Lorlatinib Medicine 08 June 2021 Extended indication Extension of indication to include 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 No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Lorlatinib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Extension of indication to include 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 Lorviqua Manufacturer Pfizer Portfolio holder Mechanism of action Tyrosine kinase inhibitor 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 No Submission date March 2021 Expected Registration February 2022 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Crizotinib, alectinib. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation In vergelijking met crizotinib is er een beter progressie vrije overleving geconstateerd met minder metastases. Deze uitkomsten zijn vergelijkbaar met alectinib. Mogelijk zal het ook ingezet kunnen worden op het moment dat alectinib niet effectief is. Duration of treatment Frequency of administration Dosage per administration References NCT03052608 Additional remarks Expected patient volume per year Patient volume 67 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Sweis (2016). Concurrent EGFR Mutation and ALK Translocation in Non-Small Cell Lung Cancer. Cureus, 8(2), e513. https://doi.org/10.7759/cureus.513 Additional remarks In 2018 waren er 5.062 patiënten met NSCLC stadium IV. Hiervan zal 60% een eerstelijnsbehandeling krijgen (3.337). Uit studies blijkt dat ongeveer 2% van de patiënten een ALK mutatie bezit. Dit betekent dat er mogelijk 67 patiënten in aanmerking zullen komen voor behandeling. Expected cost per patient per year Cost References medcijnkosten.nl Additional remarks Gemiddelde prijs per 30 stuks Lorviqua, tablet 100mg € 4.854,60 Potential total cost per year Total cost 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