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REGISTER BY 30TH JUNE AND RECEIVE A £300 DISCOUNT


                             SMi present their 17th Annual Conference on...

             European Pharmaceutical
            Pricing and Reimbursement
                             Monday 31st October & Tuesday 1st November 2011
                                  Radisson Blu Hotel Basel, Switzerland


                                                                   KEYNOTE SPEAKERS:                         OTHER SPEAKERS INCLUDE:
                                                                   Andrea Rappagliosi                        Markus Jahn
                                                                   Vice President, European Government       Manager Pricing
                                                                   Affairs & Head of Brussels Office         Novartis Pharma
                                                                   GlaxoSmithKline                           Henderson Azevedo
                                                                                                             Market Pricing Director Northern &
                                                                   Peter Kolominsky-Rabas                    Central Europe and Canada
                                                                   Director, Interdisciplinary Centre        Novartis Pharma
                                                                   Health Technology Assessment and          Jan Posthumus
                                                                   Public Health                             Head of Market Access & Market Research
                                                                                                             Basilea Pharmaceutica
                                                                                                             International Ltd.
                                                                   Martina Garau
                                                                   Senior Economist                          Frank Thoss, Lawyer
                                                                   Office of Health Economics                Strategic Policy Affairs
                                                                                                             VFA

                                                                   Isabel Henkel                             Elke Hunsche
                                                                   Director Access & Reimbursement           Director, Head of Health Economics &
                                                                   Johnson & Johnson Medical                 Pricing
   2011 has brought huge changes to the                                                                      Actelion Pharmaceuticals
   healthcare landscape – the global economic
   crisis and rising healthcare costs have caused
   governments to take cautious approaches                          CONFERENCE HIGHLIGHTS
   towards pricing and reimbursement. With an                       • Get to grips with the facts and consequences of Germanys AMNOG
   essential review of the key challenges and                       • Debate EU policy challenges in access to medicines in Europe
   developments in VBP, AMNOG and other EU                          • Analyse market access in new emerging markets
   policy challenges, SMi's 17th annual European                    • Understand Value Based Pricing: Principles and practice in the UK
   Pharmaceutical Pricing and Reimbursement                           policy context
                                                                    • Get up to speed with the latest regulations within P&R
   Conference will feature presentations on the
                                                                    • Discover the value of collaboration in HTA and managed entry
   latest P&R issues from the industry’s most
                                                                      schemes
   senior professionals and academics.



                                     PLUS TWO INTERACTIVE POST-CONFERENCE WORKSHOPS
     Sponsored by
                                                Wednesday 2nd November 2011, Radisson Blu Hotel Basel, Basel, Switzerland

                                       Workshop A - Market Access in Emerging Markets: Overview of growth
                                       opportunities and key market access challenges in emerging markets
                                 Hosted by Gustav Ando, Director, Healthcare & Pharma, IHS Global Insight, Aparna Krishnan, Manager, Emerging Markets,
                                  Healthcare & Pharma, IHS Global Insight, Ruben Gennero, Research Analyst, Healthcare & Pharma, IHS Global Insight
                                                                                   8.30am - 12.30pm

                                  Workshop B - Cooperation with Payors as a Means for AttainingReimbursement
                                                     Hosted by Norbert Jersch, Partner, Roman Rittweger Advisors in Healthcare
                                                                                 1.00pm - 5.00pm


www.smi-online.co.uk/2011europricing.asp
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
European Pharmaceutical Pricing and Reimbursement
Day One | Monday 31st October 2011                                                                                                                       www.smi-online.co.uk

8.30      Registration & coffee                                                                                                               ORPHAN DRUGS

9.00      Chairman's opening remarks
          Donald Macarthur, Global Pharmaceutical Business Analyst                                        1.50      Orphan Drug P&R in Europe: Are the payers biting back?
                                                                                                                    • Situation with approved orphan drugs in EU-5
                                 EU POLICY CHALLENGES
                                                                                                                    • Vital role of funding
          KEYNOTE ADDRESS                                                                                           • What payers won't buy
9.10      EU policy challenges in access to medicines in Europe: the value of
          collaboration in HTA and managed entry schemes                                                            • How and where HTA limits access
          • Assessment and Appraisal: is there a scope for European                                                 • Successful company strategies
            collaboration in HTA to prove clinical value to governments and
            payers?                                                                                                 Donald Macarthur, Global Pharmaceutical Business Analyst
          • How the new challenges of “valuable innovation” can be addressed
            in order to meet priorities in healthcare?
                                                                                                          2.30      Orphan Drug Challenges in Europe and Future Opportunities for
          • Will Managed Entry Schemes provide a refined tool to address
            uncertainties in patients access?                                                                       Development
          • Can stakeholders contribute effectively to the setting of shared
                                                                                                                    • Critical success factors and challenges
            rules?
          Andrea Rappagliosi, Vice President, European Government Affairs &                                         • Future opportunities in orphan drug development
          Head of Brussels Office, GlaxoSmithKline
                                                                                                                    Elke Hunsche, Director, Head of Health Economics & Pricing,
          KEYNOTE ADDRESS                                                                                           Actelion Pharmaceuticals
9.50      The role of HTA agencies
          • HTA expectations in late phase development
          • HTA agency policy and practice globally: comparing and contrasting                            3.10      Afternoon Tea
            different models
          • Opportunities for Early Engagement with HTA agencies
          Peter Kolominsky-Rabas, Director, Interdisciplinary Centre, Health                              3.40      Market Access to Orphan Drugs in Italy
          Technology Assessment and Public Health                                                                   • Mechanisms for “early reimbursement” of orphan drugs

10.30     Morning Coffee                                                                                            • The pricing and reimbursement process for orphan drugs
                                                                                                                    • Orphan drugs and innovation
                                             AMNOG
                                                                                                                    Laura Crippa, Director, Market Access and Pricing, Temas S.r.l.
11.00     Pricing in Germany with new AMNOG                                                                         Unipersonale
          • Benefit assessment of launch drugs and in-market brands
          • Pricing roadmap after benefit assessment - fixed price or central
            price-negotiation                                                                             4.20      Change Drivers in pricing and reimbursement practice
          • First experiences with the new regulation and outlook                                                   • Changing macroeconomic environment – countries under economic
          Markus Jahn, Manager Pricing, Novartis Pharma
                                                                                                                       pressure
11.40     Germanys AMNOG: Facts and consequences                                                                    • Envolving stakeholder roles – the patient
          • Regulation of the German pharmaceutical market before AMNOG
            before Jan 1st 2011                                                                                     • P&R evaluation price setting and reimbursement mechanisms
          • AMNOG-process of early benefit assessment and central price-                                            • Increased use of generics and similar - perceptions
            negotiations in detail
          • Possible consequences for other countries                                                               Jorge Wernli, Vice President, Global Pricing and Government Affairs,
          Frank Thoss, Lawyer, Strategic Policy Affairs, VFA - German                                               Vifor Pharma
          Association of Research-Based Pharmaceutical Companies

12.20     Networking Lunch                                                                                5.00      Chairman’s Closing Remarks and Close of Day One


                            Register online at www.smi-online.co.uk/2011europricing.asp • Alternat
PHARMACEUTICAL FORWARD PLANNER
June 2011                                                               18/19      Pharmaceutical and Clinical Trial Logistics Asia       19/20    COPD: Novel Therapeutics and Management
27/28    RNAi, miRNA, siRNA                                                        Pacific (Singapore)                                             Strategies
29/30    Pharmaceutical Portfolio & Product                             20/21      Pre Filled Syringes Asia (Singapore)                   24/25    Point of Care Diagnostics - Market Opportunities and
         Life Cycle Management                                                                                                                     Technology Trends
29/30    Pharmaceutical Nanotechnology                                  September 2011
29/30    KOL Management and MSL                                         19/20   Biomarkers in Clinical Trials                             November 2011
         Best Practice in Europe (Munich, Germany)                      26/27   Biosimilars and Biobetters                                31 Oct/1 Nov European Pharmaceutical Pricing
                                                                        28/29   KOL Liaison and MSL Best Practice                                   & Reimbursement (Switzerland)
July 2011                                                                                                                                 16/17     Clinical Trials in CNS
06/07     ADMET                                                         October 2011                                                      21/22     Cell Based Assay
06/07     Social Media in the Pharmaceutical Industry                   03/04     Managing Partnerships with CROs
11/12     BioBanking                                                    10/11     Pharmaceutical m-Health                                 December 2011
                                                                        12/13     GP Commissioning                                        5/6     Cold Chain Distribution
All conferences take place in central London, UK – unless indicated otherwise in brackets


                                                                                             Supported by
European Pharmaceutical Pricing and Reimbursement
k/2011europricing.asp                                                                                     Day Two | Tuesday 1st November 2011

    8.30      Re- Registration & coffee                                                                 12.20     Networking Lunch

    9.00      Chairman's opening remarks
              Neil Palmer, President and Principal Consultant, PDCI Market                              1.50      The patient’s role in market access in public healthcare systems
              Access Inc
                                                                                                                  • Increasing patient choices in an equitable way
                              ESTABLISHED MARKET OVERVIEW
                                                                                                                  • Patient-reported outcome measures
              KEYNOTE ADDRESS                                                                                     • Achieving maximum levels of patient and market access
    9.10      Value based pricing - Principles and practice in the UK policy
              context                                                                                             Bertram Haussler, Chairman of the Board of Management, IGES
              • Approaches to value base pricing (VBP)
                                                                                                                  Insitut. Berlin
              • Lessons learnt from international experience of VBP
              • Introducing VBP in the UK:
                - The Department of Health consultation
                - How might VBP be implemented and what are the expected                                2.30      The access marketing mix for launch products
                consequences?                                                                                     • Access marketing for the different stakeholders
              Martina Garau, Senior Economist, Office of Health Economics
                                                                                                                  • Preparation for launch from an access perspective: timelines,
              KEYNOTE ADDRESS
                                                                                                                    tools and techniques
    9.50      Market access in European Established Markets
              • Overview of key stakeholders in Europe’s established markets                                      Jan Posthumus, Head of Market Access & Market Research, Basilea
              • Who are the key agencies in the market
              • Understanding HTA regulations in Europe                                                           Pharmaceutica International Ltd
              Isabel Henkel, MPH, Director Access & Reimbursement, Johnson &
              Johnson Medical
                                                                                                        3.10      Afternoon Tea
    10.30     Morning Coffee

                                         MARKET ACCESS                                                  3.40      Latest regulations within pricing and reimbursement

    11.00     Market access in emerging markets                                                                   • EU initiatives in pricing and reimbursement
              • Recent developments and future trends
              • Opportunities and threats - a pharmaceutical industry perspective                                 • Risk Sharing Agreements
              • Lessons from developed markets                                                                    • Patient Access Schemes
              Henderson Azevedo, Market Pricing Director Northern & Central
              Europe and Canada, Novartis Pharma                                                                  James Killick, Partner, White & Case LLP

    11.40     Canadian Market Access Update
              • Overview of Canadian health care system and pharmaceutical                              4.20      Sweden Market Access update
                funding
              • Price regulation and the new Patented Medicine Prices Review                                      • Cost-effectiveness and cost utility
                Board (PMPRB) guidelines
                                                                                                                  • What is the value at stake?
              • CADTH - Common Drug Review (CDR), pCODR (oncology drugs),
                INESSS (Quebec), provincial and private reimbursement schemes                                     • Price analysis for new product candidates
              • Implications of the Ontario 25% pricing rule for generics and the
                evolution of Product Listing Agreements (PLAs)                                                    Jacob Brun, Pricing & Reimbursement Director, AstraZeneca
              • Outlook for Canadian pricing & reimbursement
              W. Neil Palmer, President & Principal Consultant, PDCI Market
              Access Inc.                                                                               5.00      Chairman’s Closing Remarks and Close of Conference



tively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
                                            Sponsored by
                                                                                                           SPONSORSHIP AND EXHIBITION OPPORTUNITIES
                                                  PDCI Market Access (PDCI) is Canada’s leading            SMi offer sponsorship, exhibition, advertising and branding packages,
                                                  pharmaceutical pricing and reimbursement                 uniquely tailored to complement your company’s marketing strategy.
                                                  consultancy. Established in 1996, the firm assists       Prime networking opportunities exist to entertain, enhance and expand
                                                  clients navigate the complex pricing and market          your client base within the context of an independent discussion specific
   access challenges facing pharmaceutical manufacturers. In particular, PDCI helps pharmaceutical         to your industry. Should you wish to join the increasing number of
   companies develop successful pricing and reimbursement strategies and prepare comprehensive             companies benefiting from sponsoring our conferences please call:
   submissions to CADTH/CDR, INESSS, public & private payers and the Patented Medicine Prices              Alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk
   Review Board (PMPRB). The Canadian market access capabilities are supported by PDCI’s
                                                                                                                              Want to know how you can get involved?
   comprehensive public payer claims database and the industry standard Canadian Drug Benefits Plan
                                                                                                                Interested in promoting your pharmaceutical services to this market?
   (CDBP) reference guide. PDCI also maintains extensive databases of international pharmaceutical
   prices in support of PDCI’s international payer research and global pricing strategy engagements.               Contact Kiran Sharma, SMi Marketing on +44 (0)20 7827 6050, or
   Headquartered in Ottawa, PDCI features a senior team of bilingual market access professionals with                             email: ksharma@smi-online.co.uk
   extensive pricing and reimbursement experience. www.pdci.ca
HALF-DAY POST-CONFERENCE WORKSHOP
      Wednesday 2nd November 2011
Radisson Blu Hotel Basel, Basel, Switzerland.
             8.30am - 12.30pm

           Workshop A
Market Access in Emerging Markets
 Overview of growth opportunities
and key market access challenges in
        emerging markets.


In association with


Overview of Workshop
IHS Global Insight Country Intelligence provides constantly
updated analysis of the business conditions, economic
prospects and risks in over 200 countries.

Find out about the growth opportunities in emerging markets
including BRIC-MT countries, Philippines, Indonesia, Kenya
and South Africa. Understand the evolution of healthcare
policies and their impact on pricing and reimbursement.
Identify the unique challenges to market access in these
countries in the context of global pricing and reimbursement
trends.

• Monitor and understand developments as economic and
  political conditions change
• Assess growth and development potential for individual
  economies and regional markets
• Analyze relative risks among countries around the world


Agenda
8.30 Registration and coffee

9.00    Welcome and Introduction

9.10    Emerging Versus Advanced Markets
         • Forecasted Outlook in Emerging Versus Advanced
           Markets
         • Growth Opportunities in Emerging Versus
           Advanced Markets
         • The Unique Challenges of Emerging Markets

9.50    BRIC-MT Markets Overview
         • Best Growth Opportunities in the BRIC-MT Region

10.30    Coffee Break

11.00    Latin America Overview
          • P&R Regulations Evolution in Latin America

11.40   The Next Frontier: Second Tier Emerging Markets
         • Growth opportunities and challenges in
           Philippines, Indonesia, Kenya, South Africa

12.30    Close of workshop


About the Workshop Leaders:
          Ruben Gennero is the healthcare analyst for Latin
          American markets and Spain. Before joining IHS
          Global Insight, Ruben worked at the Chilean
          Ministry of Health as a Health Management and
          was Policy Advisor for the Chilean health
authorities, participating in healthcare and pharmaceutical
reforms assessments and carrying out different proposals as
project manager. He left the Ministry of Health and worked as
an external advisor of GlaxoSmithkline Chile, focusing on
health policy and market access issues.

          Aparna Krishnan is Manager/Senior Research
          Analyst at IHS Global Insight’s Healthcare &
          Pharma Practice in London in charge of the
          practice’s subscription services namely World
          Markets     Healthcare     and    Pricing     &
Reimbursement. Her areas of expertise includes corporate
strategies, health economics, market access, drug pricing
and reimbursement and generics in the pharmaceutical and
healthcare space.

