Amy Guo

Incidence and Clinical Complications of Myelodysplastic Syndromes Among United States Medicare Beneficiaries

PURPOSE To determine the incidence and complications of myelodysplastic syndromes (MDS) among Medicare beneficiaries. METHODS Retrospective review of 2003 Medicare Standard Analytic Files utilizing International Classification of Diseases for Oncology ninth edition CM code 238.7 to identify new MDS patients, with 3-year follow-up. RESULTS Among 1,394,343 individuals in Medicare Standard Analytic Files age > or = 65 years, 162 per 100,000 were coded as newly diagnosed MDS during 2003 yielding a calculated 45,000 new cases in the United States Medicare > or = 65 years population. Patients with MDS were older (median age, 77 years), and over-represented by males. Among patients with MDS diagnosed during first quarter of 2003, 73.2% suffered cardiac-related events during 3-year follow-up, which exceeded the Medicare population (54.5%; P < .01) even when age adjusted (odds ratio, 2.10; P < .01). Significant increases in prevalence of diabetes (40.0% v 33.1%), dyspnea (49.4% v 28.5%), hepatic diseases (0.8% v 0.2%), and infections (sepsis: 22.5% v 6.1%) were noted in MDS (all P < .01) compared with the Medicare population. Patients with MDS requiring RBC transfusions had greater prevalence of these comorbidities. Acute myeloid leukemia developed within 3 years in 9.6%, with increased transformation among transfused (24.6%; P < .001). The 3-year Kaplan-Meier age-adjusted survival for MDS was 60.0%, which was significantly lower than the Medicare population (84.7%; hazard ratio, 3.08; P < .001), and mortality was further increased among transfused MDS (P < .01). In 2003, median payment for MDS was

Healthcare resource utilization and costs associated with non-adherence to imatinib treatment in chronic myeloid leukemia patients

16,181, compared to

Retrospective real-world comparison of medical visits, costs, and adherence between nilotinib and dasatinib in chronic myeloid leukemia

1,575 for the Medicare population (P < .001). CONCLUSION MDS is a common hematologic malignancy of the elderly, which places patients at risk for comorbid conditions. Transfusion dependency identifies patients with MDS at additional increased risk of organ impairment and shortened survival.

Comparative efficacy of nilotinib and dasatinib in newly diagnosed chronic myeloid leukemia: a matching-adjusted indirect comparison of randomized trials.

Abstract Background: Patients with chronic myeloid leukemia (CML) who do not adhere to treatment may experience suboptimal outcomes. Objective: To examine the association between adherence with imatinib and direct healthcare costs and resource utilization in a large group of privately insured CML patients. Patients and methods: CML patients under age 65 were identified with ICD-9 code 205.1X using MarketScan Commercial Claims data between 1/1/02 and 7/31/08. Patients were required to be continuously enrolled in a private insurance plan during the baseline and study periods, defined respectively as the 4 months prior to and the 12 months following imatinib initiation. Non-adherence was evaluated by the medication possession ratio (MPR), defined as the fraction of days during the study period that patients had filled prescriptions for imatinib, and stratified into two groups (low MPR: <85%, high MPR: ≥85%). Costs, inpatient admissions, and hospital days were compared between high and low adherence groups using Wilcoxon tests. Regression models compared utilization and costs controlling for age, sex, CML severity, Charlson comorbidity index, baseline costs, and other factors. Results: The study sample consisted of 592 patients, where 242 (40.9%) patients were classified with a low MPR, while 350 (59.1%) had a high MPR. Mean MPR was 79% (95% confidence interval 76–81%). Patients with a low MPR incurred more all-cause inpatient visits (4.1 vs. 0.4; p < 0.001) and all-cause inpatient days (14.8 vs. 1.8; p < 0.001). Regression models demonstrated a 283% increase (US

Outcomes of resecting subependymal giant cell astrocytoma (SEGA) among patients with SEGA-related tuberous sclerosis complex: a national claims database analysis

56 324; p < 0.001) in non-imatinib costs within the low- vs. high-MPR group. The generalizability of this study is limited by the use of a privately insured population under 65 years of age as well as by the limitations common to claims data analyses. Conclusions: Imatinib adherence is an important issue for patients and physicians. Better imatinib adherence was associated with significantly lower resource utilization and costs in CML patients, as lower imatinib costs in low MPR patients were more than offset by higher non-imatinib costs mostly driven by inpatient services.

