WE-ACCESS-CLL SURVEY - REIMBURSEMENT AND ACCESS TO NOVEL FIRST-LINE TREATMENTS FOR CHRONIC LYMPHOCYTIC LEUKEMIA IN POLAND AND WESTERN EUROPE
Author(s)
Anita Stozek-Tutro, MSc1, Martyna Maria Chabalowska, MSc2, Isabelle Durand-Zaleski, MPP, PhD, MD3, François R. Girardin, MD4, Claire Gorry, PhD5, Klaudia Janiszewska, MSc6, Agata Laszewska, PhD7, Steven Simoens, BA, MA, MSc, PhD8, Nadine Younan, PhD9, Pawel Kawalec, PhD, MD10.
1Jagiellonian University Medical College, Crocow, Poland, 2Health Economics and Health Technology Assessment (HEHTA), Glasgow, United Kingdom, 3Assistance Publique Hopitaux de Paris URCEco, Paris, France, 4Division of clinical Pharmacology, Department of Medicine, University Hospital of Lausanne (CHUV) & University of Lausanne, Lausanne, Switzerland, 5School of Medicine, Trinity College Dublin, Dublin, Ireland, 6HTA Consulting, Cracow, Poland, 7Medical University of Vienna, Vienna, Austria, 8KU Leuven, Leuven, Belgium, 9University of Sheffield, Sheffield, United Kingdom, 10Jagiellonian University, Kraków, Poland.
1Jagiellonian University Medical College, Crocow, Poland, 2Health Economics and Health Technology Assessment (HEHTA), Glasgow, United Kingdom, 3Assistance Publique Hopitaux de Paris URCEco, Paris, France, 4Division of clinical Pharmacology, Department of Medicine, University Hospital of Lausanne (CHUV) & University of Lausanne, Lausanne, Switzerland, 5School of Medicine, Trinity College Dublin, Dublin, Ireland, 6HTA Consulting, Cracow, Poland, 7Medical University of Vienna, Vienna, Austria, 8KU Leuven, Leuven, Belgium, 9University of Sheffield, Sheffield, United Kingdom, 10Jagiellonian University, Kraków, Poland.
OBJECTIVES: To assess the reimbursement landscape for targeted therapies in first-line (1L) chronic lymphocytic leukemia (CLL) across Poland and selected Western European countries.
METHODS: Reimbursement data were collected using a structured questionnaire and supplemented with publicly available sources. Country-specific data was provided by local experts. The analysis included reimbursement status, time to reimbursement, eligible populations, access barriers, and cost parameters based on data available as of 31 March 2026.
RESULTS: All evaluated regimens were approved for 1L CLL in the assessed EU countries and the United Kingdom, except zanubrutinib, ibrutinib+venetoclax, and ibrutinib+obinutuzumab in Switzerland. Reimbursement varied across countries, ranging from 6 reimbursed regimens in France to 4 in Switzerland, highlighting differences in access to innovative CLL therapies across Europe. The longest interval from marketing authorization to reimbursement approval was for ibrutinib in Poland (2994 days) and ibrutinib+rituximab in Switzerland (1596 days), whereas the shortest were for ibrutinib in Switzerland (57 days) and acalabrutinib in Scotland (101 days). Population-based reimbursement restrictions were present in all countries, particularly for BTK inhibitor monotherapies (e.g., ibrutinib), whereas combination regimens (e.g., venetoclax+obinutuzumab) were more often reimbursed in broader populations consistent with licensed indications. Reimbursement generally provided full coverage (100%), except in Ireland (a copayment of up to €80 per month for some patients) and Switzerland (a 10% copayment). The highest daily drug costs were observed in Poland and Switzerland, and the lowest were reported in France.
CONCLUSIONS: Despite broad regulatory approval, substantial differences remain in reimbursement scope and time to access 1L CLL targeted therapies across Europe. Access limitations are primarily driven by restrictive reimbursement criteria and delayed reimbursement approval rather than diagnostic capacity. For selected therapies, such as ibrutinib+obinutuzumab or acalabrutinib+obinutuzumab, companies’ market access strategies cannot be excluded. Broadening existing reimbursement indications may help improve patient access to 1L CLL targeted therapies across Europe.
METHODS: Reimbursement data were collected using a structured questionnaire and supplemented with publicly available sources. Country-specific data was provided by local experts. The analysis included reimbursement status, time to reimbursement, eligible populations, access barriers, and cost parameters based on data available as of 31 March 2026.
RESULTS: All evaluated regimens were approved for 1L CLL in the assessed EU countries and the United Kingdom, except zanubrutinib, ibrutinib+venetoclax, and ibrutinib+obinutuzumab in Switzerland. Reimbursement varied across countries, ranging from 6 reimbursed regimens in France to 4 in Switzerland, highlighting differences in access to innovative CLL therapies across Europe. The longest interval from marketing authorization to reimbursement approval was for ibrutinib in Poland (2994 days) and ibrutinib+rituximab in Switzerland (1596 days), whereas the shortest were for ibrutinib in Switzerland (57 days) and acalabrutinib in Scotland (101 days). Population-based reimbursement restrictions were present in all countries, particularly for BTK inhibitor monotherapies (e.g., ibrutinib), whereas combination regimens (e.g., venetoclax+obinutuzumab) were more often reimbursed in broader populations consistent with licensed indications. Reimbursement generally provided full coverage (100%), except in Ireland (a copayment of up to €80 per month for some patients) and Switzerland (a 10% copayment). The highest daily drug costs were observed in Poland and Switzerland, and the lowest were reported in France.
CONCLUSIONS: Despite broad regulatory approval, substantial differences remain in reimbursement scope and time to access 1L CLL targeted therapies across Europe. Access limitations are primarily driven by restrictive reimbursement criteria and delayed reimbursement approval rather than diagnostic capacity. For selected therapies, such as ibrutinib+obinutuzumab or acalabrutinib+obinutuzumab, companies’ market access strategies cannot be excluded. Broadening existing reimbursement indications may help improve patient access to 1L CLL targeted therapies across Europe.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR244
Topic
Health Policy & Regulatory
Topic Subcategory
Reimbursement & Access Policy
Disease
Oncology, Rare & Orphan Diseases