Surufatinib Medicine 10 June 2020 Extended indication Patients with low- or intermediate grade (G1 or G2) advanced extrapancreatic neuroendocrine tumors. Therapeutic value No estimate possible yet Total cost Registration phase No registration expected Product Active substance Surufatinib Domain Oncology Reason of inclusion New medicine (specialité) Main indication Neuroendocrine cancer Extended indication Patients with low- or intermediate grade (G1 or G2) advanced extrapancreatic neuroendocrine tumors. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Hutchison MediPharma Portfolio holder Mechanism of action Angiogenesis inhibitor Route of administration Oral Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Surufatinib inhibits tyrosine kinase activity associated with VEGFR and FGFR. Grade 1 (low-grade tumor): These cells divide at a low rate and therefore grow slowly. Grade 2 (intermediate-grade tumor): These cells divide at an intermediate rate. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration Orphan drug Yes Registration phase No registration expected Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Huidige behandelopties zijn beperkt, met name chirurgie. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Het is nog niet duidelijk hoe de plaatsbepaling zal zijn; geen enkele patiënt in de studie heeft PRRT gehad, terwijl wel 40% van de patiënten chemotherapie heeft ontvangen dat voor deze groep vrijwel nooit gegeven wordt. Het is nog onduidelijk of dit uiteindelijk in Nederland ingezet zal worden. De registratiestudies zijn in China. Studies onder een Kaukasische patiëntpopulatie zijn nog lopende. Duration of treatment Frequency of administration 1 times a day Dosage per administration 300 mg References NCT02588170 Additional remarks Expected patient volume per year Patient volume < 630 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2018 (1); Additional remarks Jaarlijks krijgen in Nederland ruim 700 mensen een neuro-endocrine tumor. 9% van alle neuro-endocrine tumoren ontstaan in de pancreas (1). In theorie komen er 630 patiënten in aanmerking voor deze indicatie. Het is echter nog de vraag of dit geneesmiddel ook echt ingezet zal worden in Nederland. 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 Overige Neuro Endocriene Tumoren en Biliary cancer. References Clinicaltrials.gov; Adisinsight. Additional remarks Lopende fase 3 studies. Other information Additional remarks