Fostemsavir

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.
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 remarks	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 remarks	Positieve CHMP-opinie in december 2020. GVS-advies wordt verwacht in december 2021.

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 remarks	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.

Patient volume

< 10

Market share is generally not included unless otherwise stated.

Additional remarks

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 remarks	In dezelfde orde van 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.

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.