Lorlatinib Medicine 12 June 2018 Extended indication Lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) previously treated with one or more ALK tyrosine kinase inhibitors (TKIs), except for patients treated with crizotinib as the only ALK TKI. Therapeutic value No judgement yet Total cost € 3,127,000.00 Registration phase Registration application pending Product Active substance Lorlatinib Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Lung cancer Extended indication Lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) previously treated with one or more ALK tyrosine kinase inhibitors (TKIs), except for patients treated with crizotinib as the only ALK TKI. Current proprietary name Already available biosimilars / generics Proprietary name Lorviqua Manufacturer Pfizer Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks ALK en ROS1 inhibitor. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date January 2018 Expected Registration February 2019 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options ALK+ TKIs (alectinib en ceritinib) en crizotinib. Therapeutic value No judgement yet This assessment does not indicate any potential inclusion in the package. Substantiation De keuze voor een geneesmiddel is afhankelijk van het genetisch mutatie profiel van de patiënt. De klinische waarde ten opzicht evan andere TKIs moet nog worden vastgesteld in de praktijk voor de 2de lijnsbehandeling. Duration of treatment Median 9 month / months Frequency of administration 1 times a day Dosage per administration 100 mg References NCT03052608; Fabrikant; Phase 2 study of lorlatinib in patients with advanced ALK/ROS1 NSCLC (NCT01970865) (IASLC 18th World Conference on Lung Cancer, 2017). Additional remarks Expected patient volume per year Patient volume 59 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fabrikant; 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 7.500 patiënten per jaar met NSCLC stadium IIIb/IV. Hiervan is 5% ALK+ (375). Aannemende dat 70% getest wordt (263), 20% van de ALK+ patiënten geïncludeerd wordt in studies, en 80% van de resterende patiënten een eerstelijns ALK TKI krijgen (210). Verdeling van 1L ALK TKI wordt ingeschat op 70% alectinib of ceritinib (147) en 30% crizotinib (63 patiënten; waarvan een geschatte 20 patiënten door zal gaan op 2L ALK TKI). In beide groepen zal ongeveer 50% resistentie ontwikkelen (respectievelijk 74 en 10), waarbij van de patiënten die alectinib of ceritinib hebben gekregen ongeveer 80% in aanmerking zal komen voor lorlatinib (59). Expected cost per patient per year Cost € 53,000.00 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 Fabrikant; G-standaard Additional remarks Competitie met meerdere ALK+ TKIs (alectinib en ceritinib) en crizotinib. Kosten van crizotinib, ceritinib, alectinib zijn gemiddeld €196,00 per dag. Verwachte behandelduur met lorlatinib is negen maanden. Potential total cost per year Total cost € 3,127,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions ROS1 positieve NSCLC References Fabrikant; NCT01970865 Additional remarks Other information Additional remarks