Extended indication HIV/aids in heavily treatment experienced patients.
Therapeutic value No judgement
Total cost 324,000.00
Registration phase Registration application pending

Product

Active substance Fostemsavir
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Main indication Viral infections other
Extended indication HIV/aids in heavily treatment experienced patients.
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 January 2021
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No judgement
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 - 50

Market share is generally not included unless otherwise stated.

Additional remarks De schatting is dat er tussen de 10 en 50 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 grootte als huidige STRs die varieren 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

324,000.00

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.