Durvalumab Medicine 10 December 2019 Extended indication Untreated extensive-stage small cell lung cancer (SCLC) in combination with chemotherapy. Therapeutic value No judgement Total cost € 45,000,000.00 Registration phase Clinical trials Product Active substance Durvalumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Untreated extensive-stage small cell lung cancer (SCLC) in combination with chemotherapy. 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 December 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Fabrikant verwacht indiening in Q4 2019 en registratie in 2020. 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 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 patientvolume 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 € 50,000.00 - 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 G-standaard Additional remarks De dosis durvalumab is 1.500 mg. Prijs per toediening is (3 * €2.328) = €6.984. De eerste 4 cycles wordt dit elke 3 weken gegeven (met of zonder tremelimumab), daarna nog een keer de combi bij 16 weken (dus 5*de combinatie. (prijs tot 16 weken is dus 5 * €6.984 = €34.920). Daarna elke 4 weken durvalumab monotherapie. Voor 6 maanden is dit (26-16) / 4 * €6.984 = €17.460 + €34.920= €52.380; voor 52 weken is dit €52.380 + 26 / 4 * €6.984 = €97.776. Durvalumab is opgenomen in de sluis voor oncologische indicaties tot er is gekomen tot een financieel arrangement. Durvalumab wordt in combinatie gegeven met chemotherapie. De kosten hiervan zijn in bovenstaande berekening niet meegenomen. Potential total cost per year Total cost € 45,000,000.00 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