FIRST PLENARY: Joint Assessment of Relative Effectiveness: Trick or Treat for Decision Makers in EU Member States

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1 FIRST PLENARY: Joint Assessment of Relative Effectiveness: Trick or Treat for Decision Makers in EU Member States Finn Børlum Kristensen, MD, PhD Professor of Health Services Research and HTA, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark Outline Assessing dimensions of value What is clinical assessment (REA)? What is Joint Clinical Assessment (REA)? What is already in place to facilitate Joint Clinical Assessment? The mechanism of joint and national clinical assessment improvement needed Perspectives of a mechanism that works Efficiency in clinical assessment (timeliness, relevance, quality, volume) Synchronisation with regulatory processes Evidence generation during life cycle 1

2 Value in health is multi dimensional Wider aspects of value Clinical value Health problem and current interventions Technical characteristics of interventions Clinical efficacy / effectiveness Safety Costs and economic aspects Organizational aspects Patient and social aspects Ethical aspects Legal aspects Assessing clinical value In comparison with relevant existing drug / procedure / device Clinical value Health problem and current use of technology Technical characteristics Safety Clinical effectiveness Costs and economic evaluation Ethical analysis Organizational aspects Patient and social aspects Legal aspects Source: European Network for Health Technology Assessment, 2

3 Clinical Assessment (REA) It s done in comparison with relevant existing drug / procedure / device It s scientific and technical work (analysis of alternatives) It informs policy making and decision making - typically by way of deliberative processes (appraisal) The timeline of reaching a sustainable and permanent HTA cooperation in Europe Health Programme 2005 Call for project proposals 2009 Call for joint action 2011 Call for joint action 2015 Call for joint action Project 2009 Collaboration JA JA JA3? HTA Cooperation? Legislation Draft Cross Border Healthcare Directive. Article 15 on HTA network CBHC Directive now decided 2013 EU Cooperation on HTA Implementing Decision HTA Network Proposal for REGULATION on HTA Member State Coordinating Group on HTA? 3

4 Current voluntary Network for HTA (Directive on patients rights in cross border healthcare Article 15, 2011) The Union shall support and facilitate cooperation and the exchange of scientific information among Member States within a voluntary network connecting national authorities or bodies responsible for health technology assessment designated by the Member States That network shall be based on the principle of good governance including transparency, objectivity, independence of expertise, fairness of procedure and appropriate stakeholder consultations... avoid duplication of assessments Tools and procedures developed to facilitate Joint Clinical Assessment HTA Core Model framework HTA Core Model for REA HTA Core Model framework Submission Templates HTA Core Model framework Early Dialogues on evidence generation EMA - Multi-HTA Dialogues Parallel Consultation Clinical Assessment (REA) Technology lifecycle Additional evidence generation 4

5 Healthcare decision making and the HTA Process Source: Value in Health, accepted Identifying the need for good practices in HTA: Summary of the ISPOR HTA Council Working Group Report Healthcare decision making the loop from national context back to national context Locate the decision National / local context Globalise the evidence Joint Clinical Assessment Localise the reporting National / local context 5

6 Legislative proposal by the European Commission (2018) Clinical Assessment as defined in the proposed legislation The Preparation of Joint Clinical Assessment Reports as defined in the proposed legislation Clinical Assessment as defined in the proposed legislation 'clinical assessment' means a compilation and evaluation of the available scientific evidence on a health technology in comparison with one or more other health technologies based on the following clinical domains of health technology assessment: the description of the health problem addressed by the health technology and the current use of other health technologies addressing that health problem, the description and technical characterisation of the health technology, the relative clinical effectiveness, and the relative safety of the health technology; 6

7 The Preparation of Joint Clinical Assessment Reports as defined in the proposed legislation The conclusions of the joint clinical assessment report shall be limited to the following: (a) an analysis of the relative effects of the health technology being assessed on the patient relevant health outcomes chosen for the assessment; (b) the degree of certainty on the relative effects based on the available evidence. The designated sub group shall request relevant health technology developers to submit documentation containing the information, data and evidence necessary for the joint clinical assessment. Informing decisions in national context Appraisal as defined in the proposed legislation drawing conclusions on the added value of the technologies concerned as part of national appraisal processes which may consider clinical as well as nonclinical data and criteria 7

8 Contextualisation / Appraisal as described in an ISPOR HTA Council Report to be published in Value in Health, January 2019 Evidence based decision making incorporates other considerations (e.g., affordability, ethical issues, feasibility and acceptability) that may require mechanisms of contextualization of assessment results, such as deliberative processes, to support them The recommendations that come from e.g. appraisal and reimbursement committees may involve both analytic judgments... and consideration of social values. Member states own scientific and technical mechanisms and joint mechanisms Stakeholders Member State national context Payer(s) National HTA Joint clinical assessment Payer(s) National HTA Member State national context Stakeholders Several payers Crossborder collaborations Payer(s) National / regional HTA Member State national context Stakeholders 8

9 Joint Clinical Assessments potentials in European scientific and technical cooperation Alignment of scientific methodologies, processes, procedures and output Scientific and technical standardisation Pooling of expertise and capacity building Increased volume of HTA production Strengthening good public governance Swifter responsiveness to new demands Question to all stakeholders: Questions to panelists In practical terms, how do you see scientific and technical cooperation on JCA fit into meeting needs of a national HTA and tariff system agency and its Transparency Committee? a regional health agency? Payers? Industry European patients? Question to European patient organisations: How could the JCA facilitate more patient relevant evidence being used in the scientific and technical work in JCA? Question to payers, industry: How can payers/industry help increase the use of JCA? Question to the European Commission: In practical terms, how is scientific and technical cooperation on JCA going to help citizens harvest from overall aim of EU to promote cooperation among EU countries on access, quality and sustainability? Question to, a national HTA agency and the European Commission: If there is one thing that would bring European scientific and technical cooperation on JCA to fruition, what would it be? 9