Value of Post-Registration Studies for Reimbursement Renewal
Post-registration studies describe parameters of real-life clinical practice such as the treated population, conditions of treatment initiation, treatment duration, adherence, associated benefits/risks as well as the impact on treatment strategies, healthcare procedures and on public health. The res...
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| Veröffentlicht in: | Therapie 2009-05, Vol.64 (3), p.209-213 |
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| creator | Molimard, Mathieu Bamberger, Marion Vray, Muriel Allicar, Marie-Pierre Ameye, Véronique Avouac, Bernard Banzet, Marie-Noëlle Becquemont, Laurent Blin, Patrick Duguay, Corinne Fagnani, Francis Girault, Danièle Haim, Muriel Hamers, Françoise Lalaude, Olivier Lamarque, Véronique Maillere, Patricia Massol, Jacques Maugendre, Philippe Meyer, Arlette Moreau-Defarges, Thierry Pathak, Atul Perillat, Anne Ravoire, Sophie Spriet, Alain Tardieu, Sophie Teisseire, Bernard Weber, Monique Zanetti, Laura |
| description | Post-registration studies describe parameters of real-life clinical practice such as the treated population, conditions of treatment initiation, treatment duration, adherence, associated benefits/risks as well as the impact on treatment strategies, healthcare procedures and on public health. The results of these studies are used in particular for re-evaluation, re-registration or in applications for reimbursement. Since 1997, 134 requests for post-registration studies have been made either by the French Transparency Committee (CT) and/or the Committee for Pricing of Healthcare Products (CEPS) and the results of these studies were taken into account in the re-evaluation of Actual Benefit (AB) or Improvement in Actual Benefit (IAB). During the roundtable discussion on this subject at the National Clinical Pharmacology Meeting held at Giens (France), the difficulties in performing such studies were identified and proposals were made to predict and anticipate requests for these studies but also for the training of physicians. |
| doi_str_mv | 10.2515/therapie/2008030 |
| format | Article |
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| identifier | ISSN: 0040-5957 |
| ispartof | Therapie, 2009-05, Vol.64 (3), p.209-213 |
| issn | 0040-5957 1958-5578 |
| language | eng |
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| source | MEDLINE; Alma/SFX Local Collection |
| subjects | Decision Making Diagnostic Tests, Routine - standards Drug Therapy - standards Drug-Related Side Effects and Adverse Reactions Guidelines as Topic Humans pharmacoepidemiology registration reimbursement renewal Reproducibility of Results |
| title | Value of Post-Registration Studies for Reimbursement Renewal |
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