Value, Access and Regulatory Strategy Workshop
Session 3: Early Dialogue Between Regulators and HTA (and Payers & Patients)
Mira Pavlovic, DrMed, MS
- Managing Director
- Medicines Development and Training (MDT) Services, France
After having obtained marketing authorisation, a product may be refused for reimbursement if its relative effectiveness is considered inferior to existing treatments or if the evidence provided is considered inadequate or insufficient. An early dialogue/scientific advice between the sponsor and the Health Technology Assessment (HTA) bodies before the start of the pivotal clinical programme is particularly useful to discuss the evidence to provide and ultimately facilitate HTA process, timely reimbursement decision(s) and market access. For this purpose, sponsors may ask for national or multinational, regulatory and/or HTA advice. The experience gathered so far will be discussed as well as ways of possible improvements.
When receiving guidance from HTA bodies, national authorities apply country/region-specific policies and legal requirements related to the specificities of their own healthcare system. Therefore, respecting HTA needs for evidence generation does not guarantee that a drug will be reimbursed. A topic of specific interest here is the choice of an adequate comparator when the latter differs in different European countries including the use of non-authorised comparators. Possible implications for trial designs will be discussed.
HTA Bodies Cooperation on Early Dialogues: Recent Advances
François Meyer, MD
- Advisor to the President, International Affairs
- French National Authority for Health (HAS), France
Enhancing the Dialogue Beyond RCTs
- Executive Director
- Statistical Methodology and Consulting Group, Novartis Pharma AG, Switzerland
The Imperfect Study Design – How to Deal with It?
Stefan Lange, MD
- Deputy Director
- Institute for Quality and Efficiency in Health Care (IQWiG), Germany