Extended indication Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug
Therapeutic value No estimate possible yet
Registration phase Registered and not reimbursed

Product

Active substance Delamanid
Domain Infectious diseases
Reason of inclusion Indication extension
Main indication Bacterial infections
Extended indication Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults, adolescents, and children and infants with a body weight of at least 10kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
Proprietary name Deltyba
Manufacturer Otsuka
Mechanism of action Antibiotic
Route of administration Oral
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date 2021
Expected Registration September 2021
Orphan drug Yes
Registration phase Registered and not reimbursed
Additional comments Positieve CHMP-opinie in juli 2021

Therapeutic value

Therapeutic value No estimate possible yet

Expected patient volume per year

References LCI richtlijn tuberculose
Additional comments In 2018 waren er in totaal 806 patiënten met multiresistente tuberculose in Nederland. De indicatie-uitbreiding van 30kg naar 10kg zal naar verwachting slechts enkele patiënten betekenen.

Expected cost per patient per year

Cost 776.00
References https://www.thepharmaletter.com/article/msf-calls-for-price-of-tb-drug-delamanid-be-cut
Additional comments Delamanid is een van de duurdere geneesmiddelen om (MDR-TB) te behandelen. In Zuid Afrika wordt vanaf 1 juni 2020 een prijs van US$940 gehanteerd. Omgerekend naar euro zou dit €776 zijn. De definitieve prijs in Nederland is nog niet bekend.

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

Indication extension No

Other information

There is currently no futher information available.