[Administrative delays of temporary recommendation for use: Impact on access to innovation in melanoma]
| Autor: | Cécile, Auger, Bernard, Guillot, Adrien, Monard, Nicolas, Albin |
|---|---|
| Jazyk: | francouzština |
| Rok vydání: | 2021 |
| Předmět: |
Adult
Clinical Trials as Topic Skin Neoplasms Pyridones Decision Making Imidazoles Antineoplastic Agents Pyrimidinones Antibodies Monoclonal Humanized Ipilimumab Drug Combinations Antineoplastic Agents Immunological Nivolumab Chemotherapy Adjuvant Insurance Health Reimbursement Oximes Humans France Neoplasm Recurrence Local Drug Approval Melanoma |
| Zdroj: | Bulletin du cancer. 109(1) |
| ISSN: | 1769-6917 |
| Popis: | Melanoma has benefited in recent years from therapeutic innovations, which have improved overall survival of patients. France has developed a regulatory arsenal allowing faster access to innovative drugs before marketing authorization: temporary authorization for use (ATU) and temporary recommendation for use (RTU).We describe here the decision-making processes that led to the non-publication of the decree on the funding of three RTU in adjuvant melanoma therapy: nivolumab, pembrolizumab and the combination of dabrafenib and trametinib, and we analyse the fate of these drugs in order to quantify the potential loss of chance.On 03AUG2018, the French National Agency for Medicines and Health Product Safety (ANSM) published 3 RTU in order to give rapid access to major innovations in adjuvant melanoma therapy: nivolumab, pembrolizumab and the combination of dabrafenib and trametinib. These drugs have respectively demonstrated reductions in the risk of recurrence by 35 %, 43% and 55% for target populations of 2200, 1900 and 650 patients per year. Despite a favourable opinion on reimbursement from the French National Authority for Health (HAS), the decrees on reimbursement will never be published, prohibiting the use of these products before the marketing authorisation, and depriving many patients of a potential cure.Despite a favourable opinion from scientists and health agencies for the rapid availability of a drug, the French public health code does not systematically imply access to a therapeutic innovation. The reform of access to innovation implemented on 01JUL2021 may help tackle this issue. |
| Databáze: | OpenAIRE |
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