Extended indication Sirturo is indicated for use as part of an appropriate combination regimen for pulmonary multidrug‑r
Therapeutic value Possible added value
Total cost 43,469.22
Registration phase Registered and reimbursed

Product

Active substance Bedaquiline
Domain Infectious diseases
Reason of inclusion Indication extension
Main indication Bacterial infections
Extended indication Sirturo is indicated for use as part of an appropriate combination regimen for pulmonary multidrug‑resistant tuberculosis (MDR‑TB) in adults and adolescent patients (12 years to less than 18 years of age and weighing at least 30 kg) when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
Proprietary name Sirturo
Manufacturer Janssen
Mechanism of action Enzyme inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional comments ATP synthase-remmer

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date November 2018
Expected Registration February 2020
Orphan drug No
Registration phase Registered and reimbursed
Additional comments Positieve CHMP-opinie in december 2019. Geregistreerd in januari 2020.

Therapeutic value

Therapeutic value Possible added value
Substantiation Bij volwassenen behoort bedaquiline al tot de standaardzorg. Er wordt verwacht dat het geneesmiddel ook bij adolescenten een meerwaarde zal hebben.
Duration of treatment Average 24 week / weeks
Frequency of administration 1 times a day
Dosage per administration 200-400 mg
Additional comments De eerste twee weken ontvangt de patiënt 400mg eenmaal per dag, daarna 200mg driemaal per week.

Expected patient volume per year

Patient volume

1 - 3

Market share is generally not included unless otherwise stated.

References Surveillance rapport RIVM geeft indicatie bij MDR / XDR TB.
Additional comments Circa 5% van de TB patiënten zijn kinderen. Indicatie hoogstens 5 maal per jaar voor totale cohort (maximaal 1 kind per jaar). Recente WHO richtlijn wordt bedaquiline als belangrijkste aangemerkt gezien ontraden van injectables. In toekomst maximaal 15 per jaar geschat voor het totale cohort (dus maximaal 2-3 kinderen per jaar).

Expected cost per patient per year

Cost 21,734.61
References G- standaard; SmPC; fabrikant
Additional comments De huidige lijstprijs van 100mg, 188 stuks is € 21.734,61 exclusief BTW.

Potential total cost per year

Total cost

43,469.22

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.