Tadalafil Medicine 07 June 2022 Extended indication Treatment of paediatric patients aged 2 years and above with pulmonary arterial hypertension (PAH) classified as WHO functional class II and III. Therapeutic value No estimate possible yet Total cost Registration phase Registered and reimbursed Product Active substance Tadalafil Domain Lung diseases Reason of inclusion Indication extension IND Main indication Lung diseases other Extended indication Treatment of paediatric patients aged 2 years and above with pulmonary arterial hypertension (PAH) classified as WHO functional class II and III. Current proprietary name Already available biosimilars / generics Proprietary name Adcirca Manufacturer Eli Lilly Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date January 2022 Expected Registration February 2023 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie december 2022. Therapeutic value Current treatment options Sildenafil Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er wordt verwacht dat tadalafil de concurrentie aan zal moeten gaan met sildenafil. Er worden vergelijkbare resultaten verwacht als bij volwassenen daarnaast is het geneesmiddel veilig bevonden. Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume < 130 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIP databank Additional remarks Het is nog de vraag of er een markt zal zijn voor dit geneesmiddel in deze leeftijdsgroep. Het maximale aantal patiënten is de groep die nu sildenafil krijgt. 116 patiënten van 0 tot en met 14 jaar ontvangen op dit moment sildenafil en 147 patiënten van 0 tot en met 24 jaar ontvangen sildenafil. Inschatting voor Tadalafil is maximaal 130 patiënten. Expected cost per patient per year Cost References Medicijnkosten.nl Additional remarks Adcirca tablet filmomhuld 20mg: €10,37 per stuk. Input Lilly: AIP Z-index november 2023 = €532,56. De prijs per 20 mg tablet is €9,51. 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