Bupivacaine

Active substance
Bupivacaine
Domain
Neurological disorders
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Pain
Extended indication
Indicated for prolonged acute pain management and reduction in need for opioids in adults.

1. Product

Proprietary name
Exparel
Manufacturer
Pacira
Mechanism of action
Anesthetic
Route of administration
Local
Therapeutical formulation
Injection
Budgetting framework
Intermural (MSZ)
Additional comments
Exparel bevat bupivacaine in een liposomale suspensie wat leidt tot een langere werking.

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Normal trajectory
Particularity
New therapeutical formulation
Submission date
June 2019
Expected Registration
August 2020
Orphan drug
No
Registration phase
Registration application pending

3. Therapeutic value

Current treatment options
Bupivacaine HCl
Therapeutic value
No judgement
Substantiation
Exparel leidt tot minder consumptie van opioïden.
Dosage per administration
Maximum 266 mg
References
NCT03682302

4. Expected patient volume per year

Patient volume

< 2,600

Market share is generally not included unless otherwise stated.

References
GIPdatabank
Additional comments
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.

5. Expected cost per patient per year

References
GIPdatabank
Additional comments
In 2017 werd er per gebruiker van bupivacaine HCl (Marcaine) €2,96 vergoed. Naar verwachting zal deze nieuwe formulering meer gaan kosten.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

Indication extension
No

9. Other information

There is currently no futher information available.