Delamanid Medicine 08 December 2020 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. 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 IND 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. Current proprietary name Already available biosimilars / generics Proprietary name Deltyba Manufacturer Otsuka Portfolio holder Mechanism of action Antibiotic Route of administration Oral Therapeutical formulation Unknown Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date December 2019 Expected Registration October 2020 Orphan drug Yes Registration phase Registered and not reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in september 2020. Therapeutic value Current treatment options Isoniazide, Rifampicine, Pyrazinamide en Ethambutol Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. 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 Dosage per administration References NCT03141060 Additional remarks Expected patient volume per year Patient volume < 10 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice 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 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. 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 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks