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Bupivacaine

Exparel

Extended indication Exparel is indicated as a brachial plexus block or femoral nerve block for treatment of post-operati
Therapeutic value No estimate possible yet
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
Proprietary name Exparel
Manufacturer Pacira
Mechanism of action Anesthetic
Route of administration Local
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
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
Submission date June 2019
Expected Registration November 2020
Orphan drug No
Registration phase Registered
Additional remarks Positieve CHMP-opinie in september 2020.

Therapeutic value

Current treatment options Bupivacaine HCl
Therapeutic value No estimate possible yet
Substantiation Exparel leidt tot minder consumptie van opioïden.
Duration of treatment one-off
Dosage per administration Maximum 266 mg
References NCT03682302

Expected patient volume per year

Patient volume

< 2,600

Market share is generally not included unless otherwise stated.
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

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

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension No

Other information

There is currently no futher information available.