OHE Lunchtime Seminar: Health Technology Assessment Scientific and Outcomes Advice on Medicinal Drug Development

Health Technology Assessment (HTA) scientific advice (SA) was created by the National Institute for Health and Care Excellence in 2009. More recent initiatives have sought to coordinate HTA SA across Europe and promote the integration of HTA SA with the advice provided by regulatory authorities (Medicines and Healthcare products Regulatory Agency, MHRA, and European Medicines Agency, EMA). Despite these efforts HTA SA is not routinely integrated into the clinical development of new medicines and it faces new challenges with the development of advanced therapy medicinal products, stratified medicines and medicines used in orphan diseases.  The role of outcomes advice in HTA is not well understood, yet is equally important.

In this lunchtime seminar, the panellists will give their perspectives on the influence of HTA scientific and outcomes advice on both the clinical development of new medicines and evidence generation to support reimbursement. Their presentations will cover:

  • The importance of developing a value proposition early in clinical development;
  • The different types of scientific advice procedures;
  • The timing of scientific and outcomes advice in the clinical development of medicines;
  • The integration of HTA with regulatory scientific advice;
  • Issues associated with new approaches to drug development (adaptive licensing, real world evidence and advanced therapies);
  • Future developments in HTA scientific advice;
  • Issues specific to outcomes advice.

The panel will be chaired by Paula Lorgelly, Deputy Director, OHE, and will include three presenters, all of whom are involved in issues directly relevant to HTA SA:

  • Dr Leeza Osipenko, Head of Scientific Advice, NICE
  • Professor Nancy Devlin, Director of Research, OHE
  • Dr François Maignen, Head of Operational Research and Data Analytics, OHE

Dr Leeza Osipenko works closely with EMA, MHRA, European HTA agencies and EUnetHTA. She chairs most of the national, international and parallel scientific advice meetings, signs off all key deliverables produced by the team and leads on business development activities via frequent public speaking engagements. Dr Osipenko holds an Honorary Fellow post at the University of Warwick Medical School and represents NICE as a Chief Analyst at the Department of Health Analytical Directors of Arm’s Length Bodies (ALBs) group. She has completed a BA in Economics & International Affairs, MSc in Technology Management and a PhD in Systems Engineering. As a Senior Research Fellow at University of Warwick, she conducted an economic evaluation of non-invasive prenatal diagnostic tests. In 2010, she became a Principal Economist at a London-based public sector consultancy, Optimity Matrix, where she led on projects for NICE, the European Commission and other public sector organisations.

Prof Nancy Devlin’s principal areas of research expertise are the measurement and valuation of patient reported health outcomes; the cost effectiveness thresholds used in making judgments about value for money in health care; use of MCDA in health care decision making; priority setting in health care; and measuring the production, performance and efficiency of hospitals. Nancy holds honorary chairs at the School of Health and Related Research at the University of Sheffield; and in the Economics Department at City University, London. She is past-President of the EuroQol Group, a European-based international network of researchers that developed the EQ-5D, and is an elected member of the Board of Directors, ISPOR. Prior to joining OHE in 2009, Nancy was a Professor of Economics at City University, where she was Head of the Economics Department and Acting Dean of Social Sciences. She has over 30 years of experience as a researcher and as an advisor to health care organisations, both in the public and private sectors in the UK and internationally.

Dr François Maignen is a pharmacist and a statistician. His areas of expertise include the clinical development and supervision of medicines. His expertise covers both the clinical development of medicines and cost-effectiveness evaluations. He has knowledge and expertise in the methodological aspects and difficulties of drug development, post-authorisation studies (observational and pharmacoepidemiology studies) and health technology appraisals. Prior to joining the OHE in 2016 François worked for NICE on scientific advice. Francois was giving advice to pharmaceutical companies on their clinical development plans particularly on phase 3 main pivotal efficacy studies. He has also developed the NICE scientific advice database. Prior to NICE Francois worked for the EMA for 15 years. His activities covered both pre- (registration of centrally authorised products in oncology, cardiology and metabolic diseases including orphan drugs) and post-authorisation procedures (including urgent safety-related), support to the scientific committees (CHMP, PRAC), EU legislation and guidelines (biosimilar and signal management in the EU), signal detection and the implementation of the European pharmacovigilance database (EudraVigilance).

If you would like to attend this seminar please reply to Kerry Sheppard.  Kerry will provide confirmation once she has received your request.

Wednesday, 5 October 2016