Buprenorphine

Active substance
Buprenorphine
Domain
Neurological disorders
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Other neurological disorders
Extended indication
Treatment of opioid dependence within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over.

1. Product

Proprietary name
Buvidal
Manufacturer
Camurus
Mechanism of action
Receptor antagonist
Route of administration
Subcutaneous
Therapeutical formulation
Injection
Budgetting framework
Extramural (GVS)
Additional comments
Opioid mu receptor agonist and opioid kappa receptor antagonist

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Normal trajectory
Submission date
December 2017
Expected Registration
November 2018
Orphan drug
No
Registration phase
Registered
Additional comments
Positieve CHMP-opinie september 2018. Geregistreerd in november 2018.

3. Therapeutic value

Current treatment options
buprenorfine tablet of methadon
Therapeutic value
No judgement
Substantiation
De tablet die is geregistreerd als substitutiebehandeling voor opioïdverslaving moet men 1x/ dag geven. Variatie op bestaande middelen, beperkte meerwaarde verwacht.
Duration of treatment
Not found
Frequency of administration
1 times a week
References
SPS
Additional comments
wekelijks of maandelijks subcutaan depot

4. Expected patient volume per year

Additional comments
Kleine patiëntaantallen verwacht.

5. Expected cost per patient per year

Cost
200 - 300
References
medicijnkosten.nl; GIP databank
Additional comments
Kosten huidige toedieningsvorm: Buprenorfine injectievloeistof 0,3MG/ML AMP 1 ML € 1,68. Vergoeding per gebruiker in 2016: €237,80 per persoon. Naar verwachting zal een vergelijkbare prijs per persoon per jaar worden gerekend.

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
Yes
Indication extensions
Chronic pain phase III
References
pipeline Camurus

9. Other information

There is currently no futher information available.