Durvalumab / Tremelimumab Medicine 09 January 2018 Extended indication Head and neck (or upper airways tract) cancers; squamous cell carcinoma of head or neck (SCCHN), 2L Durvalumab monotherapy in PDL1-positive tumours or in combination with Tremelimumab for PDL1-negative tumours. Therapeutic value No judgement Total cost € 2,150,000.00 Registration phase Clinical trials Product Active substance Durvalumab / Tremelimumab Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Head and neck cancer Extended indication Head and neck (or upper airways tract) cancers; squamous cell carcinoma of head or neck (SCCHN), 2L Durvalumab monotherapy in PDL1-positive tumours or in combination with Tremelimumab for PDL1-negative tumours. 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 Tremelimumab betreft een nieuw geneesmiddel. Durvalumab is opgenomen in de sluis voor oncologische indicaties. Therapeutic value Current treatment options Op moment van registratie zijn er ook andere immunotherapieën beschikbaar voor deze indicatie. 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 20 mg/kg / 1 mg/kg References Fabrikant; NCT02369874 Additional remarks Toedingsfrequentie: Durvalumab 1 maal per 4 weken; Tremelimumab 1 maal per 4 weken met een maximum van 4 doses. Expected patient volume per year Patient volume 25 - 60 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fabrikant; NKR Additional remarks In 2016 in totaal 6.814 PCC hoofd en nek patiënten (NKR). Hiervan hebben er 52 patiënten stadium III PCC en 8 patiënten stadium IV PCC (dus in totaal 60 patiënten). Fabrikant geeft aan dat er naar verwachting tussen de 21-29 patiënten behandeld zullen worden. Expected cost per patient per year Cost € 40,000.00 - 60,000.00 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 Additional remarks Verwacht in lijn met andere immunotherapieën. €1.098,16 voor nivolumab 10mg per ml fl 10 ml; €3.355,96 voor pembrolizumab 25 mg per ml fl 4ml. Durvalumab is opgenomen in de sluis voor oncologische indicaties tot er is gekomen tot een financieel arrangement. Potential total cost per year Total cost € 2,150,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Nog voor verschillende indicaties in ontwikkeling (blaaskanker, longkanker). Mogelijk ook 1L registratie hoofd- en halskanker. References blaaskanker, longkanker: NCT02516241, NCT02453282 Additional remarks Other information Additional remarks