Buprenorphine Medicine 13 December 2018 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. Therapeutic value No judgement Total cost Registration phase Registered Product Active substance Buprenorphine Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Neurological disorders other 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. Current proprietary name Already available biosimilars / generics Proprietary name Buvidal Manufacturer Camurus Portfolio holder Mechanism of action Receptor antagonist Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Opioid mu receptor agonist and opioid kappa receptor antagonist Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date December 2017 Expected Registration November 2018 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie september 2018. Geregistreerd in november 2018. Therapeutic value Current treatment options buprenorfine tablet of methadon Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. 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 Frequency of administration 1 times a week Dosage per administration References SPS Additional remarks wekelijks of maandelijks subcutaan depot Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Kleine patiëntaantallen verwacht. Expected cost per patient per year Cost € 200.00 - 300.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References medicijnkosten.nl; GIP databank Additional remarks 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 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 Yes Indication extensions Chronic pain phase III References pipeline Camurus Additional remarks Other information Additional remarks