Durvalumab Medicine 07 June 2022 Extended indication Locally advanced cervical cancer Therapeutic value No estimate possible yet Total cost Registration phase No registration expected Product Active substance Durvalumab Domain Oncology Reason of inclusion Indication extension IND Main indication Cervical cancer Extended indication Locally advanced cervical cancer Current proprietary name Already available biosimilars / generics Proprietary name Imfinzi Manufacturer AstraZeneca Portfolio holder AstraZeneca 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 No Submission date Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks Voor durvalumab geldt tot eind 2023 een financieel arrangement voor oncologische indicaties. Therapeutic value Current treatment options Chemoradiatietherapie + actief volgen Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De fabrikant geeft aan dat in de CALLA-studie de eindpunten niet gehaald zijn. Er werd geen statistisch significant resultaat gevonden op progressie-vrije overleving versus CRT. Duration of treatment Frequency of administration Dosage per administration Durvalumab 1500mg References NCT03830866 (CALLA). Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2018 Additional remarks Vrouwen in stadium IB2 tot IIB die node positief of FIGO (2009) IIIA-IVA komen in aanmerking voor deze behandeling. In 2018 waren er 841 patiënten met een cervixcarcinoom. Expected cost per patient per year Cost € 45,000.00 - 90,000.00 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 Additional remarks De dosis durvalumab is 1.500mg elke 4 weken tot ziekteprogressie. Prijs per toediening is dan (3 x €2.328)=€6.984. Voor 6 maanden is dit 26/4 x €6.984 = €45.396; voor 52 weken is dit 52/4x €6.984 = €90.792. In de studie wordt durvalumab onderzocht als monotherapie en in combinatie met tremelimumab. Afhankelijk van de behandelduur zal de prijs per jaar tussen de €45.000-€90.000 bedragen uitgaande van 6 of 12 maanden behandeling. Deze kosten betreffen alleen durvalumab. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks