Market Access World USA 2010

Wednesday 6th October 2010, Day One
8am
Registration and coffee
8.50am
Opening remarks from the Chair
Mr James Scott,
-, Applied Policy
9am
Keynote address: Modernizing healthcare: the path ahead
Mr Simon Stevens,
President, Global Health and Executive Vice President, UnitedHealth Group
9.30am
Panel discussion: US Healthcare Policy Reform and its Impact on Market Access

    * How will US migrate to a more data driven, quality driven rational system?
    * What will the “American solution” look like? What’s the ideal balance of ‘public’ and ‘private’ to enable both access and continued innovation?
    * How committed is the U.S. to containing costs while achieving universal coverage?
      - Progress with the national plan – how will the government’s role as an insurer increase?
      -What will be the effect of health insurance exchanges
      -Will the government be able to negotiate prices?
    * How will policy reform:
      - change / impose price controls?
      - impact ‘Cadillac’ plans?
      - impact contracting and price transparency?
      - impact re-importation of drugs?
    * What’s the tipping point – what would constitute too much government intervention?

Mr Bob Donnelly,
(Confirmed)
Senior Director, Health Policy, Johnson & Johnson
Ms Eleanor M. Perfetto,
(Confirmed)
Senior Director, Reimbursement & Regulatory Affairs, Pfizer Inc
Dr Patrick Conway,
(Confirmed)
Chief Medical Officer, OS/ASPE (Office of Secretary/Office of Assistant Secretary for Planning and Evaluation), Department of Health and Human Services
Mr Shawn Bishop,
(Confirmed)
Democratic Staff, US Senate Finance Committee
10.30am
Morning coffee break
 
Comparative Effectiveness Research in Practice and its Impact on Market Access.
What is the ultimate objective of CER – optimizing health? Quality control? Cost control? How is CER being operationalized and with what impact?
11am
How is the stimulus funding being invested by NIH – timelines, implementation pathway, structure

    * What will be the economic incentive to do these studies? What case studies are there?

Dr Michael Lauer,
Director, Division of Cardiovascular Sciences, NIH
11.20am
How is the stimulus funding being invested by AHRQ – timelines, implementation pathway, structure
• What will be the economic incentive to do these studies? What case studies are there?
Ms Jean R Slutsky,
Director, Center for Outcomes and Evidence, Agency for Healthcare Research and Quality
11.40am
What impact will CER have on coverage and market access decisions?

    * How will CER interact with development of treatments for rare diseases?
    * How will the link between HTA/CER and price evolve?
    * How will payors adopt it? What about CMS?

Ms Deborah K Williams,
Director, Public Policy, Government Affairs, US, Baxter Healthcare Corporation
12pm
How will drug development paradigm change knowing that you are in CER environment?

    * What’s really “new”, have things really changed?
    * What are the implications of US healthcare reform and the
      Patient-Centered Outcomes Research Institute for the CER
      environment?
    * What are the implications for drug development?

Ms Eleanor M. Perfetto,
Senior Director, Reimbursement & Regulatory Affairs, Pfizer Inc
12.20pm
Panel discussion

    * How will CER differ from the EU HTA experience?
    * Are the objectives of CER being met?
    * Are the economic incentives in place?
    * Where should the focus lie – broad therapeutic areas?  Non Rx? Areas of greatest unmet need? And what next?

Mr Shawn Bishop,
(Confirmed)
Democratic Staff, US Senate Finance Committee
Dr Stephen Cha,
(Confirmed)
Professional Staff to Chairman Henry A. Waxman, Committee on Energy and Commerce
1pm
Lunch
 
HTA Agency Policy and Practice Globally
Comparing and contrasting different models and their impact on market access
2pm
Opening remarks from the Chair
Dr Mel Walker,
Director, Global Integrated Payer Strategy, GlaxoSmithKline
2.10pm
Germany

    * Identifying the most important outcome from the patient and payer perspective : what is the role and value of Patient Reported Outcomes?
    * What is the ultimate objective of CER? How is it being operationalized?
    * Impact on trial design – what evidence will be required?
    * How will CER accommodate the move towards elevating patient care through personalised medicine and evaluation of biomarkers?
    * CER and speciality / orphan drugs - how to assess the (clinical) relevance of treatment effects?

