Pirtobrutinib Medicine 04 June 2026 Extended indication Extension of indication to include treatment of adult patients with chronic lymphocytic leukaemia (CLL). Therapeutic value Total cost Registration phase Registration application pending Product Active substance Pirtobrutinib Domain Hematology Reason of inclusion Indication extension IND Main indication CLL Extended indication Extension of indication to include treatment of adult patients with chronic lymphocytic leukaemia (CLL). Current proprietary name Already available biosimilars / generics Proprietary name Jaypirca Manufacturer Eli Lilly Portfolio holder Eli Lilly Mechanism of action Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date December 2025 Expected Registration July 2026 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT05023980 (BRUIN-CLL-313); NCT05254743 (BRUIN-CLL-314) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost € 109,000.00 - 110,000.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References https://zoek.officielebekendmakingen.nl/stcrt-2025-14334.html Additional remarks De lijstprijs van pirtobrutinib is € 8.400 (excl. btw) voor 56 tabletten van 100 mg. Het Zorginstituut schat in dat de kosten € 109.572 per patiënt per jaar bedragen. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks