Approval and access: Overcoming the final hurdle of drug development
Professor Luca Pani, University of Miami, Angelika Joos,MSD (Europe) Inc. Ana Palma, Sobi, Belgium
2017 is once again a year of significant change for pharma market access in Europe, with affordability on the agenda for almost every country in the region. There is a move toward greater collaboration in health technology assessment and more transparency between countries for pricing, therapeutic protocols and and details of negotiations with drug manufacturers. We also see member states working to understand the process of enabling cost-effective patient access to personalised and high-cost treatments, such as new oncology combination therapies, antibiotics and stem cell therapies, which offer the promise of efficacy in key disease areas.
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With market access being referred to as the “fourth hurdle” in drug development (beyond efficacy, safety and quality), it is vital that the requirements for both approval and access are addressed early in the process. Parallel scientific advice from HTA bodies and regulators is increasing to deliver tangible and successful strategies, but is the process smooth enough to overcome the challenges from both sides?
pharmaphorum in partnership with DIA will be hosting an expert panel debating the best way forward for life sciences companies, payers and providers in this emerging European market access paradigm.
Join our webinar to hear from experts in industry and healthcare discussing the challenges and solutions of access in the changing European market.
Topics up for discussion include:
•Integrating HTA and regulatory strategy – the best way forward
•Regional variation and implication – how to efficiently and effectively navigate EU market access
•Proving value – how to leverage real world evidence to meet increasing demands for observational data
•Future proofing market access – how to improve upon evidence generation and use technology effectively and competitively