Remdesivir

Extended indication	Extension of indication to include treatment of adults with pneumonia not requiring supplemental oxygen (moderate COVID-19).
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	Viral infections other
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 remarks	RNA-replicaseremmers.

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

Therapeutic value	No estimate possible yet

There is currently nothing known about the expected patient volume.

Cost	< 4,500.00
References	https://icer-review.org/announcements/alternative_pricing_models_for_remdesivir/
Additional remarks	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).

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.