Brigatinib Medicine 12 June 2019 Extended indication Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. Therapeutic value Possible equal value Total cost € 5,847,680.00 Registration phase Registered and reimbursed Product Active substance Brigatinib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. 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 June 2019 Expected Registration April 2020 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in februari 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 Duration of treatment Frequency of administration 1 times a day Dosage per administration 180 mg References NCT02737501 ALTA-1L studie: N. Engl. J. Med. 2018; 379:2027-2039 Additional remarks 90 mg per dag eerste 7 dagen, daarna 180 mg per dag. Expected patient volume per year Patient volume 33 - 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). De verwachting is dat slechts een klein aantal van deze patiënten in aanmerking komt voor deze behandeling. Aangezien de markt verdeeld zal worden over de vier verschillende behandelopties (Alectinib, ceritinib, crizotinib en brigatinib). 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; fabrikant. 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 € 5,847,680.00 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