Delamanid

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 with a body weight of at least 30 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.

Product

Proprietary name Deltyba
Manufacturer Otsuka
Mechanism of action Antibiotic
Route of administration Oral
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Submission date December 2019
Expected Registration December 2020
Orphan drug Yes
Registration phase Positive CHMP opinion
Additional comments Positieve CHMP-opinie in september 2020.

Therapeutic value

Current treatment options Isoniazide, Rifampicine, Pyrazinamide en Ethambutol
Therapeutic value No judgement
Substantiation Uit studies blijkt dat het niet effectiever is dan andere middelen. Het zal voornamelijk ingezet worden in het geval van specifieke resistentie of intolerantie voor andere geneesmiddelen.
Duration of treatment Average 6 month / months
Frequency of administration 2 times a day
References NCT03141060

Expected patient volume per year

Patient volume

< 10

Market share is generally not included unless otherwise stated.

References LCI richtlijn tuberculose
Additional comments In 2018 waren er in totaal 806 patiënten met multiresistente tuberculose in Nederland. Er wordt verwacht dat er niet meer dan 10 patiënten in de leeftijdsgroep van 6 - 18 jaar gebruik zullen maken van deze behandeling.

Expected cost per patient per year

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.