EUROCOVER-CLL: Reimbursement and Accessibility of New Treatments in Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) Final Analysis
Author(s)
Magdalena Monica, MSc1, Sabina Becirovic, MPharm2, Ioana Bianchi, MSc3, Natasa Duborija-Kovacevic, Prof.4, Pero Draganic, PhD, MD5, Kristina Garuoliene, PhD6, Ariel Hammerman, BSc, MSc, RPh, PhD7, Fanni Ispán, PhD8, Boryana Ivanova, PhD9, Agnes Männik, MSc, PG Cert10, Gergo Meresz, PhD11, Lusine Nazaryan, PhD12, Oleksandra Oleshchuk, PhD, MD13, Prof. Alexandra Savova, Phd, PhD14, Jana Skoupa, MD15, Nikola Stefanovic, PhD16, Tomas Tesar, MBA, MPH, PharmD, PhD17, Pawel Kawalec, PhD, MD18.
1Doctoral School of Medical and Health Sciences, Jagiellonian University Medical College, Kraków, Poland, 2Zentiva Pharma d. o. o, Sarajevo, Bosnia and Herzegovina, 3ARPIM (Romanian Association of International Pharmaceutical Manufacturers), Bucharest, Romania, 4Department of Pharmacology and Clinical Pharmacology, Medical Faculty, University of Montenegro, Podgorica, Montenegro, 5Agency for Medicinal Products, HALMED, Zagreb, Croatia, 6Vilnius University, Vilnius, Lithuania, 7Medison Pharma, Petach Tikva, Israel, 8National Institute of Health Insurance Fund Management, Budapest, Hungary, 9Department of Organization and Economics of Pharmacy, Faculty of Pharmacy, Medical University of Sofia, Sofia, Bulgaria, 10Institute of Family Medicine and Public Health, University of Tartu, Tartu, Estonia, 11ISPOR Hungary Chapter, Budapest, Hungary, 12Yerevan State Medical University, Yrevan, Armenia, 13Horbachevsky Ternopil National Medical University, Ternopil, Ukraine, 14Faculty of Pharmacy, Medical University of Sofia, Sofia, Bulgaria, 15EconHealth s.r.o, Prague, Czech Republic, 16Department of Pharmacy, Faculty of Medicine, University of Niš, Niš, Serbia, 17Department of Organisation and Management in Pharmacy, Bratislava, Slovakia, 18Jagiellonian University, Kraków, Poland.
1Doctoral School of Medical and Health Sciences, Jagiellonian University Medical College, Kraków, Poland, 2Zentiva Pharma d. o. o, Sarajevo, Bosnia and Herzegovina, 3ARPIM (Romanian Association of International Pharmaceutical Manufacturers), Bucharest, Romania, 4Department of Pharmacology and Clinical Pharmacology, Medical Faculty, University of Montenegro, Podgorica, Montenegro, 5Agency for Medicinal Products, HALMED, Zagreb, Croatia, 6Vilnius University, Vilnius, Lithuania, 7Medison Pharma, Petach Tikva, Israel, 8National Institute of Health Insurance Fund Management, Budapest, Hungary, 9Department of Organization and Economics of Pharmacy, Faculty of Pharmacy, Medical University of Sofia, Sofia, Bulgaria, 10Institute of Family Medicine and Public Health, University of Tartu, Tartu, Estonia, 11ISPOR Hungary Chapter, Budapest, Hungary, 12Yerevan State Medical University, Yrevan, Armenia, 13Horbachevsky Ternopil National Medical University, Ternopil, Ukraine, 14Faculty of Pharmacy, Medical University of Sofia, Sofia, Bulgaria, 15EconHealth s.r.o, Prague, Czech Republic, 16Department of Pharmacy, Faculty of Medicine, University of Niš, Niš, Serbia, 17Department of Organisation and Management in Pharmacy, Bratislava, Slovakia, 18Jagiellonian University, Kraków, Poland.
OBJECTIVES: This study aimed to explore reimbursement policy and access to novel targeted CLL therapies across selected countries and to analyze factors associated with differences in treatment availability and reimbursement timelines.
METHODS: Reimbursement frameworks, timelines, and accessibility of six novel CLL therapies were assessed across 15 countries in Central and Eastern Europe, the
Balkans, Armenia, and Israel. Data were collected via expert surveys in late 2024, based on publicly available national and regional sources. The survey covered reimbursement extent, timelines, policy restrictions, coverage pathways, and health technology assessment (HTA) evaluations. Comparative analyses examined regional differences in reimbursement and their potential drivers. Spearman's rank correlation was used to explore associations between the number of reimbursed therapies, reimbursement delays, and demographic, macroeconomic, and epidemiological variables.
RESULTS: The number of reimbursed therapies ranged from zero (Ukraine, Armenia) to five (Czech Republic), with a regional mean of 2.7 (SD = 1.38) and overall mean time to reimbursement of 29.3 months (SD = 21.4). Ibrutinib, reimbursed in 13 countries, had the longest mean reimbursement delay (35.6 months), while venetoclax (11 countries, 26.5 months), acalabrutinib (9 countries, 16.4 months), and zanubrutinib (6 countries, 15.2 months) had shorter delays. Gross domestic product (GPD) per capita showed a moderate positive correlation with the number of reimbursed therapies (ρ = 0.673, p = 0.006). Borderline significant associations were noted for CLL incidence and mortality (p = 0.050). Reimbursement indications were often restricted, particularly for patients without deletion 17p or TP53 mutations who experienced late relapses. Data on HTA outcomes and the number of treated patients were limited in several countries, and common challenges included funding constraints, administrative barriers, and the lack of centralized rare disease policies.
CONCLUSIONS: Significant disparities in access to targeted CLL therapies persist across the analyzed countries, with the number of reimbursed therapies
positively correlated with GDP per capita.
METHODS: Reimbursement frameworks, timelines, and accessibility of six novel CLL therapies were assessed across 15 countries in Central and Eastern Europe, the
Balkans, Armenia, and Israel. Data were collected via expert surveys in late 2024, based on publicly available national and regional sources. The survey covered reimbursement extent, timelines, policy restrictions, coverage pathways, and health technology assessment (HTA) evaluations. Comparative analyses examined regional differences in reimbursement and their potential drivers. Spearman's rank correlation was used to explore associations between the number of reimbursed therapies, reimbursement delays, and demographic, macroeconomic, and epidemiological variables.
RESULTS: The number of reimbursed therapies ranged from zero (Ukraine, Armenia) to five (Czech Republic), with a regional mean of 2.7 (SD = 1.38) and overall mean time to reimbursement of 29.3 months (SD = 21.4). Ibrutinib, reimbursed in 13 countries, had the longest mean reimbursement delay (35.6 months), while venetoclax (11 countries, 26.5 months), acalabrutinib (9 countries, 16.4 months), and zanubrutinib (6 countries, 15.2 months) had shorter delays. Gross domestic product (GPD) per capita showed a moderate positive correlation with the number of reimbursed therapies (ρ = 0.673, p = 0.006). Borderline significant associations were noted for CLL incidence and mortality (p = 0.050). Reimbursement indications were often restricted, particularly for patients without deletion 17p or TP53 mutations who experienced late relapses. Data on HTA outcomes and the number of treated patients were limited in several countries, and common challenges included funding constraints, administrative barriers, and the lack of centralized rare disease policies.
CONCLUSIONS: Significant disparities in access to targeted CLL therapies persist across the analyzed countries, with the number of reimbursed therapies
positively correlated with GDP per capita.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR73
Topic
Health Policy & Regulatory
Topic Subcategory
Health Disparities & Equity, Reimbursement & Access Policy
Disease
Oncology, Rare & Orphan Diseases