Sugemalimab Medicine 06 June 2023 Extended indication Cejemly in combination with platinum-based chemotherapy is indicated for the first‑line treatment of adults with metastatic non‑small‑cell lung cancer (NSCLC) with no sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations. Therapeutic value No estimate possible yet Total cost € 105,550,000.00 Registration phase Positive CHMP opinion Product Active substance Sugemalimab Domain Oncology Reason of inclusion New medicine (specialité) Main indication Lung cancer Extended indication Cejemly in combination with platinum-based chemotherapy is indicated for the first‑line treatment of adults with metastatic non‑small‑cell lung cancer (NSCLC) with no sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations. Current proprietary name Already available biosimilars / generics Proprietary name Cejemly Manufacturer CStone 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 No Submission date February 2023 Expected Registration August 2024 Orphan drug No Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie mei 2024 Therapeutic value Current treatment options Overige PD-1/PD-L! remmers Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De verwachting is dat dit geneesmiddel een vergelijkbare waarde zal hebben aan andere pdl-1 remmers. Er is echter geen head-to-head studie gedaan. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 1200 mg References NCT03789604 (GEMSTONE-302) Additional remarks Expected patient volume per year Patient volume < 2,111 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2020 (1); Pakketadvies Atezolizumab (2); Additional remarks Jaarlijks presenteren er ongeveer 5.027 patiënten per jaar met NSCLC stadium IV (1). Hiervan ontvangt 60% een eerstelijnsbehandeling (3.016) waarvan 70% chemotherapie 2.111 (2). Gezien de overige behandelopties met immuuntherapie in de eerste lijn zal er slechts een deel van de patiënten voor deze behandeling in aanmerking komen. Expected cost per patient per year Cost € 40,000.00 - 60,000.00 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 Afhankelijk van de studieresultaten wordt er verwacht dat de kosten van deze behandeling in lijn liggen met andere PD-L1 remmers Potential total cost per year Total cost € 105,550,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Maagkanker, oesophaguskanker References Adis insight Additional remarks Other information Additional remarks