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  • 1. Personalized MedicineA nationwide initiative for an equal access to cancer treatment in France Fabien CALVO – Deputy Director General
  • 2. The challenges of targeted therapies in cancer • Molecular genetics deciphers severe frequent cancers into specific rare cancers with specific treatment • Molecular characteristics redefine tumor classification for molecular targeted therapies • Ensuring equity of access to innovation • Offering the best treatment to patients considering the cost – effectiveness ratio20 mai 2011 2
  • 3. Molecular genetics deciphers severe frequent cancers into specific rare cancers The shift of paradigm : towards molecular subsets of cancers Molecular subsets of colorectal Molecular subsets of non small cell lung cancer : 18,000 patients cancer : 16,000 patients20 mai 2011 3
  • 4. Molecular characteristics redefine tumor classification for molecular targeted therapies The shift of paradigm : molecular alterations shared in several cancers One drug is now efficient for the treatment of several « rare cancers » Imatinib has granted European market approval 2001 for : - Chronic myeloid leukemia and acute lymphoblastic Leukemia => BCR-ABL translocation - Gastrointestinal Stromal Tumors => cKIT expression - Hypereosinophilic Syndrome =>FIP1L1/ PDGFR re- arrangements - Myelodysplastic-Myeloproliferative Diseases => PDGFR re- arrangements) - Precursor Cell Lymphoblastic Leukemia-Lymphoma - Dermatofibrosarcoma20 mai 2011 4
  • 5. Ensuring equity of access to innovation: France organisation of molecular platforms for personalised medicine Provides nation-wide molecular diagnostic tests The programme is operated by the INCa/Ministry of Health since 2006 St Cloud/ Versailles • • Paris (2) : AP-HP, Curie • Villejuif  Objectives  28 regional platforms • Lille  Perform molecular testing  Partnerships between for all patients; several laboratories located Caen • • Rouen • Reims Brest • Nancy • Strasbourg Whatever the healthcare •  in University hospitals and Rennes • Mulhouse/ Colmar institution status (public • Angers • Tours • Dijon cancer centres • Nantes • Besançon hospitals, private • Poitiers hospitals…); • Limoges Regional organization • Clermont • Lyon  Ferrand • St Etienne • Grenoble Bordeaux •  Perform high quality tests;  Cooperation between Toulouse • • Nice  leukemia, solid tumours Montpellier/ Nîmes • • Marseille pathologists and biologists20 mai 2011 5
  • 6. Predictive tests for targeted therapies prescription BCR-ABL translocation: Imatinib prescription 1- BCR-ABL detection Chronic Myeloïd Leukemia/ 1- Imatinib prescription 2- BCR-ABL quantification Acute Lymphoblastic Leukemia 2- Monitoring of minimal residual disease 3- ABL mutation 3- Resistance to Imatinib KIT and PDGFRA mutations GIST Imatinib prescription HER2 amplification Breast and gastric cancers Trastuzumab prescription KRAS mutations Colorectal cancer Panitumumab and cetuximab prescription EGFR mutations Lung cancer Gefitinib and erlotinib prescription EML4-ALK translocations Lung cancer Crizotinib prescription BRAF mutation V600E Melanoma Vemurafenib prescription20 mai 2011 6
  • 7. Benefit for all patients  For all patients  free of charge for patients & hospitals  compensation of local pathologists for sample shipments Ensure that all patients effectively benefit from molecular testing20 mai 2011 7
  • 8. Rapid access to innovation Offer each patient in France an equal access to molecular tests as soon as a new targeted therapy is available Mid 2008 : EMA approvals for Erbitux® and Vectibix® June 2009 : gefitinib approvals by EMA for patients for patients with wild type KRAS tumours with activating mutations of EGFR in their tumors  INCa allocated €2.5M to the 28 platforms at the => INCa allocated €1.7M to the 28 platforms at the end of 2008 end of 200920 mai 2011 8
  • 9. Offering the best treatment to patients considering the cost – effectiveness ratio: 1.600.000.000 Other anticancer drug Biotherapy 1.400.000.000 Cytostatic Total anticancer expenses 1.200.000.000 Growth Amount of expenses in euros 1.038.421.711 € 974.651.585 € spending of 1.000.000.000 847.382.095 € drug therapy 800.000.000 750.756.378 € expenditure 600.000.000 609.088.546 € since 2004 in 473.974.008 € France (public 400.000.000 hospital sector) 200.000.000 0 Year 2004 Year 2005 Year 2006 Year 2007 Year 2008 Year 2009 Source : ATIH-PMSI MCO base updated 2005-2008 / infography INCa and base 2009/ infographyINCa20 mai 2011 9
  • 10. Offering the best treatment to patients considering the cost – effectiveness ratio: Targeted therapy Others 9,1% Bevacizumab 19,3% represents 57 % of the cost of anticancer drugs Irinotecan 4,8% (public hospital sector) Bortezomib 5,5% Cetuximab Rituximab 6,7% 16,8% Pemetrexed 8,1% Cytostatic Trastuzumab Targeted therapy / Biotherapy Docetaxel 12,8% 11,5% Other anticancer drug All other anticancer molecule Source : ATIH-PMSI MCO base 2009/ infography INCa20 mai 2011 10
  • 11. The anticancer targeted therapy portfolio From 2004 to 2010 :  31 new drugs in oncology got a first market approval in Europe.  adapted to 49 therapeutic indications  Almost half of those new drugs are targeted therapies.  Impact on the physician’s practice and on the healthcare’s setting.  Need to have access to molecular testing for each patient in order to get a personalized medicine.20 mai 2011 11
  • 12. Funding mechanisms Offer the best treatment to patients considering the cost – effectiveness ratio • Seed fundings from INCa for the test set-up • Performance and cost evaluation • Recurrent annual fundings from the French Ministry of Health insurance20 mai 2011 12
  • 13. Example of gefitinib treatment : €69M spared cost for the health insurance EGFR testing for lung cancer patients € 1.7M 15 000 patients - 1 724 patients +(gefinitib treatment: (gefinitib treatment:8 weeks DFS; Mok 2009) 38 weeks DFS; Mok 2009) € 69M € 35M Cost of gefitinib treatment20 mai 2011 Spared Cost of gefitinib treatment 13
  • 14. Some pending issues on targeted therapies • Is increased survival a legitimate end point? • Does tumor based molecular stratification exclude patients who could benefit from treatment?20 mai 2011 14
  • 15. Is increased survival a legitimate end point ? Trastuzumab for HER2 overexpressing patients with breast cancer Metastatic setting Adjuvant setting Median Clinical Line of Type of progression trial treatment administration free survival (months) Second line H0649g Monotherapy 3,2 and further Combination with H0648g First line 7,1 chemotherapy Combination with 4-year disease-free survival : 78·6% for M77001 First line 10,6 chemotherapy 1-year trastuzumab vs 72·2% for the20 mai 2011 observation group. (Gianni Lancet Oncol. 2011) 15
  • 16. Some pending issues on targeted therapies • Is increased survival a legitimate end point? • Does tumor based molecular stratification exclude patients who could benefit from treatment?20 mai 2011 16
  • 17. Implementation of a quality assurance programme 2 types of action : • Elaboration of guidelines for the detection of mutations in solid tumors before targeted therapies prescription : • Implementation in 2011 of a national External Quality Assessment for the 28 platforms (BCR-ABL, KRAS, EGFR)  Harmonization of practices between platforms  Assurance quality optimization20 mai 2011 17
  • 18. Challenges ahead • Maintain the quality of molecular tests • Anticipate the launch of new molecules : reduction of time-to-access to molecule (In 2011, the INCa allocates €3.5M for the prospective detection of emergent biomarkers in lung cancer, colorectal cancer and melanoma). • Improve basic/clinical research interfaces : Basic science to better understanding of mutations/variations/metabolic impact/redundancy of pathways and fostering translational research • Public/private partnerships to optimize the implementation of new tests and sustain innovation.20 mai 2011 18
  • 19. Conclusions and perspectives • This initiative for targeted cancer treatment in France shows that :  innovation can be successfully integrated into the healthcare system  molecular stratification is cost effective  this organization could be easily expanded in other european settings • These platforms are key to help develop translationnal research and to sustain progress • They are instrumental to facilitate access to the best care and improve patient’s survival and quality of life • Training of medical students and professionals to personalised medicine20 mai 2011 19
  • 20. acknowledgements • 28 pathologists and molecular biologists who run these platforms and their collaborators • INCa departments of Health Care and Research – special thanks to Fréderique Nowak in charge of this program, Valerie Thibaudeau and Christine Berling • Our previous president, Dominique Maraninchi • The patients to whom this national contribution is dedicated20 mai 2011 20
  • 21. Prof Fabien CALVO – Deputy General Director fcalvo@institutcancer.fr Tel. +33 (0) 1 41 10 50 00 ● Fax +33 (0) 1 41 10 50 20 52, avenue André Morizet 92513 Boulogne-Billancourt Cedex France www.e-cancer.fr9 juin 2008
  • 22. Economical impact of molecular testing % Public fundings Nb of Number of Median PFS Cost of patients allocated for the Cancer Drug Biomarker tested spared for non treatment/ Spared cost with provision of the patients prescriptions responders patient mutation test gefitinib 15000 8 weeks 4 600 € lung EGFR 10,3% 16722 €69 M €1.7 M cancer mut erlotinib 15000 8 weeks 4 600 € 8 months 32 419 € € 201 M cetuximabcolorectal KRAS 36% 17250 6 210 8 weeks 9 263 € €57 M €2.5 M cancer mut Panitu- 4 weeks 4 390 € €27 M mumab
  • 23. 1- Is increased survival a legitimate end point ? Imatinib for patients with CML (BCR-ABL translocation)After failure of interferon -a treatment Fist line treatment6 year-survival rate = 76% (Hochhaus, Blood 2008) 6 year-survival rate = 88% (Hochhaus, Leukemia 2009) CML patients taking Imatinib and in remission after two years of treatment have similar mortality rates to people in general population (Gambacorti-Passerini C, JNCI 2011)20 mai 2011 23