Extended indication Rezolsta is indicated, in combination with other antiretroviral medicinal products, for the treatmen
Therapeutic value Possible equal value
Total cost 84,463.92
Registration phase Registered and reimbursed

Product

Active substance Darunavir / cobicistat
Domain Infectious diseases
Reason of inclusion Indication extension
Main indication Other viral infections
Extended indication Rezolsta is indicated, in combination with other antiretroviral medicinal products, for the treatment of human immunodeficiency virus‑1 (HIV‑1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg).
Proprietary name Rezolsta
Manufacturer Janssen
Mechanism of action Virus inhibitor
Route of administration Oral
Therapeutical formulation Film-coated tablet
Budgetting framework Extramural (GVS)
Additional comments 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
Submission date July 2019
Expected Registration March 2020
Orphan drug No
Registration phase Registered and reimbursed
Additional comments Positieve CHMP-opinie in januari 2020. Geregistreerd in maart 2020. Vergoeding inclusief voorwaarden.

Therapeutic value

Current treatment options Andere gebooste proteaseremmers.
Therapeutic value Possible equal value
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 continuous
Frequency of administration 1 times a day
Dosage per administration 800 mg / 150 mg
References NCT02016924

Expected patient volume per year

Patient volume

< 18

Market share is generally not included unless otherwise stated.

References HIV Monitoring Report 2018, SHM 2018; CBS
Additional comments 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 4,692.44
References G- standaard en SmPC
Additional comments Rezolsta tablet filmomhuld 800/150mg 30 stk AIP €385,68 exclusief BTW. Dosering is 1 tablet per dag.

Potential total cost per year

Total cost

84,463.92

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.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Leeftijdsgroepen van <12 jaar
References Clinicaltrials.gov

Other information

There is currently no futher information available.