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European Pharmaceutical
             Pricing & Reimbursement
                       SMi present their 18th annual conference on…




              29th-30th October 2012, Copthorne Tara Hotel, London, UK
REGISTER BY 20TH JULY AND RECEIVE A £300 DISCOUNT




    KEY SPEAKERS INCLUDE:
    Pierrick Rollet                                Anant Murthy
    VP, Global Market Access,                      Senior Director, Pricing and Market
    GlaxoSmithKline                                Access, EMEA,
                                                   Celgene
    Uday Bose
    EMEA, Oncology Business Unit                   Laura Crippa
    Head,                                          Strategic Operations Director,
    Eisai                                          Temas s.r.l.

    Toros Sahin                                    Tomas Dolezal
    Market Access Manager,                         Director,
    Sanofi                                         IHETA

    Michael Wang                         Janie Haigh
    VP, Global Market Access, Grunenthal Practice Leader, Market Access Europe,
                                         Quintiles
    Thilo Schaufler
    Head of Market Access &              Timothy Lenehan,
    Governmental Affairs,                Market Access Director,
    Abbott                               UCB Pharma


    KEY REASONS TO ATTEND:

    •   Hear from experts in the field on Value Based Pricing: Principles and practice




                    PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS
    •   Debate EU policy challenges in access to medicines in Europe
    •   Analyse market access in Russia, Turkey and Eastern Europe
    •   Learn about the latest regulations within pricing and reimbursement from industry




www.pharmaceuticalpricing.co.uk
    •   Understand the facts and consequences of Germany’s AMNOG
    •   Discover the value of collaboration in HTA and managed entry schemes




   A: Developing International Price Referencing systems                B: The potential impact of the German AMNOG on the
                                                                           European Pricing & Reimbursement environment
                                      Wednesday 31st October 2012, Copthorne Tara Hotel, London


     Workshop Leaders: Gary Johnson, Managing Director and
       Nick Taylor, Senior Business Analyst and IPR Expert,              Workshop Leader: Stefan Walzer, General Manager, MArS
                            Inpharmation                                           Market Access & Pricing Strategy UG
                        9.00am – 12.30pm                                                    1.30pm-5.00pm




Register online and receive full information on all of SMi’s conferences
Alternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
   Sponsored by
European Pharmaceutical Pricing & Reimbursement 2012
    Day One Monday 29th October 2012                www.pharmaceu
    8.30       Registration & Coffee                                                           12.20    Networking Lunch

    9.00       Chairman’s Opening Remarks                                                               PRICING AND MARKET ACCESS SYSTEMS ACROSS EUROPE
               Neil Palmer, President and Principal Consultant, PDCI Market Access
                                                                                               1.40     Market Access Strategies in Italy
                        CURRENT DEVELOPMENTS IN THE FIELD                                               •  National phase: new commissions, old commitments?
                                                                                                        •  Recognising and rewarding innovation: the updated algorhythm
    9.10       Evolution of pricing and reimbursement strategies in oncology
                                                                                                        •  Raising awareness in a regulated country
               • Review the payer and pharma perspective with respect to pricing
                                                                                                        •  The approach to Regions
                 and reimbursement
               • Examine key evolutions in how payers have been assessing                               Laura Crippa, Director, Market Access and Pricing, Temas Srl
                 oncology products
               • Review and critique of case studies                                           2.20     Pricing and reimbursement system in Turkey
               • Describe potential changes moving forward and steps Pharma                             • Healthcare Landscape and Latest Developments – where is Turkey
                 should consider to prepare                                                               compared to EU?
               Uday Bose, EMEA, Oncology Business Unit Head, Eisai Europe Ltd                           • Pricing System – how did the reforms had an impact on pricing?
                                                                                                        • Reimbursement System – how is the system working and what are
    9.50       Can talking to payers (or ex-payers) do more harm than good?                               the obstacles?
               • The ritual of talking to a small number of ex-payers, advisers to                      • Expectations for the future
                 payers etc. to investigate how a novel pharmaceutical could be
                                                                                                        Toros Sahin, Market Access Manager, Sanofi
                 priced is well established.  But does it work?
               • Do payers “game” and deliberately mislead?
               • Do payers all think the same way?  And if not, does talking to a              3.00     Survival: The first 2 years of AMNOG
                 very small number of people introduce huge sampling error?                             • AMNOG process: Put into stone? Political update
               • Does what payers say relate to what they actually do?  And, if not,                    • AMNOG learning from history: Which were the mistakes you should
                 could we just analyse their behaviour?                                                   avoid?
               Gary Johnson, Managing Director, Inpharmation                                            • Survived! Key tactics for a successful GBA submission and price
                                                                                                          negotiation
    10.30      Morning Coffee                                                                           Stefan Walzer, General Manager, MArS Market Access & Pricing
                                                                                                        Strategy UG
    11.00      Trends in HTA – What is happening where?




