What Can Be Gained from Payer/HTA Involvement in the Multi-Stakeholder Consensus Development of Core Outcome Sets for Late Phase Clinical Trials?
Author(s)
Moderator: Donna Messner, PhD, Center for Medical Technology Policy, Baltimore, MD, USA
Panelists: Foluso O Agboola, MBBS, MPH, Institute for Clinical and Economic Review, Boston, MA, USA; Emily Tsiao, PharmD, Premera Blue Cross, Mountlake Terrace, WA, USA; Jill Morrow-Gorton, MD, MBA, University of Pittsburgh (UPMC) Health Plan, Germantown, MD, USA
Presentation Documents
ISSUE: Panelists will explore the potential value of payer and health technology assessor (HTA) participation in consensus-based core outcome set (COS) development for drug clinical trials, discuss hurdles to their participation and debate the potential benefits (or drawbacks) of COS to coverage and payment decision-making.
OVERVIEW: Gene therapies and biologics promise paradigm shifts for many diseases, though at considerably higher prices. Decision makers assessing the added value of these agents for patients, in relation to their high costs, encounter major challenges: a) heterogenous outcomes hinder comparisons with traditional therapies, or b) effective new therapies impact standards of care such that traditional outcomes lose relevance. COS development may address these and other challenges by bringing together multiple stakeholder perspectives to deliberate and reach consensus on critical outcomes for decision-making. Through this lens, payers and HTA are key stakeholders in these initiatives.
Attendees will hear from moderator Donna Messner, PhD, President and CEO of Center for Medical Technology Policy. Dr. Messner and her team have developed multi-stakeholder consensus-based COS for late phase clinical trials under their Green Park Collaborative program. She will describe COS objectives and methodology, highlighting ways COS have reflected payer/HTA concerns. The panelists provided payer and HTA perspectives as participants in one of two recent COS initiatives: coreSCD (sickle cell disease) and coreASTHMA. Each panelist had her own motivations for participating and a unique experience during the consensus process. Panelists will be asked to present on the following:- What were you able to bring to the [multi-stakeholder consensus] process?
- What were you able to take away?
- Should more payers/HTA stakeholders get involved in COS development, why or why not?
- What is the potential impact of greater development and uptake of COS for future evidence-based policy-making?
Conference/Value in Health Info
Topic
Clinical Outcomes