Alectinib Medicine 09 January 2018 Extended indication First line treatment of adult patients with ALK-positive advanced non-small cell lung cancer (NSCLC), ALK+, 1L. Therapeutic value No judgement Total cost € 4,800,000.00 Registration phase Unknown Product Active substance Alectinib Domain Oncology and Hematology Reason of inclusion Main indication Lung cancer Extended indication First line treatment of adult patients with ALK-positive advanced non-small cell lung cancer (NSCLC), ALK+, 1L. Current proprietary name Already available biosimilars / generics Proprietary name Alecensa Manufacturer Roche Portfolio holder Mechanism of action Unknown 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 Unknown Submission date February 2017 Expected Registration December 2017 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Dit is een indicatie-uitbreiding. Positieve CHMP-opinie oktober 2017. Therapeutic value Current treatment options Crizotinib, Ceritinib Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Median 25.6 month / months Frequency of administration 1 times a day Dosage per administration 600 mg References Additional remarks Fabrikant: geschatte mediane behandelduur is op basis van klinische studie (J-ALEX studie). Expected patient volume per year Patient volume 90 - 150 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fabrikant Additional remarks Fabrikant: Max. patiëntvolume gebaseerd op incidentie niet-plaveiselcel stadium IV NSCLC. Waarvan het in ongeveer 5% van de patiënten een ALK mutatie betreft. Van max. naar realistisch patiëntvolume gezien de beschikbaarheid van andere behandelopties voor deze patiënten. Expected cost per patient per year Cost € < 40,000.00 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 Medicijnkosten.nl; Fabrikant Additional remarks Behandeling is dagelijks 600 mg. Per caspsule van 150 mg kost Alectinib €27,36. Bij een geheel jaar: 4x€27,36x365=€39.945. Fabrikant geeft aan: €5.782 voor 224 x 150 mg verpakking. Potential total cost per year Total cost € 4,800,000.00 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