Tralokinumab Medicine 07 June 2022 Extended indication Adtralza is indicated for the treatment of moderate-to-severe atopic dermatitis in adult and adolescent patients 12 years and older who are candidates for systemic therapy. Therapeutic value Possible equal value Total cost € 1,012,500.00 Registration phase Registered and reimbursed Product Active substance Tralokinumab Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Skin diseases Extended indication Adtralza is indicated for the treatment of moderate-to-severe atopic dermatitis in adult and adolescent patients 12 years and older who are candidates for systemic therapy. Current proprietary name Already available biosimilars / generics Proprietary name Adtralza Manufacturer Leo Pharma Portfolio holder Leo Pharma Mechanism of action Interleukin inhibitor Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date December 2021 Expected Registration October 2022 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie ontvangen september 2022. Therapeutic value Current treatment options Dupixent. Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Het is de verwachting dat tralokinumab met name de concurrentie met dupilumab aan zal gaan. De vraag is op dit moment welk geneesmiddel de minste bijwerkingen geeft. Duration of treatment Frequency of administration 1 times every 2 weeks Dosage per administration 300 mg References Additional remarks Expected patient volume per year Patient volume 50 - 100 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fabrikant: N-Control database, UMCU expertisecentrum en publicatie van Garritsen FM et al. (Use of oral immunosuppressive drugs in the treatment of atopic dermatitis in the Netherlands.J Eur Acad Dermatol Venereol. 2018 Feb 27. ) Additional remarks NControl meet de geneesmiddelverstrekkingen van circa 5,5 miljoen patiënten bij ongeveer 800 openbare apotheken in Nederland. In de publicatie van Garritsen et al. zijn de verstrekkingen van 556 N-Control apotheken geanalyseerd en nagegaan hoeveel volwassen patiënten met atopische dermatitis over een periode van vijf jaar met een systemische immunosuppressiva behandeld zijn. In opdracht van Sanofi heeft N-Control dezelfde analyse nogmaals uitgevoerd maar dan specifiek bij adolescenten. Uit deze analyse en op basis van de input van de experts (dermatologen) blijkt dat er op dit moment 50-100 adolescenten in Nederland zijn die met systemische immunosuppressiva behandeld worden. Expected cost per patient per year Cost € 13,500.00 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 Taxe September 2021 SmPC July 2021 Additional remarks Vergelijkbaar met dupilumab, zal de concurrentie aan moeten gaan wat de prijs nog zou kunnen drukken. Potential total cost per year Total cost € 1,012,500.00 Total cost for sluice Additional remarks Off label use Off label use Yes Indications off label use References Adis Insight Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks