Lorlatinib Medicine 12 June 2018 Extended indication ALK-positive and ROS1-positive advanced non-small cell lung cancer (2nd line). Therapeutic value Possible added value Total cost € 2,450,000.00 Registration phase Registration application pending Product Active substance Lorlatinib Domain Oncology and Hematology Reason of inclusion Main indication Lung cancer Extended indication ALK-positive and ROS1-positive advanced non-small cell lung cancer (2nd line). Current proprietary name Already available biosimilars / generics Proprietary name 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 New medicine ATMP Unknown Submission date February 2018 Expected Registration March 2019 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Mogelijke meerwaarde verwacht in verband met "unmet need". Duration of treatment Average 6 month / months Frequency of administration 1 times a day Dosage per administration 100 mg References NCT03052608; Fabrikant Additional remarks Expected patient volume per year Patient volume 40 - 100 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fabrikant; Pakketadvies Atezolizumab; Korpanty et al. Front Oncol. 2014; 4: 204.; GIPdatabank Additional remarks Aantal patiënten met stadium IIIb/VI NSCLC: 7.524. 3-5% ALK mutaties in NSCLC, 1-2% ROS1 mutaties in NSCLC. 202 gebruikers van Crizotinib in 2016. Aangenomen wordt dat ongeveer de helft zal worden behandeld met Lorlatinib. Fabrikant geeft aan dat het gaat om een patiënten populatie in de 2e en 3e lijn van ongeveer 40 patiënten. Expected cost per patient per year Cost € 35,000.00 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 per dag. Verwachte behandelduur met lorlatinib is zes maanden. Potential total cost per year Total cost € 2,450,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks