Access to innovative oncology medicines in Europe January 2014 Bonn, Germany BDA WORKSHOP BIOTHERAPY DEVELOPMENT ASSOCIATION

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1 BDA WORKSHOP Access to innovative oncology medicines in Europe January 2014 Bonn, Germany BIOTHERAPY DEVELOPMENT ASSOCIATION

2 Content Meeting Objectives 2 Organising Committee 2 Who should attend? 3 Conference Venue 4 Conference Hotel 4 How to get there 5 Registration fee 3 Programme, Thursday - 16 January Programme, Friday - 17 January Meeting Objectives The goal of this workshop is to facilitate a collaborative discussion between regulatory bodies, HTA organizations, healthcare providers, patients and industry on the key reasons for inequalities in access to oncology treatments within and between countries and possible ways to overcome these access disparities. Organising Committee Workshop Chairs Lothar Bergmann (Frankfurt University Hospital, Germany) Harald Enzmann (BfArM, Germany) Ilana Widera (Pfizer, Belgium) Programme overview 10 Upcoming Meetings 11 Secretariat 12 Who should attend? Representatives of European regulatory bodies, policymakers Representatives from Academia Decision makers from the pharmaceutical industry The Biotherapy Development Association Patient associations Payors Politicians The Biotherapy Development Association (BDA) is a not-for-profit organization. Our mission is to provide a unique platform to facilitate BIOTHERAPY DEVELOPMENT ASSOCIATION interactions between all stakeholders: academia, regulatory authorities, the pharmaceutical industry, patient advocates and policymakers in order to improve the efficiency of cancer drug development. BDA organizes regular meetings and workshops where all stakeholders can meet and discuss the latest challenges in oncology drug development with the goal to create an ideal scientific, regulatory and commercial environment for the development of cancer drug. For more information about BDA, please visit: Registration Fees Registration fee includes attendance to the workshop as well as all meals (lunches and networking dinner) Patient Advocates (by invitation only) Academia and Regulatory bodies Industry free 300 EU 900 EU 2 3

3 Conference Venue Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) Federal Institute for Drugs and Medical Devices Kurt-Georg-Kiesinger-Allee Bonn Germany How to get to the Federal Institute for Drugs and Medical Devices By plane from the Köln/Bonn airport Take the airport shuttle bus SB60 to Bonn s central railway station. From there proceed by sub-way as described above. Airport Düsseldorf 39.2 km Düsseldorf Conference Hotel Maritim Hotel Bonn Godesberger Allee (Access: Kurt-Georg-Kiesinger Allee 1) Bonn Germany Phone: + 49 (0) Fax: + 49 (0) Reservation phone: + 49 (0) info.bon@maritim.de By car To the right of the Rhine Take the A 562 until you reach the exit Bonn- Rheinaue. There you turn onto Ludwig-Erhard- Allee (in the direction of Bad Godesberg); subsequently, turn right onto Heinemannstraße and then right again onto Jean-Monnet-Straße. Follow this street until the end and then turn right onto Kurt-Georg-Kiesinger-Allee. By car To the left of the Rhine Take the A 565 until you reach the exit Bonn- Poppelsdorf; from there continue on Reuterstraße towards Bad Godesberg. Follow the street towards the right onto Friedrich-Ebert-Allee which later turns into Godesberger Allee. Turn off right onto Marie-Schlei-Allee and make a U-turn at the next opportunity in order to continue on Heinemannstraße in the opposite direction. Subsequently, turn left onto Jean- Monnet-Straße and then right onto Kurt-Georg- Kiesinger-Allee. Cologne 31.3 km Bonn central railway station 4.7 km bfarm Airport Cologne/Bonn Bonn By sub-way from Bonn s central railway station In order to get from Bonn s central railway station to the BfArM, take the sub-way line 66 ( Telekom Express ) bound for Königswinter/Bad Honnef and get out at the station Robert-Schuman-Platz. bfarm 120 m Hotel Maritim 4 5

4 Programme Thursday, 16 January 2014 Meeting Room: A1E203 11:00 Co-chairs kick-off meeting 13:00 Introduction Karl Broich (Bfarm, Germany) 13:10 SESSION 1 - EQUAL ACCESS : CURRENT LANDSCAPE Session Chairs: Lothar Bergmann (Frankfurt University Hospital, Germany) Harald Enzmann (BfArM, Germany) Ilana Widera (Pfizer, Belgium) 13:10 Overview on current access to anti-cancer medicines in Europe Bengt Jönsson (Stockholm School of Economics, Sweden) 13:50 The assessment of benefit and risk for marketing authorization decisions Harald Enzmann (BfArM, Germany) 16:20 SESSION 1 - EQUAL ACCESS : CURRENT LANDSCAPE cont. 16:20 EUnetHTA Wim Goettsch (EUnetHTA, The Netherlands) 16:50 Current obstacles and challenges for industry to meet these expectations Ilana Widera (Pfizer, Belgium) 17:20 The impact of access to oncology products on cancer treatment and survival Lothar Bergmann (Frankfurt University Hospital, Germany) 17:50 Q & A DISCUSSION Moderators: Session chairs Participants: Session speakers 18:30 END OF DAY 1 14:20 Differences in HTA in Europe Elisabeth George (National Institute for Health and Care Excellence, UK) 14:50 The rationale and procedure for pricing and reimbursment decisions in England Adrian Towse (Office of Health Economics, UK) 18:45 BDA / European Cancer League Joint Session: Identifying Opportunities for Action to Improve Access to Medicines in Europe 19:45 NETWORKING DINNER in Hotel Maritim Bonn 15:20 The rationale and procedure for pricing and reimbursment decisions in Germany Uwe Vosgerau (Gemeinsamer Bundesausschuss, Germany) 15:50 Break 6 7

5 Programme Friday, 17 January :15 BDA & Industry Panel meeting 11:30 SESSION 2 - EQUAL ACCESS: DIFFERENCES & HOW TO DEAL WITH IT cont. 9:00 SESSION 2 - EQUAL ACCESS: DIFFERENCES & HOW TO DEAL WITH IT Session Chairs: Stefan Schwoch (Lilly, UK) Adrian Towse (Office of Health Economics, UK) 9:00 HTA Payer assessment in the UK : present and future Elisabeth George (National Institute for Health and Care Excellence, UK) 9:30 Regulatory & HTA: How can we define common grounds? Steffen Thirstrup (University of Copenhagen - NDA Regulatory Services Ltd., UK) 10:00 DISCUSSION: On what common grounds can we start building? What is the path forward? Moderators: Session chairs Participants: Session speakers + Mila Vlaskovska(EMA, Bulgaria) 11:00 Break 11:30 Clinician point of view on Regulatory & HTA differences - What are the Clinician s needs to provide the best therapy to their cancer patients Jan H.M. Schellens (The Netherlands Cancer Institute, The Netherlands) 12:00 Patient expectations: Which elements do patients value? Kathy Oliver (International Brain Tumour Alliance, UK) 12:30 Reducing uncertainty and improving patient and health system outcomes - Recommendations of the Tapestry Networks Working Group on post-launch value assessments Ansgar Hebborn (F. Hoffmann-La Roche AG, Switzerland) 13:00 DISCUSSION Do these different assessment modes allow equal access to patients? Moderators: Ansgar Hebborn (F. Hoffmann-La Roche AG, Switzerland) Jan H.M. Schellens (The Netherlands Cancer Institute) Participants: Session speakers 13:30 NEXT STEPS Workshop chairs 14:00 CLOSING REMARKS Harald Enzmann (BfArM, Germany) 14:15 END OF Day 2 Programme 14:15 Lunch 8 9

Programme Overview Upcoming Meetings Thursday, 16 January 2014 Friday, 17 January 2014 It is a UNIQUE opportunity to address hurdles and explore potential

8:15 BDA & Industry Panel meeting 10:30 Registration open 9:00 SESSION 2 EQUAL ACCESS: DIFFERENCES & HOW TO DEAL WITH IT ITOC-1: 1 st Immunotherapy of

Discussion 13:10 13:30 Next Steps Minimal Residual Disease: End-points in clinical trials 13 & 14 MaY 2014 London, United Kingdom SESSION 1 EQUAL ACCESS:

29-31 October 2014 BUchen/Innsbruck, Austria 15:50 Break 16:20 SESSION 1 continued 17:50 Discussion 18:30 End of day 1 programme 18:45 BDA / European Cancer

6 Programme Overview Upcoming Meetings Thursday, 16 January 2014 Friday, 17 January 2014 It is a UNIQUE opportunity to address hurdles and explore potential solutions together with experts from ACADEMIA, INDUSTRY, REGULATORY AUTHORITIES, PATIENT ADVO- CATES and POLICYMAKERS. 8:15 BDA & Industry Panel meeting 10:30 Registration open 9:00 SESSION 2 EQUAL ACCESS: DIFFERENCES & HOW TO DEAL WITH IT ITOC-1: 1 st Immunotherapy of Cancer Conference March 2014 Munich, Germany 11:00 11:00 Break Co-chairs kick-off meeting 11:30 SESSION 2 continued 13:00 Introduction 13:00 Discussion 13:10 13:30 Next Steps Minimal Residual Disease: End-points in clinical trials 13 & 14 MaY 2014 London, United Kingdom SESSION 1 EQUAL ACCESS: CURRENT LANDSCAPE 14:00 Closing Remarks 14:15 End of Day 2 programme Lunch 8 th Alpine Meeting: current & future challenges of oncology drug development October 2014 BUchen/Innsbruck, Austria 15:50 Break 16:20 SESSION 1 continued 17:50 Discussion 18:30 End of day 1 programme 18:45 BDA / European Cancer League Joint Session 19:45 Networking dinner at Hotel Maritim Workshop on companion diagnostics DECEMBER 2014 Brussels, Belgium For more information about BDA, please visit our website:

7 BDA WORKSHOP Access to innovative oncology medicines in Europe January 2014 Bonn, Germany WORKSHOP SECRETARIAT Marjorie Recorbet Biotherapy Development Association (BDA) Avenue Mounier, Brussels Belgium Direct phone marjorie.recorbet@ecco-org.eu Design & Layout: Image: 2014 pdl - Dr. E. Preuß grthirteen - Fotolia.com Van Gogh, Irises, 1889, The J. Paul Getty Museum BIOTHERAPY DEVELOPMENT ASSOCIATION

BDA IMPROVING ONCOLOGY DRUG DEVELOPMENT FOR CHILDREN AND ADOLESCENTS NOVEMBER 2013 WORKSHOP ADVANCE PROGRAMME

BDA IMPROVING ONCOLOGY DRUG DEVELOPMENT FOR CHILDREN AND ADOLESCENTS NOVEMBER 2013 WORKSHOP ADVANCE PROGRAMME BDA WORKSHOP IMPROVING ONCOLOGY DRUG DEVELOPMENT FOR CHILDREN AND ADOLESCENTS 18-19 NOVEMBER 2013 PARIS, FRANCE BIOTHERAPY DEVELOPMENT ASSOCIATION encca European Network for Cancer Research in Children