The objective of this study was to evaluate and compare the cost and effects on quality of life [using quality-adjusted life years (QALYs)] of 2 treatments for sciatica secondary to lumbar disc herniation: chemonucleolysis and surgical discectomy. The design involved a combination of decision analysis and Rosser index, with assessment of probabilities from long term clinical series. Utility was based on patients' subjective assessment using a simplified self-administered Health Measurement Questionnaire (HMQ). 146 patients from 7 hospitals were enrolled, 2 to 3 months after chemonucleolysis or surgery. The end-points used were cost and QALYs for each intervention, every year for years 1 to 7. At the time of analysis (1990), the total cost of surgical discectomy was FF15,400, compared with FF8000 for chemonucleolysis. After 1 year, and including the costs of reoperation for failure and relapse and long term medical costs for the non-reoperated unsatisfactory results, discectomy costs were almost 40% higher than those of chemonucleolysis. Ratios remain unchanged after 7 years. QALY results reveal an additional benefit of 52 days of good health associated with chemonucleolysis.
-The participants in round table 6 of the Giens Workshops 2012 drafted recommendations based on the collective interpretation of important elements of the decree concerning the medico
Questions have been raised regarding the attractiveness of France versus other countries for performing clinical trials. A questionnaire was sent to pharmaceutical companies with offices in France to assess their level of activity and to get information on the pros and cons of performing phase I-IV international clinical trials in France. Eleven companies, of large to medium size and representing 44% of the shared market returned answers. In 2001, they spent 131 million euros on clinical trials -53% for phase I-III, with a staff of 1469 (not including Contact Research Organisations) -and involved 21 000 investigators recruiting 98 000 patients on local budgets, and 2257 investigators recruiting 10 270 patients on international budgets. France ranked well as regards size of market or resource availability, with an intermediate rank as regards costs, access to patients and disease prevalence, and was weak with regard to speed of recruitment and quality of investigators. Ways of improving France's attractiveness will be discussed.
Texte reçu le 24 novembre 2014 ; accepté le 15 décembre 2014Mots clés : biosimilaire ; information ; accès au marché ; traçabilité ; plan de gestion des risques ; substitution ; taux de pénétration biosimilaire Résumé -Le médicament biosimilaire (BS) correspond à un médicament biologique déclaré comme similaire à un médica-ment biologique de référence et dont le plan de développement inclut des études de comparaison par rapport à la référence, afin de confirmer la similarité du produit au niveau qualité, sécurité préclinique, et profil d'efficacité et de sécurité cliniques dont l'immunogénicité. Les biosimilaires (BS) sont différents des génériques, tant par leur complexité moléculaire que par leur réglementation. Ils représentent des enjeux économiques considérables avec l'expiration dans les 5 prochaines années des brevets de nombreux biomédicaments couvrant des aires thérapeutiques majeures comme la cancérologie, la rhumatologie ou la gastroentérologie, qui représentent des dépenses importantes pour l'Assurance maladie. La table ronde (TR) a émis des recommandations pour que l'arrivée des BS soit un succès, en s'appuyant sur le médecin prescripteur comme acteur de l'information et de la confiance, en mettant en place un suivi des patients traités par biomédicaments, et en accélérant l'accès au marché de leurs biosimilaires.Abréviations : voir en fin d'article. † Les articles, analyses et propositions issus des Ateliers de Giens n'engagent que leurs auteurs et ne préjugent pas de la position de leur organisme de tutelle.Article publié par EDP Sciences
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