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Published by: SMI Publishing, Ltd
Published: Mar. 20, 2006
Table of Contents
- Day 1
- 8.30 Registration & Coffee
- 9.00 Chairman's Opening Remarks
- Mr Boris Simkovich, President, Light Management Consulting LLC.
- 9.10 KEYNOTE ADDRESS
- Introducing the North American pricing and reimbursement system
- The current pricing and reimbursement structure in North America
- Developments in the system and their effects on the North American pharmaceutical industry
- What are the key factors that have brought about these changes?
- Who are the key stakeholders in the pricing and reimbursement market?
- Key changes which could take place in the future
- Implications of recent changes and potential developments on the European market
- Mr Boris Simkovich, President, Light Management Consulting LLC.
- 9.50 EUROPE AND NORTH AMERICA
- A comparison of their pricing methodologies in a competitive marketplace
- What are the main differences between the two pricing and reimbursement structures?
- Which is deemed the most successful?
- Who are the major stakeholders in both markets? Do their interests overlap?
- How does the pricing of drugs within the European market affect the price in North America?
- Will these two major markets become more entwined in the future?
- What can we learn?
- Mr Gary Johnson, Managing Director, Inpharmation.
- 10.30 Morning Coffee
- 11.00 US STATE GOVERNMENT ISSUES
- How does the government affect the pricing and reimbursement system in North America
- Discussion of the state legislative environment
- States explore healthcare reforms
- - Medicaid
- - Universal care
- - Single payer initiatives
- Reimbursement restrictions/cost containment measures on the rise
- How does the government deal with increasing pressure to legalise importation?
- Anti-marketing initiatives aimed at the pharmaceutical industry? Do they work?
- Mrs Kathy Feegel, Senior Director, State Government Affairs, Amgen .
- 11.40 THE IMPACT OF OBRA 90 AND THE VETERANS HEALTHCARE ACT OF 1992 ON PRICING IN THE US AND IMPLICATIONS WORLDWIDE
- Why did OBRA 90 lead to The Veterans Healthcare Act of 1992
- An overview of The Veterans Healthcare Act of 1992
- Overview of three mandated pricing programmes (FSS, FCP. 340B)
- How are prices calculated and negotiated with the Federal Government?
- Who has access to these mandated deep discounts?
- What are manufacturers required to do to maintain compliance with these programmes?
- Is this an early look at future price controls in the United States?
- What impact, if any do these programmes have on pricing outside the United States?
- Mr Thomas Fuchs, Director, Pharmaceuticals, KPMG LLP.
- 12.20 Networking Lunch
- 1.50 IMPROVING DRUG COMPLIANCE IN THE NORTH AMERICAN MARKET
- What effect did the 2003 Medicare Prescription Drug Act have on drug compliance?
- The impact of improved drug compliance in the US?
- Exploring the impact outside the US?
- How to comply with the Medicare and Medicaid pharmaceutical pricing scheme
- Compliance with state and federal regulations - challenges/limitations
- What does this mean for the industry?
- Ashok David Marin, Assistant General Counsel, US Pharmaceutical Operations, Sanofi-Aventis.
- 2.30 RECENT CHANGES TO US REIMBURSEMENT FOR PHYSICIAN-ADMINISTERED DRUGS AND SERVICES
- Summary of historical concerns regarding Medicare payment for physician-administered drugs and biologicals
- Changes in the MMA implemented to address these concerns
- Other methods employed to help ensure continued beneficiary access to life-saving treatments and quality care
- Implications of these changes on providers, patients and manufacturers
- Ms Sarah Pitluck, Principal Analyst, Genentech.
- 3.10 Afternoon Tea
- 3.40 MEDICARE DRUG BENEFIT
- Part D of Medicare
- What is it and how does it work?
- Medicare eligible patients account for half the US pharma market, this is larger than the Japanese market - how many will be covered by the new plan?
- What impact will the Medicare reform have on the US pricing of drugs for seniors?
- How will discounting to Medicare plans spill over into the rest of the market?
- Anyone who wants drug coverage through the new benefit must join a Medicare approved private insurance plan - does this complicate the process?
- How did drug benefit come to be designed this way?
- Mr Jeffrey Berkowitz, Group Vice President, US Managed Markets, Schering-Plough Corp.
- 4.20 OPTIMISING MARKET ACCESS IN NORTH AMERICA
- How can this be achieved successfully?
- How are benefit designs evolving and what are the implications for pharmaceutical manufacturers?
- What are the main barriers hindering access to the North American market?
- What are typical formulary management tools and philosophies and how are they impacting access?
- How is the Medicare part D benefit changing the environment?
- What are future trends?
- What strategies will be successful in the evolving marketplace?
- Marc Benoff, US Practice Leader, Cambridge Pharma Consultancy (a unit of IMS).
- Ms Pamela Santoni, Sr. Principal, Cambridge Pharma Consultancy (a unit of IMS).
- 5.00 Chairman’s Closing Remarks and Close of Day One
- Mr Boris Simkovich, President, Light Management Consulting LLC.
- Day 2
- 8.30 Registration & Coffee
- 9.00 Chairman's Opening Remarks
- Dr G. Lawrence Atkins, Senior Director, Public Policy & Reimbursement, Schering-Plough.
- 9.10 PATIENT REPORTED OUTCOMES AND ECONOMIC EVALUATION
- The requirements in the North American pharmaceutical market
- The existing role of PRO information in regulatory and healthcare decision making
- Evidence required by different stakeholders for decision making
- Barriers, limitations and needs for PRO information
- Recommendations for submitting PRO data to regulators and healthcare decision-makers
- The future role of PRO and economic evaluation
- Dr Andreas Pleil, Director, Worldwide Outcomes Research, Pfizer.
- 9.50 THE IMPACT OF CHANGES IN US PRICING AND REIMBURSEMENT
- How will the evolving US market effect pricing and return on investment
- Medicare Part D role in transforming the US market
- Growing dominance of managed markets in the US and effect on pricing
- Emergence of evidence-based medicine in coverage and reimbursement decisions
- Effect of Medicare coverage decisions on access to US markets
- Convergence of North American and European coverage and reimbursement
- Influence of reimbursement on development of new drugs
- Dr G. Lawrence Atkins, Senior Director, Public Policy & Reimbursement, Schering-Plough.
- 10.30 Morning Coffee
- 11.00 PRICING STRATEGIES FOR NEW DRUGS
- How does the pricing of new drugs differ from established drugs?
- Understanding the price potential of a new drug
- Optimising future returns
- Portfolio evaluations
- Lifecycle planning
- How vital is pricing for the overall success of a new drug?
- Dr Kevin Mayo, Adjunct Professor, University of the Sciences Philadelphia.
- 11.40 FUTURE PRICING SCENARIOS IN THE US
- The potential of the North American pricing structure
- Key issues and market environments making up the pricing landscape
- Conducting pricing and regulation evaluations for products throughout the development lifecycle
- Best case scenario
- Worst case scenario
- What is the most likely scenario for future pricing in North America?
- Ms Kathleen Hughes, Vice President & Director of Consulting Operations, Covance.
- 12.20 Networking Lunch
- 1.50 CANADIAN PERSPECTIVE
- Overview of Canadian pricing and reimbursement and the impact of the United State
- What are the main differences between the US and Canada
- Canadian price regulations and the Patented Medicine Prices Review Board (PMPRB)
- Canadian reimbursement schemes and the impact of the Common Drug Review (CDR)
- Optimizing market access in Canada while respecting global pricing bands
- Candian price increases: An endangered species?
- Impact of US Medicare Part D on Canada - impact of Canadian prices on the U.S
- Prospects for Canada/ US cross-border trade & re-importation
- The price gap between Canada, Europe and the United States - what are the implications?
- Canadian outlook: integration of government pricing & reimbursement schemes?
- Mr Neil Palmer, Principal Consultant, Palmer D'Angelo Consulting INCORPORATED.
- 2.30 THE LATIN AMERICAN PERSPECTIVE
- How does the Latin American market affect the North American pharmaceutical market?
- What are the differences between the North American and the Latin American pricing and reimbursement system?
- What is the future for Mexico?
- Parallel import is not an organised trade between North America and Latin America, will this ever become a threat?
- How will the pharmaceutical industry react?
- What is the future of the Latin American region?
- Mr Paul Doulton, Founding Partner, Oriundo.
- 3.10 Afternoon Tea
- 3.40 REIMPORTATION AND PARALLEL TRADE
- How do parallel trade and reimportation affect the North American pharmaceutical market?
- What is the current status of parallel import legislation in North America?
- How will the Medicare drug coverage impact the reimportation debate?
- Ensuring the safety of drugs, combating counterfeit drugs
- There is a movement toward parallel especially on a state level - will it become accepted on a national level?
- What are the risks tied to reimportation and parallel trade?
- What is the alternative? How can prices be reduced in the U.S?
- Mr Donald Zowader, Manager, Government Affairs, Takeda Pharmaceuticals.
- 4.20 PANEL DISCUSSION
- The reimportation debate
- What would be the effects of a change in the law regarding reimportation and parallel trade?
- Is this likely to happen?
- Effects on the pharmaceutical industry
- Effects on American citizens
- How do Latin America and Canada affect this debate?
- Mrs Kathy Feegel, Senior Director, State Government Affairs, Amgen .
- Mr Paul Doulton, Founding Partner, Oriundo.
- Mr Donald Macarthur, Senior Consultant, PriceSpective .
- Representative of Health Policy, , Health Canada.
- 5.00 Chairman’s Closing Remarks and Close of Day One
- Dr G. Lawrence Atkins, Senior Director, Public Policy & Reimbursement, Schering-Plough
AbstractFollowing a series of well received conferences run specifically on pricing and reimbursement in the pharmaceutical industry, SMi are delighted to announce its 2nd annual Pharmaceutical Pricing and Reimbursement in North America event. In recent years, maximising prices and securing reimbursement status for a product has become increasingly important for pharmaceutical companies as they struggle to achieve a higher return in investment from current and future drugs. This conference aims to discuss in detail the North American market; taking an in-depth analysis of current and future pricing strategies, best practices and regulation as it affects both the US and Canadian markets.
This conference offers you the essential information to keep abreast of the current pricing and reimbursement situation in North America, detailing the recent changes to the Medicare and Medicaid systems, parallel trade and reimportation, price optimisation strategies and case studies from leading experts in the industry. This conference will also seek to explore why the US drug prices are so much higher than those of their Canadian, Latin American and European counterparts and detail how best to access the American market. Gain a detailed understanding of a drug’s potential price profile and optimise future returns today by attending this essential event for the pricing and reimbursement arena!
Speakers include:
- Jeffrey Berkowitz, Group Vice President, US Managed Markets, Schering-Plough
- Kathy Feegel, Senior Director, State Government Affairs, Amgen
- Dr G. Lawrence Atkins, Senior Director, Public Policy & Reimbursement, Schering-Plough
- Dr Andreas Pleil, Director, Worldwide Outcome Research, Pfizer
- Barbara Edelman Lewis, Director, Health Economics & Outcomes Research, AstraZeneca
- Ashok Marin, Assistant General Counsel, US Pharmaceutical Operations, Sanofi-Aventis
- Sarah Pitluck, Prinicpal Analyst, Genentech
- Dr Kevin Mayo, Adjunct Professor, University of the Sciences in Philadelphia
- Dr Boris Simkovich, President, Light Management Consultancy
- Representative of Health Policy, Health Canada
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