Ripretinib Medicine 10 June 2020 Extended indication Treatment of patients with advanced gastrointestinal stromal tumour (GIST) who have received treatment with prior anticancer therapies. Prior anticancer therapies must include imatinib, sunitinib, and regorafenib (3 prior therapies). Therapeutic value No estimate possible yet Total cost € 2,000,000.00 Registration phase Registration application pending Product Active substance Ripretinib Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Stomach cancer Extended indication Treatment of patients with advanced gastrointestinal stromal tumour (GIST) who have received treatment with prior anticancer therapies. Prior anticancer therapies must include imatinib, sunitinib, and regorafenib (3 prior therapies). Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Deciphera Pharmaceuticals Portfolio holder Mechanism of action Tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks NCT03353753 Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date September 2020 Expected Registration October 2021 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options GIST wordt voornamelijk chirurgisch verwijderd. Indien dit niet effectief is, zijn imatinib, sunitinib and regorafenib in Europa geregistreerd om als behandeling te gebruiken. In de vierde lijn vindt normaal gesproken herintroductie van imatinib plaats of wordt gekozen voor een behandeling in studie. In de toekomst zal ripretinib met avapritinib gaan concurreren. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De therapeutische waarde ten opzichte van imatinib en avapritinib is nog niet bekend. Duration of treatment Frequency of administration 1 times a day Dosage per administration 150 mg References NCT03353753 Additional remarks Expected patient volume per year Patient volume < 50 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks Het patiëntvolume in de vierde lijn zal naar verwachting laag zijn. In 2016 waren er 50 diagnoses van GIST stadium IV. Er zullen maximaal 50 patiënten per jaar in aanmerking komen, ervan uitgaande dat niet iedereen in de derde lijn behandeld wordt. Expected cost per patient per year Cost € 40,000.00 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 Additional remarks Kosten zullen mogelijk vergelijkbaar zijn met sunitinib. Uitgaande van (6 week cyclus, 4 weeks on, 2 weeks off) NCT03673501. Zal dit uitkomen op €179,29 per dag is €43.500 inclusief btw, exclusief btw = €40.000. Potential total cost per year Total cost € 2,000,000.00 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 Fase III studie GIST (2L). References NCT03673501 Additional remarks Fase 3 studie voor GIST in de tweede lijn. Other information Additional remarks