Durvalumab Medicine 12 June 2018 Extended indication Squamous cell carcinoma of the head and neck, 1L PDL 1. Therapeutic value No judgement Total cost € 11,562,000.00 Registration phase Clinical trials Product Active substance Durvalumab Domain Oncology and Hematology Reason of inclusion Main indication Head and neck cancer Extended indication Squamous cell carcinoma of the head and neck, 1L PDL 1. Current proprietary name Already available biosimilars / generics Proprietary name Imfinzi Manufacturer AstraZeneca Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks PD-L1 remmer Registration Registration route National (CBG) Type of trajectory Unknown Particularity Indication extension ATMP Unknown Submission date 2019 Expected Registration 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Indicatie-uitbreiding Therapeutic value Current treatment options Carboplatin or cisplatin + 5FU + cetuximab Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times every 4 weeks Dosage per administration 1500 mg References Seiwert et al. Journal of Clinical Oncology 2016 34:15_suppl, TPS6101-TPS6101 Additional remarks Expected patient volume per year Patient volume 47 - 235 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR, Fabrikant Additional remarks PCC hoofd en nek in totaal in 2016 6814 patiënten (NKR). Hiervan hebben er 21patiënten stadium I PCC, 1195 patiënten stadium II PCC, 52 patiënten stadium III PCC en 8 patiënten stadium IV PCC. De fabrikant geeft aan zelf realistisch 47 patiënten te verwachten en maximaal 235 patiënten. Expected cost per patient per year Cost € 82,000.00 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; Pakketadvies pembrolizumab (Keytruda®) 2016 Zorginstituut Nederland Additional remarks Naar verwachting is de maandelijkse kostprijs vergelijkbaar met maandelijkse kostprijs van pembrolizumab (€6.810) Potential total cost per year Total cost € 11,562,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks