ASSESSING THE ALIGNMENT BETWEEN ADDED THERAPEUTIC VALUE AND COST-EFFECTIVENESS: AN ANALYSIS OF PORTUGUESE REIMBURSEMENT DECISIONS
Author(s)
Catarina Ribeiro, MSc1, João Soares, MSc2, Diogo Mendes, PhD1, Carlos Alves, PhD1.
1Faculty of Pharmacy, University of Coimbra, Coimbra, Portugal, 2Clevidence, Oeiras, Portugal.
1Faculty of Pharmacy, University of Coimbra, Coimbra, Portugal, 2Clevidence, Oeiras, Portugal.
OBJECTIVES: In Portugal, medicines submitted for public reimbursement undergo a Health Technology Assessment (HTA) process comprising therapeutic and economic evaluations. Therapeutic assessments classify the magnitude of added therapeutic value (ATV) (i.e., non-quantifiable, minor, moderate or major), while economic evaluations estimate incremental cost-effectiveness ratios (ICERs). This study investigated whether ICER values are associated with the magnitude of ATV among medicines approved for reimbursement in Portugal.
METHODS: An Embase® search was conducted to retrieve published ICERs for medicines evaluated in Portugal between 2015 and 2025. ICERs were cross-referenced with Portuguese HTA assessment reports to identify matching indications and comparators and retrieve the corresponding magnitude of ATV. Associations between ICERs (€/Quality-Adjusted Life Year (QALY)) and magnitudes of ATV were assessed using Spearman’s rho and Kendall’s tau, with cluster bootstrap resampling used to estimate confidence intervals in R.
RESULTS: A total of 47 reimbursement decisions covering 34 distinct medicines with available ICERs and ATV classifications were included. More than half of observations were classified as having non-quantifiable ATV (24/47), while major, minor and moderate ATV classifications accounted for 11, 7 and 5 observations, respectively. Median published ICERs were €22,317/QALY for non-quantifiable ATV, €16,720/QALY for minor ATV, €39,468/QALY for moderate ATV and €32,702/QALY for major ATV. Despite variability and overlap in ICER values across ATV categories, only a weak, non-statistically significant positive association was observed between ICERs and ATV magnitude. Spearman’s rho was 0.26 (95% CI: −0.08 to 0.55) and Kendall’s tau was 0.19 (95% CI: −0.07 to 0.42), with bootstrap confidence intervals including zero.
CONCLUSIONS: A weak positive association between ICER values and ATV magnitude was observed, although correlations were not statistically significant. These findings suggest that ATV magnitude may not be a key driver of observed ICER values in Portuguese HTA assessments, reinforcing that therapeutic and economic evaluations capture complementary but distinct dimensions of value.
METHODS: An Embase® search was conducted to retrieve published ICERs for medicines evaluated in Portugal between 2015 and 2025. ICERs were cross-referenced with Portuguese HTA assessment reports to identify matching indications and comparators and retrieve the corresponding magnitude of ATV. Associations between ICERs (€/Quality-Adjusted Life Year (QALY)) and magnitudes of ATV were assessed using Spearman’s rho and Kendall’s tau, with cluster bootstrap resampling used to estimate confidence intervals in R.
RESULTS: A total of 47 reimbursement decisions covering 34 distinct medicines with available ICERs and ATV classifications were included. More than half of observations were classified as having non-quantifiable ATV (24/47), while major, minor and moderate ATV classifications accounted for 11, 7 and 5 observations, respectively. Median published ICERs were €22,317/QALY for non-quantifiable ATV, €16,720/QALY for minor ATV, €39,468/QALY for moderate ATV and €32,702/QALY for major ATV. Despite variability and overlap in ICER values across ATV categories, only a weak, non-statistically significant positive association was observed between ICERs and ATV magnitude. Spearman’s rho was 0.26 (95% CI: −0.08 to 0.55) and Kendall’s tau was 0.19 (95% CI: −0.07 to 0.42), with bootstrap confidence intervals including zero.
CONCLUSIONS: A weak positive association between ICER values and ATV magnitude was observed, although correlations were not statistically significant. These findings suggest that ATV magnitude may not be a key driver of observed ICER values in Portuguese HTA assessments, reinforcing that therapeutic and economic evaluations capture complementary but distinct dimensions of value.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA46
Topic
Economic Evaluation, Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Value Frameworks & Dossier Format
Disease
No Additional Disease & Conditions/Specialized Treatment Areas