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2014 11-19 rb progressive fieldevaluationmerck


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Presentation on the evaluation on promising innovative technologies made at an internal meeting with Merck

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2014 11-19 rb progressive fieldevaluationmerck

  1. 1. Catalysing knowledge generation in real-world setting- Current work at INESSS Reiner Banken, M.D. M. Sc. - Advisor to the CEO- Alliances and networks Geneviève Plamondon, M.Sc. - Scientific professional- Innovation Dima Samaha, Pharm D MAS - Advisor Innovation and external affairs November 19th 2014
  2. 2. 2 Outline of the presentation 1. Quick presentation of INESSS 2. Advisory committee on HTA and innovative technologies 3. Current work on knowledge generation in real-world settings 4. The new approach proposed 5. Questions and discussion
  3. 3. 3 INESSS – 40 years of science advice for decision-making 1972 1996 Conseil d’évaluation des technologies de la santé (1988) Réseau de revue d’utilisation des médicaments January, 19, Agences d’évaluation des technologies et des modes d’intervention en santé Comité de revue de l’utilisation des médicaments 2000 Conseil consultatif de pharmacologie Conseil du médicament 2003 2003 Institut national d’excellence en santé et en services sociaux Social Services Clinical Practice Guidelines 2009 2011 1988 1991 Medical Biology Lab tests
  4. 4. 4 INESSS’ Mission • The mission of the Institute is to promote clinical excellence and the efficient use of resources in the health and social services sector Informing decisions at the macro, meso and micro level in health care and social services. An Act respecting the Institut national d'excellence en santé et en services sociaux
  5. 5. 5 INESSS assesses technologies and health and social care interventions  HTA of drugs for listing purposes (new active substances, generics, new formulations …)  HTA of laboratory tests for listing purposes  Full HTAs (health and social care interventions)  Optimal use guides  Clinical practice guidelines  Rapid HTAs  Collective prescriptions (in collaboration with MSSS)  Methodological tools  Community of Practice of Hospital-Based HTA
  6. 6. 6 HTA for drug listing purposes Act respecting the INESSS article 7 If the Institute considers that the therapeutic value of a medication has been established, it sends its recommendation to the Minister after assessing: 1. the reasonableness of the price charged 2. the cost-effectiveness ratio of the medication 3. the impact that entering the medication on the list will have on the health of the general public and on the other components of the health and social services system 4. the advisability of entering the medication on the list, given the purpose of the basic prescription drug insurance plan
  7. 7. 7 Advisory committee on HTA and innovative technologies (CÉTI) • Created in December 2012 • Advisory to the CEO Objective: To promote a common understanding of the challenges of introducing innovative technologies into the health system, and to identify possible solutions to ensure consistency in doing so, for the benefit of users Composition: Representatives from patient and user groups, from the health technologies industry, from the research and HTA communities, from the economic development community, and managers of the health and social services network (local, regional and national levels) For more information: advisory-committee-on-hta-and-innovative-technologies.html
  8. 8. 8 • The Committee’s work led to the first HTA and Innovative Technologies Forum on December 3 2013  Focus on implementing a more dynamic assessment process better suited to the particularities of innovative technologies For more information:
  9. 9. 9 CÉTI: current work and next steps  To optimise the generation of knowledge in real-world settings for innovative technologies with the greatest potential for positive impacts on patients and the health system Objectives: • To define the concepts related to the production of knowledge in real world settings; • To develop a method for generation of knowledge in real-world settings for innovative technologies, including a method to identify and prioritise the most promising technologies; • To identify and discuss the operational and implementation challenges of the proposed approach; • To propose a framework for the production of knowledge in real-world settings; • To promote and facilitate the use of this framework by different groups of stakeholders
  10. 10. 10 Knowledge generation in real-world settings • The living lab approach has been explored based on the suggestions of CÉTI members “A living lab is a user-centric innovation environment, built on realistic activities and research where all relevant partners are involved in open processes, with objective to generate sustainable values for living lab partners and stakeholders”1 • Among the key characteristics of living labs: – Value is created through the collaboration of different stakeholders in public-private-people-partnerships – Users are involved as co-creators – Activities take place in real-world environments – The innovation process is open and iterative 1- Bergvall-Kåreborn, B., IhlströmEriksson, C., Ståhlbröst, A., et Svensson, J., A Milieu for Innovation - Defining Living Lab, presented at the 2nd ISPIM Innovation Symposium, New York, december 6-9 2009, available at
  11. 11. 11 Progressive field evaluation Premises:  Applies to technologies with a high potential for positive impacts on patients and the health system and for which the added value could be best verified in real-world settings – Implies a clear definition of what qualifies as a promising innovative technology, as well as a way to judge the plausibility of the value proposition  Current work aim to develop an approach, but not its implementation  The concept of progressive field evaluation in its actual form is NOT linked to the reimbursement processes. However it bares some similarities with what has been suggested for coverage with evidence development.
  12. 12. Objectives: • Align the value proposal of an • Integrate the knowledge and the • Identify optimal conditions and • Collect information about the 12 Progessive field evaluation innovative technology with the needs of the users experience of the partners involved adapt the use of a technology accordingly effectiveness of a technology, as well as contextual and organizational elements relevant to decision makers Image adapted from the Living Lab Methodology Handbook, Ståhlbröst et Holst, 2012, available at!/file/LivingLabsMethodologyBook_web.pdf
  13. 13. 13 A starting point for the progressive field evaluation Research protocol → methods  Projects are part of public research (protocols are peer-reviewed and results are published)  Participative research designs (user centered)  Research designs allow for adjustments during the project • Data generated is open by default (with confidential elements to be defined) Innovation protocol → social contract  Project governance framework  Definition of the roles of each partner  Agreement on the level of interaction between the partners  Start and end of the project  Funding of the project
  14. 14. 14 How is the progessive field evaluation different from other approaches? • Evolving nature: the process fosters the adaptation of the use of the technology according to the users’ “real” needs • Co-responsibility: activities are influenced by all partners and the decision making (within the project) is shared • Co-production: knowledge is generated through the participation and the commitment of all partners • Transparency: the information is public (open data), the rules are clear and known (innovation protocol) and the processes are open
  15. 15. 15 Towards a learning health system Health system
  16. 16. 16 Challenges for pharmaceuticals • Defining the role and place of progressive field evaluations in relation to the life cycle of drug development and use • Cohabitation between an open collaborative approach with the rules and practice of regulation and market access • Trust between the health system, industry and patients • Links to other innovative initiatives such as adaptive licensing and IMI Get Real
  17. 17. 17 Proposal for discussions • What could be the contribution of progressive field evaluations in the post-market space? • Which would be the possible triggers for progressive field evaluations in the post-market space ? • What would be the contribution of progressive field evaluations for improving the patient care and health system performance?