         Gustav Ando leads the Healthcare and Pharma
         Practice at IHS. Formerly a healthcare analyst, he
         has extensive experience in the fields of market
         access, therapeutic development, drug safety,
         emerging markets and health outcomes. He has
developed numerous information tools for pharmaceutical
companies and has led consulting projects on global pricing
trends, reference pricing, risk-sharing agreements,
therapeutic-specific market access strategies, bespoke
database creation and internal corporate P&R strategy
benchmarking.
HALF-DAY POST-CONFERENCE WORKSHOP
      Wednesday 2nd November 2011
Radisson Blu Hotel Basel, Basel, Switzerland.
              1.00pm - 5.00pm

            Workshop B
Cooperation with Payors as a Means
   for Attaining Reimbursement

                      In association with
  Roman Rittweger Advisors in Healthcare
Overview of Workshop
The pricing and reimbursement landscape is increasingly
directed by cost-benefit analyses through government
agencies closely linked to payors' and governments' cost
containment initiatives. In order to convince payors of a
pharmaceutical product's benefit, seeking cooperation
between the pharmaceutical industry and payors is of
utmost importance. In this interactive workshop, we will
work out strategies for approaching the relevant players
of public health systems in order to provide them with
arguments for supporting a product's reimbursement.
“Traditional”cost-saving value added services such as
disease management, targeted patient training or cost-
sharing schemes will be addressed as well as promising
new opportunities from linking smartphone apps to
patient management platforms and to generate
outcomes data from that, e.g. register studies.

This Workshop Will Cover:
• How payors can be motivated to enter pharma
  cooperations
• Some current best practice examples and new ideas
• Development and discussion of participants' own ideas
  for value added services


Agenda
1.00 Registration & Coffee
1.30   Welcome and introduction
1.40 Reimbursement decision-making in key
     European countries
     • The pivotal position of public payors
     • Challenges for the pharmaceutical industry
     • Potential new opportunities
2.10 Interactive work in two-person small teams,
     supported by the workshop leader
     • Concrete services adding value to products to
       be chosen by workshop participants
     • Possible strategies for approaching public payors
3.50   Coffee Break
3.50 Presentation and discussion of ideas developed
     in the working teams
5.00   End of Workshop

For more information and updates visit the conference
website at www.smi-online.co.uk/2011europricing.asp


About the Workshop Leader:
             Norbert Jersch PhD is partner of Roman
             Rittweger Advisors in Healthcare. For several
             years, THEgained business experience at
             ABOUT he SMi PHARMACEUTICAL TEAM
             Roche have been where he hadin the
             SMi Diagnostics         involved     developed
             the diabetes home monitoring 1993 and He
             pharmaceutical industry since market.
             became VP of global product planning and
             have developed a series of informative and
marketing for the diabetes care product line. Norbert
    niche events, covering the latest issues and
Jersch joint and managed two small IT companies which
developed software for documentation and Events
    developments surrounding the industry. QM and
    bring together senior industry professionals and
provided IT services to physicians. In 2002 he managed
    serving companies who have a focus on being at the
4sigma GmbH, an innovative service provider for payors
andforefront of developments in this management. After
      a market leader in disease area. SMi aim to
having restructured and topical discussion its daughters
    generate informed the company and through the
Norbert Jersch entered into theand executive briefings.
    medium of both conferences consulting business. With
his expertise from implementing diabetes care and not
    Our pharmaceutical events are research-based and
only diabetes products he became a pioneer in diabetes
    content driven with regular contact with major
disease management. He successfully set up excellent
    industry personnel and cover a wide range of industry
relations with medical and governmental organizations
    sectors. For more information, please visit www.smi-
including IDF and WHO. He was the organizer of the first
World Diabetes Day in 1991. For the last few years he has
    online.co.uk/pharma
been working on value added service programs and on
eHealth and IT solutions for Pharma and Medtech
companies.
EUROPEAN PHARMACEUTICAL PRICING AND REIMBURSEMENT
    Conference: Monday 31st October & Tuesday 1st November 2011, Radisson Blu Hotel Basel, Switzerland                                            Workshop: Wednesday 2nd November 2011, Switzerland

                                                                                              4 WAYS TO REGISTER
                                       www.smi-online.co.uk/2011europricing.asp
FAX your booking form to +44 (0) 870 9090 712        POST your booking form to: Events Team, SMi Group Ltd, Great Guildford
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European Pharmaceutical Pricing and Reimbursement conference

