Alectinib Medicine 05 December 2023 Extended indication Alecensa as monotherapy is indicated as adjuvant treatment following complete tumour resection for adult patients with ALK‑positive NSCLC at high risk of recurrence. Therapeutic value No estimate possible yet Total cost € 3,888,000.00 Registration phase Registered Product Active substance Alectinib Domain Oncology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Alecensa as monotherapy is indicated as adjuvant treatment following complete tumour resection for adult patients with ALK‑positive NSCLC at high risk of recurrence. 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 ATMP No Submission date November 2023 Expected Registration June 2024 Orphan drug No Registration phase Registered Reimbursement Reimbursed from the basic package Medicine sluice Out of the sluice Additional remarks Geregistreerd juni 2024. In mei 2024 is het advies gegeven aan VWS om alectinib in de sluis te plaatsen. Het maximale macrokostenbeslag is meer dan €50.000 per patiënt en meer dan €10.000.000 totaal per jaar. Zorginstituut Nederland heeft de minister van Volksgezondheid, Welzijn en Sport (VWS) in oktober 2025 geadviseerd om alectinib (Alecensa®) te vergoeden uit het basispakket van de zorgverzekering. 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 23.9 month / months Frequency of administration 2 times a day Dosage per administration 600mg References EPAR Alecensa; 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 maximaal 84. Expected cost per patient per year Cost € < 64,800.00 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 € 3,888,000.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks