Revisiting Archetypes: New Archetypes for Strategic Global Value Evidence Planning
Author(s)
Ruchik S. Patel, PharmD, MBA1, Yamini Misra, MBA1, Yumi Asukai, BS, MSc2, Denise Globe, PhD, MSHA,2, Sissi V Pham, PharmD1.
1AESARA, Durham, NC, USA, 2Gilead Sciences, Foster City, CA, USA.
1AESARA, Durham, NC, USA, 2Gilead Sciences, Foster City, CA, USA.
Presentation Documents
OBJECTIVES: Classify value evidence needs into archetypes to help global Health Economics and Outcomes Research (HEOR) functions strategically allocate resources and communicate value effectively across markets.
METHODS: A multi-phase methodology was applied to address heterogeneity in healthcare decision-making practices across markets: identified an initial sample of thirteen representative markets, selected for diversity in geography and healthcare decision-making policies; conducted a comprehensive review of local policy guidance documents to identify value methods and elements considered in local value assessments; categorized value evidence methods and elements by relative impact on decision-making and visualized with heatmaps. Impact of the evidence on decision-making was refined and validated with feedback from local access experts. Lastly, heatmaps identified trends in minimum value evidence packages requirements to support definition of value-evidence archetypes.
RESULTS: The analysis identified four value evidence archetypes with some overlap: 1. Comparative Clinical Effectiveness (CCE), 2. CCE + Cost Evaluations + Real-world evidence (RWE), 3. CCE + Cost-effectiveness or Cost-utility analysis (CEA/CUA) + RWE, 4. CCE + Cost Evaluation. These overlaps observed for the archetypes reflect the difficulty healthcare decision-makers have in prioritizing high- priced medicines with limited budgets. Most markets now require diverse evidence types including cost effectiveness analyses in addition to clinical effectiveness. Some countries rely exclusively on the CEA/CUA with clear established thresholds, others leverage it as an entry requirement to negotiations preferring to rely on other direct cost-evaluations (eg, Budget Impact Analysis). RWE’s role is expanding, underpinning both cost and clinical evaluations.
CONCLUSIONS: Value evidence archetypes do not align directly with traditional payer archetypes. Payer archetypes have focused on final pricing decisions, while evidence archetypes address pre- and post-approval evidence needs, enabling better effort and impact estimation for HEOR teams. This archetyping will also empower HEOR to better communicate impact based on external healthcare decision-making needs.
METHODS: A multi-phase methodology was applied to address heterogeneity in healthcare decision-making practices across markets: identified an initial sample of thirteen representative markets, selected for diversity in geography and healthcare decision-making policies; conducted a comprehensive review of local policy guidance documents to identify value methods and elements considered in local value assessments; categorized value evidence methods and elements by relative impact on decision-making and visualized with heatmaps. Impact of the evidence on decision-making was refined and validated with feedback from local access experts. Lastly, heatmaps identified trends in minimum value evidence packages requirements to support definition of value-evidence archetypes.
RESULTS: The analysis identified four value evidence archetypes with some overlap: 1. Comparative Clinical Effectiveness (CCE), 2. CCE + Cost Evaluations + Real-world evidence (RWE), 3. CCE + Cost-effectiveness or Cost-utility analysis (CEA/CUA) + RWE, 4. CCE + Cost Evaluation. These overlaps observed for the archetypes reflect the difficulty healthcare decision-makers have in prioritizing high- priced medicines with limited budgets. Most markets now require diverse evidence types including cost effectiveness analyses in addition to clinical effectiveness. Some countries rely exclusively on the CEA/CUA with clear established thresholds, others leverage it as an entry requirement to negotiations preferring to rely on other direct cost-evaluations (eg, Budget Impact Analysis). RWE’s role is expanding, underpinning both cost and clinical evaluations.
CONCLUSIONS: Value evidence archetypes do not align directly with traditional payer archetypes. Payer archetypes have focused on final pricing decisions, while evidence archetypes address pre- and post-approval evidence needs, enabling better effort and impact estimation for HEOR teams. This archetyping will also empower HEOR to better communicate impact based on external healthcare decision-making needs.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
HTA59
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Systems & Structure, Value Frameworks & Dossier Format
Disease
No Additional Disease & Conditions/Specialized Treatment Areas