THE IMPACT OF GENERALIZED RISK ADJUSTED COST-EFFECTIVENESS ANALYSIS (GRACE) ON VALUE ASSESSMENT: FROM FORMAL ADOPTION TO GLOBAL METHODOLOGICAL TRENDS
Author(s)
Yunni Yi, PhD, MSc1, Anne Meiwald, MSc, BSc1, Louise Heron, MA, MSc1, Alex Hirst, BSc, MSc2.
1Adelphi Values PROVE, Bollington, United Kingdom, 2Senior Director, Adelphi Values PROVE, Bollington, United Kingdom.
1Adelphi Values PROVE, Bollington, United Kingdom, 2Senior Director, Adelphi Values PROVE, Bollington, United Kingdom.
Presentation Documents
OBJECTIVES: The GRACE framework extends traditional cost-effectiveness analysis (CEA) to better reflect societal value regarding disease severity and risk-aversion. This study examines GRACE application status, its impact on value assessment, and integration of its core principles in global HTA frameworks.
METHODS: A review of HTA websites, PubMed, and ISPOR proceedings (2020-2026) was conducted. Data were extracted from primary studies applying GRACE to identify its impact on incremental cost effectiveness ratios (ICERs) and willingness-to-pay (WTP) thresholds. Current methodological guidelines from major HTA bodies were analyzed for GRACE alignment.
RESULTS: ICER (US) remains the primary formal adopter, integrating GRACE into its "Value Assessment Framework" for severe diseases. Five applications were identified: sickle cell disease (SCD), non-small cell lung cancer (NSCLC), Hepatitis C, and neurology. In SCD and NSCLC, GRACE increased WTP thresholds by ~50% and reduced ICERs by 7-13% respectively. In Hepatitis C, incorporating "insurance value" reduced ICERs by over 90%. In neurology, net monetary benefit increased by 11.6% through better valuing of disability prevention. Aggregate analysis of 69 drugs across 53 diseases demonstrated GRACE is budget-neutral, redistributing value from mild to severe conditions. GRACE principles increasingly appear in international HTA: NICE (UK) implemented 2026 threshold updates to £25,000-£35,000/QALY with "Severity Modifiers," while CADTH (Canada) and EU Member States shifted toward "Unmet Medical Need" weightings prioritizing severe health shortfalls.
CONCLUSIONS: GRACE systematically corrects undervaluation of treatments for severe conditions. Formal adoption by ICER and emergence of severity modifiers globally signal a significant shift from "flat" QALYs toward risk-adjusted models. While challenges exist regarding empirical estimation of risk-aversion parameters and measurement of untreated health baselines, the adoption of GRACE like method by major HTA bodies is a critical step toward more consistent and equitable healthcare resource allocation.
METHODS: A review of HTA websites, PubMed, and ISPOR proceedings (2020-2026) was conducted. Data were extracted from primary studies applying GRACE to identify its impact on incremental cost effectiveness ratios (ICERs) and willingness-to-pay (WTP) thresholds. Current methodological guidelines from major HTA bodies were analyzed for GRACE alignment.
RESULTS: ICER (US) remains the primary formal adopter, integrating GRACE into its "Value Assessment Framework" for severe diseases. Five applications were identified: sickle cell disease (SCD), non-small cell lung cancer (NSCLC), Hepatitis C, and neurology. In SCD and NSCLC, GRACE increased WTP thresholds by ~50% and reduced ICERs by 7-13% respectively. In Hepatitis C, incorporating "insurance value" reduced ICERs by over 90%. In neurology, net monetary benefit increased by 11.6% through better valuing of disability prevention. Aggregate analysis of 69 drugs across 53 diseases demonstrated GRACE is budget-neutral, redistributing value from mild to severe conditions. GRACE principles increasingly appear in international HTA: NICE (UK) implemented 2026 threshold updates to £25,000-£35,000/QALY with "Severity Modifiers," while CADTH (Canada) and EU Member States shifted toward "Unmet Medical Need" weightings prioritizing severe health shortfalls.
CONCLUSIONS: GRACE systematically corrects undervaluation of treatments for severe conditions. Formal adoption by ICER and emergence of severity modifiers globally signal a significant shift from "flat" QALYs toward risk-adjusted models. While challenges exist regarding empirical estimation of risk-aversion parameters and measurement of untreated health baselines, the adoption of GRACE like method by major HTA bodies is a critical step toward more consistent and equitable healthcare resource allocation.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
EE304
Topic
Economic Evaluation
Topic Subcategory
Thresholds & Opportunity Cost
Disease
No Additional Disease & Conditions/Specialized Treatment Areas