Atazanavir / cobicistat Medicine 08 December 2020 Extended indication Extension of indication to include the use of EVOTAZ in combination with other antiretroviral agents in the treatment of HIV-1 infection in adolescent patients aged ≥ 12 to < 18 years, weighing ≥ 35 kg without known mutations associated with resistance to atazanavir. Therapeutic value No judgement Total cost Registration phase Registration application pending Product Active substance Atazanavir / cobicistat Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication Viral infections other Extended indication Extension of indication to include the use of EVOTAZ in combination with other antiretroviral agents in the treatment of HIV-1 infection in adolescent patients aged ≥ 12 to < 18 years, weighing ≥ 35 kg without known mutations associated with resistance to atazanavir. Current proprietary name Already available biosimilars / generics Proprietary name Evotaz Manufacturer BMS Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date September 2020 Expected Registration July 2021 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks Atazanavir en cobicistat kosten los: REYATAZ, CAPSULE 150MG 0,3 g €15,02. TYBOST, TABLET 150MG 0,15 g € 1,09. Potential total cost per year Total cost 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