Economic impact on US Medicare of a new diagnosis of myelodysplastic syndromes and the incremental costs associated with blood transfusion need

Abstract Objective: To compare healthcare resource utilization, costs, and treatment adherence associated with dasatinib versus nilotinib treatment as second-line therapies in chronic myeloid leukemia (CML) patients. Methods: Two large retrospective claims databases (01/1999–06/2009) were combined to identify CML patients (ICD-9 code 205.1x) who received one or more prescriptions of dasatinib or nilotinib. Studied patients had continuous enrollment ≥1 month prior to and after the index date, defined as the first prescription for dasatinib or nilotinib. Patients were followed for up to 6 months from the index date to the earliest of the termination of healthcare plan enrollment or end of data availability. Patients with bone marrow or stem cell transplant during the study period were excluded. Poisson regression models were used to compare healthcare resource utilization between the two groups. Results were reported as incidence rate ratios (IRR). Healthcare cost differences were estimated for each cost component using generalized linear models or two-part models. Treatment adherence was measured by the proportion of days covered (PDC) and compared using generalized linear models. Multivariate regressions were used to control for potential confounding factors. Results: A total of 521 CML patients receiving second-line tyrosine kinase inhibitors (TKI) (452 dasatinib and 69 nilotinib) were studied. During the study period, dasatinib patients were estimated to have more than twice as many inpatient days (IRR = 2.44; p < 0.001) and nearly double the number of inpatient admissions (IRR = 1.99; p = 0.047) compared to nilotinib patients. Over the follow-up period, dasatinib patients incurred

Second-Line Treatment Outcomes After First-Line Sunitinib Therapy in Metastatic Renal Cell Carcinoma

8828 more in total medical service costs (p < 0.001); cost differences were mainly driven by an adjusted inpatient cost difference of

Persistence and compliance of deferoxamine versus deferasirox in Medicaid patients with sickle-cell disease

8520 (p = 0.003). Dasatinib patients were less adherent, with a PDC value approximately 13% lower compared to nilotinib patients (p = 0.009). Conclusions: Among CML patients treated with second-line TKIs, nilotinib patients were more adherent and experienced lower healthcare resource utilization, resulting in medical service cost savings compared to dasatinib patients.

Surgical resection of subependymal giant cell astrocytomas (SEGAs) and changes in SEGA-related conditions: a US national claims database study

Abstract Objective: Nilotinib and dasatinib have not been directly compared in a randomized trial for the treatment of newly diagnosed chronic myeloid leukemia in the chronic phase (CML-CP). The purpose of this study was to indirectly compare rates of major molecular response (MMR), progression-free survival (PFS) and overall survival by month 12 with nilotinib and dasatinib treatment of newly diagnosed CML-CP. Methods: Individual patient data from a randomized trial of nilotinib vs. imatinib (ENESTnd) and published summary data from a separate randomized trial of dasatinib vs. imatinib (DASISION) were utilized. A matching-adjusted indirect comparison was conducted by weighting individual patients treated with nilotinib to match baseline characteristics reported for dasatinib-treated patients, including age, gender, ECOG performance status and hematology lab values. After matching, efficacy outcomes were compared for patients treated with nilotinib 300 mg twice daily vs. dasatinib 100 mg once daily. Patients randomized to imatinib 400 mg once daily in each trial were used to assess the adequacy of the matching. Results: Before matching, patients randomized to nilotinib in ENESTnd (n = 273) were older, with a lower median platelet count and more favorable performance status compared to patients randomized to dasatinib in DASISION (n = 259). After matching, all baseline characteristics were balanced across treatment groups. Matched patients treated with nilotinib vs. dasatinib experienced significantly higher rates of MMR (56.8 vs. 45.9%, p = 0.014) and overall survival (99.5 vs. 97.3%, p = 0.046) and numerically higher rates of PFS (98.8 vs. 96.5%). Matched imatinib arms showed no statistically significant or clinically meaningful differences in these outcomes. Limitations: Baseline measures unavailable in one or both trials could not be matched. Adverse event rates were not formally compared across trials due to differences in reporting. Conclusion: Nilotinib was associated with significantly higher rates of MMR and overall survival compared with dasatinib by month 12 in the treatment of newly diagnosed CML-CP.

Effectiveness of aromatase inhibitors and tamoxifen in reducing subsequent breast cancer

Abstract Objective: To examine the outcomes following resection of subependymal giant cell astrocytoma (SEGA) among patients with SEGA-associated tuberous sclerosis complex (TSC). Methods: Using three large US national healthcare claims databases, we retrospectively examined the outcomes of SEGA surgery among TSC patients who underwent SEGA surgery between 2000 and 2009. The examined outcomes were: prevalence rates of post-surgery SEGA, repeated SEGA surgery, and postoperative complications (surgical procedure complications, nervous system complications, postoperative infections, complications of subdural empyemas, and complications of epidural abscesses). Descriptive data analysis and two-sided one sample t-test for mean or proportion were used to assess the characteristics of patients and the outcomes of SEGA surgery. Results: The selected patients (N = 47) had a mean age of 11.6 years at their first SEGA surgery and 66% were male. During the third through twelfth months following surgery, 34% had post-surgery SEGA (diagnosis) and 12% underwent repeated SEGA surgeries. During the first post-surgery year, 48.9% of patients developed postoperative complications (34.0% had complications relating to the surgical procedure, 12.8% had nervous system complications, 6.4% developed postoperative infections, 17.0% had complications of subdural empyemas, and 2.1% had complications of epidural abscesses). Conclusions: SEGA surgery was associated with statistically significant risks of developing post-surgery SEGA, requiring repeated SEGA surgery and developing postoperative complications. Future efforts in reducing these outcomes, either through improving surgical procedures or through alternative treatments, are urgently needed. Limitations: This study has its limitation in data source representativeness and measurement accuracy.