Personalised Medicine: a nationwide initiative for an equal access to cancer treatment in France


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EuroBioForum 2012 | 18 April 2012
Presentation by Frédérique Nowak, Head of Pathology and Genetics, French National Cancer Institute

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Personalised Medicine: a nationwide initiative for an equal access to cancer treatment in France

  1. 1. Personalized Medicine:A nationwide initiative for an equal access to cancer treatment in France Frédérique Nowak Institut National du Cancer – 18/04/2012
  2. 2. Institut national du cancer (INCa)• The French National Cancer Institute is a health and science agency dedicated to oncology.• INCa was created through the Public Health Act of 9 August 2004• INCa is involved in all aspects of the fight: - Public health : Observation – Prevention - Screening - Care: Improve the quality of care for all cancer patients - Research: Orient the national cancer policy towards international competition - Information: Give every individual the means to help fight cancer 2
  3. 3. The cancer plan 2009-2013 The Cancer Plan 2009-2013:• follows on from the Cancer Plan 2003-2007• 5 areas :  Research  Observation  Prevention-screening  Patient care  Life during and after cancer• 30 measures/ 118 actions 3
  4. 4. The shift of paradigm for cancer treatment Towards molecular subsets of cancers Molecular genetics deciphers severe frequent cancers into specific rare cancers Molecular subsets of non small cell lung cancer : 20,000 patients Molecular alterations shared in several cancers One drug is now efficient for the treatment of several « rare cancers » 4
  5. 5. Predictive tests for targeted therapies prescription Imatinib prescriptionBCR-ABL translocation: Chronic Myeloïd Leukemia/ 1- Imatinib prescription 1- BCR-ABL detection Acute Lymphoblastic 2- Monitoring of minimal residual 2- BCR-ABL quantification Leukemia disease 3- ABL mutation 3- Resistance to ImatinibKIT and PDGFRA GIST Imatinib prescriptionmutationsHER2 amplification Breast and gastric cancers Trastuzumab prescription Panitumumab and cetuximabKRAS mutations Colorectal cancer prescriptionEGFR mutations Lung cancer Gefitinib and erlotinib prescriptionALK translocations Lung cancer Crizotinib prescriptionBRAFV600 mutation Melanoma Vemurafenib prescription 5
  6. 6. Ensuring equity of access to innovation: France organisation of molecular centres for personalized medicineProvides nationwide molecular diagnostic testsThe programme is operated by the INCa/Ministry of Health since 2006 St Cloud/ Versailles • • Paris (2) : AP-HP, Curie • Villejuif Objectives  28 regional centres • Lille Perform molecular testing  Partnerships between • Rouen Caen • • Reims for all patients; several laboratories located Brest • • Nancy • Strasbourg Mulhouse/ Rennes • Colmar Whatever the healthcare in University hospitals and • Angers • Tours • Dijon • Nantes • Besançon institution status (public cancer centres • Poitiers hospitals, private • Limoges • Clermont • Lyon  Regional organization Ferrand • St Etienne • Grenoble hospitals…); Bordeaux • Perform high quality tests;  Cooperation between Toulouse • Montpellier/ • Marseille • Nice Nîmes • pathologists and biologists leukemia, solid tumours 6
  7. 7. Benefit for all patients Molecular tests are performed :  For all patients  free of charge for patients & hospitals  With compensation of local pathologists for sample shipments Ensure that all patients effectively benefit from molecular testing 7
  8. 8. Rapid access to innovation: EGFR testing in lung cancer June 2009 : gefitinib approvals by EMA for patients with activating mutations of EGFR in their tumours  Mutations : 9,6%  60 % of external prescriptions 20761  Median time for results : 7 days 20000 16834Nombre de patients  Non contributive results : Non contributive results (%) 10000 5,2% 5,0 2667 3,7% 1269 0 1,5% 2008 2009 2010 2011 0,0 non amplifiable depleted sample Rate of tumor cells DNA below detection thresold
  9. 9. Funding mechanismsOffer 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 insurance This programme benefits also from INCa/private partnerships 9
  10. 10. 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 treatment Spared cost of gefitinib treatment 10
  11. 11. Ensure the best quality for molecular testsImplementation of a quality assurance programme• Elaboration of guidelines for: - the detection of mutations in solid tumors; - the organization of molecular testing; - Reports of molecular tests• Implementation in 2011 of a national External Quality Assessment for the 28 centres (BCR-ABL, KRAS, EGFR) Assurance quality optimization guide the molecular genetics centres to becoming accredited to ISO 15189 standard as soon as possible 11
  12. 12. A new approach for rapid access to targeted therapiesBiomarkers for targeted therapies currentlyevaluated in clinical trials (Phases I to III) : Cancer Molecular target EGFR mutations KRAS mutations HER2 mutations Lung BRAF mutation PI3KCA mutations ALK translocations KRAS mutations Colon - rectum BRAF mutations microsatellite instability if < 60 years BRAF mutations Melanoma KIT mutations
  13. 13. Anticipate the launch of new moleculesThe INCa allocated €3.5M in 2010 and €2.8M in 2011 for the prospective detectionof emerging biomarkers  For the 20,000 patients with lung adenocarcinoma, additional analysis of : - EGFR mutations conferring resistance to TKI-EGFR; - KRAS, HER2, PI3KCA and BRAF mutations; - ALK translocation.  For the 17,000 patients with colorectal cancer, additional analysis of : - BRAF mutation; - MSI test.  BRAF and cKIT mutations for patients with melanoma Be ready to perform the test as soon as the therapy is available
  14. 14. Improve interface with researchMake the most of the generated data=> implementation of a lung cancer database :  funded by INCa, coordinated by IFCT (Intergroupe Français de Cancérologie Thoracique) and molecular genetics centres representatives  evaluate the correlation between molecular alteration identification and targeted therapy prescription  collect both clinical data, molecular data and clinical follow up of patientsImprove interfaces with clinical research Potential evolution of their mission : molecular genetics centres could become testing laboratories for clinical trialsImprove interfaces with translational research 14
  15. 15. An expanding list of predictive tests Towards an « all in one approach »: implementation of next generation sequencing techniquesfor clinical diagnostics
  16. 16. Conclusions and perspectiveso 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 settingso These molecular genetics centres are key to help develop translationnal research and to sustain progresso They are instrumental to facilitate access to the best care and improve patient’s survival and quality of lifeo Training of medical students and professionals to personalised medicine 16