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Situation De La Chimiothérapie Des Cancers Rapport 2012

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Situation De La Chimiothérapie Des Cancers Rapport 2012 Chimiotherapie-2012_44 pages 19/07/13 10:35 Page1 Mesure 21 SOINS Situation de la chimiothérapie COLLECTION des cancers États des lieux & des connaissances RAPPORT 2012 ANALYSE DES TENDANCES RÉCENTES DE LA PRATIQUE ET DES DÉPENSES DE LA CHIMIOTHÉRAPIE DES CANCERS EN FRANCE CYTOTOXIQUES, AUTRES ANTICANCÉREUX, THÉRAPIES CIBLÉES (INHIBITEURS DE TYROSINES KINASES ET APPARENTÉS, ANTICORPS MONOCLONAUX) ET HORMONOTHÉRAPIES www.e-cancer.fr Chimiotherapie-2012_44 pages 19/07/13 10:35 Page2 2 SITUATION DE LA CHIMIOTHÉRAPIE DES CANCERS RAPPORT 2012 L’Institut national du cancer est l’agence nationale sanitaire et scientifique chargée de coordonner la lutte contre le cancer en France. Ce document est téléchargeable sur le site : www.e-cancer.fr CE DOCUMENT S’INSCRIT DANS LA MISE EN ŒUVRE DU PLAN CANCER 2009-2013. Mesure 21 : Garantir un égal accès aux traitements et aux innovations Action 21.1 : Faciliter l’accès aux traitements par molécules innovantes. Intégrer dans le rapport annuel de l’INCa un rapport de situation sur les molécules anticancéreuses. COORDINATION DU RAPPORT l Dr Natalie HOOG LABOURET, Pôle Recherche et Innovation, responsable de la Mission Réforme du Médicament l Thomas MORTIER, Pôle Recherche et Innovation, Mission Réforme du Médicament ANALYSE DES DONNÉES l Dr Christine LE BIHAN-BENJAMIN, Pôle Santé Publique et Soins, Département Observation, Veille et Innovation l Mathieu ROCCHI, Pôle Santé Publique et Soins, Département Observation, Veille et Innovation l Natalie VONGMANY, Pôle Santé Publique et Soins, Département Observation, Veille et Innovation l Dr Philippe Jean BOUSQUET, Pôle Santé Publique et Soins, responsable du Département Observation, Veille et Innovation CONTRIBUTIONS AU RAPPORT l Frédérique NOWAK, Pôle Recherche et Innovation, responsable du Département Innovation l Jonathan FINZI, Direction des Recommandations et de la Qualité de l’Expertise, Département Recommandations et bon usage du médicament l Dr Laetitia VERDONI, Direction des Recommandations et de la Qualité de l’Expertise, responsable du Département Recommandations et bon usage du médicament l Dr Valérie MAZEAU WOYNAR, directrice des Recommandations et de la Qualité de l’Expertise, Département Recommandations et bon usage du médicament Nous remercions le service Évaluation des médicaments de la Direction de l'évaluation médicale, économique et de santé publique de la Haute Autorité de santé et le président de la Commission de la transparence, le Pr Gilles Bouvenot, pour leur relecture et leur apport au chapitre sur l’Évolution de l’offre des anticancéreux. Ce document doit être cité comme suit : ©Situation de la chimiothérapie des cancers - Rapport 2012. Collection États des lieux et des connaissances, ouvrage collectif édité par l’INCa, Boulogne-Billancourt, juin 2013. Il peut être reproduit ou diffusé librement pour un usage personnel et non destiné à des fins commerciales ou pour des courtes citations. Pour tout autre usage, il convient de demander l’autorisation auprès de l’INCa en remplissant le formulaire de demande de reproduction disponible auprès du département communication institutionnelle de l’INCa à l’adresse suivante : [email protected] SOMMAIRE GLOSSAIRE ...................................................................................................................................................................... 7 AVERTISSEMENT ............................................................................................................................................................. 8 PRÉAMBULE .................................................................................................................................................................... 9 MÉTHODOLOGIE ........................................................................................................................................................... 10 1. ÉPIDÉMIOLOGIE DES CANCERS EN FRANCE ............................................................................................................ 19 2. ACTIVITÉ EN CANCÉROLOGIE POUR CHIMIOTHÉRAPIE ............................................................................................ 22 2.1. Séjours, séances et journées pour chimiothérapie ..................................................................................... 22 2.1.1. Secteur MCO : séjours et séances .................................................................................................. 22 2.1.2. Hospitalisation à domicile : journées ............................................................................................. 25 2.2. Personnes prises en charge pour une chimiothérapie antitumorale en MCO ............................................... 28 2.3. Dépenses liées aux anticancéreux de la liste en sus en milieu hospitalier .................................................... 31 2.3.1. Secteur MCO ................................................................................................................................. 33 2.3.2. Hospitalisation à domicile ............................................................................................................. 38 2.3.3. Évolutions réglementaires des cinq anticancéreux de la liste en sus les plus coûteux ...................... 39 2.4. Analyse des dépenses liées aux anticancéreux en ville ............................................................................... 42 2.4.1. La rétrocession ............................................................................................................................. 42 2.4.2. L’officine ...................................................................................................................................... 44 3. ACCÈS À L’INNOVATION ........................................................................................................................................ 52 3.1. Tests génétiques ...................................................................................................................................... 52 3.2. Thérapies ciblées ..................................................................................................................................... 54 3.2.1. Nouveaux anticancéreux mis sur le marché depuis 2004 et part des thérapies ciblées au sein de ceux-ci .................................................................................................................................................... 54 3.2.2. Indications des thérapies ciblées en fonction de la localisation du cancer ...................................... 56 3.3. Évolution de l’offre des anticancéreux depuis 2004 jusqu’en 2012 ............................................................. 57 3.3.1. AMM initiales et extensions d’indication ....................................................................................... 58 3.3.2. Évaluation des indications par la Commission de la transparence : SMR et ASMR ........................... 61 3.3.3. Focus sur les indications autorisées depuis 5 ans et leurs ASMR ..................................................... 62 4. CONCLUSIONS ET PERSPECTIVES ........................................................................................................................... 67 ANNEXES ...................................................................................................................................................................... 71 ANNEXE 1 : LISTE DES ANTICANCÉREUX INSCRITS SUR LA LISTE EN SUS AU PREMIER JANVIER 2012 ................................ 71 ANNEXE 2 : LISTE DES SPÉCIALITÉS REMBOURSÉES EN 2011 PAR LE RÉGIME GÉNÉRAL DE L’ASSURANCE MALADIE CLASSÉES SELON LE TYPE D’ANTICANCÉREUX ET SELON LA VOIE D’ADMINISTRATION (RETROCED’AM) ............................ 72 ANNEXE 3 : LISTE DES SPÉCIALITÉS DISPENSÉES EN VILLE REMBOURSÉES PAR LE RÉGIME GÉNÉRAL DE L’ASSURANCE MALADIE EN 2011, CLASSÉES SELON LE TYPE D’ANTICANCÉREUX ET SELON LA VOIE D’ADMINISTRATION (MEDIC’AM) .... 74 ANNEXE 4 : DONNÉES RÉGLEMENTAIRES DES CINQ SPÉCIALITÉS LES PLUS COÛTEUSES POUR LES ÉTABLISSEMENTS DE SANTÉ PUBLICS ET PRIVÉS EN FRANCE EN 2011 .............................................................................................................. 76 RAPPORT SITUATION DE LA CHIMIOTHÉRAPIE DES CANCERS EN 2012 Page | 3 ANNEXE 5 : ÉVOLUTIONS RÉGLEMENTAIRES DES CINQ SPÉCIALITÉS LES PLUS COÛTEUSES POUR L’OFFICINE EN FRANCE EN 2011 ........................................................................................................................................................................ 81 ANNEXE 6: NOUVELLES MOLÉCULES MISES SUR LE MARCHÉ DEPUIS LE 1ER JANVIER 2004 AYANT UNE PREMIÈRE AMM EUROPÉENNE EN CANCÉROLOGIE .................................................................................................................................. 85 ANNEXE 7 : ACTUALITÉS RÉGLEMENTAIRES EN 2012 ...................................................................................................... 89 ANNEXE 8 : ÉVALUATIONS DES SMR ET DES ASMR ......................................................................................................... 93 ANNEXE 9 : ARTICLE 18 DE LA LOI N° 2011-2012 DU 29 DÉCEMBRE 2011 RELATIVE AU RENFORCEMENT DE LA SÉCURITÉ SANITAIRE DU MÉDICAMENT ET DES PRODUITS DE SANTÉ ............................................................................................. 97 ANNEXE 10 : DÉCRET N° 2012-742 DU 9 MAI 2012 RELATIF AUX RECOMMANDATIONS TEMPORAIRES D’UTILISATION DES SPÉCIALITÉS PHARMACEUTIQUES .................................................................................................................................
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