Ipilimumab Medicine 09 January 2018 Extended indication Renal cell carcinoma, 1L. In combinatie met Nivolumab. Therapeutic value No judgement Total cost € 15,844,000.00 Registration phase Registration application pending Product Active substance Ipilimumab Domain Oncology and Hematology Reason of inclusion Main indication Kidney cancer Extended indication Renal cell carcinoma, 1L. In combinatie met Nivolumab. Current proprietary name Already available biosimilars / generics Proprietary name Yervoy Manufacturer BMS Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks CTLA-4 antilichaam Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Indication extension ATMP Unknown Submission date November 2017 Expected Registration August 2018 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options TKIs; sunitinib, pazopanib en binnenkort cabozantinib en atezolizumab/bevacizumab. Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Median 12 week / weeks Frequency of administration 1 times every 3 weeks Dosage per administration 1 mg/kg References NCT02231749; ESMO 2017 presentatie Additional remarks Behandelschema: 4 doseringen; 1 maal per 3 weken. Expected patient volume per year Patient volume 367 - 565 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fabrikant; NKR Additional remarks Fabrikant geeft een patiëntvolume aan van 367-442. De werkgroep schat in dat er 500-600 gemetastaseerde niercelcarcinomen zijn. In 2016 waren er 565 diagnoses niercarcinoom stadium 4. Expected cost per patient per year Cost € 34,000.00 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 Fabrikant Additional remarks Uitgaande van een gemiddeld gewicht van 70 kg zijn de behandelkosten per individuele patiënt €34.000 (bij 4 doseringen). De berekening is als volgt: voor een patiënt van 70 kg is 70x1 mg=70 mg ipilimumab nodig: 2x10 ml flacons (2x €4250) is €8.500 per gift. €8500x 4 doseringen= €34.000 Ipilimumab pppj. NB: berekening is alleen vooor Ipilimumab, Nivolumab komt hier nog bij. Potential total cost per year Total cost € 15,844,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks