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.