Pierre Levy

Venous thromboembolism (VTE, including deep vein thrombosis [DVT] and pulmonary embolism [PE]) has an annual incidence rate of 104–183 per 100,000 person-years. After a VTE episode, the two-year recurrence rate is about 17%. Consequently, effective and safe anticoagulation is paramount. Edoxaban is a direct oral anticoagulant (DOAC) approved VTE treatment. Current safety and efficacy data are derived from clinical trials, and information about treatment durations beyond 12 months are not available. ETNA-VTE-Europe is an 18-month prospective, single-arm, non-interventional, multinational post-authorisation safety study. Approximately 310 sites across eight European countries (Austria, Belgium, Germany, Ireland, Italy, the Netherlands, Switzerland and the United Kingdom) will participate in the study, with the intention to represent the regional distributions of centres, healthcare settings and specialties. An estimated cohort of 2700 patients will be recruited, the only enrolment criteria being acute symptomatic VTE, no participation in an interventional study, and treating physician decision to prescribe edoxaban independently from the registry. Data from patient medical records and/or telephone interviews will be collected at baseline, 1, 3, 6, 12 and 18 months. The primary objective is to evaluate the 18-month rate of symptomatic VTE recurrence in patients with VTE treated with edoxaban outside a clinical trial. The co-primary objective is to evaluate the real-world rates of bleeding and adverse drug reactions. Secondary outcomes include rates of other patient-relevant safety events, adherence to and discontinuation of edoxaban. Furthermore, 12-month ETNA-VTE-Europe data will be considered in the context of those for patients receiving different anticoagulants in the PREFER in VTE registry and Hokusai-VTE clinical trial. ETNA-VTE-Europe will allow the safety and effectiveness of edoxaban to be evaluated over an extended period in acute symptomatic VTE patients encountered in routine clinical practice. Findings will be informative for European practitioners prescribing edoxaban as part of real-world VTE treatment/prevention. ClinicalTrials.gov Identifier: NCT02943993 .

This study was carried out at district level to describe the cost structure and measure the effectiveness of delivering supplementary immunization activity (SIA) and routine immunization (RI) for measles in Benin, a country heavily affected by this disease. This cost-effectiveness study was cross sectional and considered 1-year time horizon. RI consists to vaccinate an annual cohort of children aged 0–1 year old and SIA consists to provide a second dose of measles vaccine to children aged 0–5 years old in order to reach both those who did not seroconvert and who were not vaccinated through RI. Ingredients approach to costing was used. Effectiveness indicators included measles vaccine doses used, vaccinated children, measles cases averted and disability adjusted life years averted. Data were collected from all the 18 health care centers of the health district of Natitingou for the year 2011. In the analysis, the coverage was 89 % for RI and 104 % for SIA. SIA total cost was higher than RI total cost (15,796,560 FCFA versus 9,851,938 FCFA). Personnel and vaccines were the most important cost components for the two strategies. Fuel for cold chain took a non-negligible part of RI total cost (4.03 %) because 83 % of refrigerators were working with kerosene. Cost structures were disproportionate as social mobilization and trainings were not financed during RI contrarily to SIA. In comparison with no intervention, the two strategies combined permitted to avoid 12,671 measles cases or 19,023 DALYs. The benefit of SIA was 5601 measles cases averted and 6955 additional DALYs averted. Cost per vaccinated child for SIA (442 FCFA) was lower than for RI (1242 FCFA), in line with previous data from the literature. Cost per DALY averted was 2271 FCFA (4.73 USD) for SIA and 769 FCFA (1.60 USD) for RI. Analysis showed that low vaccine efficacy decreased the cost-effectiveness ratios for the two strategies. SIA was more cost-effective when the proportion of previously unvaccinated children was higher. For the two strategies, costs per DALY were more likely to vary with measles case fatality ratio. SIA is costlier than RI. Both SIA and RI for measles are cost-effective interventions to improve health in Benin compared to no vaccination. Policy makers could make RI more efficient if sufficient funds were allocated to communications activities and to staff motivation (trainings, salaries).

The Expanded Program of Immunization (EPI) offers services to the population free of charge but these activities are costly with the greatest part being the cost of vaccines. In spite of the growing international solidarity towards funding for immunization, the growing objectives continue to outweigh the available resources. It is therefore crucial for any immunization system to seek greater efficiency so as to optimize the use of available means in a bid to ensure sustainability. It is in this light that we carried out this study which aims to assess the productive efficiency of routine EPI for children aged 0 - 11 months with respect to the fixed and outreach vaccine delivery strategies in Ngong health district. The study is descriptive and cross-sectional. Data were collected retrospectively for all 16 health centers of the district that offered EPI services during the period February - May 2009.