bevacizumab group was $4951 PPPM compared to sorafenib and $4610 PPPM compared to sunitinib (both p < 0.05). Bevacizumab patients incurred incremental PPPM outpatient services cost compared to sorafenib and sunitinib of $2772 and $2548, respectively (both p < 0.05). CONCLUSIONS: Assuming median progression-free survival of 8.5 months as shown for bevacizumab (Bukowski, et al., J Clin Oncol 2007), the incremental costs would be estimated at $39 188-42 080 per patient compared to those treated with sunitinib or sorafenib. Assuming similar efficacies, oral AI therapies may result in cost savings to patients and healthcare payers over IV therapies.

Economic consequences of not recognizing bipolar disorder patients: a cross-sectional descriptive analysis.

BACKGROUND: This retrospective study compared treatment patterns and costs for patients with recognized and unrecognized bipolar disorder with those of depressed patients without a bipolar disorder claim. METHOD: Claims data for 7 large national employers covering 585,584 persons aged less than 65 years were used to identify patients diagnosed with depression and initially treated with antidepressants. Data on employees, as well as spouses and dependents, for the period 1998 to mid-2001 were used. Patients were identified as bipolar based on the criteria of a bipolar diagnosis claim (ICD-9 codes: 296.0, 296.1, 296.4-296.8) and/or a mood stabilizer prescription claim. Of the patients identified as bipolar, unrecognized bipolar disorder (unrecognized-BP) patients met the criteria after antidepressant initiation, while recognized bipolar disorder (recognized-BP) patients met the criteria at or before initiation. The remaining patients in the sample were non-bipolar depressed (non-BP) patients. Outcome measures included treatment patterns and monthly medical costs in the 12 months subsequent to initiation of antidepressant treatment. RESULTS: Of the 9009 patients treated for depression with antidepressants, there were 8383 non-BP patients (93.1%), 293 recognized-BP patients (3.3%), and 333 unrecognized-BP patients (3.7%). Use of combination therapies varied among the non-BP (11%), unrecognized-BP (32%), and recognized-BP patients (44%) (all pairwise p <.01). Use of mood stabilizers was less frequent among unrecognized-BP patients (14%) than recognized-BP patients (34%) (p <.0001). Unrecognized-BP patients incurred significantly greater (p <.05) mean monthly medical costs ($1179 US dollars) in the 12 months following initiation of antidepressant treatment compared with recognized-BP patients ($801 US dollars) and non-BP patients ($585 US dollars). Monthly indirect costs were significantly greater (p <.05) for unrecognized-BP ($570 US dollars) and recognized-BP ($514 US dollars) employees compared with non-BP employees ($335 US dollars) in the 12 months following antidepressant initiation. CONCLUSIONS: Patterns of medication treatment for bipolar disorder were suboptimal. Accurate and timely recognition of bipolar disease was associated with lower medical costs and lower indirect costs due to work loss.