Avacopan Medicine 09 January 2018 Extended indication Treatment of patients with active ANCA-associated vasculitis (including granulomatosis with polyangiitis and microscopic polyangiitis). Therapeutic value No judgement Total cost Registration phase Registration application pending Product Active substance Avacopan Domain Chronic immune diseases Reason of inclusion Main indication Cardiovascular diseases Extended indication Treatment of patients with active ANCA-associated vasculitis (including granulomatosis with polyangiitis and microscopic polyangiitis). Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer ChemoCentryx Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity New medicine with Priority Medicines (PRIME) ATMP Unknown Submission date January 2018 Expected Registration February 2019 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks PRIME-status sinds mei 2016. Therapeutic value Current treatment options EMA: 'At the time of orphan designation, no satisfactory treatments were authorised in the EU for C3 glomerulopathy.' Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume < 2,720 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References EMA Additional remarks EMA Orphan designation: 'At the time of designation granulomatosis with polyangiitis affected approximately 1.6 in 10,000 people in the European Union (EU).' Expected cost per patient per year Cost References Additional remarks 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 Unknown Indication extensions References Additional remarks Other information Additional remarks