Bupivacaine / meloxicam Medicine 10 December 2019 Extended indication Zynrelef is indicated for treatment of somatic postoperative 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 / meloxicam Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Pain Extended indication Zynrelef is indicated for treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults Current proprietary name Already available biosimilars / generics Proprietary name Zynrelef Manufacturer Heron Portfolio holder Mechanism of action Anesthetic Route of administration Local Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Toediening vindt plaats op de plek van de chirurgische ingreep. Het betreft hier een verdovingsmiddel in combinatie met een NSAID om de ontsteking te remmen. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New therapeutical formulation ATMP Unknown Submission date March 2019 Expected Registration September 2020 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in juli 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 In vergelijking met placebo en bupivacaine HCl leidt bupivacaine/meloxicam tot een significant verminderde postoperatieve pijn en consumptie van opioïden. Duration of treatment Frequency of administration Dosage per administration 60-300 mg References NCT03295721; NCT03237481; Viscusi et al. Reg Anesth Pain Med. 2019 May 21. pii: rapm-2019-100531 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