Pembrolizumab Medicine 09 January 2018 Extended indication Adjuvant melanoma stage III Therapeutic value No judgement Total cost € 17,500,000.00 Registration phase Unknown Product Active substance Pembrolizumab Domain Oncology and Hematology Reason of inclusion Main indication Skin cancer Extended indication Adjuvant melanoma stage III Current proprietary name Already available biosimilars / generics Proprietary name Keytruda Manufacturer MSD Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Anti-PD-1 Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Indication extension ATMP Unknown Submission date Expected Registration 2018 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Pembrolizumab heeft in de sluis gezeten, de afspraken die gedurende die periode zijn gemaakt t.a.v. de vergoeding gelden ook voor deze indicatie-uitbreiding. Therapeutic value Current treatment options Alle PD1 en PDL1 remmers worden verwacht voor deze indicatie Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 17 times a year Dosage per administration 200 mg References Fabrikant Additional remarks Toedieningsfrequentie is 1 maal per 3 weken Expected patient volume per year Patient volume 350 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Oncoline Additional remarks NKR 2015: 427 diagnoses melanoom stadium 3. Oncoline: momenteel wordt er niet geadviseerd om patiënten met melanoom buiten onderzoeksverband systemisch adjuvante behandeling te geven. Inschatting van de fabrikant bij Nivolumab is 350. 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 Medicijnkosten.nl, AIP fabrikant. Additional remarks AIP per nov 2017: €2624,38 per injectieflacon 25MG/ML FL 4ML (oplossing). € 1312,19 per injectieflacon 50MG FL (poeder). Potential total cost per year Total cost € 17,500,000.00 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