Apremilast Medicine 04 June 2024 Extended indication Extension of indication to include the treatment of moderate to severe chronic plaque psoriasis in children and adolescents from the age of 6 years who have a contraindication, have an inadequate response, or are intolerant to at least one other systemic therapy or phototherap. Therapeutic value No estimate possible yet Total cost € 1,060,000.00 Registration phase Registered and reimbursed Product Active substance Apremilast Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Skin diseases Extended indication Extension of indication to include the treatment of moderate to severe chronic plaque psoriasis in children and adolescents from the age of 6 years who have a contraindication, have an inadequate response, or are intolerant to at least one other systemic therapy or phototherap. Current proprietary name Already available biosimilars / generics Proprietary name Otezla Manufacturer Amgen 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 No Submission date January 2024 Expected Registration November 2024 Orphan drug Yes Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie september 2024. Therapeutic value Current treatment options TNF remmers, IL-12/IL-23 remmers. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Apremilast is een alternatief voor andere biologicals die al ingezet worden binnen deze indicatie. Bij volwassenen wordt wat minder effectiviteit gezien dan andere behandelopties. Bij kinderen met prikangst zal het een mooi alternatief kunnen zijn. Er zijn geen head-to-head studies met de andere biologicals. Duration of treatment Frequency of administration 2 times a day Dosage per administration 20mg - 30mg References NCT04175613 Additional remarks Voor patiënten die 50kg of meer wegen is de aanbevolen onderhoudsdosering tweemaal daags 30mg. Voor patiënten die 20kg tot minder dan 50kg wegen is de aanbevolen onderhoudsdosering tweemaal daags 20mg. Expected patient volume per year Patient volume < 100 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks In Nederland zijn dat er circa 165.000 patiënten met plaque psoriasis. Aangezien de indicatie voor patiënten van 6 tot 18 jaar is gesteld is de verwachting dat er niet meer dan 100 patiënten voor in aanmerking komen. Expected cost per patient per year Cost € 10,600.00 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 Additional remarks Gemiddelde prijs per dag OTEZLA, TABLET 60 mg €31,91. Potential total cost per year Total cost € 1,060,000.00 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