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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
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Catalysing knowledge generation in real-world setting- Current work at INESSS

Reiner Banken, M.D. M. Sc. - Advisor to the CEO- Alliances and networksGenevive Plamondon, M.Sc. - Scientific professional- InnovationDima Samaha, Pharm D MAS - Advisor Innovation and external affairs

November 19th 20141Outline of the presentationQuick presentation of INESSSAdvisory committee on HTA and innovative technologiesCurrent work on knowledge generation in real-world settingsThe new approach proposedQuestions and discussionNINESSS 40 years of science advice for decision-making

Conseil dvaluation des technologies de la sant(1988)Agences dvaluationdes technologies etdes modes dintervention en santComit de revue de lutilisation des mdicaments 2000Rseau de revue dutilisation desmdicamentsConseil consultatifde pharmacologieConseil du mdicament20032003Social ServicesClinical Practice GuidelinesInstitut nationaldexcellenceen sant et enservices sociaux

2009January, 19, 201119881996197219912011Medical BiologyLab testsNINESSS MissionThe mission of the Institute is to promote clinical excellence and the efficient use of resources in the health and social services sectorInforming decisions at the macro, meso and micro level in health care and social services.An Act respecting the Institut national d'excellence en sant et en services sociaux NINESSS 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 purposesFull HTAs (health and social care interventions)Optimal use guidesClinical practice guidelines Rapid HTAsCollective prescriptions (in collaboration with MSSS)Methodological toolsCommunity of Practice of Hospital-Based HTA

NHTA for drug listing purposesAct respecting the INESSS article 7If 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 charged2. the cost-effectiveness ratio of the medication3. 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 NAdvisory committee on HTA and innovative technologies (CTI)Created in December 2012Advisory 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 usersComposition: 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: NThe Committees 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: NCTI: current work and next stepsTo 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 stakeholdersNKnowledge generation in real-world settingsThe living lab approach has been explored based on the suggestions of CTI 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 stakeholders1

Among the key characteristics of living labs: Value is created through the collaboration of different stakeholders in public-private-people-partnershipsUsers are involved as co-creatorsActivities take place in real-world environmentsThe innovation process is open and iterative

1- Bergvall-Kreborn, B., Ihlstrm Eriksson, C., Sthlbrst, 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 NProgressive field evaluationPremises: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 settingsImplies a clear definition of what qualifies as a promising innovative technology, as well as a way to judge the plausibility of the value propositionCurrent work aim to develop an approach, but not its implementationThe 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.NProgessive field evaluationImage adapted from the Living Lab Methodology Handbook, Sthlbrst et Holst, 2012, available at!/file/LivingLabsMethodologyBook_web.pdf Objectives:Align the value proposal of an innovative technology with the needs of the users Integrate the knowledge and the experience of the partners involvedIdentify optimal conditions and adapt the use of a technology accordinglyCollect information about the effectiveness of a technology, as well as contextual and organizational elements relevant to decision makers

NA starting point for the progressive field evaluationResearch protocol methodsProjects 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 projectData generated is open by default (with confidential elements to be defined)Innovation protocol social contractProject governance frameworkDefinition of the roles of each partnerAgreement on the level of interaction between the partnersStart and end of the projectFunding of the project

NHow 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 needsCo-responsibility: activities are influenced by all partners and the decision making (within the project) is sharedCo-production: knowledge is generated through the participation and the commitment of all partnersTransparency: the information is public (open data), the rules are clear and known (innovation protocol) and the processes are openNTowards a learning health systemHealth system

NChallenges for pharmaceuticalsDefining the role and place of progressive field evaluations in relation to the life cycle of drug development and useCohabitation between an open collaborative approach with the rules and practice of regulation and market accessTrust between the health system, industry and patientsLinks to other innovative initiatives such as adaptive licensing and IMI Get Real

NProposal for discussionsWhat 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?