Alectinib Medicine 05 December 2023 Extended indication The adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA ALK-positive NSCLC Therapeutic value No estimate possible yet Total cost € 3,887,700.00 Registration phase Clinical trials Product Active substance Alectinib Domain Oncology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication The adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA ALK-positive NSCLC Current proprietary name Already available biosimilars / generics Proprietary name Alecensa Manufacturer Roche Portfolio holder Roche Mechanism of action Tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date 2024 Expected Registration October 2025 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Chemotherapie Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Maximal 24 month / months Frequency of administration 2 times a day Dosage per administration 600mg References https://www.ema.europa.eu/en/documents/product-information/alecensa-epar-product-information_nl.pdf https://classic.clinicaltrials.gov/ct2/show/NCT03456076 Additional remarks Expected patient volume per year Patient volume 36 - 84 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References https://www.zorginstituutnederland.nl/publicaties/adviezen/2021/11/15/pakketadvies-osimertinib-tagrisso-bij-niet-kleincellige-longkanker-nsclc https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9020874/ Additional remarks Volgens de budget impact analyse van osimertinib in de adjuvante NSCLC indicatie doen zich jaarlijks 1.193 stadium IB-IIIA gereseceerd NSCLC patiënten voor. Hiervan heeft minimaal 3% en maximaal 7% een ALK mutatie. Het jaarlijks patiëntvolume komt hiermee op minimaal 36 en max 84. Expected cost per patient per year Cost € 64,795.00 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 Z-index en SMPC Alecensa Additional remarks Volgens de Z-index bedraagt de prijs voor Alecensa 150mg 240 stuks €5.399,64. De dosering is 600mg 2x daags. Hiermee komen de jaarlijkse kosten op €64.795,68 per patiënt. Potential total cost per year Total cost € 3,887,700.00 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