ABSTRACT
INTRODUCTION: 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). METHOD: 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. RESULTS: 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. CONCLUSION: 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.
Subject(s)
Antineoplastic Agents/supply & distribution , Drug Approval/legislation & jurisprudence , Melanoma/drug therapy , Skin Neoplasms/drug therapy , Adult , Antibodies, Monoclonal, Humanized/economics , Antibodies, Monoclonal, Humanized/therapeutic use , Antineoplastic Agents/economics , Antineoplastic Agents/therapeutic use , Antineoplastic Agents, Immunological/economics , Antineoplastic Agents, Immunological/supply & distribution , Antineoplastic Agents, Immunological/therapeutic use , Chemotherapy, Adjuvant , Clinical Trials as Topic , Decision Making , Drug Combinations , France , Humans , Imidazoles/economics , Imidazoles/supply & distribution , Imidazoles/therapeutic use , Insurance, Health, Reimbursement , Ipilimumab/therapeutic use , Neoplasm Recurrence, Local/prevention & control , Nivolumab/economics , Nivolumab/therapeutic use , Oximes/economics , Oximes/supply & distribution , Oximes/therapeutic use , Pyridones/economics , Pyridones/supply & distribution , Pyridones/therapeutic use , Pyrimidinones/economics , Pyrimidinones/supply & distribution , Pyrimidinones/therapeutic useSubject(s)
Anti-HIV Agents/supply & distribution , Drug Industry/ethics , Pyrimidinones/supply & distribution , Drug Industry/economics , Drug Industry/legislation & jurisprudence , Health Services Accessibility , Humans , Lopinavir , Thailand , United States , Voluntary Health Agencies , Vulnerable PopulationsSubject(s)
Drug Industry/legislation & jurisprudence , Drug and Narcotic Control/legislation & jurisprudence , Health Services Accessibility/legislation & jurisprudence , Patents as Topic/legislation & jurisprudence , Pyrimidinones/supply & distribution , Ritonavir/supply & distribution , Drug Approval/legislation & jurisprudence , Drug Combinations , Drug Industry/economics , HIV Protease Inhibitors/economics , HIV Protease Inhibitors/supply & distribution , Humans , Lopinavir , Pyrimidinones/economics , Ritonavir/economics , ThailandSubject(s)
HIV Infections/drug therapy , HIV Infections/economics , HIV Protease Inhibitors/economics , Private Sector , Pyrimidinones/economics , Ritonavir/economics , Developing Countries , Drug Industry , HIV Protease Inhibitors/supply & distribution , Humans , Lopinavir , Pyrimidinones/supply & distribution , Ritonavir/supply & distributionSubject(s)
Drug Approval/organization & administration , HIV Infections/drug therapy , HIV Protease Inhibitors , Pyrimidinones , HIV Protease Inhibitors/economics , HIV Protease Inhibitors/supply & distribution , Humans , Lopinavir , Pyrimidinones/economics , Pyrimidinones/supply & distribution , United States , United States Food and Drug AdministrationABSTRACT
Details and information sources on Kaletra (lopinavir plus low-dose ritonavir), a protease inhibitor approved last week.
Subject(s)
Drug Approval/legislation & jurisprudence , HIV Infections/drug therapy , HIV Protease Inhibitors , Pyrimidinones , HIV Protease Inhibitors/economics , HIV Protease Inhibitors/supply & distribution , Humans , Lopinavir , Pyrimidinones/economics , Pyrimidinones/supply & distribution , United States , United States Food and Drug AdministrationABSTRACT
AIDS: In November, Abbott Laboratories expanded its early access program criteria for ABT-378/r in the United States. Patients who have up to 200 CD4 T cells and who have failed numerous antiretroviral regimens are now eligible for the program. In February 2000, the program will be expanded further. At that time, patients who have no viable therapy with any of the approved antiretrovirals may have access to ABT-378/r regardless of their viral loads, CD4 T cell counts, or history of protease inhibitor use. Contact information is provided.^ieng
