Bm Donato

Chemotherapy Use, Outcomes, and Costs for Older Persons With Advanced Non-Small-Cell Lung Cancer: Evidence From Surveillance, Epidemiology and End Results-Medicare

PURPOSE There is limited published documentation regarding US community patterns of care for older patients with advanced non-small-cell lung cancer (NSCLC). Using the Surveillance, Epidemiology and End Results (SEER)-Medicare database, we examined community treatment patterns for advanced NSCLC, focusing on chemotherapy. METHODS Patients with locally advanced or metastatic (TNM system stages IIIb and IV) NSCLC diagnosed between January 1, 1994, and December 31, 1999, were stratified based on chemotherapy agents received during the first 3 months following diagnosis. Cox proportional hazards models were used to compare survival, controlling for age, sex, race, noncancer comorbidity, stage at diagnosis, SEER region, and receipt of cancer-related surgery or radiation therapy in the first 3 months following diagnosis. Lifetime medical costs were calculated for each group. RESULTS 14,875 patients met inclusion criteria: 7,411 (49.8%) stage III and 7,464 (50.2%) stage IV at diagnosis. Thirty-one percent received chemotherapy, 8% received surgery, and 53% received radiation therapy either as initial or adjuvant treatment. Persons > or = 75 years of age, females, African Americans, and those with more than one comorbidity were significantly less likely to receive chemotherapy (P < .01). Survival was inferior for those who did not receive a platinum-containing agent (P < .01). Lifetime costs were highest for those receiving platinum + taxane combinations, exceeding other regimens by more than

Patterns of use of systemic chemotherapy for Medicare beneficiaries with urothelial bladder cancer

10,000 USD per patient. CONCLUSION Chemotherapy prolongs survival in community settings, but is underutilized for persons with advanced NSCLC. Reasons for lower use in minorities and variation across regions deserve further study.

Indirect comparison of the efficacy of cetuximab and cisplatin in squamous cell carcinoma of the head and neck

OBJECTIVES Examine the association between clinical, demographic, and socioeconomic factors and the receipt of systemic chemotherapy for bladder cancer. Examine factors influencing the use of combination chemotherapy plus cystectomy and use of specific chemotherapy drugs over time for bladder cancer. MATERIALS AND METHODS Data from the SEER-Medicare database were analyzed for patients diagnosed with urothelial carcinoma of the bladder between 1992 and 2002. Cox proportional hazards regression analyses were used to assess differences in use of systemic chemotherapy based on demographic and clinical factors, site of care, and year of diagnosis. We assessed the proportion of patients who received chemotherapy in the adjuvant and neoadjuvant settings as well as use of chemotherapy in the monotherapy setting. We estimated the proportion of claims made for several commonly used chemotherapy agents in the outpatient setting by year. RESULTS During follow-up, 13%, 28%, 37%, and 57% of patients with stages 1 through 4, respectively, received systemic chemotherapy for bladder cancer. Chemotherapy use in the neoadjuvant or adjuvant settings within 6 months of diagnosis was not commonly found. Neoadjuvant chemotherapy was delivered to 1.4% of stage 2 patients and 11% of stage 4 patients. In 2003, the most frequent claims for intravenous chemotherapy were for gemcitabine, carboplatin, and placlitaxel. CONCLUSIONS Chemotherapy was not generally used as recommended for persons with invasive bladder cancer in this patient population. Studies to clarify potential underutilization and variation in patterns of administration are warranted.

Status Update of the Reimbursement Review Environment in the Public Sector across Four Latin American Countries

Abstract Background: Cetuximab (Erbitux *Erbitux is a registered trade name of Bristol–Myers Squibb, Princeton, NJ, USA.) is the only new medical therapy for locally and regionally advanced SCCHN to be licensed in industrialized countries in the past 15 years and presents an alternative to cisplatin which is the current therapeutic standard. In the absence of a published head-to-head trial, we estimated the relative benefit of cetuximab and cisplatin using an indirect comparison methodology. Methods: We performed a systematic review of the Medline and Embase databases between 1998 and 2008 to find published trials of cisplatin plus radiotherapy vs. radiotherapy alone and synthesized the information with meta-analysis. Those results were combined with trial-based results of cetuximab plus radiotherapy vs. radiotherapy alone. Inclusion criteria stipulated that cisplatin be administered concurrently with radiation, the radiation protocol be comparable to the registration trial for cisplatin (once-daily, twice-daily, or concomitant boost) and cisplatin dosing be comparable to that in common use (i.e. day 1, 22 and 43 of treatment). Endpoints were locoregional control and overall survival. Two reviewers examined 269 abstracts which yielded four trials meeting the inclusion criteria. Results: There was little evidence of superiority of either platinum-based radiotherapy or cetuximab-based radiotherapy. All estimated hazard ratios were near 1.0 (equivalence), all confidence intervals spanned the null value (1.0), and no consistent pattern was observed regarding the direction of the effect. The results remained robust in sensitivity analysis. Conclusion: This is the first quantitative analysis allowing formal comparison between cetuximab and radiotherapy versus cisplatin and radiotherapy. Based on state-of-the-art methodology for indirect comparisons, it was not possible to identify either treatment regimen as superior in prolonging either locoregional control or overall survival. Until the publication of more studies, and particularly a head-to-head comparison, the two treatments may be considered equally efficacious when given alongside radiotherapy. The choice of treatment may focus on the toxicity profile of the medications.