  • 1. REGISTER BY 30TH JUNE AND RECEIVE A £300 DISCOUNT SMi present their 17th Annual Conference on... European Pharmaceutical Pricing and Reimbursement Monday 31st October & Tuesday 1st November 2011 Radisson Blu Hotel Basel, Switzerland KEYNOTE SPEAKERS: OTHER SPEAKERS INCLUDE: Andrea Rappagliosi Markus Jahn Vice President, European Government Manager Pricing Affairs & Head of Brussels Office Novartis Pharma GlaxoSmithKline Henderson Azevedo Market Pricing Director Northern & Peter Kolominsky-Rabas Central Europe and Canada Director, Interdisciplinary Centre Novartis Pharma Health Technology Assessment and Jan Posthumus Public Health Head of Market Access & Market Research Basilea Pharmaceutica International Ltd. Martina Garau Senior Economist Frank Thoss, Lawyer Office of Health Economics Strategic Policy Affairs VFA Isabel Henkel Elke Hunsche Director Access & Reimbursement Director, Head of Health Economics & Johnson & Johnson Medical Pricing 2011 has brought huge changes to the Actelion Pharmaceuticals healthcare landscape – the global economic crisis and rising healthcare costs have caused governments to take cautious approaches CONFERENCE HIGHLIGHTS towards pricing and reimbursement. With an • Get to grips with the facts and consequences of Germanys AMNOG essential review of the key challenges and • Debate EU policy challenges in access to medicines in Europe developments in VBP, AMNOG and other EU • Analyse market access in new emerging markets policy challenges, SMi's 17th annual European • Understand Value Based Pricing: Principles and practice in the UK Pharmaceutical Pricing and Reimbursement policy context • Get up to speed with the latest regulations within P&R Conference will feature presentations on the • Discover the value of collaboration in HTA and managed entry latest P&R issues from the industry’s most schemes senior professionals and academics. PLUS TWO INTERACTIVE POST-CONFERENCE WORKSHOPS Sponsored by Wednesday 2nd November 2011, Radisson Blu Hotel Basel, Basel, Switzerland Workshop A - Market Access in Emerging Markets: Overview of growth opportunities and key market access challenges in emerging markets Hosted by Gustav Ando, Director, Healthcare & Pharma, IHS Global Insight, Aparna Krishnan, Manager, Emerging Markets, Healthcare & Pharma, IHS Global Insight, Ruben Gennero, Research Analyst, Healthcare & Pharma, IHS Global Insight 8.30am - 12.30pm Workshop B - Cooperation with Payors as a Means for AttainingReimbursement Hosted by Norbert Jersch, Partner, Roman Rittweger Advisors in Healthcare 1.00pm - 5.00pm www.smi-online.co.uk/2011europricing.asp 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
  • 2. European Pharmaceutical Pricing and Reimbursement Day One | Monday 31st October 2011 www.smi-online.co.uk 8.30 Registration & coffee ORPHAN DRUGS 9.00 Chairman's opening remarks Donald Macarthur, Global Pharmaceutical Business Analyst 1.50 Orphan Drug P&R in Europe: Are the payers biting back? • Situation with approved orphan drugs in EU-5 EU POLICY CHALLENGES • Vital role of funding KEYNOTE ADDRESS • What payers won't buy 9.10 EU policy challenges in access to medicines in Europe: the value of collaboration in HTA and managed entry schemes • How and where HTA limits access • Assessment and Appraisal: is there a scope for European • Successful company strategies collaboration in HTA to prove clinical value to governments and payers? Donald Macarthur, Global Pharmaceutical Business Analyst • How the new challenges of “valuable innovation” can be addressed in order to meet priorities in healthcare? 2.30 Orphan Drug Challenges in Europe and Future Opportunities for • Will Managed Entry Schemes provide a refined tool to address uncertainties in patients access? Development • Can stakeholders contribute effectively to the setting of shared • Critical success factors and challenges rules? Andrea Rappagliosi, Vice President, European Government Affairs & • Future opportunities in orphan drug development Head of Brussels Office, GlaxoSmithKline Elke Hunsche, Director, Head of Health Economics & Pricing, KEYNOTE ADDRESS Actelion Pharmaceuticals 9.50 The role of HTA agencies • HTA expectations in late phase development • HTA agency policy and practice globally: comparing and contrasting 3.10 Afternoon Tea different models • Opportunities for Early Engagement with HTA agencies Peter Kolominsky-Rabas, Director, Interdisciplinary Centre, Health 3.40 Market Access to Orphan Drugs in Italy Technology Assessment and Public Health • Mechanisms for “early reimbursement” of orphan drugs 10.30 Morning Coffee • The pricing and reimbursement process for orphan drugs • Orphan drugs and innovation AMNOG Laura Crippa, Director, Market Access and Pricing, Temas S.r.l. 11.00 Pricing in Germany with new AMNOG Unipersonale • Benefit assessment of launch drugs and in-market brands • Pricing roadmap after benefit assessment - fixed price or central price-negotiation 4.20 Change Drivers in pricing and reimbursement practice • First experiences with the new regulation and outlook • Changing macroeconomic environment – countries under economic Markus Jahn, Manager Pricing, Novartis Pharma pressure 11.40 Germanys AMNOG: Facts and consequences • Envolving stakeholder roles – the patient • Regulation of the German pharmaceutical market before AMNOG before Jan 1st 2011 • P&R evaluation price setting and reimbursement mechanisms • AMNOG-process of early benefit assessment and central price- • Increased use of generics and similar - perceptions negotiations in detail • Possible consequences for other countries Jorge Wernli, Vice President, Global Pricing and Government Affairs, Frank Thoss, Lawyer, Strategic Policy Affairs, VFA - German Vifor Pharma Association of Research-Based Pharmaceutical Companies 12.20 Networking Lunch 5.00 Chairman’s Closing Remarks and Close of Day One Register online at www.smi-online.co.uk/2011europricing.asp • Alternat PHARMACEUTICAL FORWARD PLANNER June 2011 18/19 Pharmaceutical and Clinical Trial Logistics Asia 19/20 COPD: Novel Therapeutics and Management 27/28 RNAi, miRNA, siRNA Pacific (Singapore) Strategies 29/30 Pharmaceutical Portfolio & Product 20/21 Pre Filled Syringes Asia (Singapore) 24/25 Point of Care Diagnostics - Market Opportunities and Life Cycle Management Technology Trends 29/30 Pharmaceutical Nanotechnology September 2011 29/30 KOL Management and MSL 19/20 Biomarkers in Clinical Trials November 2011 Best Practice in Europe (Munich, Germany) 26/27 Biosimilars and Biobetters 31 Oct/1 Nov European Pharmaceutical Pricing 28/29 KOL Liaison and MSL Best Practice & Reimbursement (Switzerland) July 2011 16/17 Clinical Trials in CNS 06/07 ADMET October 2011 21/22 Cell Based Assay 06/07 Social Media in the Pharmaceutical Industry 03/04 Managing Partnerships with CROs 11/12 BioBanking 10/11 Pharmaceutical m-Health December 2011 12/13 GP Commissioning 5/6 Cold Chain Distribution All conferences take place in central London, UK – unless indicated otherwise in brackets Supported by
