Day 1: Tuesday, 8 March 2016
12.15 – 13.15 Lunch
13.15 – 13.30 Introduction & welcome – Dr Panos Kanavos
13.30 – 15.15 Session 1 – Creating value along the product development continuum: Advances in regulatory practices and their impact
Chair: Dr Panos Kanavos, Associate Professor in International Health Policy, London School of Economics and Political Science
This session will address key challenges in assessing the value of a new technology along its product development process, including how to deal with incomplete evidence. It will reflect on the closer interaction between the regulatory and the HTA processes and debate the implications for the future.
The session will discuss the projects on adaptive pathways at the European Medicines Agency (EMA) and the alignment of evidentiary requirements between Marketing Authorisation (MA) and Health Technology Assessment (HTA). Novel pilot projects that attempt to address some of the key challenges in HTA and the barriers to access these technologies will close the session with new ideas to be discussed during the panel, where key stakeholders will be given the opportunity to share their perspectives. Understanding the challenges in conducting HTA and the different perspectives or solutions to improving access to care are particularly relevant given the exponential uptake of HTA in European Member States, and more recently also, in a number of emerging settings.
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13.30 – 13.50 Advances in the regulatory framework and their implications for Member States Professor Hans-Georg Eichler, Chief Medical Officer, European Medicines Agency
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13.50 – 14.10 Reactions from Sweden, Karl Arnberg, Dental and Pharmaceutical Benefits Board (TLV), Sweden
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14.25 – 14.40 Dealing with real-life evidence: A patient perspective Dr Bettina Ryll, Director, Melanoma Patient Network Europe
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14.40 – 15.15 Panel discussion
15.15 – 15.45 Coffee and networking break
15.45 – 17.30 Session 2 – A prospective view of Health Technology Assessment: Stakeholder perspectives
Chair: Professor David Taylor, Emeritus Professor, University College London
This session will debate the development of HTA and its likely evolution in the future. It will engage stakeholders from national governments, HTA bodies, supra-national and international organisations, the patient community and industry. The session will conclude with a panel discussion on next steps in HTA to improve access to medicines and ultimately health outcomes.
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15.45 – 16.10 Current and future challenges and opportunities in HTA Dr Panos Kanavos, London School of Economics and Political Science
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16.10 – 16.20 Beyond the World Health Assembly resolution: what challenges are countries facing in introducing HTA? Dr Nicola Magrini, Secretary of the Expert Committee on WHO Model list on the Selection and Use of Essential Medicines, Essential Medicines and Health Products Department, World Health Organization
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16.30 – 16.40 The interface between external price referencing, value-based pricing, and HTA: the difficulties in demonstrating value across different country settings Dr Claudine Sapède, Global HTA and Payment Policy Lead, Roche
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16.40 – 16.50 Quality-of-life measures: capturing the perspectives of patients and carers Jean Mossman, Policy Lead, European Brain Council
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16.50 – 17.00 Achieving value through HTA and managed entry agreements: the Polish experience Anna Zawada, Agency for Health Technology Assessment (AHTAPol), Poland
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17.00 – 17.30 Panel discussion
17.30 – 18.15 Networking break and transfer to LSE for Keynote
This is a free event, open to all, and will be held in the Sheikh Zayed Theatre in the New Academic Building, LSE
Commentary: Dr Mary Baker, MBE
Reception
Day 2: Wednesday, 9 March 2016
8.45 – 9.15 Coffee
9.15 – 11.00 Session 3 – Towards understanding, incentivising and improving bio-pharmaceutical innovation
Chair: Professor David Taylor, Emeritus Professor, University College London
This session will give an insight into the latest innovation advances in cancer research, reflect on the drivers and limitations of bio-pharmaceutical innovation at an early stage and discuss new and emerging models of Research and Development (R&D) in order to address unmet needs. Investors and assessors will share their views on challenges and opportunities ahead.
The antimicrobial resistance space and the Review by the UK Government will be used as a topic of how R&D activities can be incentivised, whereas the application of multiple evaluation criteria and the “Mechanism of Coordinated Access to Orphan Drugs” (MoCA) project will be used as a case study of how drug “innovation” can be assessed and rewarded in practice as part of HTA. The session will conclude with a panel discussion on next steps to improve the efficiency of innovation.
