Apremilast Medicine 13 December 2018 Extended indication Ziekte van Behçet Therapeutic value No judgement Total cost € 2,820,000.00 Registration phase Clinical trials Product Active substance Apremilast Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Cardiovascular diseases Extended indication Ziekte van Behçet Current proprietary name Already available biosimilars / generics Proprietary name Otezla Manufacturer Celgene Portfolio holder Mechanism of action Enzyme inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise ErasmusMC, AMC/VUMC/READE Additional remarks PDE4-inhibitor Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date 2019 Expected Registration May 2020 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Registratie verwacht in Q2 2020. Therapeutic value Current treatment options Geen geregistreerde opties; Off-label Revlimid en anti-TNFα Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Doordat er relatief weinig bijwerkingen zijn is dit mogelijk een goed alternatief voor de huidige behandelopties. Duration of treatment Frequency of administration 2 times a day Dosage per administration 30 mg References RELIEF: NCT02307513 Additional remarks Expected patient volume per year Patient volume 150 - 450 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie Additional remarks In totaal in Nederland 450 patiënten met de ziekte van Behçet. Meest ernstige vorm hiervan betreft zo'n 150-200 patiënten. Geen geregistreerde behandelopties op dit moment, dus veel patiënten zullen in aanmerking komen voor dit geneesmiddel. Expected cost per patient per year Cost € 9,400.00 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 G-standaard Additional remarks Kosten per patiënt per jaar, o.b.v. lijstprijs 1 juli 2018 Potential total cost per year Total cost € 2,820,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks