Amy Pavlock, VMD Carlo Federici, MSc Oriana Ciani, PhD, MSc ISPOR International Initiatives on the Assessment of the Value of Medical Technologies Amy Pavlock, VMD Carlo Federici, MSc Oriana Ciani, PhD, MSc Friday, 14 December, 2018

ISPOR International Initiatives on the Assessment of the Value of Medical Technologies Objectives: Identify the current and possible future role of HTA, cost-effectiveness and budget affordability metrics, and other tools/approaches/methods used to assess the value of medical technologies’ continuous, disruptive transformative innovation globally and locally Present reflections on the future role that HTA and other tools could have in assessing medical technologies throughout their lifecycle to inform adoption/reimbursement or local decisions and health care policies A long-term objective may involve building up a platform for continuous dialogue at an international level between interested stakeholders in the field of medical technologies

ISPOR International Initiatives on the Assessment of the Value of Medical Technologies Methods: Gap analysis focusing on assessment of the value of medical technologies, including the role of HTA, at different stages of the lifecycle via a systematic literature review using 2 research questions: What is the literature on assessment of the value of medical technologies at different stages of the product lifecycle and what is the role of HTA in determining/assessing value? Are there identifiable differences in the role of HTA assessing the value of medical devices? Subsequent conduct of survey/mapping designed to complement the systematic overview where needed

ISPOR International Initiatives on the Assessment of the Value of Medical Technologies Two reviewers from NICE UK and ISPOR independently screened the identified records a 3rd reviewer was consulted to reconcile the differences between the initial reviewers Preliminary data extraction from included abstracts was performed

Information retrieved from included papers (I) ISPOR International Initiatives on the Assessment of the Value of Medical Technologies Information retrieved from included papers (I) Objective of Study Type of Study Country(ies)/ Region(s) Type of Medical Technology Medical Technology Lifecycle Stage(s) Type of Value Assessment The aim of the study empirical, methodological, qualitative/surveys, model-based Jurisdictions where the assessment was done Medical device, diagnostic, m-Health, etc. Early (before market access), middle (at launch), late, whole lifecycle Formal HTA, clinical performance, economic performance, broaden societal impact etc.

Information retrieved from included papers (II) ISPOR International Initiatives on the Assessment of the Value of Medical Technologies Information retrieved from included papers (II) Organization Performing Value Assessment Type(s) of Evidence Collected Methods used for assessment Conclusions Limitations Name and type of organization (HTA agency, SHI, private companies etc.) Clinical effectiveness, performance, safety, costs, etc. MCDA, modelling, mixed methods etc. Summary of conclusions relating to value assessment of MDs, barriers and facilitating factors Limitation of the study

ISPOR International Initiatives on the Assessment of the Value of Medical Technologies Preliminary results (I)

ISPOR International Initiatives on the Assessment of the Value of Medical Technologies Preliminary results (II)

ISPOR International Initiatives on the Assessment of the Value of Medical Technologies Preliminary results (III) Conclusions: Growing experience and literature in the assessment of the value for medical technologies Most of the studies are commentaries unspecific with respect to type of technologies, stage of lifecycle development, geographic region More applied studies refer directly to high income setting, device/diagnostics types of products, and early stage of development Wide scope raises challenges in focus for this review

ISPOR International Initiatives on the Assessment of the Value of Medical Technologies Next Steps: Ultimate full-text data extraction and provide a critical overview of methods and roles of value assessment framework in the literature Invite additional international agencies, individuals, and/or regions to participate in this project Conduct interviews to integrate the results of the review Provide policy recommendations on the future role that HTA and other tools could have in assessing medical technologies

Thank you for your attention. Acknowledgments Thank you for your attention. oriana.ciani@unibocconi.it carlo.federici@unibocconi.it amy.pavlock@ispor.org Adriana Velazquez Berumen Carlo Federici, MSc Finn Børlum Kristensen, MD, PhD Giuditta Callea, PhD Julie Polisena, PhD, MSc Leandro Pecchia, PhD Mirella Marlow, MBA, MA Oriana Ciani, PhD, MSc Øyvind Melien, MD, PhD, MSc

Disclosure No funding has been supplied for this project and there are no conflicts of interest for any participants.