Dr Stefan Lange,
Deputy Director,, IQWiG
2.30pm
France
Dr François Meyer,
Director, Health Technology Assessment Division, Haute Autorit� de Sant�
2.50pm
UK

    * Scope of HTA
    * Approaches to comparative effectiveness
    * Approaches to cost effectiveness

Sir Michael Rawlins,
Chairman, National Institute of Health & Clinical Excellence (NICE)
3.10pm
Panel discussion

    * What has been the impact of scientific assessment so far?
    * How are relationships with pharma being structured – how is scientific advice and liaison encouraged and structured? What firewalls are required?
    * How do regional / local structures impact funding decisions and access?
    * How are HTA approaches applied to specialty and orphan drugs?
    * How are HTA agencies sharing evidence globally – how joined up and efficient is the global network – what are the associations achieving?
    * How are additionality and disinvestment being applied by HTA agencies?
    * What are their prognoses for the future?

Professor Finn Børlum Kristensen,
Director, Coordinating Secretariat,, EUnetHTA
3.40pm
Afternoon tea break
 
Industry case studies
How are companies adapting market access approaches to different HTA requirements internationally?
4pm
Case study: HTA policy and practice globally—how different models impact market access requirements and HEOR data needs

    * How can pharmaceutical manufacturers evaluate, develop a plan to address and establish a product’s value potential based on diverging HTA needs?
    * What are the implications for early phase and clinical drug development?
    * Using cross-functional teams to achieve value demonstration and market access success

Mr Paul Hodgkins,
Senior Global Director, Health Economics and Outcomes Research, Shire Pharmaceuticals
4.30pm
Case study: Adapting market access approaches to different HTA requirements internationally

    * Differences in the use of HTA tools globally (US, EU, Canada, Australia)
    * Horizon scanning and its use to drive collaboration
    * PROs and Health Economic approaches in theory and practice
    * Spectrum of value assessment/decision tools from early to late phase development

Ms Patty Fritz,
Vice President Government Affairs US, UCB Group
Mr Herve Lilliu,
Head of Global Health Outcomes, Market Access and Pricing, UCB Group
5pm
Panel discussion Seeking early advice and liaison with stakeholders – when is the optimum time to be considering reimbursability and demonstrating value?

    * Engaging with HTAs and working in parallel with regulators to marry the priorities of both
    * How early? Phase IIa or even earlier?
    * How is pharma optimizing interaction between its HTA, commercial and clinical operations to support market access and value driven products?

Professor Finn Børlum Kristensen,
Director, Coordinating Secretariat,, EUnetHTA
5.30pm
Closing remarks
5.45pm
Drinks reception

Thursday 7th October 2010, Day Two
8am
Registration and coffee
8.50am
Opening remarks from the Chair
Mr Ed Schoonveld,
Principal, ZS Associates
 
Adapting to the Changing Environment
9am
CER in the context of speciality drugs: what are the pricing, reimbursement and access challenges for targeted, personalized therapies?

    * How are these products and services be reimbursed? How might these decisions evolve?
    * To what extent do payers think they should be treated differently from other products?
    * What are meaningful outcomes and evidence by which they will be assessed?

Dr Naomi Aronson,
Executive Director, Office of Clinical Affairs & Technology Evaluation Center (TEC), Blue Cross Blue Shield Association
9.30am
Case study: How the nation’s largest health plan evaluates CER and observational research in making formulary decisions

    * Unit costs versus outcomes
    * Evaluating an outcomes-based formulary
    * Examples of drugs treating osteoporosis and COPD
    * Why set guidelines for evaluating CER?
    * How our CER grading system works?

Mr Brian Sweet,
Chief Clinical Pharmacy Officer, Wellpoint, Inc
10am
Pricing and reimbursement in oncology - adapting to the challenges of using HTA methodologies on patient access to premium priced targeted products?

