Durvalumab / Tremelimumab Medicine 12 June 2018 Extended indication Squamous cell carcinoma of the head and neck, 1L PDL 1 Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Durvalumab / Tremelimumab Domain Oncology and Hematology Reason of inclusion Indication extension IND 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 / Tremelimumab 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 Anti PD-L1 + anti CTLA-4 Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2019 Expected Registration 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Durvalumab is opgenomen in de sluis voor oncologische indicaties. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Twee fase II studies (EAGLE en KESTREL) nog gaande (ESMO 2017). Nog geen publicatie. Duration of treatment Frequency of administration 1 times a month Dosage per administration 1500 mg / 75 mg References NCT02551159 Additional remarks Toedingsfrequentie 1 maal per 4 weken. Maximaal 4 doses tremelimumab Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR, Fabrikant. Additional remarks In 2016 in 6.814 PCC hoofd en nek patiënten (NKR). Hiervan hebben er 21 patiënten stadium I PCC, 1.195 patiënten stadium II PCC, 52 patiënten stadium III PCC en 8 patiënten stadium IV PCC . De fabrikant geeft aan zelf realistisch 658 patiënten te verwachten en maximaal 940 patiënten. Expected cost per patient per year Cost € 100,000.00 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 voor Durvalumab vergelijkbaar met maandelijkse kostprijs van pembrolizumab (€6.810,00), daar komt Tremelimumab nog bij (max 4 doses). Durvalumab is opgenomen in de sluis voor oncologische indicaties tot er is gekomen tot een financieel arrangement. Potential total cost per year Total cost 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