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Delamanid

Deltyba

Extended indication Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug
Therapeutic value No estimate possible yet
Total cost 7,760.00
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 with a body weight of at least 30kg 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)
Submission date December 2019
Expected Registration October 2020
Orphan drug Yes
Registration phase Registered and not reimbursed
Additional remarks Positieve CHMP-opinie in september 2020.

Therapeutic value

Current treatment options Isoniazide, Rifampicine, Pyrazinamide en Ethambutol
Therapeutic value No estimate possible yet
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 remarks 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

Cost 776.00
References https://www.thepharmaletter.com/article/msf-calls-for-price-of-tb-drug-delamanid-be-cut
Additional remarks 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

Total cost

7,760.00

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

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.