  • 3. European Pharmaceutical Pricing and Reimbursement k/2011europricing.asp Day Two | Tuesday 1st November 2011 8.30 Re- Registration & coffee 12.20 Networking Lunch 9.00 Chairman's opening remarks Neil Palmer, President and Principal Consultant, PDCI Market 1.50 The patient’s role in market access in public healthcare systems Access Inc • Increasing patient choices in an equitable way ESTABLISHED MARKET OVERVIEW • Patient-reported outcome measures KEYNOTE ADDRESS • Achieving maximum levels of patient and market access 9.10 Value based pricing - Principles and practice in the UK policy context Bertram Haussler, Chairman of the Board of Management, IGES • Approaches to value base pricing (VBP) Insitut. Berlin • Lessons learnt from international experience of VBP • Introducing VBP in the UK: - The Department of Health consultation - How might VBP be implemented and what are the expected 2.30 The access marketing mix for launch products consequences? • Access marketing for the different stakeholders Martina Garau, Senior Economist, Office of Health Economics • Preparation for launch from an access perspective: timelines, KEYNOTE ADDRESS tools and techniques 9.50 Market access in European Established Markets • Overview of key stakeholders in Europe’s established markets Jan Posthumus, Head of Market Access & Market Research, Basilea • Who are the key agencies in the market • Understanding HTA regulations in Europe Pharmaceutica International Ltd Isabel Henkel, MPH, Director Access & Reimbursement, Johnson & Johnson Medical 3.10 Afternoon Tea 10.30 Morning Coffee MARKET ACCESS 3.40 Latest regulations within pricing and reimbursement 11.00 Market access in emerging markets • EU initiatives in pricing and reimbursement • Recent developments and future trends • Opportunities and threats - a pharmaceutical industry perspective • Risk Sharing Agreements • Lessons from developed markets • Patient Access Schemes Henderson Azevedo, Market Pricing Director Northern & Central Europe and Canada, Novartis Pharma James Killick, Partner, White & Case LLP 11.40 Canadian Market Access Update • Overview of Canadian health care system and pharmaceutical 4.20 Sweden Market Access update funding • Price regulation and the new Patented Medicine Prices Review • Cost-effectiveness and cost utility Board (PMPRB) guidelines • What is the value at stake? • CADTH - Common Drug Review (CDR), pCODR (oncology drugs), INESSS (Quebec), provincial and private reimbursement schemes • Price analysis for new product candidates • Implications of the Ontario 25% pricing rule for generics and the evolution of Product Listing Agreements (PLAs) Jacob Brun, Pricing & Reimbursement Director, AstraZeneca • Outlook for Canadian pricing & reimbursement W. Neil Palmer, President & Principal Consultant, PDCI Market Access Inc. 5.00 Chairman’s Closing Remarks and Close of Conference tively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711 Sponsored by SPONSORSHIP AND EXHIBITION OPPORTUNITIES PDCI Market Access (PDCI) is Canada’s leading SMi offer sponsorship, exhibition, advertising and branding packages, pharmaceutical pricing and reimbursement uniquely tailored to complement your company’s marketing strategy. consultancy. Established in 1996, the firm assists Prime networking opportunities exist to entertain, enhance and expand clients navigate the complex pricing and market your client base within the context of an independent discussion specific access challenges facing pharmaceutical manufacturers. In particular, PDCI helps pharmaceutical to your industry. Should you wish to join the increasing number of companies develop successful pricing and reimbursement strategies and prepare comprehensive companies benefiting from sponsoring our conferences please call: submissions to CADTH/CDR, INESSS, public & private payers and the Patented Medicine Prices Alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk Review Board (PMPRB). The Canadian market access capabilities are supported by PDCI’s Want to know how you can get involved? comprehensive public payer claims database and the industry standard Canadian Drug Benefits Plan Interested in promoting your pharmaceutical services to this market? (CDBP) reference guide. PDCI also maintains extensive databases of international pharmaceutical prices in support of PDCI’s international payer research and global pricing strategy engagements. Contact Kiran Sharma, SMi Marketing on +44 (0)20 7827 6050, or Headquartered in Ottawa, PDCI features a senior team of bilingual market access professionals with email: ksharma@smi-online.co.uk extensive pricing and reimbursement experience. www.pdci.ca
  • 4. HALF-DAY POST-CONFERENCE WORKSHOP Wednesday 2nd November 2011 Radisson Blu Hotel Basel, Basel, Switzerland. 8.30am - 12.30pm Workshop A Market Access in Emerging Markets Overview of growth opportunities and key market access challenges in emerging markets. In association with Overview of Workshop IHS Global Insight Country Intelligence provides constantly updated analysis of the business conditions, economic prospects and risks in over 200 countries. Find out about the growth opportunities in emerging markets including BRIC-MT countries, Philippines, Indonesia, Kenya and South Africa. Understand the evolution of healthcare policies and their impact on pricing and reimbursement. Identify the unique challenges to market access in these countries in the context of global pricing and reimbursement trends. • Monitor and understand developments as economic and political conditions change • Assess growth and development potential for individual economies and regional markets • Analyze relative risks among countries around the world Agenda 8.30 Registration and coffee 9.00 Welcome and Introduction 9.10 Emerging Versus Advanced Markets • Forecasted Outlook in Emerging Versus Advanced Markets • Growth Opportunities in Emerging Versus Advanced Markets • The Unique Challenges of Emerging Markets 9.50 BRIC-MT Markets Overview • Best Growth Opportunities in the BRIC-MT Region 10.30 Coffee Break 11.00 Latin America Overview • P&R Regulations Evolution in Latin America 11.40 The Next Frontier: Second Tier Emerging Markets • Growth opportunities and challenges in Philippines, Indonesia, Kenya, South Africa 12.30 Close of workshop About the Workshop Leaders: Ruben Gennero is the healthcare analyst for Latin American markets and Spain. Before joining IHS Global Insight, Ruben worked at the Chilean Ministry of Health as a Health Management and was Policy Advisor for the Chilean health authorities, participating in healthcare and pharmaceutical reforms assessments and carrying out different proposals as project manager. He left the Ministry of Health and worked as an external advisor of GlaxoSmithkline Chile, focusing on health policy and market access issues. Aparna Krishnan is Manager/Senior Research Analyst at IHS Global Insight’s Healthcare & Pharma Practice in London in charge of the practice’s subscription services namely World Markets Healthcare and Pricing & Reimbursement. Her areas of expertise includes corporate strategies, health economics, market access, drug pricing and reimbursement and generics in the pharmaceutical and healthcare space. Gustav Ando leads the Healthcare and Pharma Practice at IHS. Formerly a healthcare analyst, he has extensive experience in the fields of market access, therapeutic development, drug safety, emerging markets and health outcomes. He has developed numerous information tools for pharmaceutical companies and has led consulting projects on global pricing trends, reference pricing, risk-sharing agreements, therapeutic-specific market access strategies, bespoke database creation and internal corporate P&R strategy benchmarking.
  • 5. HALF-DAY POST-CONFERENCE WORKSHOP Wednesday 2nd November 2011 Radisson Blu Hotel Basel, Basel, Switzerland. 1.00pm - 5.00pm Workshop B Cooperation with Payors as a Means for Attaining Reimbursement In association with Roman Rittweger Advisors in Healthcare Overview of Workshop The pricing and reimbursement landscape is increasingly directed by cost-benefit analyses through government agencies closely linked to payors' and governments' cost containment initiatives. In order to convince payors of a pharmaceutical product's benefit, seeking cooperation between the pharmaceutical industry and payors is of utmost importance. In this interactive workshop, we will work out strategies for approaching the relevant players of public health systems in order to provide them with arguments for supporting a product's reimbursement. “Traditional”cost-saving value added services such as disease management, targeted patient training or cost- sharing schemes will be addressed as well as promising new opportunities from linking smartphone apps to patient management platforms and to generate outcomes data from that, e.g. register studies. This Workshop Will Cover: • How payors can be motivated to enter pharma cooperations • Some current best practice examples and new ideas • Development and discussion of participants' own ideas for value added services Agenda 1.00 Registration & Coffee 1.30 Welcome and introduction 1.40 Reimbursement decision-making in key European countries • The pivotal position of public payors • Challenges for the pharmaceutical industry • Potential new opportunities 2.10 Interactive work in two-person small teams, supported by the workshop leader • Concrete services adding value to products to be chosen by workshop participants • Possible strategies for approaching public payors 3.50 Coffee Break 3.50 Presentation and discussion of ideas developed in the working teams 5.00 End of Workshop For more information and updates visit the conference website at www.smi-online.co.uk/2011europricing.asp About the Workshop Leader: Norbert Jersch PhD is partner of Roman Rittweger Advisors in Healthcare. For several years, THEgained business experience at ABOUT he SMi PHARMACEUTICAL TEAM Roche have been where he hadin the SMi Diagnostics involved developed the diabetes home monitoring 1993 and He pharmaceutical industry since market. became VP of global product planning and have developed a series of informative and marketing for the diabetes care product line. Norbert niche events, covering the latest issues and Jersch joint and managed two small IT companies which developed software for documentation and Events developments surrounding the industry. QM and bring together senior industry professionals and provided IT services to physicians. In 2002 he managed serving companies who have a focus on being at the 4sigma GmbH, an innovative service provider for payors andforefront of developments in this management. After a market leader in disease area. SMi aim to having restructured and topical discussion its daughters generate informed the company and through the Norbert Jersch entered into theand executive briefings. medium of both conferences consulting business. With his expertise from implementing diabetes care and not Our pharmaceutical events are research-based and only diabetes products he became a pioneer in diabetes content driven with regular contact with major disease management. He successfully set up excellent industry personnel and cover a wide range of industry relations with medical and governmental organizations sectors. For more information, please visit www.smi- including IDF and WHO. He was the organizer of the first World Diabetes Day in 1991. For the last few years he has online.co.uk/pharma been working on value added service programs and on eHealth and IT solutions for Pharma and Medtech companies.
