Nivolumab Medicine 08 June 2021 Extended indication Opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy Therapeutic value No estimate possible yet Total cost € 23,550,000.00 Registration phase Registered and reimbursed Product Active substance Nivolumab Domain Oncology Reason of inclusion Indication extension IND Main indication Oncology other Extended indication Opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy 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 Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date January 2021 Expected Registration July 2021 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in juni 2021. Voor nivolumab is er een financieel arrangement afgesloten met het Ministerie van VWS (lopend tot 1 januari 2024). Het verlengde financieel arrangement voor nivolumab heeft mede betrekking op alle (toekomstige) bewezen effectieve indicaties van nivolumab. Therapeutic value Current treatment options De mediane follow-up tijd was 24,4 maanden onder de 532 patiënten die nivolumab toegediend kregen, de mediane ziektevrije overleving was 22,4 maanden, ten opzichte van 11 maanden onder de 262 patiënten die placebo kregen. 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 CheckMate 577 (NCT027434940) Additional remarks Expected patient volume per year Patient volume < 471 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks In 2019 waren er 471 patiënten met slokdarm- of GEJ/cardia carcinoom die neo-adjuvante chemoradiatie en chirurgische resectie hebben ondergaan en residuele ziekte (gedefinieerd als geen ypT0 en ypN0) hadden. 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 Horizonscan Geneesmiddelen. Additional remarks Kosten verwacht in lijn met andere indicaties van nivolumab. Potential total cost per year Total cost € 23,550,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks