Registration and Coffee
Chairperson’s Welcome Address
MARKET ACCESS STRATEGIES
Market Access/HTA harmonization within Europe
- The benefits of Country and Regional harmonization
- Impact of EUnetHTA Joint Action 3
- The pitfalls of a fragmented MA/HTA
- What lies ahead?
Andrea Rappagliosi, VP, Head of Public Affairs Europe, Global Public Affairs, Sanofi
Analysing the potential synergy between RCT/HEOR data and real world Evidence*
- Understand the impact of RWE decisions on price and market access
- The shift from RCT to RWE; closing the gap
- RWE strategies
Timothy Kneen, Executive President - Europe & Canada, Merck
Morning Break & Networking
Keynote presentation: Communicating Medical Product Value at the Time of Market Authorization and along the Product Lifecycle
- Develop a Target Product Profile (TPP) as a strategic development tool to identify desired target concepts and facilitate communication regarding a particular clinical development program
- Manage benefit-risk profile up to and beyond product approval by designing studies comprise not only of confirmatory clinical trials of efficacy or safety
- Learn how to communicate the benefit-risk profile to external stakeholders that is consistent with the FDA-required labeling in a truthful and non-misleading way
Nneka Onwudiwe, PRO/PE Regulatory Review Officer, United States Government
New EU legislation for medical devices (MDR) and in vitro diagnostic medical devices (IVDR), upcoming legislation on EU HTA for medical devices
- Challenges in the transition of the new EU regulation
- New challenges for R&D and Market Access
- Key differences from Pharmaceutical regulation
Dr. Simone Breitkopf, Head HEOR, Governmental and Public Affairs
Market Access changes in Germany
- Impact of “Arzneimittelversorgungsstärkungsgesetz” on patients treatment
- Central versus regional hurdles
- Topics 2018 and beyond
Marco Penske, Head Market Access & Healthcare Affairs, Boehringer Ingelheim
CHALLENGES AND OPPORTUNITIES
In a world increasingly focused on highly specialised medicines, how can less specialised products continue to demonstrate value and gain Market Access, Pricing & Reimbursement
- Increasingly, health systems are looking to save money on more ‘minor’ conditions or with older treatments in order to make money available for the higher cost, highly specialised innovations, particularly those in rare diseases
- Incremental innovation and improvements in the management of ‘everyday’ diseases impacting many more patients can be under-valued and underrated
- Research and development into common and debilitating diseases may be deprioritised without pricing and reimbursement which reward gradual improvements
- How can companies which do not operate in the highly specialised space continue to demonstrate the value of their products which may improve a patient’s experience but be challenging to quantify?
- Are HTAs capable of valuing incremental improvements which over time can revolutionise care?
Karen Hockey, Director Global Market Access & Government Affairs, Norgine
Challenges and opportunities in the use of Real Word Evidence for orphan drugs and rare diseases
- How are patient registries used to generate real-world data for rare diseases and orphan drugs?
- Need for additional observational data both pre- and post-launch
- Do different stakeholder types have different RWE information needs for decision making?
- Future of Orphan Drug Pricing In the next five years
Tea Break & Networking
Overcoming barriers of Biosimilars Market Access within the EU
- Identify the main barriers
- Create new strategies to overcome them
- Current state of Biosimilars in EU, what future brings?
Panel Discussion: The impact of Brexit in the next decade in EU
- New opportunities
- Potential risks
- Post Brexit scenario for global regulatory environment
Chairperson’s closing remarks & networking drinks reception
Chairperson’s Opening Remarks
PRICING, REIMBURSEMENT AND PATIENT ACCESS
Market Access and Pricing in Germany
- G-BA and the results of pharma dialogue / new pharma law April 2017
- The opportunities beneath of the removal of mixed pricing?
- The criteria for re-evaluation of pre AMNOG drugs
- Orphan Pricing: Balance between incentives and patient access
- European Standing Committee for Early Dialogue: EUNETHTA Status quo
Dr. Karina Ehrig, Scientific advisor, Federal Joint Committee (G-BA)
The importance of the voice of patients in the regulatory and reimbursement process.
- Delays in access result in a loss of muscle function for patients.
- Brexit and the move of the EMA risk adding further delays.
- Building a consensus to improve access to new drugs.
Robert Meadowcroft, Chief Executive, Muscular Dystrophy UK
Morning Break & Networking
Market access strategies and payer relationships management*
- Advantages of market access teams in payer relationship
- Payer evidence requirement in early development
- Best practices to obtain better pricing and reimbursement
- Strategies to improve a better payer relationship
Anne Marciniak, MD, PhD, Senior Director, Specialty Care Lead, Allergan
How Patient Perspectives Add Value to Access Decisions*
- Understanding and including the patients perspectives in designing clinical trials and clinical endpoint
- Key principles that insure access to treatment based on need
- Patient-centeredness, patient advocacy
Ryotaro Ishikawa Oka, Global Market Access Director, GPA Respiratory, Novartis
COLLABORATION AND LOOKING TO THE FUTURE
Societal perception of drug prices: myths and reality
Dr Dana Vigier, VP Market Access and Governmental Affairs, BMS
- The importance of conveying the full value of our offerings
- Expanding the value concept beyond narrow cost-effectiveness
- Broadening the stakeholder network we address
Dr. Thilo Schaufler, Senior International Health Policy Leader, F. Hoffmann–La Roche
Global Market Access Trends predicting the future
- Unlocking data from early access
- Effective communications with internal and external stakeholders
- Embracing the digital vision
- Future trends and developments in the healthcare distribution
Tea Break & Networking
Acquisitions, harmony and collaboration
- Risk sharing agreements: incorporating financial models with performance based/outcomes based models
- How to find the right partner?
- In licensing and out licensing
Oliver Stahl, Sr. Director Corporate Affairs & PRA, Lilly Deutschland GmbH,/mark>
Panel Discussion: International collaboration on pricing
- The importance of making MA the core of the company
- Bridge between pre-launch strategy and post-launch
- International Drug Price Indicator Guide WHO
- Increasing collaboration between EU countries
- Frontiers in Health Care
- What will the future bring?
Ulf Staginnus, VP, Head of Europe Value Demonstration & Access, Shire