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9.15 – 9.30 Researching and advancing innovation in cancer: a challenging pathway Prof Gordon McVie, European Institute of Oncology, Italy
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9.30 – 9.45 Driving innovation: an early stage investor perspective Giovanni Mariggi, Principal at Medicxi Ventures, Switzerland
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9.45 – 10.00 Tackling antimicrobial resistance: A health crisis endangering global wealth Professor Kevin Outterson, Boston University School of Law, United States
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10.05 – 10.15 Valuing the value of innovation: application of multiple criteria and the MoCA project Dr Ri de Ridder, Director at National Institute for Health and Disability Insurance (RIZIV-INAMI), Belgium
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10:15 – 10:25 Does biopharmaceutical innovation care about our incentives? Dr Jack Scannell, Innogen Institute, University of Edinburgh, United Kingdom
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10.25 – 11.00 Panel discussion (joined by Richard Mason, Head of Johnson & Johnson Innovation, London)
11.00 – 11.30 Coffee and networking break
11.30 – 13.00 Session 4 – How to overcome existing challenges affecting the use of real-life evidence in assessing the value of innovation
Chair: Huseyin Naci, Assistant Professor of Health Policy, London School of Economics and Political Science
This session will discuss these challenges in the context of using patient level data to study effectiveness in real-life and will present the experiences of a selection of countries with real-life data across different therapeutic areas.
Interest in real-life data is high yet their use in decision-making is still limited due to a number of challenges encompassing the spectrum from data collection, analysis to interpretation. Even in countries with mature health care systems, not all databases are electronic and when they are they are often not fully integrated, vertically and horizontally. Further, access to anonymised patient level data for researchers is still a major hurdle which prevents real-life data from reaching their full potential. But there are also a number of opportunities including greater availability of large datasets (eg FDA adverse reporting system) and increasingly sophisticated solutions to handle big data and analytical methods to deal with the non-randomised nature of this data.
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11:30 – 11.50 Real-life data: Where we are and where we want to be Dr Christine Leopold, Post-Doctoral Research Fellow, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute
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11.50 – 12:10 Value-based reimbursement through the AIFA registries
Differential reimbursement for drugs with multiple indications through outcome-based agreements Angelica Carletto, Italian Medicines Agency (AIFA)
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12.10-12.30 Whose preferences should we use in decision making in health care? Valentina Rupel, Institute of Economic Research, Ljubljana, Slovenia
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12:30 – 13:00 Panel discussion and audience questions
13.15 – 14.30 Lunch
14.30 – 16.15 Session 5 – HTA in perspective: Future trends
Chair: Dr Guillaume Dedet, World Health Organization
The session will present and debate the application of innovative approaches to HTA and how these may build on existing initiatives at national, EU and international level. It will present and debate new methods for HTA using multi-criteria decision analysis, predictive models for the assessment of orphan medicinal products and methods tailored for a wider range of technologies, including medical devices.
The session will start by summarising some of the existing initiatives, particularly, EU-level initiatives such as the European Network for Health Technology Assessment (EUNetHTA) for a centralised HTA, and a number of other initiatives aiming to improve the coordination and cooperation at EU-level. It will then present and discuss a number of methodological and empirical innovations, such as MCDA and will conclude with the new developments around patient empowerment and patient-centred care and the added-value of greater collaboration between the key stakeholders.
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14.45 – 15.00 Explaining differences in the assessment of value across European countries Elena Nicod, Research Officer, London School of Economics and Political Science
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15.00 – 15.15 Towards the development of a decision support system for HTA: application of the Advance Value Framework with different HTA agencies Aris Angelis, Research Officer, London School of Economics and Political Science
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15.15 – 15.30 Strategic procurement Hanne Bak-Pedersen, World Health Organization
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15.30 – 15.45 Better coordination at EU level Dr François Meyer, Advisor to the President and Health of International Affairs, Haute Autorité de Santé, France
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15.45 – 16.15: Panel discussion and audience questions
16.15 – 16.30 Summary of key messages
16.30 Close and departures