A generally applicable cost-effectiveness model for the evaluation of vaccines against cervical cancer

OBJECTIVE: This study aimed at evaluating the cost-effectiveness of human papillomavirus virus (HPV) vaccination in France, using a generally applicable succinct cohort model. METHODS: A lifetime Markov cohort model, adapted to the French setting, simulate the natural history of oncogenic HPV infection towards cervical cancer (CC). Additional modules account for the effects of screening and vaccination. The girls’ cohort is vaccinated at age 12 and follows current screening. Costs and outcomes (discounted at 3 and 1.5%, respectively) were compared with a cohort receiving screening alone. RESULTS: The model results agreed well with real-life data. Vaccination in addition to screening would substantially reduce the incidence of and mortality from CC, compared with screening alone, at an estimated cost-effectiveness of €9,706 per quality-adjusted-life-year. Sensitivity analysis showed that the discount rate and the parameters related to the disease history have the largest impact on the results. CONCLUSION: This succinct cohort model indicated that HPV vaccination would be a cost-effective policy option in France. It uses readily available data and should be generally applicable to the evaluation of HPV vaccination in a variety of countries and settings

Disability-adjusted life years lost due to diabetes in France, Italy, Germany, Spain, and the United Kingdom: a burden of illness study

To compare the burden of disease (BoD) attributable to diabetes expressed in disability-adjusted life years (DALYs) for five European countries in 2010

Intact Fish Skin Graft vs. Standard of Care in Patients with Neuroischaemic Diabetic Foot Ulcers (KereFish Study) : An International, Multicentre, Double-Blind, Randomised, Controlled Trial Study Design and Rationale

Publisher Copyright: © 2022 by the authors.Background: Cell and/or tissue-based wound care products have slowly advanced in the treatment of non-healing ulcers, however, few studies have evaluated the effectiveness of these devices in the management of severe diabetic foot ulcers. Method: This study (KereFish) is part of a multi-national, multi-centre, randomised, controlled clinical investigation (Odin) with patients suffering from deep diabetic wounds, allowing peripheral artery disease as evaluated by an ankle brachial index equal or higher than 0.6. The study has parallel treatment groups: Group 1 treatment with Kerecis® Omega3 Wound™ versus Group 2 treatment with standard of care. The primary objective is to test the hypothesis that a larger number of severe diabetic ulcers and amputation wounds, including those with moderate arterial disease, will heal in 16 weeks when treated with Kerecis® Omega3 Wound™ than with standard of care. Conclusion: This study has received the ethics committee approval of each participating country. Inclusion of participants began in March 2020 and ended in July 2022. The first results will be presented in March 2023. The study is registered in ClinicalTrials.gov as Identifier: NCT04537520.Peer reviewe

Characteristics of patients with type 2 diabetes mellitus newly treated with GLP-1 receptor agonists (CHADIG Study): a cross-sectional multicentre study in Spain

Objective: Several glucagon-like peptide-1 (GLP-1) receptor agonists (GLP-1Ra) have been made recently available in Spain for type 2 diabetes mellitus (DM2) treatment. There are no published data on the clinical and sociodemographic profile of patients initiating treatment with GLP-1Ra in Spain. Our objective was to understand these patients' characteristics in a real-world clinical practice setting. Design: Cross-sectional observational study. Setting: Spanish specialist outpatient clinics. Participants: 403 adults with DM2 initiating GLP-1Ra treatment were included. Primary and secondary outcome measures: Sociodemographic and DM2-related clinical data, including treatment at and after GLP-1Ra initiation and comorbidities, were collected. Results: Evaluable patients (n=403; 50.9% female) were included ( July 2013 to March 2014) at 24 centres by 53 specialists (47 endocrinology, 6 internal medicine), with the following profile (value±SD): age (58.3±10.4 years), diabetes duration (9.9±7 years), body mass index (BMI; 36.2±5.5) and glycated haemoglobin (HbA1c; 8.4±1.4%); 14% had HbA1c≤7%. Previous antidiabetic treatment: 53.8% only oral antidiabetic drugs (OADs), 5.2% insulin and 40% insulin and OAD; of those receiving OAD, 35% single drug, 38.2% 2 drugs and 24% 3 drugs. Concomitant to GLP-1Ra, 55.3% were only on OAD, 36.2% on insulin and OAD, and 7.2% only on insulin. Of those receiving OAD, the GLP-1Ra was mainly associated with 1 drug (65%) or 2 drugs (31.8%). GLP-1Ra are frequently added to existing antidiabetic drugs, with dipeptidyl peptidase-4 inhibitors being the OAD most frequently switched (45% receiving 1 before starting GLP-1Ra, only 2.7% receiving it concomitantly). Conclusions: In Spain, GLP-1Ra therapy is usually started in combination with OADs or OADs and insulin. These drugs are used in relatively young patients often not reaching therapeutic goals with other treatment combinations, roughly a decade after diagnosis and with a relatively high BMI. The latter could be explaine

L’évaluation économique dans le champ de la santé

Contrairement aux choix effectués dans d’autres pays, ce n’est que récemment que l’évaluation des actions de santé a intégré une dimension économique de manière explicite en France. Il existe pourtant depuis toujours des limites dans les ressources que l’on accepte de consacrer collectivement à la santé. Une évaluation économique comparative est dès lors indispensable pour orienter les choix de santé et contribuer à la régulation des prix. Les méthodologies reposent sur l’estimation de ratios différentiels coût/résultats comparés à une référence. L’interprétation de ces ratios n’est jamais isolée du contexte de la décision. L’évaluation économique en santé ne participe pas du rationnement des soins, mais elle contribue à la rationalité des décisions dans l’intérêt de tous