                    Register online at www.pharmaceuticalpricing.co.uk• Alternatively fa
               • An analysis from Quintiles HTA Watch comparing actual
                                                                                               3.40     Afternoon Tea
                 assessments and decisions from leading HTA agencies
               • Update on GB-A and IQWiG decisions – how do these compare with
                 other HTA agencies?                                                           4.00     The Role of the HTA; A Central European Perspective
               • Use of PROs – to what extent can these influence decisions?                            • Recent developments in the region: HTA on the way
               Janice Haigh, Practice Leader, Market Access Europe, Quintiles                           • New legislative and regulatory challenges for pharmaceuticals
                                                                                                        • Market access strategies tailored for CEE markets
    11.40      Implementing HTA in Switzerland - A Multi-Stakeholder Approach                           • How to escape from price reference trap?
               • The Euro-crisis exposed weaknesses of Swiss reimbursement                              • Different approaches to orphan drugs and innovative treatments
                 system, emphasizing need for a more value-based approach                               Tomas Dolezal, Director, IHETA
               • Under the current system, there is little incentive to register new
                 products or additional indications for reimbursement
                                                                                               4.40     The impact of Value Based Pricing in the UK
               • Pharmaceutical industry, health insurances, physician organisation
                                                                                                        • VBP – What will it look like?
                 collaborated to present a joint reform proposal to the Swiss
                 government                                                                             • Challenges for the industry
               • The implementation of formalized HTA in Switzerland will present                       • Impact on innovation
                 further challenges to all stakeholders                                                 Leslie Galloway, Chairman, Ethical Medicines Industry Group
               Thilo Schaufler, Head of Market Access and Governmental Affairs,
               Abbott                                                                          5.20     Chairman’s Closing Remarks and Close of Day One




           Sponsored by
                                    Inpharmation specialises in evidence based market modelling for the pharma industry. All the top 10 global pharma companies are clients.
                                    Inpharmation allows clients to model pricing strategy, international pricing (parellel trade, reference pricing etc.), future sales (forecasting),
                                    promotional response and marketing mix, risk, R&D portfolio. All modelling projects are ‘evidence based’ and are backed up by rigorous research
                                    and validation. Inpharmation’s key capabilities are a strategic understanding of the pharma industry, a detailed knowledge of modelling techniques
                                    and advanced programming skills. www.inpharmation.co.uk
                                    PDCI Market Access (PDCI) is a leading pharmaceutical pricing and reimbursement (P&R) consultancy based in Ottawa and Toronto. Established
                                    in 1996, the firm features a senior team of multilingual market access professionals with extensive experience assisting clients through the
                                    challenging market access environment facing pharmaceutical and medical device manufacturers in Canada. PDCI develops successful P&R
                                    strategies and prepares comprehensive submissions to CDR, pCODR, public & private payers and the PMPRB. The firm’s senior consultants
                                    facilitate meetings with CDR/payers/PMPRB, negotiate product listing agreements (PLAs) and resolve pricing compliance issues with the PMPRB.
                                    As part of its C-MAP research and subscriptions services, PDCI maintains databases of international pharmaceutical prices, provincial drug claims
                                    and costs and is the publisher of the comprehensive Canadian Drug Benefit Plan (CDBP) reference guide that assists subscribers navigate the
                                    complex submission requirements of HTA agencies and reimbursement authorities in Canada. www.pdci.ca

Supported by
European Pharmaceutical Pricing & Reimbursement 2012
ticalpricing.co.uk                   Day Two Tuesday 30th October 2012

     8.30      Re-registration & Coffee                                                       12.20     Networking Lunch

     9.00      Chairman's Opening Remarks                                                     1.30      Latest changes to P&R in Japan
               Gary Johnson, Managing Director, Inpharmation                                            • Launch price setting
                                                                                                        • Price revision
                          MARKET ACCESS FOR ORPHAN DRUGS                                                • Premium for new drug development
                                                                                                        • Promotion of generic use
                                                                                                        • Prospects for Health Technology Assessments
     9.10      Value and patient access considerations: a possible framework                            Donald Macarthur, Global Pharmaceutical Business Analyst,
               for Improving access to rare diseases treatments                                         JustPharmaReports
               • Rare Diseases environment - key facts & features
               • Rare diseases treatments – drivers & challenges for improved                 2.10      Panel Discussion: Market Access Developments:
                 patient access                                                                         Europe vs Rest of the World
               • Value & patient access considerations for rare diseases                                • How can markets adapt to the changes in payer needs
                 treatments: which possible framework for improved patient                              • Methods of flexible financial arrangements
                 access? Options, issues and future directions                                          • What can these markets learn from each other
               Pierrick Rollet, VP, Global Market Access, GlaxoSmithKline                               Chair: Gary Johnson, Managing Director, Inpharmation
                                                                                                        Neil Palmer, President and Principal Consultant, PDCI Market
     9.50      Developments in Orphan Drugs Market Access                                               Access
                                                                                                        Timothy Lenehan, Market Access Director, UCB Pharma
               • EU rules and market access scenario of Orphan Drugs
               • The Italian market access fast track
                                                                                              2.40      Afternoon Tea
               • Premium price
               • Research and development incentives and reward                                                        PRICING UPDATES AND REFORMS
               Fabrizio Gianfrate, Professor of Health Economics,
               University of Ferrara                                                          3.00      Distant Cries: Designing clinical trial needs today for tomorrow’s
                                                                                                        access and pricing
     10.30     Morning Coffee                                                                           • The importance of effective clinical trial design for pricing
                                                                                                        • Advantages in terms of market access
                   WORLDWIDE DEVELOPMENTS IN MARKET ACCESS                                              • Short term effects and long term developments
                                                                                                        Michael Wang, VP, Global Market Access, Grunenthal
     11.00     Canadian Market Access Overview                                                          Cyrus Chowdhury, Managing Director, CB Partners




ax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
               • Overview of Canadian health care system and pharmaceutical
                                                                                              3.40      Risk-Sharing: Developing a commercial strategy
                 funding
                                                                                                        • How should manufacturers define opportunities for innovating
               • Price regulation: impact of the new PMPRB guidelines                                     pricing?
               • CADTH/CDR, pCODR, provincial reimbursement schemes &                                   • Orphan Drugs: How are they different?
                 listing (risk sharing) agreements                                                      • How to weigh challenges and opportunities
               • National implications of the Ontario 20% pricing rule for                              • Innovating pricing in the context of EU P&R reforms
                 generics                                                                               Anant Murthy, Senior Director, Pricing & Market Access, EMEA,
               • Implications of international pricing/reimbursement policy                             Celgene
                 reforms (AMNOG, VBP) on Canada
               • Outlook for Canadian pricing & reimbursement                                 4.20      Effects of the proposed reform of the EU Transparency Directive
               Neil Palmer, President and Principal Consultant, PDCI Market                             • Overview of issues arising under the current Transparency
               Access Inc.                                                                                Directive
                                                                                                        • Proposal to amend the Transparency Directive, including:
                                                                                                          - shorter periods for Member States to take decisions
     11.40     Update on Healthcare Reform in the Russian Federation
                                                                                                          - taking account of HTA procedures
               • Evolution of Reform




  SMi's Pharmaceutical Forward Planner 2012
                                                                                                          - monitoring and sanctioning non-compliance
               • Current Status                                                                         • Prognosis for when the proposal might be adopted
               • What’s Expected                                                                        James Killick, Partner, White & Case L L P
               • What does this mean for Pharma Companies?
               Timothy Lenehan, Market Access Director, UCB Pharma                            5.00      Chairman's Closing Remarks and Close of Day Two




                                                                                                                                       SPONSORSHIP OPPORTUNITIES
                                                                                                                             Our pharmaceutical events are research-based and
                                                                                                                               content-driven with regular contact with major
                                                                                                                            industry personnel and cover a wide range of industry
                                                                                                                              sectors. For more information, please contact Alia
                                                                                                                                   Malick on +44 (0) 207 827 6168 or email
  JULY                                     OCTOBER                                 NOVEMBER
  2-3 KOL Management and MSL Best          3-4 Partnerships with CROs              5-6 Cell Based Assays



                                                                                                                                          amalick@smi-online.co.uk
        Practice in Europe (Switzerland)   8-9 Pharmaceutical Orphan               5-6 Clinical Trials in CNS
  9-10 ADMET                                     Drugs                             28-29 Diabetes



                                                                                                                            Want to know how you can get involved? Interested in
  9-10 Social Media in the                 22-23 COPD: Novel




                                                                                                                              promoting your pharmaceutical services to this
        Pharmaceutical Industry                  Therapeuticsand                   DECEMBER




                                                                                                                                    market? Contact Margaret Mugema,
  11-12 BioBanking                               Management Strategies             3-4 Cold Chain Distribution




                                                                                                                              SMi Marketing on +44 (0)20 7827 6072 or email
                                           24-25 Point of Care Diagnostics




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  SEPTEMBER                                      - Market Opportunities            All conferences take place in central
  17-18 Next Generation Sequencing               and Technology Trends             London, UK
  19-20 Cancer Vaccines                    29-30 European Pharmaceutical Pricing
  24-25 Biosimilars and Biobetters               & Reimbursement
  26-27 KOL Management
A: Developing International
       Price Referencing systems
  HALF-DAY POST-CONFERENCE AM WORKSHOP
         Wednesday 31st October 2012
              9.00am – 12.30pm
         Copthorne Tara Hotel, London




