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.

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

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.

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

Expected patient volume per year

Additional comments Kleine patiëntaantallen verwacht.

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.

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 Yes
Indication extensions Chronic pain phase III
References pipeline Camurus

Other information

There is currently no futher information available.