Economic Evaluation of Enoxaparin Sodium versus Heparin in Unstable Angina: A French Sub-Study of the ESSENCE Trial

Objectives: To perform an evaluation from the societal perspective of the cost of treatment with enoxaparin sodium versus unfractionated heparin (UFH) in patients with unstable angina and non-Q wave myocardial infarction in France. Design: Four complementary cost-minimisation analyses based on the results of the Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q wave Coronary Events (ESSENCE) international trial were conducted. We assessed differences in medical resource consumption and in duration of hospital stay in the whole study population (n = 3171) and for the French patients (n = 133). Results: Results were consistent for the study group as a whole and for the French subgroup. Among patients treated with enoxaparin sodium, there was a statistically significant reduction in the use of angiography and percutaneous transluminal coronary angioplasty (whole group study: p = 0.024 and 0.006, respectively) and a trend towards shorter lengths of hospital stay. The differences in angiography and angioplasty rates led to estimated average net cost savings with enoxaparin sodium of French Francs (FF)1555 per treated patient (whole study population) and FF9993 (French subgroup) [1996 values]. The analyses based on the duration of hospital stay resulted in estimated net cost savings with enoxaparin sodium of between FF1014 per treated patient (whole study population) and FF2804 (French subgroup). Conclusion: Our study confirmed earlier results which show that enoxaparin sodium is cost saving in the treatment of unstable angina.Anticoagulants, Cost analysis, Enoxaparin sodium, Heparin, Pharmacoeconomics, Unstable angina pectoris

Cost Effectiveness of a Low-Molecular-Weight Heparin in Prolonged Prophylaxis Against Deep Vein Thrombosis After Total Hip Replacement

The risk of late-occurring deep vein thrombosis and pulmonary embolism after total hip replacement persists for at least 3 weeks after hospital discharge. Recent clinical trials have demonstrated that prolonged prophylaxis with enoxaparin, a low-molecular-weight heparin (LMWH), significantly reduces this risk. We used a decision-analysis model to determine the incremental outcomes associated with the routine use of such prophylaxis, administered during hospitalisation for total hip replacement and for 3 weeks after discharge, instead of short term prophylaxis administered only during hospitalisation. For a hypothetical cohort of 100 000 patients undergoing hip surgery, prolonged LMWH prophylaxis saved between 601 and 783 additional lives compared with prophylaxis stopped at discharge. This was obtained at a net direct marginal cost ranging from 1118 to 1300 French francs (F) per patient. The cost-effectiveness ratio ranged from F11 158 to F34 591 per life-year saved and from F23 532 to F35 268 per venous thromboembolic event (routinely diagnosed and treated) avoided. Prolonged LMWH anticoagulant prophylaxis with enoxaparin is more effective in routine practice after elective hip surgery than conventional short term perioperative prophylaxis in terms of the number of deaths or thromboembolic events avoided. Such prophylaxis also appears to be clearly cost effective, using French cost data.Pharmacoeconomics, Deep-vein-thrombosis, Pulmonary-embolism, Cost-effectiveness, Enoxaparin-sodium, Hospitalisation, Hip-surgery, Low-molecular-weight-heparins

Cost-effectiveness analysis of vaccination against rotavirus with RIX4414 in France.

International audienceBACKGROUND: It is estimated that annually 300 000 cases of rotavirus-induced gastroenteritis (RVGE) occur in children aged up to 5 years in France. A two-dose vaccine against rotavirus infection (RIX4414; Rotarix, GlaxoSmithKline), has been shown to be highly effective against severe RVGE. OBJECTIVE: This study evaluated the cost effectiveness of general vaccination against rotavirus using RIX4414 in France. METHODS: A Markov model simulated RVGE events and the associated outcomes and costs relating to general vaccination of infants against rotavirus infection using RIX4414 (Rotarix) in a birth cohort of children aged up to 5 years in France with a combined adjustment for age distribution with the seasonality of the infection. Costs and outcomes were estimated from a limited societal perspective, including direct medical costs paid out of pocket or by third-party payers, as well as the proportion of direct medical costs reimbursed by the health authorities. Indirect costs were not included in the base-case analysis. The primary outcome measure was the incremental cost per QALY. RESULTS: Vaccination with RIX4414 incurred an incremental cost of 44 583 Euro per QALY at a public price of 57 Euro per vaccine dose. Univariate sensitivity analyses showed that the parameters with the largest influence on the results were the transition probabilities of severe diarrhoea, seeking medical advice and emergency visits, utility scores of diarrhoea (mild) in children and infants, and the discount rate for benefits. Probabilistic multivariate sensitivity analysis confirmed these results. The acceptability curve indicated that 94% of the results were under an informal threshold of 50 000 Euro per QALY. Comparing our results with those of a recently published study using pooled data for two rotavirus vaccine products in France, the main differences are explained by differences in model structure and in data input values. They include a different age distribution of the infection, shorter duration of the at-risk period (3 years instead of 5 years), different vaccine efficacy, different unit cost data, different disease duration, and different disutility values for the health states in the model. There is a need for agreed standards to improve comparability of results from different studies. CONCLUSIONS: The results demonstrate that a generalized vaccination strategy with RIX4414 would be cost effective in France from a limited societal perspective, depending on the baseline assumptions for disease progression and on utility scores selected

Design

prototyping and control of an active orthosis for the rehabilitation of the elbow articular comple