    * Comparing different HTA agency / payor approaches to market access
    * How are these products and services be reimbursed? How might these decisions evolve?
    * To what extent do payers think they should be treated differently from other products?
    * What are meaningful outcomes and evidence by which they will be assessed?
    * The changing relationship between regulatory and HTA agencies – how will it impact market access in oncology?
    * Accessing the influencers – how will pharma’s commercialisation strategies need to evolve to drive market access for these products 

Steve Buckanavage, Vice President - Brand Marketing, Emerging Oncology Brands, AstraZeneca
Mr Steve Buckanavage,
Vice President Global Marketing, Emerging Brands, Oncology & Infection, AstraZeneca Pharmaceuticals LP
10.30am
The Medicaid program in 2010 and beyond

    * How will the still faltering US economy impact state Medicaid programs, including drug coverage?
    * What tools are states using to contain costs?
    * Will the Stimulus impact programs through 2010?
    * How will states be impacted, and how are they likely to benefit from Health Care Reform enactment?
    * What types of program innovations might we see?

Mr Bob Donnelly,
Senior Director, Health Policy, Johnson & Johnson
11am
Morning Refreshments
11.30am
Canada’s pharmaceutical price review regime and trends

    * 2010 sees the implementation of the Board’s revised Excessive Pricing Guidelines – what lies beyond: application and effect on future pricing of patented drug products
    * Price review in Canada compared to trends in other countries
    * Evolving pharmaceutical environment and potential implications

Michelle Boudreau,
Executive Director, Patented Medicine Prices Review Board
12pm
Canada's regionalisation: industry's value proposition within the regional healthcare systems

    * Complexity of the Common Drug Review process
    * Province by Province listing processes. What is the impact of product listing agreements? What is the opportunity to work together?

Ms Krista Scaldwell,
Vice President of Market Access, Bristol-Myers Squibb
12.30pm
Risk sharing and alternative pricing schemes: opportunity or problem for the pharma industry?

    * Types of deal structures and their value to Pharma companies
    * Why do these deals even exist and who benefits?
    * Which deals does Pharma like? Which not?
    * Finding the deal that makes sense
    * Deal theory vs. implementation
    * Recent trends and the future of risk sharing

Mr Ed Schoonveld,
Principal, ZS Associates
1pm
Lunch
2.15pm
Demonstrating Value through Evidence, Outcomes, Real life studies and Quality Measures
Mohan Bala,
Director, Outcomes Research ... Market Access Senior Director, Sanofi-Aventis
2.45pm
Case study: How real-world use of data changed the WellPoint formulary - an asthma case study
Mr Marcus Wilson,
President, HealthCore, a wholly owned subsidiary of WellPoint, Inc
 
Demonstrating Value through Evidence, Outcomes, Real life studies and Quality Measures
3.15pm
Panel discussion: Evidence and outcomes - going beyond safety and efficacy to support value and access

    * What do customers value? Can industry and customers align?
    * Generating evidence of the right outcomes to support market
      access
    * What is the role of Real Life / Observational studies in the
      future security of market access?
    * How might the requirement for new sources of evidence and real life data be used by payers to inform reimbursement decisions?

Dr Stefan Lange,
Deputy Director,, IQWiG
Dr Josephine A. Sollano,
Head, Global Outcomes Research, Pfizer Oncology Global Medical Group
Ms Mary Helen Tran,
Executive Director, Global Health Outcomes Lead, Global Market Access, Merck Ltd
4.15pm
Afternoon tea break
4.30pm
Panel discussion: Quality Improvement Measures – how will they impact price, perceived value and market access?

    * How might new quality measures be applied to pharma’s products and services?
      -in prescription, dispensing and delivery
    * How can pharma demonstrate improved quality of care? What metrics might be used?
      -How will improved quality for patients translate into value for money for payors via new health technology assessment criteria?
      -How will quality improvement measures be used to set prices?
    * How will quality improvement measures be operationalized by pharma and payors?
    * Case studies

5pm
Panel discussion: Pharma’s Response Strategy: What new processes and capabilities are required now to truly assess and capitalize on short and long-term value potential in terms of reimbursability?

    * Seeking early advice and liaison with all stakeholders – when is the optimum time to be considering reimbursability? – how will reform impact these interactions?
    * How is pharma optimizing interaction between its HTA, commercial and clinical operations to support market access and value driven products?
    * Linking to demands that comparative effectiveness might impose
    * Regulatory approval alone is not enough - how can pharma achieve reimbursement tier 1 or 2 for their products?

5.30pm
Close of day 2