Delamanid

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.
Therapeutic value	No estimate possible yet
Total cost	7,760.00
Registration phase	Registered

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 30 kg 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
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.

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.

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.