Asciminib Medicine 10 June 2020 Extended indication Philadelphia chromosoom positieve (Ph+) Chronische Myeloïde Leukemie (CML) vanaf derde lijn. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Asciminib Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication CML Extended indication Philadelphia chromosoom positieve (Ph+) Chronische Myeloïde Leukemie (CML) vanaf derde 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 July 2021 Expected Registration August 2022 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Verschillende TKI's: imatinib, nilotinib, dasatinib, bosutinib, ponatinib. Therapeutic value No estimate possible yet 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 derde lijn behandeld. In 2017 zijn er volgens het NKR 210 diagnoses van Chronische Myeloïde Leukemie gesteld. Dit betekent dat er 32 patiënten in aanmerking zullen komen voor deze behandeling. De vraag is echter of het echt een derdelijns behandeling wordt of dat het ingezet wordt na twee eerdere TKI’s, bij intolerantie komen er in dat geval meer patiënten in aanmerking. 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