Treatment patterns in patients with advanced breast cancer who were exposed to an anthracycline, a taxane, and capecitabine: A descriptive report

In Latin America, social security and public sectors represent the largest financiers and providers of health care. Many countries in the region have compulsory packages of basic health care benefits. As part of an effort to improve quality of care and access, several health technology assessment agencies, both governmental and academia, among a number of Latin American countries have been formally established in the past few years. Several Latin American countries have recently developed and published methodological guidelines in economic evaluation, indicating that there is a growing interest in evaluating health-related products, drugs, and technologies used by the population. Presentations on the health care system and the role of health technology assessment, pharmacoeconomics, and risk sharing policies, from the public sector perspective, in the Latin American countries Argentina, Brazil, Colombia, and Mexico were made at the 3rd Latin American ISPOR Conference held in Mexico City in 2011 and are discussed in this article. In conclusion, there is a clear need for Latin American countries to evaluate the value of new technologies that are being incorporated into their health care system. In addition, health technology assessment guidelines are important for their local needs in terms of regulation along with common country unions. In the future, the Latin American region needs to increase drug access along with implementing cost-containment measures to improve quality and health outcomes.

Estimated hospitalizations attributable to Diabetes Mellitus within the public healthcare system in Brazil from 2008 to 2010: study DIAPS 79

OBJECTIVE The aim of this work was to analyze chemotherapy treatment patterns in patients with advanced breast cancer who had been previously exposed to an anthracycline, a taxane, and capecitabine. METHODS This retrospective cohort study used medical and pharmacy administrative claims with health-plan enrollment data and medical-record review from a large, US-based health insurer database, the HealthCore Integrated Research Database. Women were included if they were aged > or =18 years at the initial breast cancer diagnosis between January 1999 and July 2005 and had received all 3 drug classes of interest, as well as an initial diagnosis of American Joint Committee on Cancer stage I to III breast cancer with metastatic recurrence or an initial diagnosis of stage IV disease. Information about demographics, clinical and pathologic characteristics, survival, and treatments were obtained from computerized data and medical record review. Descriptive analyses were conducted to characterize the treatment patterns. RESULTS One hundred forty-four women with advanced breast cancer were identified. Patients ranged in age from 28 to 76 years, with a mean (SD) age of 48.2 (9.1) years, and with 54 patients (37.5%) aged 40 to 49 years and 48 patients (33.3%) aged 50 to 59 years at the time of initial diagnosis. Ninety-three patients (64.6%) were white, 15 (10.4%) were black, 7 (4.9%) were Hispanic, and 4 (2.8%) were Asian. Overall, 89 patients (61.8%) received > or =1 additional chemotherapy regimen after exposure to all 3 chemotherapy agents of interest; 55 (38.2%) received > or =2 additional regimens. A variety of chemotherapeutic regimens were prescribed; 14 monotherapy regimens and 37 combination therapy regimens were used. The most common regimens (both as single agents and combination therapy) included gemcitabine, vinorelbine, or retreatment with a taxane. Of the 89 patients who received > or =1 retreatment, 7 (7.9%) were retreated with anthracycline, 12 (13.5%) with a taxane, and 9 (10.1%) with capecitabine. For first and second treatment after exposure to all 3 agents of interest, the most common single-agent regimens were gemcitabine (first: 17 patients [19.1%]; second: 9 patients [16.4%]) and vinorelbine (first: 14 patients [15.7%]; second: 9 patients [16.4%]). The most common combination therapies for first retreatment were carboplatin based (6 patients [6.7%]). CONCLUSIONS Of these patients with advanced breast cancer, 61.8% received > or =1 additional chemotherapy regimen after previous treatment with an anthracycline, a taxane, and capecitabine. The variety of agents prescribed suggests a lack of standard of care. Rigorous clinical effectiveness studies of common regimens in heavily pretreated and chemotherapy-resistant populations with breast cancer are warranted.

Estimation of the cost-effectiveness of apixaban versus vitamin K antagonists in the management of atrial fibrillation in Argentina

OBJECTIVE To estimate the number of hospitalizations attributable to diabetes mellitus (DM) and its complications within the public healthcare system in Brazil (SUS) and the mean cost paid per hospitalization. METHODS The official database from the Hospital Information System of the Unified Health System (SIH/SUS) was consulted from 2008 to 2010. The proportion of hospitalizations attributable to DM was estimated using attributable risk methodology. The mean cost per hospitalization corresponds to direct medical costs in nursing and intensive care, from the perspective of the SUS. RESULTS The proportion of hospitalizations attributable to DM accounted for 8.1% to 12.2% of total admissions in the period, varying according to use of maximum (self-reported with correction factor) or minimal (self-reported) DM prevalence. The hospitalization rate was 47 to 70.8 per 10.000 inhabitants per year. The mean cost per hospitalization varied from 1.302 Brazilian Reais (BRL) to 1,315 BRL. Assuming the maximum prevalence, hospitalizations were distributed as 10.3% as DM itself, 36.6% as chronic DM-associated complications and 53.1% as general medical conditions. Advancing age was accompanied by an increase in hospitalization rates and corresponding costs, and more pronounced in male patients. CONCLUSION The results express the importance of DM in terms of the use of health care resources and demonstrate that studies of hospitalizations with DM as a primary diagnosis are not sufficient to assess the magnitude of the impact of this disease.

Patterns of Care and Treatment Target Success among Persons with Type 2 Diabetes Mellitus in Dubai: A Retrospective Cohort Study

Apixaban, a novel oral anticoagulant which has been approved for the prevention of stroke and systemic embolism in non-valvular atrial fibrillation, reduces both ischemic and haemorrhagic stroke and produces fewer bleedings than vitamin K antagonist warfarin. These clinical results lead to a decrease in health care resource utilization and, therefore, have a positive impact on health economics of atrial fibrillation. The cost-effectiveness of apixaban has been assessed in a variety of clinical settings and countries. However, data from emergent markets, as is the case of Argentina, are still scarce.We performed a cost-effectiveness analysis of apixaban versus warfarin in non-valvular atrial fibrillation (NVAF) in patients suitable for oral anticoagulation in Argentina. A Markov-based model including both costs and effects were used to simulate a cohort of patients with NVAF. Local epidemiological, resource utilization and cost data were used and all inputs were validated by a Delphi Panel of local experts. We adopted the payer’s perspective with costs expressed in 2012 US Dollars.The study revealed that apixaban is cost-effective compared with warfarin using a willingness to pay threshold ranging from 1 to 3 per capita Gross Domestic Product (11558 – 34664 USD) with an incremental cost-effectiveness ratio of 786.08 USD per QALY gained. The benefit is primarily a result of the reduction in stroke and bleeding events.The study demonstrates that apixaban is a cost-effective alternative to warfarin in Argentina.

Quality of Care for Patients with Type 2 Diabetes Mellitus in Dubai: A HEDIS-Like Assessment

OBJECTIVES Despite the high prevalence of type 2 diabetes mellitus (T2DM), few data exist describing its management in Dubai. This study characterized the treatment and estimated levels of glycemic, lipid, and blood pressure control among a sample with T2DM at a large Dubai Hospital. METHODS This retrospective cohort study systematically sampled charts from adults seeking care for T2DM from October 2009 to March 2010 until the target (N = 250) was reached. Data on patient characteristics, pharmacotherapy, complications, and laboratory testing were abstracted until September 2011. The frequency of treatments and modifications over the period was calculated, and measures of glycosylated hemoglobin A1c, low-density lipoprotein, and blood pressure control were compared with guideline targets. Frequencies of complications were compared according to treatment type. RESULTS One-third of the cohort comprised men, and the mean age was 58 years. At enrolment, the mean time from T2DM diagnosis was nearly 15 years and 74% had received insulin. During the study period, the most common regimens were insulin + oral combinations (55%) and oral combination therapy (39%). Overall, 67% received any insulin therapy during the study; and by study end, 78% had received insulin at any time. At the most recent assessment, guideline targets for glycosylated hemoglobin A1c, blood pressure, and low-density lipoprotein were met by 23%, 29%, and 71%, respectively. Complications were more frequent among those treated with combination or insulin therapies. CONCLUSIONS This study provides baseline data from Dubai for future comparisons of the effectiveness of new treatments, and to better understand the humanistic and economic burden of T2DM and its complications.

The Relative Clinical and Economic Value of Ipilimumab in the Treatment of Metastatic Melanoma Versus Other Anti-Cancer Agents for Metastatic Diseases from a Brazilian Private Health Care System Perspective.

Objective. As little data are available on the quality of type 2 diabetes mellitus (T2DM) care in the Arabian Gulf States, we estimated the proportion of patients receiving recommended monitoring at the Dubai Hospital for T2DM over one year. Methods. Charts from 150 adults with T2DM were systematically sampled and quality of care was assessed during one calendar year, using a Healthcare Effectiveness Data and Information Set- (HEDIS-) like assessment. Screening for glycosylated haemoglobin (HbA1c), low-density lipoprotein (LDL), blood pressure, retinopathy, and nephropathy was considered. Patients were classified based on their most recent test in the period, and predictors of receiving quality care were examined. Results. Mean age was 58 years (standard deviation (SD): 12.4 years) and 33% were males. Over the year, 98% underwent HbA1c screening (50% had control and 28% displayed poor control); 91% underwent LDL screening (65% had control); 55% had blood pressure control; 30% had retinopathy screening; and 22% received attention for nephropathy. No individual characteristics examined predicted receiving quality care. Conclusion. Some guideline monitoring was conducted for most patients; and rates of monitoring for selected measures were comparable to benchmarks from the United States. Greater understanding of factors leading to high adherence would be useful for other areas of preventive care and other jurisdictions.