Brigatinib Medicine 09 January 2018 Extended indication Adult patients with anaplastic lymphoma kinase (ALK+) non-small cell lung cancer (NSCLC) who have been previously treated with crizotinib. Therapeutic value No judgement Total cost € 3,375,000.00 Registration phase Registration application pending Product Active substance Brigatinib Domain Oncology and Hematology Reason of inclusion Main indication Lung cancer Extended indication Adult patients with anaplastic lymphoma kinase (ALK+) non-small cell lung cancer (NSCLC) who have been previously treated with crizotinib. Current proprietary name Already available biosimilars / generics Proprietary name Alunbrig Manufacturer Takeda Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New medicine ATMP Unknown Submission date March 2017 Expected Registration September 2018 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Fabrikant geeft aan dat de verwachte registratie plaatsvindt in de tweede helft van 2018. Therapeutic value Current treatment options Ceritinib Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Average 6 month / months Frequency of administration 1 times a day Dosage per administration 180 mg References Fabrikant; Kim et al. J Clin Oncol 34, 2016 (suppl; abstr 9007). Additional remarks Expected patient volume per year Patient volume 20 - 70 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fabrikant; NKR; Kabnkerzorg in beeld, 2014; CieBOM Additional remarks Fabrikant: Max. patiëntvolume: Van 9.289 patiënten met NSCLC (IKNL, 2016), is 53% stadium IIIb/IV (4.923, IKNL, Kankerzorg in beeld, 2014). Hiervan is 4% ALK+ (197, NVMO CieBOM, Apr 2016). Aannemende dat 70% getest wordt (138), 20% van de ALK+ patiënten geïncludeerd wordt in studies, en 80% van de resterende patiënten crizotinib ontvangt zijn er jaarlijks 88 patiënten op crizotinib. Als 80% hiervan een volgende lijn ontvangt is er een potentieel van 71 patiënten. Van max. naar realistisch patiëntvolume: Ceritinib is reeds beschikbaar voor deze groep. Aangenomen aandeel van 30%. Expected cost per patient per year Cost € 70,000.00 - 80,000.00 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 Medicijnkosten.nl Additional remarks Gebaseerd op kosten crizotinib (€95,58 per 250 mg) en alectinib (€27,36 per 150 mg). Potential total cost per year Total cost € 3,375,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks