Pembrolizumab Medicine 09 January 2018 Extended indication Head & Neck cancer, metastatic, 2L Therapeutic value No judgement Total cost € 5,000,000.00 Registration phase Registration application pending Product Active substance Pembrolizumab Domain Oncology and Hematology Reason of inclusion Main indication Head and neck cancer Extended indication Head & Neck cancer, metastatic, 2L 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 August 2018 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Al geregistreerd door FDA. 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 Nivolumab, Durvalumab, Tremelimumab Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 200 mg References Fabrikant Additional remarks Expected patient volume per year Patient volume > 100 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks NKR 2015: totaal 3202, per stadia: 1) 970; 2) 300; 3) 427; 4) 1189. Gezien de huidige behandelopties / concurrentie zal het realistisch patiëntvolume lager liggen. Schatting 100 patiënten. 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 € 5,000,000.00 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