Your Tailored Comparative Effectiveness/HTA Agenda

Suggested agenda for attendees interested in Comparative Effectiveness and HTA

Wednesday 26 March

Creating An Adaptive Pathway For Medicines To Patients – Could This Be An Approach That Fulfills The Needs Of All Decision Makers? A Roundtable Discussion
9:00-10:00 AM
Discuss whether a move away from having the Marketing Authorisation as a ‘magic moment’ by introducing a more staggered, progressive or adaptive approach would create an environment that meets the needs of all stakeholders in the drug development process. Hear perspectives from the HTA, regulatory, industry, agency and patient representatives.

How Do Payers View Current Developments In The HTA And Regulatory Environment?
11:00 AM-12:30 PM
A variety of collaborative efforts have been undertaken in recent years to support the interface between HTA bodies and regulators. How are these interfaces delivering to those that are responsible for paying for drugs and services? Payers will be asked what they do with HTAs and how they include such assessments in their decision-making.

Established Interactions Throughout The Registration Pathway: What Exists And What Is Missing?
2:00-3:30 PM
There are multiple opportunities for interactions at different stages during the lifecycle of a drug. Discuss if these interactions are worthwhile and for whom, how they can be improved, who should be the players and what should be their role? Hear how the HTA and EMA are working together and the views of industry representatives.


Regulatory Town Hall Meeting
2:00-3:30 PM
At the Town Hall Meeting attendees can put burning questions to expert regulators about  transparency; implementation of the pharmacovigilance legislation; latest changes to the clinical trial legislation; innovation – products in the pipeline; and EU-enlargement with Croatia.


Health Economic Aspects of Personalised Medicine
2:00-3:30 PM
Personalised medicine approaches aim at assuring optimal use of healthcare budgets by only providing a therapy to those patients that benefit from the treatment. However this approach drives towards many different and often more expensive treatments. This session will address the question: How to make personalised medicine affordable?

Databases, Registries and Other Data Capture Tools: How Can We Avoid Multiplicity and Create an Integrated Data-Capture Approach Along the Product Development Cycle?
4:00-5:30 PM
Various data capture tools are being developed to address different needs at different stages of the product lifecycle. This session will discuss the possibility of creating a wealth of data with these different tools and how these individual systems can be integrated to create a data continuum that supports informed decision-making by all actors and to avoid duplication.

Thursday 27 March

Marketing Authorisation and Beyond: Moving From Early Dialogue to Continuous Dialogue – Creating an Integrated Research and Development Pathway: Providing a ‘One-Stop Shop’ For Industry?
9:00-10:30 AM
Debate whether it is possible to develop a system of integrated, comprehensive Scientific Advice that brings together early and late dialogue, to inform the life cycle of drug development. Would this enable sponsors to have just one integrated research pathway, rather than generating different data for regulators, HTA bodies and payers throughout the product life cycle?


Transparency of Payments to the Healthcare Sector
9:00-10:30 AM
Discuss the rules on transparency of payments/benefits to the health care sector (health care professionals, hospitals, health institutions etc.) made by pharmaceutical companies, their implementation, and their practical impact on companies.

How to Realise Biosimilars’ Full Potential
11:00 AM -12:30 PM
The increasing uptake of existing biosimilars has generated considerable interest and debate about the future potential of the biosimilars space but despite the widespread optimism, a number of key challenges relating to the known active substance remain – pharmacovigilance, naming and traceability – which if not adequately addressed, can limit the potential of biosimilars before it is fully realised. This session will review these three independent but interlinked challenges, providing case studies and examples to illustrate key points and reflect on what needs to be done to ensure the conversation remains focused on patient safety first.

How Do We Bring the Patient’s Voice Into the Discussion? How Do We Ensure That All the Right Voices are Heard?
2:00-3:30 PM
Find out what the reaction is from stakeholders to the idea of an integrated research pathway and discuss how to ensure that the right people are involved at the right time, including the patients? What is the potential future role of patients in the drug review process?

Are Our Healthcare Systems Ready to Support These Approaches? What – If Anything – Needs to Change? A Roundtable Discussion
4:00-5:30 PM
Hear industry, patient, payer and authority/ministry perspectives on whether all stakeholders are ready to work in an integrated way and, if not, what needs to change?