We are thrilled to announce that we are being joined by payers from UK, Italy, France and Bulgaria at this year’s World Orphan Drug Congress USA 2016!
Sheela Upadhyaya, Associate Director Highly Specialised Technologies, Centre for Health Technology Evaluation from the National Institute for Health and Care Excellence, UK will be providing the English perspective to Market access for orphan drugs.
Her session will cover:
- A brief outline of the NICE highly Specialised Technology (HST) Evaluation process
- Topic selection and NICE HST Prioritisation Criteria
- Working with stakeholders : including patient support organisations
Francois Meyer, Advisor to the President, International Affairs from HAUTE AUTORITE DE SANTE, France will delve into Health Technology Assessment of Orphan Drug in Europe, by exploring:
- The situation in France
- Adaptive pathways, managed entry agreements and other initiative
- The growing role of Real World Data
- European cooperation between HTA bodies
- Cooperation with EMA ( scientific Advice and post – launch studies)
Carlo Tomino, Research and Development Coordinator at San Raffaele Institute of Research, Rome (Former Head of Research and Clinical Trials, Italian Medicines Agency) will be combining the worlds of Rare diseases, orphan drugs and real world data and looking at how they can fit together:
- Need for good quality clinical trials
- How Italy is using data from “real world” registries
- Strong collaboration with patients/advocates and regulatory agencies
- A new perspective of “consistent value assessment” from an International panel group
And finally, Rumen Stefanov, Director, Institute for Rare Diseases, Bulgaria is going to provide insight into Orphan Drugs in Eastern Europe by examining the the case of Bulgaria and cross-border access.
- Mapping of centres of expertise for rare diseases in Bulgaria
- Generating and collecting rare disease data at local level
- Funding for rare disease therapies in deficit spending context
- Multi-criteria decision analysis in assessment and appraisal of orphan drugs
*Please note that access to this sessions is limited to those who purchase a 3 day or a 2.5 day ticket.