Omadacycline Medicine 09 January 2018 Extended indication Behandeling van infecties zoals huidinfectie (acute bacterial skin and skin structure infections (ABSSSI)); pneumonie (community-acquired bacterial pneumonia (CABP)) en mogelijk ook urineweginfectie. Breedspectrum antibioticum vooral bij verdenking van resistente infecties (huid/weke delen, long, urineweg). Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Omadacycline Domain Infectious diseases Reason of inclusion Main indication Bacterial infections Extended indication Behandeling van infecties zoals huidinfectie (acute bacterial skin and skin structure infections (ABSSSI)); pneumonie (community-acquired bacterial pneumonia (CABP)) en mogelijk ook urineweginfectie. Breedspectrum antibioticum vooral bij verdenking van resistente infecties (huid/weke delen, long, urineweg). Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Paratek Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Omdacycline is een breedspectrum antibioticum en behoort tot de aminomethylcyclines subklasse van de tetracyclinen. Naast tablet ook beschikbaar middels intraveneus infuus. Intramurale start, extramurale uitbehandeling. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity New medicine ATMP Unknown Submission date Expected Registration 2018 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Alternatief voor meerdere bestaande middelen. Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Vooralsnog geen meerwaarde of gelijke waarde gezien de lage incidentie van resistentie in Nederland en de beschikbaarheid van reeds beschikbare middelen die adequaat ingezet kunnen worden. Duration of treatment Frequency of administration 1 times a day Dosage per administration 100 mg en 200 mg References Pubmed, Google scholar, IDSA guideline 2014 diagnosis and management of skin and soft tissue infections. Additional remarks 100 mg 1 maal per dag IV gevolgd door 200 mg 1 maal per dag oraal. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Gaat waarschijnlijk beperkt gebruikt worden. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Yes Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks