Duvelisib Medicine 12 June 2018 Extended indication Treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma, 2L Therapeutic value No judgement Total cost Registration phase Registration application pending Product Active substance Duvelisib Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication CLL Extended indication Treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma, 2L Current proprietary name Already available biosimilars / generics Proprietary name Copiktra Manufacturer Verastem Portfolio holder Mechanism of action Serine / threonine kinase inhibitor 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 December 2019 Expected Registration January 2021 Orphan drug Yes Registration phase Registration application pending 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 Median 11.6 month / months Frequency of administration 2 times a day Dosage per administration 25 mg References NCT02004522; https://www.targetedonc.com/conference/soho-2019/dose-modifications-to-duvelisib-do-not-compromise-outcomes-in-rr-cllsll 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 € < 160,000.00 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://www.drugs.com/price-guide/copiktra Additional remarks In de Verenigde Staten is een prijs bekend van ongeveer $13,000 (~€12.800) voor 56 orale capsules van 25 mg. Bij en behandelduur van 11,6 maanden zou dit neerkomen op een inname van 706 capsules en dus ongeveer €160.000 per patiënt per jaar. 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 Non-Hodgkin's Lymphoma References adisinsight; clinicaltrials.gov Additional remarks Lopende fase 3 studie Other information Additional remarks