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29th-30th October 2012, Copthorne Tara Hotel, London, UK

KEY SPEAKERS INCLUDE:

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PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPSWednesday 31st October 2012, Copthorne Tara Hotel, London

A: Developing International Price Referencing systemsWorkshop Leaders: Gary Johnson, Managing Director and

Nick Taylor, Senior Business Analyst and IPR Expert,Inpharmation

9.00am – 12.30pm

KEY REASONS TO ATTEND:

• Hear from experts in the field on Value Based Pricing: Principles and practice• 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• Understand the facts and consequences of Germany’s AMNOG• Discover the value of collaboration in HTA and managed entry schemes

Pierrick RolletVP, Global Market Access, GlaxoSmithKline

Uday BoseEMEA, Oncology Business Unit Head,Eisai

Toros SahinMarket Access Manager,Sanofi

Michael WangVP, Global Market Access, Grunenthal

Thilo SchauflerHead of Market Access &Governmental Affairs, Abbott

Anant MurthySenior Director, Pricing and MarketAccess, EMEA, Celgene

Laura CrippaStrategic Operations Director, Temas s.r.l.

Tomas DolezalDirector, IHETA

Janie HaighPractice Leader, Market Access Europe, Quintiles

Timothy Lenehan, Market Access Director, UCB Pharma

SMi present their 18th annual conference on…

European Pharmaceutical Pricing & Reimbursement

B: The potential impact of the German AMNOG on theEuropean Pricing & Reimbursement environment

Workshop Leader: Stefan Walzer, General Manager, MArSMarket Access & Pricing Strategy UG

1.30pm-5.00pm

European Pharmaceutical Pricing & Reimbursement 2012Day One Monday 29th October 2012

Register online at www.pharmaceuticalpricing.co.uk• Alternatively fa

www.pharmaceu

Supported by

Sponsored by

8.30 Registration & Coffee

9.00 Chairman’s Opening RemarksNeil Palmer, President and Principal Consultant, PDCI Market Access

CURRENT DEVELOPMENTS IN THE FIELD

9.10 Evolution of pricing and reimbursement strategies in oncology• Review the payer and pharma perspective with respect to pricing

and reimbursement• Examine key evolutions in how payers have been assessing

oncology products• Review and critique of case studies• Describe potential changes moving forward and steps Pharma

should consider to prepareUday Bose, EMEA, Oncology Business Unit Head, Eisai Europe Ltd

9.50 Can talking to payers (or ex-payers) do more harm than good?• The ritual of talking to a small number of ex-payers, advisers to

payers etc. to investigate how a novel pharmaceutical could bepriced 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

very small number of people introduce huge sampling error? • Does what payers say relate to what they actually do?  And, if not,

could we just analyse their behaviour?Gary Johnson, Managing Director, Inpharmation

10.30 Morning Coffee

11.00 Trends in HTA – What is happening where?• An analysis from Quintiles HTA Watch comparing actual

assessments and decisions from leading HTA agencies• Update on GB-A and IQWiG decisions – how do these compare with

other HTA agencies?• Use of PROs – to what extent can these influence decisions?Janice Haigh, Practice Leader, Market Access Europe, Quintiles

11.40 Implementing HTA in Switzerland - A Multi-Stakeholder Approach• The Euro-crisis exposed weaknesses of Swiss reimbursement

system, emphasizing need for a more value-based approach• Under the current system, there is little incentive to register new

products or additional indications for reimbursement• Pharmaceutical industry, health insurances, physician organisation

collaborated to present a joint reform proposal to the Swissgovernment

• The implementation of formalized HTA in Switzerland will presentfurther challenges to all stakeholders

Thilo Schaufler, Head of Market Access and Governmental Affairs,Abbott

12.20 Networking Lunch

PRICING AND MARKET ACCESS SYSTEMS ACROSS EUROPE

1.40 Market Access Strategies in Italy•  National phase: new commissions, old commitments?•  Recognising and rewarding innovation: the updated algorhythm•  Raising awareness in a regulated country•  The approach to Regions Laura Crippa, Director, Market Access and Pricing, Temas Srl

2.20 Pricing and reimbursement system in Turkey• Healthcare Landscape and Latest Developments – where is Turkey

compared to EU?• Pricing System – how did the reforms had an impact on pricing?• Reimbursement System – how is the system working and what are

the obstacles?• Expectations for the futureToros Sahin, Market Access Manager, Sanofi

3.00 Survival: The first 2 years of AMNOG• AMNOG process: Put into stone? Political update• AMNOG learning from history: Which were the mistakes you should

avoid?• Survived! Key tactics for a successful GBA submission and price

negotiationStefan Walzer, General Manager, MArS Market Access & PricingStrategy UG

3.40 Afternoon Tea

4.00 The Role of the HTA; A Central European Perspective• Recent developments in the region: HTA on the way• New legislative and regulatory challenges for pharmaceuticals• Market access strategies tailored for CEE markets• How to escape from price reference trap?• Different approaches to orphan drugs and innovative treatmentsTomas Dolezal, Director, IHETA

4.40 The impact of Value Based Pricing in the UK• VBP – What will it look like?• Challenges for the industry• Impact on innovationLeslie Galloway, Chairman, Ethical Medicines Industry Group

5.20 Chairman’s Closing Remarks and Close of Day One

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 researchand validation. Inpharmation’s key capabilities are a strategic understanding of the pharma industry, a detailed knowledge of modelling techniquesand 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. Establishedin 1996, the firm features a senior team of multilingual market access professionals with extensive experience assisting clients through thechallenging market access environment facing pharmaceutical and medical device manufacturers in Canada. PDCI develops successful P&Rstrategies and prepares comprehensive submissions to CDR, pCODR, public & private payers and the PMPRB. The firm’s senior consultantsfacilitate 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 claimsand costs and is the publisher of the comprehensive Canadian Drug Benefit Plan (CDBP) reference guide that assists subscribers navigate thecomplex submission requirements of HTA agencies and reimbursement authorities in Canada. www.pdci.ca

ax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711

ticalpricing.co.uk

8.30 Re-registration & Coffee

9.00 Chairman's Opening RemarksGary Johnson, Managing Director, Inpharmation

MARKET ACCESS FOR ORPHAN DRUGS

9.10 Value and patient access considerations: a possible framework for Improving access to rare diseases treatments • Rare Diseases environment - key facts & features • Rare diseases treatments – drivers & challenges for improved

patient access• Value & patient access considerations for rare diseases

treatments: which possible framework for improved patientaccess? Options, issues and future directions

Pierrick Rollet, VP, Global Market Access, GlaxoSmithKline

9.50 Developments in Orphan Drugs Market Access• EU rules and market access scenario of Orphan Drugs• The Italian market access fast track• Premium price• Research and development incentives and rewardFabrizio Gianfrate, Professor of Health Economics, University of Ferrara

10.30 Morning Coffee

WORLDWIDE DEVELOPMENTS IN MARKET ACCESS

11.00 Canadian Market Access Overview • Overview of Canadian health care system and pharmaceutical

funding • Price regulation: impact of the new PMPRB guidelines• CADTH/CDR, pCODR, provincial reimbursement schemes &

listing (risk sharing) agreements • National implications of the Ontario 20% pricing rule for

generics• Implications of international pricing/reimbursement policy

reforms (AMNOG, VBP) on Canada • Outlook for Canadian pricing & reimbursement Neil Palmer, President and Principal Consultant, PDCI MarketAccess Inc.

11.40 Update on Healthcare Reform in the Russian Federation• Evolution of Reform• Current Status• What’s Expected• What does this mean for Pharma Companies?Timothy Lenehan, Market Access Director, UCB Pharma

12.20 Networking Lunch

1.30 Latest changes to P&R in Japan• Launch price setting• Price revision• Premium for new drug development• Promotion of generic use• Prospects for Health Technology AssessmentsDonald Macarthur, Global Pharmaceutical Business Analyst,JustPharmaReports

2.10 Panel Discussion: Market Access Developments: Europe vs Rest of the World• How can markets adapt to the changes in payer needs• Methods of flexible financial arrangements• What can these markets learn from each otherChair: Gary Johnson, Managing Director, InpharmationNeil Palmer, President and Principal Consultant, PDCI MarketAccessTimothy Lenehan, Market Access Director, UCB Pharma

2.40 Afternoon Tea

PRICING UPDATES AND REFORMS

3.00 Distant Cries: Designing clinical trial needs today for tomorrow’s access and pricing• The importance of effective clinical trial design for pricing• Advantages in terms of market access• Short term effects and long term developmentsMichael Wang, VP, Global Market Access, GrunenthalCyrus Chowdhury, Managing Director, CB Partners

3.40 Risk-Sharing: Developing a commercial strategy• How should manufacturers define opportunities for innovating

pricing?• Orphan Drugs: How are they different? • How to weigh challenges and opportunities • Innovating pricing in the context of EU P&R reformsAnant Murthy, Senior Director, Pricing & Market Access, EMEA,Celgene

4.20 Effects of the proposed reform of the EU Transparency Directive• Overview of issues arising under the current Transparency

Directive• Proposal to amend the Transparency Directive, including:

- shorter periods for Member States to take decisions - taking account of HTA procedures - monitoring and sanctioning non-compliance

• Prognosis for when the proposal might be adopted James Killick, Partner, White & Case L L P

5.00 Chairman's Closing Remarks and Close of Day Two

JULY2-3 KOL Management and MSL Best

Practice in Europe (Switzerland)9-10 ADMET9-10 Social Media in the

Pharmaceutical Industry11-12 BioBanking

SEPTEMBER17-18 Next Generation Sequencing19-20 Cancer Vaccines24-25 Biosimilars and Biobetters26-27 KOL Management

