Toripalimab Medicine 06 June 2023 Extended indication Loqtorzi, in combination with cisplatin and paclitaxel, is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma. Therapeutic value Possible equal value Total cost € 16,480,000.00 Registration phase Registered Product Active substance Toripalimab Domain Oncology Reason of inclusion New medicine (specialité) Main indication Oncology other Extended indication Loqtorzi, in combination with cisplatin and paclitaxel, is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Shanghai Junshi Portfolio holder Shanghai Junshi Mechanism of action PD-1 / PD-L1 inhibitor Route of administration Intravenous Therapeutical formulation Injection 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 December 2022 Expected Registration September 2024 Orphan drug Yes Registration phase Registered Reimbursement Medicine sluice Additional remarks Geregistreerd september 2024. Dit geneesmiddel voldoet aan het sluiscriterium van meer dan €20.000.000 per jaar (tezamen met de tevens in juli 2024 goedgekeurde indicatie voor nasopharyngeal carcinoma) en is in de sluis geplaatst. Therapeutic value Current treatment options Pembrolizumab Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation In de finale analyse van de progressie-vrije survival werd een significante verbetering van de progressie-vrije survival geobserveerd in de toripalimab arm ten opzichte van de placebo arm (hazard ratio [HR] = 0.58; 95% CI, 0.46-0,74; p < 0.0001). Deze studie heeft volledig plaatsgevonden in China. Recent is pembrolizumab door de cieBOM goedgekeurd. Er wordt verwacht dat toripalimab een vergelijkbare effectiviteit zal hebben. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration References NCT03829969, https://doi.org/10.1016/j.ccell.2022.02.007 Additional remarks Expected patient volume per year Patient volume < 412 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2022 Additional remarks - In 2022 waren er 1.539 patiënten met slokdarmkanker stadium 3 en 4; (1) - In 2022 waren er 668 patiënten met slokdarmkanker stadium 1 en 2, waarvan 37,9% recurrent. Dit zijn 253 patiënten. (2) Dit is bij elkaar opgeteld 1.792. - Hiervan heeft ongeveer 23% een plaveiselcelcarcinoom is 412. We gaan uit van een patiëntvolume van 412. Expected cost per patient per year Cost € 30,000.00 - 50,000.00 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 GIP databank Additional remarks Mogelijk vergelijkbaar met andere PD1 remmers Potential total cost per year Total cost € 16,480,000.00 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 Meedere fase 3 studies (zie AdisInsight), nu momenteel 3 indicaties opgenomen hiervan op de Horizonscan (NSCLC, NPC en ESCC). References Adis Insight Additional remarks Other information Additional remarks