REAL WORLD SURVIVAL OUTCOMES FOLLOWING REIMBURSED ANTI-PD-1 IMMUNOTHERAPY FOR MELANOMA IN IRELAND A POPULATION-BASED NATIONAL CANCER REGISTRY STUDY
Author(s)
Arianna Almirall Sanchez, PhD, MD1, Cathal Walsh, Professor2, Roisin Adams, Professor3, Theresa Redaniel, Professor4, Ciaran Haugh, BSc4, Lea Trela-Larsen, BSc, PhD5, Caroline Walsh, Professor6, Belinda Hernandez, Professor6, Joanne Feeney, Professor6, Laura Mc Cullagh, Professor6.
1Killester, Ireland, 2School of Medicine, Trinity College Dublin/ National Centre for Pharmacoeconomics, DUBLIN, Ireland, 3School of Medicine, Trinity College Dublin/ National Centre for Pharmacoeconomics, Dublin, Ireland, 4National Cancer Registry Ireland, Cork, Ireland, 5NCPE Ireland, Dublin, Ireland, 6National Centre for Pharmacoeconomics, DUBLIN, Ireland.
1Killester, Ireland, 2School of Medicine, Trinity College Dublin/ National Centre for Pharmacoeconomics, DUBLIN, Ireland, 3School of Medicine, Trinity College Dublin/ National Centre for Pharmacoeconomics, Dublin, Ireland, 4National Cancer Registry Ireland, Cork, Ireland, 5NCPE Ireland, Dublin, Ireland, 6National Centre for Pharmacoeconomics, DUBLIN, Ireland.
OBJECTIVES: Immune checkpoint inhibitors have substantially improved outcomes for melanoma; however, reimbursement decisions are primarily informed by clinical trials conducted in selected populations with limited long-term follow-up. Population-based real-world evidence is increasingly required to evaluate treatment effectiveness in routine practice and inform post-reimbursement health technology assessment (HTA). OBJECTIVES: To evaluate real-world utilisation patterns and survival outcomes among Irish patients receiving anti-PD-1 immunotherapy for melanoma cancer
METHODS: A retrospective population-based cohort study was conducted using National Cancer Registry Ireland (NCRI) data. Adults diagnosed with melanoma between 2014 and 2023 who received pembrolizumab or nivolumab were identified. Patients were classified into advanced/unresectable disease and adjuvant Stage III or Stage IIB/IIC cohorts using registry stage, surgery and treatment sequencing. Overall survival (OS) was estimated using Kaplan-Meier methods, and multivariable Cox regression identified predictors of mortality.
RESULTS: Overall, 656 patients received anti-PD-1 immunotherapy, demonstrating substantial uptake within routine melanoma care in Ireland. Most patients (58.6%) were treated for advanced/unresectable disease, while 35.9% and 5.5% received adjuvant treatment for Stage III and Stage IIB/IIC melanoma, respectively, reflecting the expansion of reimbursed indications over time. During 1,496 person-years of follow-up, 241 deaths occurred and median OS for the overall cohort was 4.8 years. Survival varied markedly by treatment pathway, with one-year survival exceeding 90% in adjuvant cohorts compared with approximately 75% among patients treated for advanced disease. Although crude survival estimates were broadly comparable between pembrolizumab and nivolumab, survival differed significantly across clinical indications (p<0.001). Multivariable analyses demonstrated that patients aged ≥75 years had a substantially increased risk of mortality (HR=2.17 for pembrolizumab; HR=3.17 for nivolumab), whereas treatment initiation during 2021-2023 was associated with improved survival (HR=0.41 and HR=0.54, respectively).
CONCLUSIONS: These findings demonstrate the value of routinely collected data for post-reimbursement evaluation, reducing uncertainty surrounding long-term outcomes and supporting evidence-informed HTA and reimbursement decision-making.
METHODS: A retrospective population-based cohort study was conducted using National Cancer Registry Ireland (NCRI) data. Adults diagnosed with melanoma between 2014 and 2023 who received pembrolizumab or nivolumab were identified. Patients were classified into advanced/unresectable disease and adjuvant Stage III or Stage IIB/IIC cohorts using registry stage, surgery and treatment sequencing. Overall survival (OS) was estimated using Kaplan-Meier methods, and multivariable Cox regression identified predictors of mortality.
RESULTS: Overall, 656 patients received anti-PD-1 immunotherapy, demonstrating substantial uptake within routine melanoma care in Ireland. Most patients (58.6%) were treated for advanced/unresectable disease, while 35.9% and 5.5% received adjuvant treatment for Stage III and Stage IIB/IIC melanoma, respectively, reflecting the expansion of reimbursed indications over time. During 1,496 person-years of follow-up, 241 deaths occurred and median OS for the overall cohort was 4.8 years. Survival varied markedly by treatment pathway, with one-year survival exceeding 90% in adjuvant cohorts compared with approximately 75% among patients treated for advanced disease. Although crude survival estimates were broadly comparable between pembrolizumab and nivolumab, survival differed significantly across clinical indications (p<0.001). Multivariable analyses demonstrated that patients aged ≥75 years had a substantially increased risk of mortality (HR=2.17 for pembrolizumab; HR=3.17 for nivolumab), whereas treatment initiation during 2021-2023 was associated with improved survival (HR=0.41 and HR=0.54, respectively).
CONCLUSIONS: These findings demonstrate the value of routinely collected data for post-reimbursement evaluation, reducing uncertainty surrounding long-term outcomes and supporting evidence-informed HTA and reimbursement decision-making.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
CO156
Topic
Clinical Outcomes, Epidemiology & Public Health, Real World Data & Information Systems
Topic Subcategory
Clinician Reported Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Oncology