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Pharmaceutical Pricing & Reimbursement in North America
20 March - 21 March 2006
Pharmaceutical Pricing & Reimbursement in North America

Following a series of well received conferences run specifically on pricing and reimbursement in the pharmaceutical industry, SAE Media Group 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
  • Conference agenda

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Boris Simkovich

    Boris Simkovich, President, Light Management Consulting LLC

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    9:10

    KEYNOTE ADDRESS

    Boris Simkovich

    Boris Simkovich, President, Light Management Consulting LLC

  • 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
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    9:50

    EUROPE AND NORTH AMERICA

    Gary Johnson

    Gary Johnson, Managing Director, Inpharmation

  • 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?
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    10:30

    Morning Coffee

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    11:00

    US STATE GOVERNMENT ISSUES

    Kathy Feegel

    Kathy Feegel, Senior Director, State Government Affairs, Amgen

  • 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?
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    11:40

    THE IMPACT OF OBRA 90 AND THE VETERANS HEALTHCARE ACT OF 1992 ON PRICING IN THE US AND IMPLICATIONS WORLDWIDE

    Thomas Fuchs

    Thomas Fuchs, Director, Pharmaceuticals, KPMG LLP

  • 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?
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    12:20

    Networking Lunch

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    13:50

    IMPROVING DRUG COMPLIANCE IN THE NORTH AMERICAN MARKET

    Ashok David Marin

    Ashok David Marin, Assistant General Counsel, US Pharmaceutical Operations, Sanofi-Aventis

  • 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?
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    14:30

    RECENT CHANGES TO US REIMBURSEMENT FOR PHYSICIAN-ADMINISTERED DRUGS AND SERVICES

    Sarah Pitluck

    Sarah Pitluck, Principal Analyst, Genentech

  • 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
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    15:10

    Afternoon Tea

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    15:40

    MEDICARE DRUG BENEFIT

    Jeffrey Berkowitz

    Jeffrey Berkowitz, Group Vice President, US Managed Markets, Schering-Plough

  • 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?
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    16:20

    OPTIMISING MARKET ACCESS IN NORTH AMERICA

  • 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

    Marc Benoff, US Practice Leader, Cambridge Pharma Consultancy (a unit of IMS)

    Pamela Santoni

    Pamela Santoni, Sr. Principal, Cambridge Pharma Consultancy (a unit of IMS)

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    17:00

    Chairman’s Closing Remarks and Close of Day One

    Boris Simkovich

    Boris Simkovich, President, Light Management Consulting LLC

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    G. Lawrence Atkins

    G. Lawrence Atkins, Senior Director, Public Policy & Reimbursement, Schering-Plough

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    9:10

    PATIENT REPORTED OUTCOMES AND ECONOMIC EVALUATION

    Andreas Pleil

    Andreas Pleil, Director, Worldwide Outcomes Research, Pfizer

  • 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
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    9:50

    THE IMPACT OF CHANGES IN US PRICING AND REIMBURSEMENT

    G. Lawrence Atkins

    G. Lawrence Atkins, Senior Director, Public Policy & Reimbursement, Schering-Plough

  • 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
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    10:30

    Morning Coffee

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    11:00

    PRICING STRATEGIES FOR NEW DRUGS

    Kevin  Mayo

    Kevin Mayo, Adjunct Professor, University of the Sciences Philadelphia

  • 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?
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    11:40

    FUTURE PRICING SCENARIOS IN THE US

    Kathleen Hughes

    Kathleen Hughes, Vice President & Director of Consulting Operations, Covance

  • 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?
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    12:20

    Networking Lunch

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    13:50

    CANADIAN PERSPECTIVE

    Neil Palmer

    Neil Palmer, Principal Consultant, Palmer D'Angelo Consulting INCORPORATED

  • 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?
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    14:30

    THE LATIN AMERICAN PERSPECTIVE

    Paul Doulton

    Paul Doulton, Founding Partner, Oriundo

  • 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?
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    15:10

    Afternoon Tea

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    15:40

    REIMPORTATION AND PARALLEL TRADE

    Donald Zowader

    Donald Zowader, Manager, Government Affairs, Takeda Pharmaceuticals

  • 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?
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    16:20

    PANEL DISCUSSION

  • 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?
  • Kathy Feegel

    Kathy Feegel, Senior Director, State Government Affairs, Amgen

    Paul Doulton

    Paul Doulton, Founding Partner, Oriundo

    Donald Macarthur

    Donald Macarthur, Senior Consultant, PriceSpective

     Representative of Health Policy

    Representative of Health Policy, , Health Canada

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    17:00

    Chairman’s Closing Remarks and Close of Day One

    G. Lawrence Atkins

    G. Lawrence Atkins, Senior Director, Public Policy & Reimbursement, Schering-Plough

    Workshops

    Achieving Pricing & Reimbursement Success in the US Market
    Workshop

    Achieving Pricing & Reimbursement Success in the US Market

    Millennium Gloucester Hotel
    22 March 2006
    London, United Kingdom

    Millennium Gloucester Hotel

    Harrington Gardens
    London SW7 4LH
    United Kingdom

    Millennium Gloucester Hotel

    HOTEL BOOKING FORM

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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