Durvalumab Medicine 04 June 2024 Extended indication Extension of indication to include IMFINZI in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy after surgery, for the treatment of adults with resectable (tumours ≥ 4 cm and/or node positive) NSCLC and no known EGFR mutations or ALK rearrangements. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Durvalumab Domain Oncology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Extension of indication to include IMFINZI in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy after surgery, for the treatment of adults with resectable (tumours ≥ 4 cm and/or node positive) NSCLC and no known EGFR mutations or ALK rearrangements. 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 January 2024 Expected Registration March 2025 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Verwachte registratie op basis van IHSI-inschatting. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT03800134 (AEGEAN) Additional remarks Expected patient volume per year Patient volume 1,514 - 2,246 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2020 (1); Additional remarks In totaal zijn er op basis van bovenstaande data 2.246 patiënten met stadium IB-IIIA NSCLC (1). Op dit moment wordt neo-adjuvante behandeling in Nederland enkel gegeven aan patiënten in stadium 1B en 2, dit betreft (418+206+632=1.256 patiënten). Daarnaast komt mogelijk de groep patiënten die chirurgie ontvangt bij stadium IIIA in aanmerking voor deze therapie, dit betreffen (258 patiënten). Over deze laatste groep dient echter nog te worden besloten hoe de behandelingen in de praktijk gaat lopen, gezien er ook voor kan worden gekozen om bij een grotere groep patiënten chirurgie toe te passen (maximaal alle 990 patiënten met Stadium IIIA). Om die reden zal het patiëntvolume dat in aanmerking komt 1.514 tot 2.246 patiënten betreffen. Expected cost per patient per year Cost References Additional remarks 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