Bupivacaine Medicine 10 December 2019 Extended indication Indicated for prolonged acute pain management and reduction in need for opioids in adults. Therapeutic value No judgement Total cost Registration phase Registration application pending Product Active substance Bupivacaine Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Pain Extended indication Indicated for prolonged acute pain management and reduction in need for opioids in adults. Current proprietary name Already available biosimilars / generics Proprietary name Exparel Manufacturer Pacira Portfolio holder Mechanism of action Anesthetic Route of administration Local Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Exparel bevat bupivacaine in een liposomale suspensie wat leidt tot een langere werking. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New therapeutical formulation ATMP Unknown Submission date June 2019 Expected Registration August 2020 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Bupivacaine HCl Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Exparel leidt tot minder consumptie van opioïden. Duration of treatment Frequency of administration Dosage per administration Maximum 266 mg References NCT03682302 Additional remarks Expected patient volume per year Patient volume < 2,600 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIPdatabank Additional remarks In 2017 waren er 2.599 gebruikers van bupivacaine HCl (Marcaine). Mogelijk stapt een gedeelte van deze gebruikers over. Naar verwachting met name in het geval van een thoraxingreep (de belangrijkste indicatie) of een laparoscopische ingreep. Expected cost per patient per year Cost References GIPdatabank Additional remarks In 2017 werd er per gebruiker van bupivacaine HCl (Marcaine) €2,96 vergoed. Naar verwachting zal deze nieuwe formulering meer gaan kosten. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks