Pembrolizumab Medicine 09 January 2018 Extended indication Keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a ≥ 50% TPS and progressing on or after platinum-containing chemotherapy. (2L) Therapeutic value No judgement yet Total cost Registration phase Registered and reimbursed Product Active substance Pembrolizumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Head and neck cancer Extended indication Keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a ≥ 50% TPS and progressing on or after platinum-containing chemotherapy. (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 Normal trajectory Particularity Unknown ATMP Unknown Submission date December 2017 Expected Registration September 2018 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Al geregistreerd door FDA. Positieve CHMP-opinie juli 2018. Geregistreerd in september 2018. Therapeutic value Current treatment options Nivolumab, Durvalumab, Tremelimumab Therapeutic value No judgement yet 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 (SmPC) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2015 Additional remarks Totaal 3.202, per stadia: 1) 970; 2) 300; 3) 427; 4) 1.189. 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 Fabrikant (G-Standaard) Additional remarks Voor alle indicatie van pembrolizumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis (lopend tot eind 2019). AIP per nov 2017: €2.624,38 per injectieflacon 25MG/ML FL 4ML (oplossing). € 1.312,19 per injectieflacon 50MG FL (poeder). Inschatting: in lijn met andere indicaties. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Fabrikant Additional remarks Indication extension Indication extensions Yes Indication extensions Indicatie-uitbreidingen worden weergegeven in de Horizonscan (Maagkanker, Huidkanker, Borstkanker, Longkanker, Nierkanker, etc.) References Fabrikant Additional remarks Other information Additional remarks