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EuroBioForum 2013 - Day 1 | Emmanuelle Benzimra


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EuroBioForum 2013 2nd Annual Conference
27-28 May 2013 - Hilton Munich City, Munich, Germany



Navigating the Challenges of Personalised Medicine Access in Europe

Emmanuelle Benzimra
General Delegate at EPEMED, The European Personalised Medicine Association


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EuroBioForum 2013 - Day 1 | Emmanuelle Benzimra

  1. 1. 27-28 May 2013, Munich, Germany EuroBioForum 2013 2nd Annual Conference Emmanuelle Benzimra General Delegate European PErsonalised MEDicine association EPEMED
  2. 2. Navigating the Challenges of Personalized Medicine Access in Europe EuroBioforum - MUNICH 27 May 2013 Emmanuelle BENZIMRA, General Delegate
  3. 3. BiomarkersBiomarkers and PM areand PM are includedincluded in medical practicesin medical practices sincesince thethe 19th19th centurycentury butbut theirtheir developmentdevelopment hashas acceleratedaccelerated in the lastin the last decadedecade 1960 Biomarkers of cancer : alpha-foetoprotein & CE antigen Couple Herceptin/Herceptest (Roche, Genentech/Dako) Amplichip Cyp450 (Roche/Affymetrix) 1848 Biomarker of myeloma: Ig chain (BJ) in 75% cases Ig : immunoglobulin BJ : protein of Bence-Jones PSA : prostate specific antigen TPMT: thiopurine-méthyltransférase 1980 Biomarker of diabetes: glycemia Biomarker of diabetes: Hb A1c Couple Selzentry/Trofile (Pfizer) Biomarker of cancer: Ovarian (CA 125) Prostatic (PSA) 1998 20102000 2005 2007 2006 Erbitux (Merck/Imclone)or Vectibix (Amgen) & KRAS test Dasatinib (BMS) & Philadelphia chromosome « Omics » and start of the genome sequencing 1986 First use of Pharmacogenetic definition 1959 Discovery of genetic polymorphism of TPMT (Weinshilboum & Sladek) 1997 First use of Pharmacogenomic definition 2011 Couple Zelboraf®/ Cobas® 4800 BRAFV600E mutation test (Roche/Daiichi) 2012 Couple Tysabri®/Stratify- JCV antibody Elisa test (Biogen Idec/Quest) Couple Xalkori®/Vysis® ALK Break Apart test (Pfizer/Abbott)
  4. 4. DespiteDespite promisingpromising marketmarket forecastsforecasts andand currentcurrent developmentdevelopment efforts, aefforts, a smallsmall numbernumber ofof companioncompanion diagnostics havediagnostics have reachedreached thethe marketmarket < 3 to 5% of companion biomarkers commercialized 30 to 50 % of Biomarkers associated in development •Utility, specificity and validation of biomarkers •Some biomarkers are only developed for the drugs R&D • Remaining hurdles associated to regulatory questions, market access (evaluation, coding, pricing and reimbursement ) of the RX-DX couple or of the CDx alone • Hurdles associated to partnership model, commercialisation business model (alone/in association, distribution flows…) Attrition rate of biomarkers within the pipeline of the pharma industry Source: LEEM, Nature Reviews march 2009, « Biomarkers : The expanding global market », Yonker 2006
  5. 5. TheThe European Challenge:European Challenge: TheThe 27 Member States of the EU27 Member States of the EU
  6. 6. Personalised Medicine in EU: OverviewPersonalised Medicine in EU: Overview Very few value-based reimbursement initiatives for innovative Dx Many barriers and levels of complexity Heterogeneous region in terms of regulation & reimbursement Differences in centralised & de-centralised systems in the individual states Differences in HTA (Health Technology Assessment) systems between and within countries
  7. 7. The European ChallengeThe European Challenge EPEMED White paper: Market access challenges in the EU for high medical value diagnostic tests Iain Miller†1,2, Joanna Ashton-Chess1,3, Herman Spolders1,4, Vincent Fert1,5, Joseph Ferrara6, Werner Kroll1,7, Jon Askaa8, Patrick Larcier3, Patrick F Terry1,9, Anne Bruinvels10 & Alain Huriez1,3 Ref: Personalized Medicine (2011) 8(2), 137–148
  8. 8. European Opportunities forEuropean Opportunities for PMPM Quality of the scientific research and medical practices European Commission initiatives Recast of IVD directive (input provided by EPEMED) EMA initiatives (innovation task force, scientific advices for qualification of biomarkers, EMA "reflection paper on methodological issues associated with PGx biomarkers)…(input provided by EPEMED) High level quality Biobanks (IBBL, IMIDBB,…) EC grants (FP7 health 2011), IMI programs European associations (EuroBioforum, EPEMED, EDMA, EAPM, EBE ..)
  9. 9. Why EPEMED ?Why EPEMED ? EPEMED is an independent, broad and inclusive not-for-profit organisation founded in 2009 and bringing together forces in personalised medicine in the EU. A central point of communication for the different parties involved in progressing personalised medicine Addressing issues in personalised medicine that confront the industry, regulators, payers & insurers as well as governments in Europe Aiming to provide a platform for the harmonisation of personalised medicine development and implementation across Europe, focusing on the role of diagnostics, to make personalised medicine a reality
  10. 10. EPEMED’s Value PropositionEPEMED’s Value Proposition Key Value Points for Members • Forum to share best practices • Publications, white papers, conferences, education & promotion on Personalised Medicine subjects • Privileged access to European decision makers • Input to policy makers on relevant legislation
  11. 11. Success Factors: EPEMED’sSuccess Factors: EPEMED’s propositionspropositions One of the major current issues related to the EU low market uptake of IVD Personalized Medicine tests is the reimbursement process, which is complex, heavy, non-harmonised, and carried out by different commissions in every country, in most of cases handling also drugs dossiers. There are not appropriate competences at payers level ensuring dossiers submitted are understood and evaluated in a fair and knowledgeable manner. Moreover, PM being one of the most striking examples of innovation, tools should be there to nourish research results and to help them turning into marketable products.
  12. 12. Success Factors: EPEMED’sSuccess Factors: EPEMED’s propositionspropositions European wide coordination initiative is needed among health technology bodies which reimburse all diagnostics - including molecular diagnostics, companion diagnostics, and personalised medicine products in order to ensure reimbursement allows innovation. Clarification and description of requirements to be met for reimbursement. A more unified and coordinated accreditation procedures should be established for European clinical testing laboratories, enabling to break the actual national protectionism. A more focused and coordinated effort should be established to make use of patient registries, patient biological samples, and patient outcome data in a targeted personalised medicine development program with results published in a timely manner.
  13. 13. EPEMED 2012EPEMED 2012--2013 European Market Access2013 European Market Access StudyStudy 15 months collaboration: EPEMED & La Charité Institute for Social Medicine, Epidemiology, and Health Economics, Universitätsmedizin Berlin (Pr Stefan Willich & Dr Markus Buecheler) Scope: Personalized Medicine in Europe - Navigating Market Access Challenges for Co- developed and further Combined Molecular Rx/Dx Technologies and Realizing the Potential Aim: Devise recommendations how to shape a post-approval environment that facilitates broad and equitable access to CDx/Rx. Approach: Description of the post-approval patient access pathways for CDx/Rx in 5 largest EU countries (Ge, UK, Fr, I, S) • Analyse best practices and barriers to patient access • Develop recommendations after interviews with KOLs Deliverables (starting Q4 2013): Study report, peer-reviewed paper, position paper, conferences.
  14. 14. EPEMED 2012EPEMED 2012--2013 European2013 European Market Access StudyMarket Access Study Preliminary findings will be presented on 28/29 October 2013 in Luxembourg (Health Economics Personalised Medicine Symposium) ! SAVE THE DATE & JOIN US !!
  15. 15. Thank you for your attention ! For more information or to download recent study reports, white paper or webinars, please visit Contact: