Bedaquiline Medicine 04 December 2025 Extended indication Extension of indication to include treatment of paediatric patients (2 years to less than 5 years of age and weighing at least 7 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampicin and isoniazid. Therapeutic value Possible added value Total cost Registration phase Registered Product Active substance Bedaquiline Domain Infectious diseases Reason of inclusion Indication extension IND Main indication Bacterial infections Extended indication Extension of indication to include treatment of paediatric patients (2 years to less than 5 years of age and weighing at least 7 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampicin and isoniazid. Current proprietary name Already available biosimilars / generics Proprietary name Sirturo Manufacturer Janssen Portfolio holder Mechanism of action Enzyme inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks ATP synthaseremmer Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP Submission date February 2025 Expected Registration August 2025 Orphan drug No Registration phase Registered Reimbursement Reimbursed from the basic package Medicine sluice Rejected Additional remarks Positieve CHMP-opinie in juli 2025. Therapeutic value Current treatment options Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Deze indicatieuitbreiding zal wel van een eventuele toegevoegde waarde zijn voor het kleine patiëntvolume waarop het van toepassing is. Duration of treatment Frequency of administration 1 times a day Dosage per administration References NCT02354014 (TMC207-C211); Expertopinie Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Declaratiedata (1); Expertopinie (2) Additional remarks In 2022 waren er 17 gebruikers van bedaquiline (volwassenen en kind 5 tot 18 jaar). In 2021 kregen acht personen de diagnose multiresistente tuberculose (MDR) (2). Deze uitbreiding naar twee jaar en ouder zal een zeer klein effect hebben op het patiëntvolume. Expected cost per patient per year Cost References G- standaard; SmPC; fabrikant Additional remarks De huidige lijstprijs van 100mg, 188 stuks is € 21.734,61 exclusief BTW. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks