Cost-effectiveness analysis and budget impact of rivaroxaban compared with dalteparin in patients with cancer at risk of recurrent venous thromboembolism.

OBJECTIVES: In the 'Comparison of an Oral Factor Xa Inhibitor With Low Molecular Weight Heparin in Patients With Cancer With Venous Thromboembolism' (SELECT-D) trial, rivaroxaban showed relatively low venous thromboembolism (VTE) recurrence but higher bleeding compared with dalteparin in patients with cancer. We aim to calculate the cost-effectiveness and budget impact of rivaroxaban compared with dalteparin in patients with cancer at risk of recurrent VTE. SETTING: We built a Markov model to calculate the cost-effectiveness from a societal perspective over a 5-year time horizon for the Dutch healthcare setting. PARTICIPANTS: A hypothetical cohort of 1000 cancer patients with VTE entered the model with baseline characteristics based on the SELECT-D trial. INTERVENTION: Six months of treatment with rivaroxaban (15 mg two times per day for first 3 weeks followed by 20 mg once daily) was compared with 6 months of treatment with dalteparin (200 IU/kg daily during month 1 followed by 150 IU/kg daily). PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome of the cost-effectiveness analysis was the incremental cost-effectiveness ratio (ICER). The robustness of the model was evaluated in probabilistic and univariate sensitivity analyses. A budget impact analysis was performed to calculate the total annual financial consequences for a societal perspective in the Netherlands. RESULTS: In the base case and all scenarios, rivaroxaban were cost-saving while also slightly improving the patient's health, resulting in economically dominant ICERs. In the probabilistic sensitivity analysis, 77.8% and 98.7% of the simulations showed rivaroxaban to be cost-saving and more effective for a 5-year and 6-month time horizon, respectively. Rivaroxaban can save up to €11 326 763 (CI €5 164 254 to €17 363 231) in approximately 8000 cancer patients with VTE per year compared with dalteparin based on a 1-year time horizon. CONCLUSIONS: Treatment with rivaroxaban is economically dominant over dalteparin in patients with cancer at risk for recurrent VTE in the Netherlands. The use of rivaroxaban instead of dalteparin can save over €10 million per year, primarily driven by the difference in drug costs.

Within-Gender Changes in HIV Prevalence among Adults between 2005/6 and 2010/11 in Zimbabwe.

INTRODUCTION: Zimbabwe has reported significant declines in HIV prevalence between 2005/06 and 2010/11 Demography and Health Surveys; a within-gender analysis to identify the magnitude and factors associated with this change, which can be masked, is critical for targeting interventions. METHODS: We analyzed change in HIV prevalence for 6,947 women and 5,848 men in the 2005/06 survey and 7,313 women and 6,250 men in 2010/11 surveys using 2005/06 as referent. The data was analyzed taking into consideration the survey design and therefore the svy, mean command in Stata was used in both linear and logistic regression. RESULTS: There were similar proportional declines in prevalence at national level for males (15% p=0.011) and females (16%,p=0.008). However, there were variations in decline by provincial setting, demographic variables of age, educational level and some sexual risk behaviours. In logistic regression analysis, statistically significant declines were observed among men in Manicaland, Mashonaland East and Harare (p<0.01) and for women in Manicaland, Mashonaland Central and Harare (p<0.01). Although not statistically significant, numerical increases were observed among men in Matebeleland North, Matebeleland South, Midlands and for both men and women in Bulawayo. Young women in the age range 15-34 experienced a decline in prevalence (p<0.01) while older men 30-44 had a statistically significant decline (p<0.01). Having a secondary and above education, regardless of employment status for both men and women recorded a significant decline. For sexual risk behaviours, currently in union for men and women and not in union for women there was a significant decline in prevalence. CONCLUSION: Zimbabwe has reported a significant decline among both men and women but there are important differentials across provinces, demographic characteristics and sexual risk behaviours that suggest that the epidemic in Zimbabwe is heterogeneous and therefore interventions must be targeted in order to achieve epidemic control.

Direct treatment comparison of DAbigatran and RIvaroxaban versus NAdroparin in the prevention of venous thromboembolism after total knee arthroplasty surgery: design of a randomised pilot study (DARINA).

INTRODUCTION: Two novel agents, dabigatran and rivaroxaban, recently gained market authorisation for prevention of venous thromboembolism (VTE) after hip and knee arthroplasty. However, safety data of the new oral anticoagulants with a long-term use of 42 days are not available for total knee arthroplasty (TKA). Furthermore, there are no clinical trials comparing dabigatran and/or rivaroxaban with nadroparin, which is used in most Dutch departments of orthopaedic surgery. Our aim is to compare the 42-day use of dabigatran and rivaroxaban versus nadroparin after TKA in a clinical explorative pilot study by assessing the incidence of major bleeding and clinically relevant non-major bleeding using a standardised model of bleeding definitions. METHODS AND ANALYSIS: A randomised open-label pilot study was conducted. Patients ≥18 years and weighing more than 40 kg who were scheduled for a primary elective TKA were included. Patients were randomly assigned to three groups. Patients took either a daily oral dose of dabigatran etexilate 220 mg (n=50), 10 mg of oral rivaroxaban (n=50) or subcutaneous nadroparin 0.3 ml (n=50) for 42 days. The primary safety outcome measure was the incidence of bleeding events. Major bleeding events and clinically relevant non-major bleeding events were defined according to accepted guidelines. The secondary measures of this study were the occurrence of VTE, time until the bleeding event, compliance, duration of hospital stay, rehospitalisation, outpatient clinic visits and interventions following complications. Additionally, coagulation monitoring, knee flexion range of motion and Knee injury and Osteoarthritis Outcome Score were evaluated. DISSEMINATION: The results of this trial provided insight into the validity of design for an adequately powered multicentre study investigating the safety of the new oral anticoagulants compared with nadroparin, an anticoagulant applied for prevention of VTE after knee arthroplasty in the Dutch situation. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT01431456.