Overview of workshop
  In association with




The workshop will show why understanding the IPR
system is so important in todays economic climate.
Attendees will learn that IPR is a system – a small change
in one part has knock-on effects throughout the system.
The right price in one country and an optimal launch order
can have huge effects on revenues. Modeling systems can
be complicated especially as they often behave counter-
intuitively. However, trying to model everything can lead to
paralyzing complexity. The key to good modelling is a good
understanding of the system – knowing what is important.
The workshop will conclude with a real life case study
demonstrating how correct modelling of the IPR system
can maximise revenues.
Why you should attend:
• Learn how best to develop and apply international
  price referencing
• Discover the importance of correct modeling on
  product success
• Develop techniques to improve of pricing strategies by
  discussing industry case studies
• Evaluate the key points that must be considered when
  modelling this complex system
• Network with key industry professionals

Programme:
8:30  Registration & coffee

9:00    Welcome & introductions

9:10    Why International Price Referencing is
        becoming ever more important

9:45    Examples of the main errors when trying to
        model the effects of international price
        referencing

10:45   Morning coffee break

11:00   The keys to successful modelling of the
        international price referencing system

12:10   Case study showing how correct modelling
        greatly enhances product revenues

12:30   Close of workshop

About the workshop host:
Gary Johnson is Managing Director of Inpharmation Ltd. He
has consulted for all the top 10 pharma companies and many
others too. He is author of the book Principles of
Pharmaceutical Pricing: An Evidence Based Approach and a
finalist for the MCA Business Book of the Year Award. He has
a number of prestigious 'best paper' awards at international
conferences. Prior to founding Inpharmation, Gary held senior
positions in major pharma companies. He has degrees in
Medical Science from Nottingham and Management from
London. He is a Sloan Fellow of London Business School and
a Fellow of the Royal Society of Medicine

About Inpharmation
Inpharmation specialises in evidence based market
modelling for the pharma industry. All the top 10 global
pharma companies are clients. Inpharmation allows clients to
model pricing strategy, international pricing (parallel trade,
reference pricing etc.), future sales (forecasting), promotional
response and marketing mix, risk, R&D portfolio. All
modelling projects are ‘evidence based’ and are backed up by
rigorous research and validation. Inpharmation’s key
capabilities are a strategic understanding of the pharma
industry, a detailed knowledge of modelling techniques and
advanced programming skills.
B: The potential impact of the
      German AMNOG on the
        European Pricing &
   Reimbursement environment
HALF-DAY POST-CONFERENCE PM WORKSHOP
       Wednesday 31st October 2012
             1.30am – 5.00pm
       Copthorne Tara Hotel, London




Overview of workshop
   In association with




The purpose of this workshop is to analyse the potential
impact of the German AMNOG process on the European
Pricing & Reimbursement (P&R) environment. P&R
processes of key European countries will be analysed with
respect to a potential spill-over of the German AMNOG
process. The impact of NICE on various European P&R
decisions is well known. However the impact of the
German AMNOG which focuses much more on evidence
based medicine instead of cost-effectiveness, on other
European P&R negotiations is not yet known but could
have an even greater impact on a European level. The
workshop will introduce briefly the AMNOG process and will
lay out the potential spill-over areas for other European
P&R negotiations. The various European pricing &
reimbursement school of thoughts will be analysed with
respect to the potential impact of the German AMNOG
which will then also be openly discussed with the audience.
Why you should attend:
• Learn how best to develop pricing strategies across
  Europe
• Consider the latest developments in the AMNOG and
  their effects on other national pricing systems
• Understand and predict potential obstacles and discuss
  how best to prepare and avoid them
• Network with key industry professionals
• Utilize the experience of an expert in the field

Programme:
1.30  Welcome and introduction
1.40  The German AMNOG process: A brief re-cap
2.00  European Pricing & Reimbursement (P&R)
      schools of thought and the potential link to
      AMNOG
2.30  Interactive work in small teams supported by
      the workshop leader:
      • AMNOG impact on P&R in the three schools of
        thought
      • Potential opportunities & risks for the various
        stakeholders in case of more or less
        harmonization between
4.00  Coffee break
4.15  Presentation of workshop results
4:45  Re-cap and closure

About the workshop host:
Dr . Walzer has more than 8 years experience in payer strategy and its
implementation and is the founder and general manager MArS Market
Access & Pricing Strategy UG (h.b.) based in Germany. He previously
worked as a payer consultant for various global pharmaceutical and
medical device companies, successfully launching their products across
the world. Dr . Walzer was also the Global Payer Strategy Leader for
various products and compounds of F. Hoffmann – La Roche AG, where
he successfully developed early payer strategies as well as launching
and maintaining the eimbursement process for top oncology brands
and early compounds. Dr Walzer has been working on various projects
around AMNOG in the last years and is well connected to various
academic institutions in Germany and Europe. Dr . Walzer received a
Master of Science in Economics from the University of Tuebingen
(Germany), a PhD in Health Economics from the University of Zurich
(Switzerland) and a Diploma in Clinical Trials from the London School of



About MArS Market Access & Pricing Strategy:
Hygiene and Tropical Medicine (UK). He is co-author of more than 25
peer-reviewed scientific articles and more than 40 scientific abstracts.


MArS Market Access & Pricing Strategy is a specialized
consulting agency in the health care market access area with a
special focus and experience in the following two key areas:
• Global development and market access strategies in the
  various lifecycle stages of a product (Phase I-Phase IV)
• German market access strategies with the focus on the
  German Law for Reforming the Market for Pharmaceuticals
  (AMNOG)
EUROPEAN PHARMACEUTICAL PRICING & REIMBURSEMENT

                                                                                                   4 WAYS TO REGISTER
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                                                                                                                      CONFERENCE PRICES
          Conference: Monday 29th and Tuesday 30th October 2012, Copthorne Tara Hotel, London, UK Workshops: Wednesday 31st October 2012, London




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European Pharmaceutical Pricing & Reimbursement Conference

  • 1. European Pharmaceutical Pricing & Reimbursement SMi present their 18th annual conference on… 29th-30th October 2012, Copthorne Tara Hotel, London, UK REGISTER BY 20TH JULY AND RECEIVE A £300 DISCOUNT KEY SPEAKERS INCLUDE: Pierrick Rollet Anant Murthy VP, Global Market Access, Senior Director, Pricing and Market GlaxoSmithKline Access, EMEA, Celgene Uday Bose EMEA, Oncology Business Unit Laura Crippa Head, Strategic Operations Director, Eisai Temas s.r.l. Toros Sahin Tomas Dolezal Market Access Manager, Director, Sanofi IHETA Michael Wang Janie Haigh VP, Global Market Access, Grunenthal Practice Leader, Market Access Europe, Quintiles Thilo Schaufler Head of Market Access & Timothy Lenehan, Governmental Affairs, Market Access Director, Abbott UCB Pharma KEY REASONS TO ATTEND: • Hear from experts in the field on Value Based Pricing: Principles and practice PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS • Debate EU policy challenges in access to medicines in Europe • Analyse market access in Russia, Turkey and Eastern Europe • Learn about the latest regulations within pricing and reimbursement from industry www.pharmaceuticalpricing.co.uk • Understand the facts and consequences of Germany’s AMNOG • Discover the value of collaboration in HTA and managed entry schemes A: Developing International Price Referencing systems B: The potential impact of the German AMNOG on the European Pricing & Reimbursement environment Wednesday 31st October 2012, Copthorne Tara Hotel, London Workshop Leaders: Gary Johnson, Managing Director and Nick Taylor, Senior Business Analyst and IPR Expert, Workshop Leader: Stefan Walzer, General Manager, MArS Inpharmation Market Access & Pricing Strategy UG 9.00am – 12.30pm 1.30pm-5.00pm Register online and receive full information on all of SMi’s conferences Alternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711 Sponsored by
  • 2. European Pharmaceutical Pricing & Reimbursement 2012 Day One Monday 29th October 2012 www.pharmaceu 8.30 Registration & Coffee 12.20 Networking Lunch 9.00 Chairman’s Opening Remarks PRICING AND MARKET ACCESS SYSTEMS ACROSS EUROPE Neil Palmer, President and Principal Consultant, PDCI Market Access 1.40 Market Access Strategies in Italy CURRENT DEVELOPMENTS IN THE FIELD •  National phase: new commissions, old commitments? •  Recognising and rewarding innovation: the updated algorhythm 9.10 Evolution of pricing and reimbursement strategies in oncology •  Raising awareness in a regulated country • Review the payer and pharma perspective with respect to pricing •  The approach to Regions and reimbursement • Examine key evolutions in how payers have been assessing Laura Crippa, Director, Market Access and Pricing, Temas Srl oncology products • Review and critique of case studies 2.20 Pricing and reimbursement system in Turkey • Describe potential changes moving forward and steps Pharma • Healthcare Landscape and Latest Developments – where is Turkey should consider to prepare compared to EU? Uday Bose, EMEA, Oncology Business Unit Head, Eisai Europe Ltd • Pricing System – how did the reforms had an impact on pricing? • Reimbursement System – how is the system working and what are 9.50 Can talking to payers (or ex-payers) do more harm than good? the obstacles? • The ritual of talking to a small number of ex-payers, advisers to • Expectations for the future payers etc. to investigate how a novel pharmaceutical could be Toros Sahin, Market Access Manager, Sanofi priced is well established.  But does it work? • Do payers “game” and deliberately mislead? • Do payers all think the same way?  And if not, does talking to a 3.00 Survival: The first 2 years of AMNOG very small number of people introduce huge sampling error? • AMNOG process: Put into stone? Political update • Does what payers say relate to what they actually do?  And, if not, • AMNOG learning from history: Which were the mistakes you should could we just analyse their behaviour? avoid? Gary Johnson, Managing Director, Inpharmation • Survived! Key tactics for a successful GBA submission and price negotiation 10.30 Morning Coffee Stefan Walzer, General Manager, MArS Market Access & Pricing Strategy UG 11.00 Trends in HTA – What is happening where? Register online at www.pharmaceuticalpricing.co.uk• Alternatively fa • An analysis from Quintiles HTA Watch comparing actual 3.40 Afternoon Tea assessments and decisions from leading HTA agencies • Update on GB-A and IQWiG decisions – how do these compare with other HTA agencies? 