Pretomanid Medicine 03 June 2025 Extended indication Extension of indication to include in combination with bedaquiline, linezolid and moxifloxacin the treatment of adults with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to rifampicin, with or without resistance to isoniazid Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Pretomanid Domain Infectious diseases Reason of inclusion Indication extension IND Main indication Bacterial infections Extended indication Extension of indication to include in combination with bedaquiline, linezolid and moxifloxacin the treatment of adults with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to rifampicin, with or without resistance to isoniazid Current proprietary name Already available biosimilars / generics Proprietary name Dovprela Manufacturer Global Alliance for TB Drug Development Portfolio holder Mechanism of action Antibiotic Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date March 2025 Expected Registration January 2026 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Maximal 24 week / weeks Frequency of administration 1 times a day Dosage per administration 200 mg References NCT02589782 (TB-PRACTECAL) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost € < 3,800.00 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 Drugs.com (1); TB Alliance (2). Additional remarks De prijs in de Verenigde Staten is €689 voor 26 tabletten (~€603) (1). Een behandeling van 24 weken zou dan €3.896 kosten in Nederland (€603/26∗24∗7). Via de Global Drug Facility wordt pretomanid geleverd voor $169 per behandeling (minder dan $1 per tablet) in lage- en middeninkomenslanden (2). 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