CLINICAL AND HUMANISTIC IMPACT OF USING PEMBROLIZUMAB ACROSS THE REIMBURSED INDICATIONS IN ITALY
Author(s)
Sam Greenall, MSc1, Virginia Eterno, MSc2, Amy Barber, MSc3, Catarina Neves, MSc4, Joao Pedro Ferreira, MSc5, Bernardo Rodrigues, MSc5, Vivek Khurana, MD MPH6, Annabelle Davies, MSc7.
1Lumanity, Manchester, United Kingdom, 2MSD Italy, Rome, Italy, 3Lumanity, London, United Kingdom, 4Lumanity, Utrecht, Netherlands, 5MSD, Lisbon, Portugal, 6MSD Sharp & Dohme GmbH, Munich, Germany, 7MSD (UK) Limited, London, United Kingdom.
1Lumanity, Manchester, United Kingdom, 2MSD Italy, Rome, Italy, 3Lumanity, London, United Kingdom, 4Lumanity, Utrecht, Netherlands, 5MSD, Lisbon, Portugal, 6MSD Sharp & Dohme GmbH, Munich, Germany, 7MSD (UK) Limited, London, United Kingdom.
OBJECTIVES: With 24 therapeutic indications approved in Italy between 2016 and 2025, it is crucial to understand pembrolizumab’s impact since its launch. A clinical and humanistic outcomes (CHO) model has been developed to quantify these across all pembrolizumab indications reimbursed in Italy.
METHODS: The population-level CHO model combines cost-effectiveness analyses from the 24 indications submitted for health technology assessment (HTA) to the Agenzia Italiana del Farmaco (AIFA) by 2025, evaluating pembrolizumab against relevant comparators. It then scales incremental outcomes estimated for the average patient in each reimbursed indication to account for the number of patients eligible for treatment (2016-2025) and projected to be eligible for treatment (2026-2031) with pembrolizumab in Italy. Modelled outcomes included deaths and disease progressions/recurrences avoided, and discounted lifetime life years (LYs) and quality-adjusted LYs (QALYs) gained. Patient numbers are based on epidemiological estimates derived from national cancer registry (AIRTUM).
RESULTS: Assuming 196,713 eligible patients were treated with pembrolizumab in 2016-2025, an estimated 26,451 deaths and 17,006 disease progressions/recurrences would be avoided, and would result in lifetime gains of 564,929 LYs and 440,168 QALYs. While comprising only 13% of the 196,713 pembrolizumab-eligible patients, those treated in the perioperative/adjuvant setting would contribute to 27% and 26% of the lifetime LYs and QALYs gains, respectively. A projected use of pembrolizumab in 2026-2031 in a further 312,414 eligible patients could result in an additional 37,977 deaths and 32,793 disease progressions/recurrences avoided, and lifetime gains of 941,971 LYs and 736,797 QALYs.
CONCLUSIONS: Using pembrolizumab in its approved indications is estimated to result in meaningful clinical and humanistic benefits. As national and international strategies focus on prevention, early diagnosis and access to high-quality care, these findings can support planning and investment in cancer care in Italy.
METHODS: The population-level CHO model combines cost-effectiveness analyses from the 24 indications submitted for health technology assessment (HTA) to the Agenzia Italiana del Farmaco (AIFA) by 2025, evaluating pembrolizumab against relevant comparators. It then scales incremental outcomes estimated for the average patient in each reimbursed indication to account for the number of patients eligible for treatment (2016-2025) and projected to be eligible for treatment (2026-2031) with pembrolizumab in Italy. Modelled outcomes included deaths and disease progressions/recurrences avoided, and discounted lifetime life years (LYs) and quality-adjusted LYs (QALYs) gained. Patient numbers are based on epidemiological estimates derived from national cancer registry (AIRTUM).
RESULTS: Assuming 196,713 eligible patients were treated with pembrolizumab in 2016-2025, an estimated 26,451 deaths and 17,006 disease progressions/recurrences would be avoided, and would result in lifetime gains of 564,929 LYs and 440,168 QALYs. While comprising only 13% of the 196,713 pembrolizumab-eligible patients, those treated in the perioperative/adjuvant setting would contribute to 27% and 26% of the lifetime LYs and QALYs gains, respectively. A projected use of pembrolizumab in 2026-2031 in a further 312,414 eligible patients could result in an additional 37,977 deaths and 32,793 disease progressions/recurrences avoided, and lifetime gains of 941,971 LYs and 736,797 QALYs.
CONCLUSIONS: Using pembrolizumab in its approved indications is estimated to result in meaningful clinical and humanistic benefits. As national and international strategies focus on prevention, early diagnosis and access to high-quality care, these findings can support planning and investment in cancer care in Italy.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
CO114
Topic
Clinical Outcomes, Economic Evaluation, Health Policy & Regulatory
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Oncology