4.00 The Role of the HTA; A Central European Perspective • Use of PROs – to what extent can these influence decisions? • Recent developments in the region: HTA on the way Janice Haigh, Practice Leader, Market Access Europe, Quintiles • New legislative and regulatory challenges for pharmaceuticals • Market access strategies tailored for CEE markets 11.40 Implementing HTA in Switzerland - A Multi-Stakeholder Approach • How to escape from price reference trap? • The Euro-crisis exposed weaknesses of Swiss reimbursement • Different approaches to orphan drugs and innovative treatments system, emphasizing need for a more value-based approach Tomas Dolezal, Director, IHETA • Under the current system, there is little incentive to register new products or additional indications for reimbursement 4.40 The impact of Value Based Pricing in the UK • Pharmaceutical industry, health insurances, physician organisation • VBP – What will it look like? collaborated to present a joint reform proposal to the Swiss government • Challenges for the industry • The implementation of formalized HTA in Switzerland will present • Impact on innovation further challenges to all stakeholders Leslie Galloway, Chairman, Ethical Medicines Industry Group Thilo Schaufler, Head of Market Access and Governmental Affairs, Abbott 5.20 Chairman’s Closing Remarks and Close of Day One Sponsored by Inpharmation specialises in evidence based market modelling for the pharma industry. All the top 10 global pharma companies are clients. Inpharmation allows clients to model pricing strategy, international pricing (parellel trade, reference pricing etc.), future sales (forecasting), promotional response and marketing mix, risk, R&D portfolio. All modelling projects are ‘evidence based’ and are backed up by rigorous research and validation. Inpharmation’s key capabilities are a strategic understanding of the pharma industry, a detailed knowledge of modelling techniques and advanced programming skills. www.inpharmation.co.uk PDCI Market Access (PDCI) is a leading pharmaceutical pricing and reimbursement (P&R) consultancy based in Ottawa and Toronto. Established in 1996, the firm features a senior team of multilingual market access professionals with extensive experience assisting clients through the challenging market access environment facing pharmaceutical and medical device manufacturers in Canada. PDCI develops successful P&R strategies and prepares comprehensive submissions to CDR, pCODR, public & private payers and the PMPRB. The firm’s senior consultants facilitate meetings with CDR/payers/PMPRB, negotiate product listing agreements (PLAs) and resolve pricing compliance issues with the PMPRB. As part of its C-MAP research and subscriptions services, PDCI maintains databases of international pharmaceutical prices, provincial drug claims and costs and is the publisher of the comprehensive Canadian Drug Benefit Plan (CDBP) reference guide that assists subscribers navigate the complex submission requirements of HTA agencies and reimbursement authorities in Canada. www.pdci.ca Supported by
  • 3. European Pharmaceutical Pricing & Reimbursement 2012 ticalpricing.co.uk Day Two Tuesday 30th October 2012 8.30 Re-registration & Coffee 12.20 Networking Lunch 9.00 Chairman's Opening Remarks 1.30 Latest changes to P&R in Japan Gary Johnson, Managing Director, Inpharmation • Launch price setting • Price revision MARKET ACCESS FOR ORPHAN DRUGS • Premium for new drug development • Promotion of generic use • Prospects for Health Technology Assessments 9.10 Value and patient access considerations: a possible framework Donald Macarthur, Global Pharmaceutical Business Analyst, for Improving access to rare diseases treatments JustPharmaReports • Rare Diseases environment - key facts & features • Rare diseases treatments – drivers & challenges for improved 2.10 Panel Discussion: Market Access Developments: patient access Europe vs Rest of the World • Value & patient access considerations for rare diseases • How can markets adapt to the changes in payer needs treatments: which possible framework for improved patient • Methods of flexible financial arrangements access? Options, issues and future directions • What can these markets learn from each other Pierrick Rollet, VP, Global Market Access, GlaxoSmithKline Chair: Gary Johnson, Managing Director, Inpharmation Neil Palmer, President and Principal Consultant, PDCI Market 9.50 Developments in Orphan Drugs Market Access Access Timothy Lenehan, Market Access Director, UCB Pharma • EU rules and market access scenario of Orphan Drugs • The Italian market access fast track 2.40 Afternoon Tea • Premium price • Research and development incentives and reward PRICING UPDATES AND REFORMS Fabrizio Gianfrate, Professor of Health Economics, University of Ferrara 3.00 Distant Cries: Designing clinical trial needs today for tomorrow’s access and pricing 10.30 Morning Coffee • The importance of effective clinical trial design for pricing • Advantages in terms of market access WORLDWIDE DEVELOPMENTS IN MARKET ACCESS • Short term effects and long term developments Michael Wang, VP, Global Market Access, Grunenthal 11.00 Canadian Market Access Overview Cyrus Chowdhury, Managing Director, CB