Bupivacaine Medicine 10 December 2019 Extended indication Exparel is indicated as a brachial plexus block or femoral nerve block for treatment of post-operative pain in adults, and as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds in adults Therapeutic value No estimate possible yet Total cost Registration phase Registered Product Active substance Bupivacaine Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Pain Extended indication Exparel is indicated as a brachial plexus block or femoral nerve block for treatment of post-operative pain in adults, and as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds 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 November 2020 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in september 2020. Therapeutic value Current treatment options Bupivacaine HCl Therapeutic value No estimate possible yet 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. In de Verenigde Staten is een dosis van 266mg (20 mL) $344,20. 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