Extended indication Extension of indication to include treatment of adults with pneumonia not requiring supplemental oxy
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Remdesivir
Domain Infectious diseases
Reason of inclusion Indication extension
Main indication Other viral infections
Extended indication Extension of indication to include treatment of adults with pneumonia not requiring supplemental oxygen (moderate COVID-19).
Proprietary name Veklury
Manufacturer Gilead
Mechanism of action Virus inhibitor
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments RNA-replicaseremmers.

Registration

Registration route Centralised (EMA)
ATMP No
Submission date February 2021
Expected Registration December 2021
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost < 4,500.00
References https://icer-review.org/announcements/alternative_pricing_models_for_remdesivir/
Additional comments In het geval van remdesivir suggereert het initiële ICER-COVID-model een prijs van ongeveer $4.500 per behandelingskuur, gebaseerd op de veronderstelling dat de mortaliteit baat heeft bij de bevindingen van de ACCT-studie met een behandelingskuur van 10 dagen. Er wordt door ICER uitgegaan van $10 productiekosten voor een behandelingskuur van 10 dagen en $5 productiekosten voor een behandelingskuur van 5 dagen (exclusief R&D).

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.