A DECADE OF ONCOLOGY HEALTH TECHNOLOGY ASSESSMENT IN PORTUGAL: TRENDS IN CLINICAL EVALUATION AND FUNDING RECOMMENDATIONS (2016-2025)
Author(s)
Raquel Martins Cardoso, MSc1, Carlos Alves, PhD1, Julian Perelman, PhD2.
1Faculty of Pharmacy, University of Coimbra, Coimbra, Portugal, 2NOVA National School of Public Health, Public Health Research Centre, Comprehensive Health Research Center, NOVA University of Lisbon, Lisbon, Portugal.
1Faculty of Pharmacy, University of Coimbra, Coimbra, Portugal, 2NOVA National School of Public Health, Public Health Research Centre, Comprehensive Health Research Center, NOVA University of Lisbon, Lisbon, Portugal.
OBJECTIVES: The Portuguese National System for Health Technology Assessment (SiNATS) was established in 2016 to strengthen the transparency and scientific rigor of health technology assessment (HTA) in Portugal. Given the growing clinical and economic importance of oncology, this study characterizes oncology drug HTA in Portugal over a 10-year period, describing trends in therapeutic assessment and funding recommendations.
METHODS: A descriptive review of publicly available HTA reports for oncology medicines assessed by SiNATS between January 2016 and December 2025 was conducted. Data were extracted on therapeutic area, indication, pharmacotherapeutic assessment outcomes, therapeutic added value classification, and final funding recommendation. Descriptive analyses were performed.
RESULTS: A total of 224 oncology HTA submission reports were identified between 2016 and 2025, corresponding to 288 individual assessments, as some reports included separate assessments for different therapeutic subpopulations. The most frequently assessed therapeutic areas were hematological malignancies (n=40/224; 18%), lung cancer (n=36/224; 16%) and breast cancer (n=30/224; 13%). Additionally, 137 (48%) correspond to 1st-line therapies, 82 (28%) to 2nd-line therapies, 35 (12%) to ≥3rd-line therapies, and 33 [11%] to maintenance/adjuvant/neo-adjuvant therapies. Among the 288 individual assessments, pharmacotherapeutic evaluation concluded for ATV in 206 (72%) (25 [9%] major, 25 [9%] moderate, 19 [7%] minor, 105 [37%] non-quantifiable, and 32 [11%] not reporting the magnitude), while 24 (8%) concluded for therapeutic equivalence, and 58 (20%) did not identified therapeutic value. The certainty of evidence supporting ATV was high in 47 (23%) of assessments, moderate in 64 (31%), and low in 93 (45%), with 2 (1%) assessments not reporting this finding. Funding was not recommended for 32 drugs among the 224 submission reports.
CONCLUSIONS: Over its first decade, SiNATS assessed an increasing number of oncology medicines while maintaining a high proportion of favorable funding recommendations. This review characterizes oncology HTA practice in Portugal and highlights patterns in therapeutic value assessment and reimbursement recommendations.
METHODS: A descriptive review of publicly available HTA reports for oncology medicines assessed by SiNATS between January 2016 and December 2025 was conducted. Data were extracted on therapeutic area, indication, pharmacotherapeutic assessment outcomes, therapeutic added value classification, and final funding recommendation. Descriptive analyses were performed.
RESULTS: A total of 224 oncology HTA submission reports were identified between 2016 and 2025, corresponding to 288 individual assessments, as some reports included separate assessments for different therapeutic subpopulations. The most frequently assessed therapeutic areas were hematological malignancies (n=40/224; 18%), lung cancer (n=36/224; 16%) and breast cancer (n=30/224; 13%). Additionally, 137 (48%) correspond to 1st-line therapies, 82 (28%) to 2nd-line therapies, 35 (12%) to ≥3rd-line therapies, and 33 [11%] to maintenance/adjuvant/neo-adjuvant therapies. Among the 288 individual assessments, pharmacotherapeutic evaluation concluded for ATV in 206 (72%) (25 [9%] major, 25 [9%] moderate, 19 [7%] minor, 105 [37%] non-quantifiable, and 32 [11%] not reporting the magnitude), while 24 (8%) concluded for therapeutic equivalence, and 58 (20%) did not identified therapeutic value. The certainty of evidence supporting ATV was high in 47 (23%) of assessments, moderate in 64 (31%), and low in 93 (45%), with 2 (1%) assessments not reporting this finding. Funding was not recommended for 32 drugs among the 224 submission reports.
CONCLUSIONS: Over its first decade, SiNATS assessed an increasing number of oncology medicines while maintaining a high proportion of favorable funding recommendations. This review characterizes oncology HTA practice in Portugal and highlights patterns in therapeutic value assessment and reimbursement recommendations.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA261
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Value Frameworks & Dossier Format
Disease
Oncology