Extended indication Rukobia, in combination with other antiretrovirals, is indicated for the treatment of adults with mu
Therapeutic value No estimate possible yet
Total cost 108,000.00
Registration phase Registered

Product

Active substance Fostemsavir
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Main indication HIV
Extended indication Rukobia, in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.
Proprietary name Rukobia
Manufacturer ViiV
Mechanism of action HIV inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional comments Scrip pipeline watch 3 nov 2017: BRIGHTE trail, positive results in heavily pretreated patients. Antiretroviral designed to prevent HIV attachment to and entry into CD4+ T cells, first-in-class.

Registration

Registration route Centralised (EMA)
Type of trajectory Accelerated assessment
Submission date February 2020
Expected Registration February 2021
Orphan drug No
Registration phase Registered
Additional comments Positieve CHMP-opinie in december 2020.

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation Dit middel zal naar verwachting worden ingezet als een laatste redmiddel bij patiënten die virologisch niet of slecht kunnen worden onderdrukt.
Duration of treatment lifetime
Frequency of administration 2 times a day
Dosage per administration 600 mg
References clinicaltrials.gov, NCT02362503

Expected patient volume per year

Patient volume

< 10

Market share is generally not included unless otherwise stated.

Additional comments De schatting is dat er maximaal 10 patiënten in aanmerking zullen komen voor dit middel. Dit gegeven dat het middel wordt ingezet als laatste redmiddel bij patiënten die virologisch niet of slecht kunnen worden onderdrukt.

Expected cost per patient per year

Cost 9,600.00 - 12,000.00
References Fabrikant
Additional comments In dezelfde orde grootte als huidige STRs die variëren tussen de €800-€1.000 per maand (gelijke kosten verwacht). De kosten bestaan grotendeels niet uit meerkosten maar uit vervanging van bestaande middelen.

Potential total cost per year

Total cost

108,000.00

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.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension No
References SPS

Other information

There is currently no futher information available.