Partners ax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711 • Overview of Canadian health care system and pharmaceutical 3.40 Risk-Sharing: Developing a commercial strategy funding • How should manufacturers define opportunities for innovating • Price regulation: impact of the new PMPRB guidelines pricing? • CADTH/CDR, pCODR, provincial reimbursement schemes & • Orphan Drugs: How are they different? listing (risk sharing) agreements • How to weigh challenges and opportunities • National implications of the Ontario 20% pricing rule for • Innovating pricing in the context of EU P&R reforms generics Anant Murthy, Senior Director, Pricing & Market Access, EMEA, • Implications of international pricing/reimbursement policy Celgene reforms (AMNOG, VBP) on Canada • Outlook for Canadian pricing & reimbursement 4.20 Effects of the proposed reform of the EU Transparency Directive Neil Palmer, President and Principal Consultant, PDCI Market • Overview of issues arising under the current Transparency Access Inc. Directive • Proposal to amend the Transparency Directive, including: - shorter periods for Member States to take decisions 11.40 Update on Healthcare Reform in the Russian Federation - taking account of HTA procedures • Evolution of Reform SMi's Pharmaceutical Forward Planner 2012 - monitoring and sanctioning non-compliance • Current Status • Prognosis for when the proposal might be adopted • What’s Expected James Killick, Partner, White & Case L L P • What does this mean for Pharma Companies? Timothy Lenehan, Market Access Director, UCB Pharma 5.00 Chairman's Closing Remarks and Close of Day Two SPONSORSHIP OPPORTUNITIES Our pharmaceutical events are research-based and content-driven with regular contact with major industry personnel and cover a wide range of industry sectors. For more information, please contact Alia Malick on +44 (0) 207 827 6168 or email JULY OCTOBER NOVEMBER 2-3 KOL Management and MSL Best 3-4 Partnerships with CROs 5-6 Cell Based Assays amalick@smi-online.co.uk Practice in Europe (Switzerland) 8-9 Pharmaceutical Orphan 5-6 Clinical Trials in CNS 9-10 ADMET Drugs 28-29 Diabetes Want to know how you can get involved? Interested in 9-10 Social Media in the 22-23 COPD: Novel promoting your pharmaceutical services to this Pharmaceutical Industry Therapeuticsand DECEMBER market? Contact Margaret Mugema, 11-12 BioBanking Management Strategies 3-4 Cold Chain Distribution SMi Marketing on +44 (0)20 7827 6072 or email 24-25 Point of Care Diagnostics mmugema@smi-online.co.uk SEPTEMBER - Market Opportunities All conferences take place in central 17-18 Next Generation Sequencing and Technology Trends London, UK 19-20 Cancer Vaccines 29-30 European Pharmaceutical Pricing 24-25 Biosimilars and Biobetters & Reimbursement 26-27 KOL Management
  • 4. A: Developing International Price Referencing systems HALF-DAY POST-CONFERENCE AM WORKSHOP Wednesday 31st October 2012 9.00am – 12.30pm Copthorne Tara Hotel, London Overview of workshop In association with The workshop will show why understanding the IPR system is so important in todays economic climate. Attendees will learn that IPR is a system – a small change in one part has knock-on effects throughout the system. The right price in one country and an optimal launch order can have huge effects on revenues. Modeling systems can be complicated especially as they often behave counter- intuitively. However, trying to model everything can lead to paralyzing complexity. The key to good modelling is a good understanding of the system – knowing what is important. The workshop will conclude with a real life case study demonstrating how correct modelling of the IPR system can maximise revenues. Why you should attend: • Learn how best to develop and apply international price referencing • Discover the importance of correct modeling on product success • Develop techniques to improve of pricing strategies by discussing industry case studies • Evaluate the key points that must be considered when modelling this complex system • Network with key industry professionals Programme: 8:30 Registration & coffee 9:00 Welcome & introductions 9:10 Why International Price Referencing is becoming ever more important 9:45 Examples of the main errors when trying to model the effects of international price referencing 10:45 Morning coffee break 11:00 The keys to successful modelling of the international price referencing system 12:10 Case study showing how correct modelling greatly enhances product revenues 12:30 Close of workshop About the workshop host: Gary Johnson is Managing Director of Inpharmation Ltd. He has consulted for all the top 10 pharma companies and many others too. He is author of the book Principles of Pharmaceutical Pricing: An Evidence Based Approach and a finalist for the MCA Business Book of the Year Award. He has a number of prestigious 'best paper' awards at international conferences. Prior to founding Inpharmation, Gary held senior positions in major pharma companies. He has degrees in Medical Science from Nottingham and Management from London. He is a Sloan Fellow of London Business School and a Fellow of the Royal Society of Medicine About Inpharmation Inpharmation specialises in evidence based market modelling for the pharma industry. All the top 10 global pharma companies are clients. Inpharmation allows clients to model pricing strategy, international pricing (parallel trade, reference pricing etc.), future sales (forecasting), promotional response and marketing mix, risk, R&D portfolio. All modelling projects are ‘evidence based’ and are backed up by rigorous research and validation. Inpharmation’s key capabilities are a strategic understanding of the pharma industry, a detailed knowledge of modelling techniques and advanced programming skills.
  • 5. B: The potential impact of the German AMNOG on the European Pricing & Reimbursement environment HALF-DAY POST-CONFERENCE PM WORKSHOP Wednesday 31st October 2012 1.30am – 5.00pm Copthorne Tara Hotel, London Overview of workshop In association with The purpose of this workshop is to analyse the potential impact of the German AMNOG process on the European Pricing & Reimbursement (P&R) environment. P&R processes of key European countries will be analysed with respect to a potential spill-over of the German AMNOG process. The impact of NICE on various European P&R decisions is well known. However the impact of the German AMNOG which focuses much more on evidence based medicine instead of cost-effectiveness, on other European P&R negotiations is not yet known but could have an even greater impact on a European level. The workshop will introduce briefly the AMNOG process and will lay out the potential spill-over areas for other European P&R negotiations. The various European pricing & reimbursement school of thoughts will be analysed with respect to the potential impact of the German AMNOG which will then also be openly discussed with the audience. Why you should attend: • Learn how best to develop pricing strategies across Europe • Consider the latest developments in the AMNOG and their effects on other national pricing systems • Understand and predict potential obstacles and discuss how best to prepare and avoid them • Network with key industry professionals • Utilize the experience of an expert in the field Programme: 1.30 Welcome and introduction 1.40 The German AMNOG process: A brief re-cap 2.00 European Pricing & Reimbursement (P&R) schools of thought and the potential link to AMNOG 2.30 Interactive work in small teams supported by the workshop leader: • AMNOG impact on P&R in the three schools of thought • Potential opportunities & risks for the various stakeholders in case of more or less harmonization between 4.00 Coffee break 4.15 Presentation of workshop results 4:45 Re-cap and closure About the workshop host: Dr . Walzer has more than 8 years experience in payer strategy and its implementation and is the founder and general manager MArS Market Access & Pricing Strategy UG (h.b.) based in Germany. He previously worked as a payer consultant for various global pharmaceutical and medical device companies, successfully launching their products across the world. Dr . Walzer was also the Global Payer Strategy Leader for various products and compounds of F. Hoffmann – La Roche AG, where he successfully developed early payer strategies as well as launching and maintaining the eimbursement process for top oncology brands and early compounds. Dr Walzer has been working on various projects around AMNOG in the last years and is well connected to various academic institutions in Germany and Europe. Dr . Walzer received a Master of Science in Economics from the University of Tuebingen (Germany), a PhD in Health Economics from the University of Zurich (Switzerland) and a Diploma in Clinical Trials from the London School of About MArS Market Access & Pricing Strategy: Hygiene and Tropical Medicine (UK). He is co-author of more than 25 peer-reviewed scientific articles and more than 40 scientific abstracts. MArS Market Access & Pricing Strategy is a specialized consulting agency in the health care market access area with a special focus and experience in the following two key areas: • Global development and market access strategies in the various lifecycle stages of a product (Phase I-Phase IV) • German market access strategies with the focus on the German Law for Reforming the Market for Pharmaceuticals (AMNOG)
  • 6. EUROPEAN PHARMACEUTICAL PRICING & REIMBURSEMENT 4 WAYS TO REGISTER www.pharmaceuticalpricing.co.uk FAX your booking form to +44 (0) 870 9090 712 POST your booking form to: Events Team, SMi Group Ltd, 2nd Floor South, PHONE on +44 (0) 870 9090 711 CONFERENCE PRICES Conference: Monday 29th and Tuesday 30th October 2012, Copthorne Tara Hotel, London, UK Workshops: Wednesday 31st October 2012, London EARLY BIRD Harling House, 47-51 Great Suffolk Street, London, SE1 0BS DISCOUNT DELEGATE DETAILS □ Book by 20th July to receive £300 off the conference price I would like to attend: (Please tick as appropriate) Fee Total □ Conference & 2 Workshops £2697.00 + VAT £3236.40 □ Conference & 1 Workshop £2098.00 + VAT £2517.60 □ Conference only £1499.00 + VAT £1798.80 □ 1 Workshop only £599.00 + VAT £718.80 VENUE □ 2 Workshops only £1198.00 + VAT £1437.60 Unique Reference Number Workshop A □ Workshop B □ Our Reference P-050 DOCUMENTATION PROMOTIONAL LITERATURE DISTRIBUTION GROUP DISCOUNTS AVAILABLE □ Distribution of your company’s promotional literature to all conference attendees £999.00 + VAT £1198.80 Title: Forename: Surname: The Conference fee includes refreshments, lunch, conference papers and Job Title: CD ROM containing all of the presentations. 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