Darunavir / cobicistat Medicine 10 December 2019 Extended indication To modify the approved therapeutic indication to include new population (adolescents aged 12 years and older weighing at least 35 kg) for the treatment of HIV-1 Therapeutic value Possible equal value Total cost € 69,156.00 Registration phase Registration application pending Product Active substance Darunavir / cobicistat Domain Infectious diseases Reason of inclusion Indication extension IND Main indication Viral infections other Extended indication To modify the approved therapeutic indication to include new population (adolescents aged 12 years and older weighing at least 35 kg) for the treatment of HIV-1 Current proprietary name Already available biosimilars / generics Proprietary name Rezolsta Manufacturer Janssen Portfolio holder Mechanism of action Virus inhibitor Route of administration Oral Therapeutical formulation Film-coated tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Darunavir is een proteaseremmer. Cobicistat versterkt de werking van darunavir doordat het de tijd dat darunavir in het lichaam werkzaam is, verlengt. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date July 2019 Expected Registration February 2020 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Andere gebooste proteaseremmers. Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation De therapeutische waarde van darunavir / cobicistat is vergelijkbaar ten opzichte van andere proteaseremmers. Het gebruik zal wel een versimpeling van het regime van de patiënt tot gevolg hebben. Duration of treatment Frequency of administration 1 times a day Dosage per administration 800 mg / 150 mg References NCT02016924 Additional remarks Expected patient volume per year Patient volume < 18 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References HIV Monitoring Report 2018, SHM 2018; CBS Additional remarks Per 31 december 2017 zijn er 183 kinderen onder de 18 jaar in Nederland in zorg. De meerderheid gebruikt een integraseremmer based regime. Ongeveer 10% gebruikt een darunavir, dit zijn 18 kinderen in totaal. Een deel hiervan zal mogelijk overstappen op dit middel. Expected cost per patient per year Cost € 3,842.00 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 GIPdatabank Additional remarks In 2017 werd bij volwassenen per gebruiker €3.842,00 vergoedt Potential total cost per year Total cost € 69,156.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Leeftijdsgroepen van <12 jaar References Clinicaltrials.gov Additional remarks Other information Additional remarks