Durvalumab Medicine 10 December 2019 Extended indication Extension of indication to include the use of IMFINZI in combination with etoposide and either carboplatin or cisplatin for the first-linetreatment of adults with extensive-stage small cell lung cancer (ES-SCLC). Therapeutic value No judgement Total cost € 27,276,000.00 Registration phase Registration application pending Product Active substance Durvalumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Extension of indication to include the use of IMFINZI in combination with etoposide and either carboplatin or cisplatin for the first-linetreatment of adults with extensive-stage small cell lung cancer (ES-SCLC). Current proprietary name Already available biosimilars / generics Proprietary name Imfinzi Manufacturer AstraZeneca Portfolio holder Mechanism of action PD-1 / PD-L1 inhibitor Route of administration Intravenous Therapeutical formulation Intravenous drip 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 December 2019 Expected Registration November 2020 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Voor durvalumab geldt per 1 september 2019 tot en met 31 oktober 2023 een financieel arrangement voor oncologische indicaties. De fabrikant geeft aan dat het eindpunt van de fase 3 studie niet gehaald is. Therapeutic value Current treatment options Chemotherapie en immuuntherapie Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation De HR voor OS in de Caspian studie zoals gepresenteerd op het WCLC was 0.74, wat mogelijk zal leiden tot een negatief CieBOM advies. Duration of treatment Median 28 week / weeks Frequency of administration 1 times every 3 weeks Dosage per administration 1500 mg References NCT03043872 Additional remarks Expected patient volume per year Patient volume 500 - 700 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks In 2016 werden er 1.118 diagnoses stadium 4 SCLC geregistreerd. Inschatting patiëntvolume is sterk afhankelijk van precieze indicatie. De inschatting is dat er uiteindelijk 500-700 patiënten in aanmerking kunnen komen voor deze behandeling (gelijk aan de inschatting voor atezolizumab en pembrolizumab). Expected cost per patient per year Cost € 34,920.00 - 56,000.00 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 G-standaard; fabrikant Additional remarks De dosis durvalumab is 1.500 mg. Prijs per toediening is (3 x €2.328) = €6.984. De eerste 4 cycles wordt dit elke 3 weken gegeven. Daarna elke 4 weken durvalumab monotherapie. Voor 5,1 maanden (median PFS) weken is dit €6.984x5 = €34.920. Durvalumab wordt in combinatie gegeven met chemotherapie. De kosten hiervan zijn in bovenstaande berekening niet meegenomen. Voor durvalumab geldt per 1 september 2019 tot en met 31 oktober 2023 een financieel arrangement voor oncologische indicaties Potential total cost per year Total cost € 27,276,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Nog voor veel indicaties in ontwikkeling, monotherapie en in combinatie met tremelimumab. Meerdere studies teruggetrokken, 1 PhIII studie loopt nog: Monotherapy Versus Single-agent Cytotoxic Chemotherapy in Patients With Mutant EGFR Non-small Cell Lung Cancer (NSCLC) After Failure of at Least 1 Previous EGFR-directed Tyrosine Kinase Inhibitor (TKI) and Platinum-doublet Chemotherapy. References Additional remarks Other information Additional remarks