Duvelisib Medicine 12 June 2018 Extended indication Treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma, 2L Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Duvelisib Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Leukemia Extended indication Treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma, 2L Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Verastem Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Selective PI3K δ/γ inhibitor Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2019 Expected Registration 2020 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks DUO trial: improved progression free survival (PFS). Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Momenteel te weinig informatie beschikbaar voor opname in de richtlijn. Duration of treatment Frequency of administration 2 times a day Dosage per administration 25 mg References NCT02004522 Additional remarks De werkgroep ziet voorlopig geen indicatie voor duvelisib. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks Aantal diagnoses CLL en SLL in 2016: 781 en 139 respectievelijk. Nog te weinig bekend over de mogelijke plaatsbepaling om een goede inschatting te kunnen doen van het patiëntvolume. 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 No Indication extensions References SPS Additional remarks Other information Additional remarks