Pre-conference workshop: Tuesday 28 April 2009
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| Introduction to European market access systems |
 This workshop is designed to provide participants with an up to date understanding of the procedures employed by European health authorities to regulate pricing, reimbursement and market access. We will systematically describe the reimbursement legislation, processes and organisations within each country, including requirements at national, regional and local level as appropriate. The workshop will address the implications of these requirements for the pharmaceutical and/or medical device manufacturer bringing a new product to market. It will also examine the interaction between decisions in different countries, and describe the implications of this. The primary focus will be on the five major markets in Europe, France, Germany, Italy, Spain and the UK.
Jim Furniss, Director, Market Access Solutions
Sasha Richardson, Principal Consultant
Bob Swann, Senior Consultant
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9am | Registration, coffee and introductions
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9.10am | Overview of healthcare systems in Europe
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9.40am | Overview of pricing and reimbursement control systems in Europe
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10.30am | Morning coffee
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10.45am | Market access in France
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11.15am | Market access in Germany
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11.45am | Market access in Italy
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12.15pm | Lunch
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1.30pm | Market access in Spain
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2pm | Market access in the UK
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2.45pm | Interaction between markets – international price referencing and parallel trade
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3.30pm | Afternoon tea
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3.45pm | Trends and likely future development in Europe (including risk sharing)
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4.30pm | Review and discussion
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Day One: Wednesday 29 April 2009
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8.30am | Registration & coffee
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9am | Opening remarks from the chair
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9.15am | Conclusions of EU Commission High Level Pharma Forum; their implementation and the impact on the market access environment
• Background to the forum
• Final conclusions:
- Pricing & reimbursement
- Patient information
- Relative effectiveness
• What impact will the forum have on market access in Europe?
• Implementation challenges
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| | Mr Andrea Rappagliosi, Vice President, Corporate Health Policy & Government Relations, Merck Serono, Switzerland
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9.45am | Price regulation and reform in the UK: view from small / mid size pharma
• EMIG background
• The landscape for smaller pharmaceutical companies
• How the PPRS has impacted on smaller companies to date
• Current re-negotiations
• EMIG’s view of a fairer system
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10.15am | UK; Health Technology Appraisal in the UK
• Latest developments in technology appraisal
• The decision making process and consideration of cost effectiveness
• Schemes, deals and value based pricing
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10.45am | France; latest developments in pricing and reimbursement policy
•Key policy development
•HTA initiatives
•The role of generics
•What reimbursement changes are anticipated in the future?
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| | Dr Francois Meyer, Directeur de l'évaluation médicale, économique et de santé publique, HAS, France
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11.15am | Morning tea
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11.45am | Germany; latest developments in pricing and reimbursement policy
• Short introduction to the operative framework of the Federal Joint Committee
• Introduction of cost-effectiveness analyses and ceiling prices in Germany
• Co-signing procedure for “special” pharmaceuticals
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12.15pm | Panel discussion: improving efficiency and performance in national pharmaceutical policy
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1pm | Lunch
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2pm | Netherlands; latest developments in pricing and reimbursement policy
• Clustering new drugs: straight or jacket?
• Financing hospital drugs: listing or capsizing?
• Pharmacoeconomics: tool or crowbar?
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2.30pm | Sweden; latest changes in reimbursement and pricing policy legislation
• A brief introduction to the Swedish system
• Combining cost effectiveness and severity of disease in decision making
• Important decisions recently made by the TLV, applications from reimbursement on new drugs and from the review
• Changes on the pharmacy side
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3pm | Afternoon tea
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3.30pm | USA; latest developments in pricing and reimbursement policy
• Perspective and process
• Assessment of new drugs
• Cost effectiveness and affordability
• Bridging the evidence gap
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4pm | Canada: latest developments in pricing and reimbursement policy
- Health care system in Canada
- History of the Pharmaceutical Provisions of the Patent Act
- PMPRB Mandate
- Price Regulatory Regime
- Regulations and Guidelines
- Pharmaceutical Trends
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| | Dr Brien Benoit, Chairperson, Patented Medicine Prices Review Board, Canada
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4.30pm | Comparing European, US and Canadian pricing, reimbursement and HTA environments
• Role of HTA agencies, assessments and recommendations
• Prices and price regulation factors (e.g., internal & external referencing)
• Assessing the level of innovation/improvement as part of the P&R process
• Cost-effectiveness thresholds vs. budget impact – which is the critical factor for reimbursement?
• Impact of national, regional and local decision makers
• Outlook and implications of evolving P&R, HTA policies
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| | Mr Neil Palmer, Vice President, Pricing & Reimbursement, RTI Health Solutions, Canada
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5pm | Closing remarks from the chair
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5.15pm | Networking drinks reception
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Day Two: Thursday 30 April 2009
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7.30am | Registration
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8am | Breakfast briefing: the patient’s perspective in reimbursement assessments
 • Discussing the changes in patients involvement in health care decision making
• Discussing the considerations about incorporating the patients’ voice in evaluating treatment benefit for reimbursement decisions
• Showing how appropriate studies including the patients’ perspective can enhance health technology assessments and reimbursement discussions
• Encouraging discussion on the value of the patients’ perspective, identify gaps and challenges of ensuring acceptance of the patients view in technology assessment and reimbursement discussions
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9am | Tea & coffee
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9.15am | Opening remarks from the chair
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| | Mr Jim Furniss, Director, Market Access Solutions, Bridgehead International, United Kingdom
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9.30am | Price reform in Europe: the role of industry
• Trends in price reform
• How are decisions made?
• What role has industry played?
• What working practices should be developed to ensure that beneficial treatments reach patients?
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| | Anne-Toni Rodgers, Director, Government Affairs and Public Policy - Europe, Baxter World Trade SA, Belgium
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10am | Italy; latest developments in pricing policy regulations
• Recent policy initiatives impacting pricing and reimbursement
• The role of AIFA and the regions
• Therapeutic reference pricing
• Future trends
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10.30am | Spain; latest developments in pricing policy regulations
• Reference prices, new groups of drugs, new practice
• The evolution of generics
• Regional developments and implementation of national regulations
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11am | Morning tea & coffee
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11.30am | China; latest developments in pricing and reimbursement policy
• The Chinese healthcare system
• Main insurance cover schemes
• Urban medicare assistance system
• Rural cooperative medical scheme
• Commercial health insurance
• Challenges in obtaining market access
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| | Dr Ziyan Wang, Manager, Health Economics, Johnson & Johnson, Belgium
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12pm | Russia; pricing and reimbursement policy in Russia
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| | Dr Maria Avxentieva, Head of the Research Department of Standardization, Licensing and Accreditation, Moscow Medical Academy
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12.30pm | Pricing and reimbursement strategies for obtaining market access
• Market access outlook: look out!
• What are the questions that payers ask? Can we (and do we want) to answer them?
• Product value proposition; what’s the evidence?
• Critical success factors
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| | Mr Ian Johnson, Technical Director, Evidence Research Unit, United Kingdom
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1pm | Lunch
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2.15pm | More effective use of pharmacoeconomic data in pricing and reimbursement application
• What evidence is required, and how that differs between authorities and markets
• When to start planning to create the right evidence
• How to address gaps in the evidence
• Presenting the evidence effectively
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| | Mr Jim Furniss, Director, Market Access Solutions, Bridgehead International, United Kingdom
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2.45pm | How to use health economic data for evidence based decision making?
• Demand for evidence based decision making at all levels
• Limiting resources and value for money
• Impact of the economic hurdles – for better or worse
• Thresholds – why, how and do they work?
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3.15pm | Panel discussion: partnering with policy makers
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3.45pm | Closing remarks from the chair and afternoon tea
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Post-conference workshop: Friday 1 April 2009
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| Pricing research for pharmaceutical products |
 The appropriate pricing of new medicines is a crucial factor determining profitability within the pharmaceutical industry. An understanding of how demand varies with price and the demand curve is the key to optimal pricing. In this workshop we will demonstrate how factors such as multiple markets and indications, reference pricing, parallel trade, and differences in reimbursement systems combine to form the demand curve. We will then go on to review the types of research that can help us predict the demand curve and improve pricing decisions. In addition, we will look at recent UK policy initiatives that may impact pricing strategy.
Neil Hawkins, Director, Health Economics, Oxford Outcomes
Andrew Lloyd, Director, PRO Group, Oxford Outcomes
Mark Sculpher, Director, Health Economics, Oxford Outcomes
Professor Andrew Briggs, Lindsay Chair in Health Policy & Economic Evaluations, Department of Public Health, University of Glasgow
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10am | Registration, coffee and introductions
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10.10am | Understanding the demand curve
- The principles of pricing
- Factors affecting the demand curve
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12.30pm | Lunch
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1.30pm | Predicting the demand curve
- Cost-effectiveness modelling
- Conjoint analysis
- Focus Groups
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2.30pm | Afternoon tea
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3.30pm | UK policy initiatives
- Value based pricing
- Risk share schemes
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4pm | Closing remarks
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