Durvalumab Medicine 07 June 2022 Extended indication Limited stage small cell lung cancer (LS-SCLC) following concurrent platinum-based chemotherapy and radiation therapy in combination with Tremelimumab. Therapeutic value No estimate possible yet Total cost € 34,425,000.00 Registration phase Registered Product Active substance Durvalumab Domain Oncology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Limited stage small cell lung cancer (LS-SCLC) following concurrent platinum-based chemotherapy and radiation therapy in combination with Tremelimumab. 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 Anti PD-L1 + anti CTLA-4 Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date July 2024 Expected Registration March 2025 Orphan drug No Registration phase Registered Reimbursement Reimbursement request pending Medicine sluice Broadly excluded Additional remarks Zorginstituut Nederland beoordeelt of durvalumab (Imfinzi®) kan worden vergoed. Het advies wordt in juni of juli 2026 gepubliceerd. Therapeutic value Current treatment options No active treatment (observation) Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er zijn nog geen resultaten van de ADRIATIC studie bekend. Publicatie wordt een dezer dagen verwacht. Duration of treatment Frequency of administration 1 times every 4 weeks Dosage per administration Durvalumab 1.500mg, tremelimumab 75mg (maximum van vier doseringen).). References NCT03703297 (ADRIATIC) Additional remarks Expected patient volume per year Patient volume < 510 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2018 (1); Additional remarks In 2018 waren er 510 patiënten met kleincellig longcarcinoom in stadium 1,2 en 3. Mogelijk zal een gedeelte van deze patiëntengroep in aanmerking komen voor de behandeling. 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 vier weken tot ziekteprogressie. Prijs per toediening is dan 3x€2.328=€6.984. Voor 6 maanden is dit 26/4x€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 en €90.000 bedragen uitgaande van zes of twaalf maanden behandeling. Deze kosten betreffen alleen durvalumab. Potential total cost per year Total cost € 34,425,000.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks