Asciminib Medicine 10 June 2020 Extended indication Philadelphia chromosoom positieve (Ph+) Chronische Myeloïde Leukemie (CML) in 3e lijn. Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Asciminib Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Leukemia Extended indication Philadelphia chromosoom positieve (Ph+) Chronische Myeloïde Leukemie (CML) in 3e lijn. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Novartis Portfolio holder Mechanism of action Tyrosine kinase inhibitor 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 Unknown ATMP Unknown Submission date March 2021 Expected Registration June 2022 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Verschillende TKI's: imatinib, nilotinib, dasatinib, bosutinib, ponatinib Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 2 times a day Dosage per administration 40 mg References N Engl J Med. 2019 Dec 12;381(24):2315-2326. doi: 10.1056/NEJMoa1902328. NCT03106779 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NCCN clinical pratice guidelines CML 2018; NKR; fabrikant Additional remarks Volgens de NCCN clinical practice guidelines voor CML, wordt in 2021 naar verwachting circa 15% van de CML patiënten in de 3e lijn behandeld. Volgens het NKR zijn er in 2017 210 diagnoses van Chronische Myeloïde Leukemie gesteld. Dit betekent dat er 32 patiënten in aanmerking zullen komen voor deze behandeling. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions 1e lijn Ph+ CML References fabrikant Additional remarks In 2025 Other information Additional remarks