OCTOBER3-4 Partnerships with CROs8-9 Pharmaceutical Orphan

Drugs22-23 COPD: Novel

TherapeuticsandManagement Strategies

24-25 Point of Care Diagnostics- Market Opportunitiesand Technology Trends

29-30 European Pharmaceutical Pricing& Reimbursement

NOVEMBER5-6 Cell Based Assays5-6 Clinical Trials in CNS28-29 Diabetes

DECEMBER3-4 Cold Chain Distribution

All conferences take place in centralLondon, UK

SMi's Pharmaceutical Forward Planner 2012 SPONSORSHIP OPPORTUNITIESOur pharmaceutical events are research-based and

content-driven with regular contact with majorindustry personnel and cover a wide range of industry

sectors. For more information, please contact AliaMalick on +44 (0) 207 827 6168 or email

amalick@smi-online.co.uk

Want to know how you can get involved? Interested inpromoting your pharmaceutical services to this

market? Contact Margaret Mugema, SMi Marketing on +44 (0)20 7827 6072 or email

mmugema@smi-online.co.uk

European Pharmaceutical Pricing & Reimbursement 2012Day Two Tuesday 30th October 2012

Overview of workshopThe workshop will show why understanding the IPRsystem is so important in todays economic climate.Attendees will learn that IPR is a system – a small changein one part has knock-on effects throughout the system.The right price in one country and an optimal launch ordercan have huge effects on revenues. Modeling systems canbe complicated especially as they often behave counter-intuitively. However, trying to model everything can lead toparalyzing complexity. The key to good modelling is a goodunderstanding of the system – knowing what is important.The workshop will conclude with a real life case studydemonstrating how correct modelling of the IPR systemcan 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. Hehas consulted for all the top 10 pharma companies and manyothers too. He is author of the book Principles ofPharmaceutical Pricing: An Evidence Based Approach and afinalist for the MCA Business Book of the Year Award. He hasa number of prestigious 'best paper' awards at internationalconferences. Prior to founding Inpharmation, Gary held seniorpositions in major pharma companies. He has degrees inMedical Science from Nottingham and Management fromLondon. He is a Sloan Fellow of London Business School anda Fellow of the Royal Society of Medicine

About InpharmationInpharmation specialises in evidence based marketmodelling for the pharma industry. All the top 10 globalpharma companies are clients. Inpharmation allows clients tomodel pricing strategy, international pricing (parallel trade,reference pricing etc.), future sales (forecasting), promotionalresponse and marketing mix, risk, R&D portfolio. Allmodelling projects are ‘evidence based’ and are backed up byrigorous research and validation. Inpharmation’s keycapabilities are a strategic understanding of the pharmaindustry, a detailed knowledge of modelling techniques andadvanced programming skills.

A: Developing InternationalPrice Referencing systems

HALF-DAY POST-CONFERENCE AM WORKSHOPWednesday 31st October 2012

9.00am – 12.30pmCopthorne Tara Hotel, London

In association with

B: The potential impact of theGerman AMNOG on the

European Pricing &Reimbursement environment

In association with

HALF-DAY POST-CONFERENCE PM WORKSHOPWednesday 31st October 2012

1.30am – 5.00pmCopthorne Tara Hotel, London

Overview of workshopThe purpose of this workshop is to analyse the potentialimpact of the German AMNOG process on the EuropeanPricing & Reimbursement (P&R) environment. P&Rprocesses of key European countries will be analysed withrespect to a potential spill-over of the German AMNOGprocess. The impact of NICE on various European P&Rdecisions is well known. However the impact of theGerman AMNOG which focuses much more on evidencebased medicine instead of cost-effectiveness, on otherEuropean P&R negotiations is not yet known but couldhave an even greater impact on a European level. Theworkshop will introduce briefly the AMNOG process and willlay out the potential spill-over areas for other EuropeanP&R negotiations. The various European pricing &reimbursement school of thoughts will be analysed withrespect to the potential impact of the German AMNOGwhich 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 introduction1.40 The German AMNOG process: A brief re-cap2.00 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 break4.15 Presentation of workshop results4:45 Re-cap and closure

About the workshop host:Dr . Walzer has more than 8 years experience in payer strategy and itsimplementation and is the founder and general manager MArS MarketAccess & Pricing Strategy UG (h.b.) based in Germany. He previouslyworked as a payer consultant for various global pharmaceutical andmedical device companies, successfully launching their products acrossthe world. Dr . Walzer was also the Global Payer Strategy Leader forvarious products and compounds of F. Hoffmann – La Roche AG, wherehe successfully developed early payer strategies as well as launchingand maintaining the eimbursement process for top oncology brandsand early compounds. Dr Walzer has been working on various projectsaround AMNOG in the last years and is well connected to variousacademic institutions in Germany and Europe. Dr . Walzer received aMaster 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 ofHygiene and Tropical Medicine (UK). He is co-author of more than 25peer-reviewed scientific articles and more than 40 scientific abstracts.

About MArS Market Access & Pricing Strategy:MArS Market Access & Pricing Strategy is a specializedconsulting agency in the health care market access area with aspecial 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 & REIMBURSEMENTConference: Monday 29th and Tuesday 30th October 2012, Copthorne Tara Hotel, London, UK Workshops: Wednesday 31st October 2012, London

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