Ipilimumab Medicine 09 January 2018 Extended indication Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma. Therapeutic value No judgement Total cost € 15,844,000.00 Registration phase Positive CHMP opinion Product Active substance Ipilimumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Kidney cancer Extended indication Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma. 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 Unknown ATMP Unknown Submission date November 2017 Expected Registration January 2019 Orphan drug No Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Negatieve CHMP-opinie juli 2018. Fabrikant heeft in september 2018 een herbeoordeling aangevraagd. Positieve CHMP-opinie november 2018. 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 In 2016 waren er 565 diagnoses niercarcinoom stadium 4. De inschatting is dat er tussen 367 en 565 mensen met dit middel behandeld kunnen gaan worden. 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 Yes Indication extensions Malignant melanoma - first-line adjuvant monotherapy References SPS Additional remarks Other information Additional remarks