  • 6. EUROPEAN PHARMACEUTICAL PRICING AND REIMBURSEMENT Conference: Monday 31st October & Tuesday 1st November 2011, Radisson Blu Hotel Basel, Switzerland Workshop: Wednesday 2nd November 2011, Switzerland 4 WAYS TO REGISTER www.smi-online.co.uk/2011europricing.asp FAX your booking form to +44 (0) 870 9090 712 POST your booking form to: Events Team, SMi Group Ltd, Great Guildford PHONE on +44 (0) 870 9090 711 Business Square, 30 Great Guildford Street London, SE1 0HS, UK EARLY BIRD □ Book by 30th June to receive £300 off the conference price DISCOUNT CONFERENCE PRICES I would like to attend: (Please tick as appropriate) Fee □ Conference & Interactive Workshops (A & B) £2597.00 □ Conference & One Interactive Workshop £1998.00 Please indicate which workshop you wish to attend: Workshop A □ Workshop B □ Unique Reference Number □ Conference only £1399.00 □ Two Half-Day Workshops (A & B) £1198.00 Our Reference LVP-008 □ One Interactive Workshop £599.00 Please indicate which workshop you wish to attend: Workshop A □ Workshop B □ DELEGATE DETAILS PROMOTIONAL LITERATURE DISTRIBUTION Please complete fully and clearly in capital letters. Please photocopy for additional delegates. □ Distribution of your company’s promotional literature to all conference attendees £999.00 + VAT £1198.80 Title: Forename: GROUP DISCOUNTS AVAILABLE Surname: The conference fee includes refreshments, lunch, conference papers and access Job Title: to the Document Portal containing all of the presentations. Department/Division: Company/Organisation: VENUE Radisson Blu Hotel Basel, Switzerland Email: □ Please contact me to book my hotel Address: Alternatively call us on +44 (0) 870 9090 711, email: hotels@smi-online.co.uk or fax +44 (0) 870 9090 712 Town/City: Post/Zip Code: Country: DOCUMENTATION Direct Tel: Direct Fax: I cannot attend but would like to purchase access to the following Document Portal/paper copy documentation Price Total Mobile: □ Access to the conference documentation Switchboard: on the Document Portal £499.00 + VAT £598.80 □ The Conference Presentations – paper copy £499.00 - £499.00 Signature: Date: (or only £300 if ordered with the Document Portal) I agree to be bound by SMi's Terms and Conditions of Booking. ACCOUNTS DEPT PAYMENT Title: Forename: Payment must be made to SMi Group Ltd, and received before the event, by one of the Surname: following methods quoting reference P-008 and the delegate’s name. Bookings made within 7 days of the event require payment on booking, methods of payment are below. Please Email: indicate method of payment: Address (if different from above): □ UK BACS Sort Code 300009, Account 00936418 □ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU Swift (BIC): LOYDGB21013, Account 00936418 IBAN GB48 LOYD 3000 0900 9364 18 Town/City: □ Cheque We can only accept Sterling cheques drawn on a UK bank. Post/Zip Code: Country: □ Credit Card □ Visa □ MasterCard □ American Express All credit card payments will be subject to standard credit card charges. Direct Tel: Direct Fax: Card No: □□□□ □□□□ □□□□ □□□□ Terms and Conditions of Booking Valid From □□/□□ Expiry Date □□/□□ CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX card Payment: If payment is not made at the time of booking, then an invoice will be issued and must be paid immediately and prior to the start of the event. If payment has not been received then credit card details will be requested and payment taken before entry to the event. Bookings within 7 days of event require payment on booking. Access to the Document Portal will not be given until payment has been received. Cardholder’s Name: Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, another delegate to take your place at any time prior to the start of the event. Two or more delegates may not ‘share’ a place at an event. Please make separate bookings for each delegate. Signature: Date: Cancellation: If you wish to cancel your attendance at an event and you are unable to send a I agree to be bound by SMi's Terms and Conditions of Booking. substitute, then we will refund/credit 50% of the due fee less a £50 administration charge, providing that cancellation is made in writing and received at least 28 days prior to the start of the Card Billing Address (If different from above): event. Regretfully cancellation after this time cannot be accepted. We will however provide the conferences documentation via the Document Portal to any delegate who has paid but is unable to attend for any reason. Due to the interactive nature of the Briefings we are not normally able to provide documentation in these circumstances. We cannot accept cancellations of orders placed for Documentation or the Document Portal as these are reproduced specifically to order. If we have to cancel the event for any reason, then we will make a full refund immediately, but disclaim any further liability. Alterations: It may become necessary for us to make alterations to the content, speakers, timing, venue or date of the event compared to the advertised programme. Data Protection: The SMi Group gathers personal data in accordance with the UK Data Protection Act 1998 and we may use this to contact you by telephone, fax, post or email to tell you about other VAT products and services. Unless you tick here □ we may also share your data with third parties VAT at 20% is charged on Document Portal and Literature Distribution for all UK customers and for offering complementary products or services. If you have any queries or want to update any of the data that we hold then please contact our Database Manager databasemanager@smi-online.co.uk those EU customers not supplying a registration number for their own country here: or visit our website www.smi-online.co.uk/updates quoting the URN as detailed above your address on the attached letter. ____________________________________________________________________________ If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at events@smi-online.co.uk