Nivolumab Medicine 07 December 2021 Extended indication Extension of indication to include in combination with fluoropyrimidineand platinum-based combination chemotherapy the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) for OPDIVO. Therapeutic value Possible added value Total cost Registration phase Registered Product Active substance Nivolumab Domain Oncology Reason of inclusion Indication extension IND Main indication Oncology other Extended indication Extension of indication to include in combination with fluoropyrimidineand platinum-based combination chemotherapy the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) for OPDIVO. Current proprietary name Already available biosimilars / generics Proprietary name Opdivo Manufacturer BMS 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 Op dit moment geregistreerd na fluoropyrimidine- en platinum-based combinatie chemotherapie. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date August 2021 Expected Registration April 2022 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks EC decision is verleend op 1 april 2022 Therapeutic value Current treatment options Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Uit de eerste resultaten van de CheckMate 648 studie bleek dat de mediane OS, nivo/chemo versus chemo 15.4 (11.9–19.5) versus 9.1 (7.7–10.0) HR = 0.54 was. Er wordt op basis van deze gegevens verwacht dat de PASKWIL-criteria gehaald zullen worden. Duration of treatment Frequency of administration Dosage per administration References NCT03143153 (CheckMate 648) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks Aantal patiënten met slokdarmkanker stadium II/III/IV betrof 1.596. In ongeveer 25%-30% van de gevallen zal het een plaveisel carcinoom betreffen. Expected cost per patient per year Cost € 15,000.00 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 G-standaard Additional remarks Nivolumab 10mg/ml flacon, 4ml (40mg): €405,03; nivolumab 10mg/ml flacon, 10ml (100mg): €1.012,56; nivolumab 10mg/ml flacon, 24ml (240mg): €2.430,15; Z-index, 1 augustus 2018, exclusief btw. Uitgaande van 2,6 maanden iedere 2 weken 240mg, zou het neerkomen op zo'n €15.000 per patiënt per jaar. Voor alle indicaties van nivolumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis. BMS en het ministerie van VWS hebben een financieel arrangement afgesloten voor nivolumab dat recent verlengd is tot 1 januari 2024. Het verlengde financieel arrangement voor nivolumab heeft mede betrekking op alle (toekomstige) bewezen effectieve indicaties van nivolumab. 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 No Indication extensions References Additional remarks adisinsight Buiten de indicaties in de Horizonscan Geneesmiddelen geen nieuwe indicatie uitbreidingen bekend. Other information Additional remarks