Day 1 - Thursday 4th May 2023
9th RWE, Market Access, Pricing & Reimbursement Global Congress 2023 Europe
Trends and Strategies to Achieve Optimum Patient Access to Healthcare
Dr. Marco Rauland, Vice President, Global Value Demonstration, Market Access & Pricing, Merck KGaA
MARKET ACCESS TRENDS & STRATEGIES
- Trends that will continue to impact, Market Access, Pricing and Reimbursement in healthcare
- Unlocking data from early access
- Effective communications with internal and external stakeholders
- Embracing the digital vision
- Future trends and developments in the healthcare distribution
Moderator:
Dr. Marco Rauland, Vice President, Global Value Demonstration, Market Access & Pricing, Merck KGaA
Panelist:
Libby Hamson, Senior Manager, Market Access, Pfizer
Senior Representative, OPTiMAX Access
- Current trends in parallel advice: What has changed?
- Importance of seeking early regulatory, HTA, and joint consultation
- Risk and advantages of using parallel consultation at the EU or national level?
- Successful strategies to maximise the benefit of parallel consultation
- Overview and key aspects
- Status and timeline
- EU joint HTA and national submissions
- Challenges and implications
Elvira Müller, Vice President, Evidence & Access, CERTARA
- Impact of the Life Science Strategy Sector Deal
- NHS 10 Year Plan
- Future of the UK Government/Industry Voluntary Scheme for Branded medicines.
Santoke Naal, Director Market Access, IGES U.K. Pharma Ltd
- When and how to integrate value planning into development
- Staying responsive to changing market conditions Trends to watch
- Enabling diverse perspectives through timely engagement
Esther Nzenza, Founder and CEO, Decisive Consulting Ltd.
- Historical use, and impact, of value-based pricing in multi-indication drugs and combination drugs
- Lessons to be learnt from historical VBP cases
- Potential avenues to improve on value-based pricing of ‘special’ drug categories
- Examples of how health systems are adapting their pricing mechanisms
Mitun Patel, Director, Red Nucleus
Higia Vassoler, Associate Director, Red Nucleus
REAL-WORLD EVIDENCE
- Plasma-derived medicines (PDMPs) are essential for some 300,000 patients across the EU who rely on these therapies every day to treat a variety of rare, chronic, and life threatening conditions. Without these treatments, many patients would have a substantially diminished quality of life, and some may not survive.
- PDMPs are a finite resource because the manufacture of these medicines is dependent on the amounts of human plasma collected.
- Using the AIFA CTS Innovation Algorithm and the WHO Framework for Appropriate Medical Use, a broad range of Key Opinion leaders, in the field of immunology, neurology, rheumatology and dermatology, debated about the appropriate use of Immunoglobulins for their patients. The discussion
was concluded in a Green Paper developed by Vintura.
Maarten Van Baelen, Executive Director, Plasma Protein Therapeutics Association
- Robust RWE generation to accelerate drug approval and inform clinical practice during a rapidly
evolving pandemic - COVID-19 and the wide-ranging role of RWE in informing decision making: From disease monitoring to
treatment effectiveness - Methodological considerations and cautionary tales of RWE generation in COVID-19
- Best practices and lessons learned for effectively utilizing RWD/RWE in future pandemics
Stephane Read, Sr Technical Consultant, Epidemiology, Certara Evidence & Access
- Recognize the potential of Personalized Medicine in Oncology / Cancer Patients benefits;
- Identify challenges which could be encountered during HTA process;
- Develop strategies to overcome or to remove any barrier for Patient Access to Precision Oncology
- PRO, HRQoL, RWE, RWD
- Cost to Society, Health System and Government
- Technology and Evidence Development
Rafael Souza, Head, Access Solutions & Pricing, New Markets, BeiGene Switzerland
- The use of RWD early in the process to boost trial diversity and inclusion
- Challenge in setting diversity goals early in clinical trial planning
- Development of a diversity plan to ensure adequate representation of racial and ethnic subgroups in clinical trials
- Utilizing RWE in the post-marketing setting to complement clinical trial findings and support post marketing requirements or commitments for safety and efficacy data in a diverse patient population
Riad Dirani, VP of Global HEOR, Medical Operations & Excellence, Teva
- Regulatory challenges following Brexit and its effect
- Steps taken by MHRA to alleviate the effects of leaving the European regulatory network.
- Understanding the current state of pharmaceutical sector
- Addressing the priorities for negotiations
- The ability of UK citizens to access new medications
Moderator:
Matthias Heck, Sr Director, International TA Policy Strategy, Alexion Pharmaceuticals
Santoke Naal, Director Market Access, IGES U.K. Pharma Ltd
Networking Drinks Reception
