Brigatinib Medicine 12 June 2019 Extended indication Eerstelijns behandeling van volwassen patiënten met ALK-positieve gevorderde Non Small Cell Longkanker (NSCLC). Therapeutic value Possible equal value Total cost € 9,210,096.00 Registration phase Clinical trials Product Active substance Brigatinib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Eerstelijns behandeling van volwassen patiënten met ALK-positieve gevorderde Non Small Cell Longkanker (NSCLC). Current proprietary name Already available biosimilars / generics Proprietary name Alunbrig Manufacturer Takeda Portfolio holder Mechanism of action Tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Film-coated tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks ALK-inhibitor (proteïne kinase remmer) Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date 2019 Expected Registration March 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks De registratie wordt verwacht in maart 2020. Therapeutic value Current treatment options Alectinib, crizotinib, ceritinib Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Er wordt een gelijke waarde ten opzichte van alectinib verwacht. Duration of treatment Frequency of administration 1 times a day Dosage per administration 180 mg References NCT02737501 Additional remarks Expected patient volume per year Patient volume < 126 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Pakketadvies Atezolizumab; Korpanty et al. Front Oncol. 2014; 4: 204.; GIPdatabank; Tiseo et al. Lung Cancer. 2011 Feb;71(2):241-3. Additional remarks Jaarlijks presenteren er ongeveer 4.500 patiënten per jaar met NSCLC stadium IV. Hiervan is 5% ALK+ (225). Aannemende dat 70% getest wordt (158), 20% van de ALK+ patiënten geïncludeerd wordt in studies, en 80% van de resterende patiënten een eerstelijns ALK TKI krijgen (126). Gezien de concurrentie verwacht de fabrikant een marktaandeel van 25% te kunnen veroveren (32). Expected cost per patient per year Cost € 73,096.00 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 G-standaard Additional remarks Kosten per patiënt per volledig behandeljaar, op basis van lijstprijs en rekening houdend met afwijkende startdosering: € 1.059 + € 72.037 = € 73.096. Exclusief BTW. Potential total cost per year Total cost € 9,210,096.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks