Agenda at a Glance

Market Access Conference Day 1

Day 1: 6th February 2020

Anne Marciniak, Sr. Director, Head of Market Access Europe, Aimmune Therapeutics

Market Access Strategies

  • Challenges that needs to be identified and addressed for efficient HTA harmonization in Europe
  • In-depth analysis of EUnetHTA JA3 assessments and their evolution over time
  • Real-world update on ongoing discussions around JCAs
  • Recognize the potential for joint HTA in terms of opportunities and challenges

Anne Marciniak, Sr. Director, Head of Market Access Europe, Aimmune Therapeutics

    • Understand the impact of RWE decisions on price and market access
    • The shift from RCT to RWE: closing the gap
    • RWE strategies

Miriam Luz, Head of Market Access, Biogen

    • Understanding the current state of pharmaceutical sector
    • The potential effect of leaving the EU
    • Addressing the priorities for negotiations
    • The ability of UK citizens to access new medications
    • NICE assessments and product launches
    • Importance of Accelerated Access Review (AAR)

10:45 - Morning Break & Networking

  • Developing a Strong Evidence, value framework and Pricing Strategy

    • Keeping on top of pricing and market access trends

    Identify a clinical or economic advantage and generate the appropriate clinical and health economic evidence to support a strong value proposition

    • The importance of Patient Reported Outcomes

    • New challenges for R&D and Market Access
    • Key differences from Pharmaceutical regulations 
    • Requirements for Medical Devices in key markets
    • Market Access strategies for new devices

Isabel Henkel, Global Director, Market Access, Essity

Challenges And Opportunities

    • A common situation is where a company has individual level data on its own trial but only has published aggregate level data on a competitor’s trial. In this situation, Matching Adjusted Indirect Comparison (MAIC) is an established way to adjust for between-trial population imbalances (different distributions of observed patient covariates).
    • This methodology uses a method of moments, that does not require individual patient data in the competitor trial, to estimate the propensity score using logistic regression
    • We investigated an alternative approach where we used the method of moments in conjunction with the propensity score regression model that results in the largest possible effective sample size (ESS).
    • Analytical results are obtained for the simplest possible case where there is one matching covariate, that provide new and valuable insights, but more generally numerical methods must be used to perform the necessary optimisation.
    • We investigated the properties of our proposed method by applying it to a well-known (but artificial) example from NICE Technical Support Document 18, and we also performed a simulation study.
    • Worthwhile gains in effective sample size can be obtained in situations where considerable adjustment is required.

Dan Jackson, Principal Statistical Methodology Expert, AstraZeneca

    • Latest legislation and impact
    • Market Access at national level
    • Developments at regional level
    • Outlook 2020

Dr. Marco Penske, HP Country Commercial - Market Access, Boehringer Ingelheim Pharma GmbH & Co. KG

    • The increasing relevance of Emerging Markets
    • EMs Embrace Technological Innovation
    • Creating value through partnership
    • How to Avoid the Pitfalls of Innovation in Emerging Markets

Giovanny Leon, Pricing and Access Regional Director, LatAM & Canada, Novartis

15:15 pm - Tea Break & Networking

    • Re-Purposed Drugs.. what do you mean?
    • Benefits of reuse
    • Challenges
    • Opportunities
    • Access pathway

Amer Omar, Senior Director, EMEA, Genetic Diseases, Lupin

    • How are patient registries used to generate real-world data for rare diseases and orphan drugs?
    • Addressing the need for additional observational data both pre- and post-launch
    • Do different stakeholder types have different RWE information needs for decision making?

Gina Ewy, Head Global Market Access, Hansa Biopharma AB

    • What are the potential effects of leaving the EU?
    • Understanding the priorities for negotiations
    • Is there a long-term solution that provides legal certainty and compliance?
    • What are the contingency plans for Pharmaceutical and life science industry?

Panellist:

Dr. Alexander Natz, Secretary General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)

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