Recombinant zoster vaccin Medicine 09 January 2018 Extended indication Preventie van gordelroos bij personen van 50 jaar en ouder. Therapeutic value No judgement Total cost € 2,010,367,200.00 Registration phase Unknown Product Active substance Recombinant zoster vaccin Domain Infectious diseases Reason of inclusion Main indication Viral infections other Extended indication Preventie van gordelroos bij personen van 50 jaar en ouder. Current proprietary name Already available biosimilars / generics Proprietary name Shingrix Manufacturer GSK Portfolio holder Mechanism of action Unknown Route of administration Intramuscular Therapeutical formulation Injection Budgetting framework Unknown Centre of expertise Additional remarks Dit is een recombinant zoster vaccin (i.t.t. Zostavax wat een levend verzwakt varicella-zostervirus is). Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date January 2017 Expected Registration February 2018 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Zostavax Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Average 6 month / months Frequency of administration Dosage per administration 50 ug References Additional remarks Toedieningsfrequentie: eenmalig 2 injecties op t=0 en op t=2-6 maanden Expected patient volume per year Patient volume < 6,701,224 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References CBS Additional remarks 6,7 mln. Inwoners van 50+, betreft het maximale volume. Expected cost per patient per year Cost € 300.00 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 Additional remarks Zostavax kost €144,54 per injectie (19400PU FL). Potential total cost per year Total cost € 2,010,367,200.00 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