Ralinepag Medicine 04 June 2026 Extended indication Ralinepag in combination with standard therapy for the treatment of symptomatic WHO group 1 pulmonary arterial hypertension in adults and the elderly. Therapeutic value No estimate possible yet Total cost € 12,555,000.00 Registration phase Clinical trials Product Active substance Ralinepag Domain Lung diseases Reason of inclusion New medicine (specialité) Main indication Lung diseases other Extended indication Ralinepag in combination with standard therapy for the treatment of symptomatic WHO group 1 pulmonary arterial hypertension in adults and the elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer United Therapeutics Corporation Portfolio holder Mechanism of action Receptor agonist 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 ATMP No Submission date 2026 Expected Registration 2027 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Ralinepag wordt onderzocht in de ADVANCE OUTCOMES fase 3-trial. United Therapeutics verwacht de resultaten van deze studie in 2026. Hierbij kan een registratie in 2027 verwacht worden. Therapeutic value Current treatment options Epoprostenol; treprostinil; iloprost; selexipag Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Het is de verwachting dat ralinepag een kleine rol zal spelen binnen dit indicatiegebied. Selexipag dat qua werking vergelijkbaar is heeft tot nu toe geen goede resultaten opgeleverd. Er is weinig effect en er zijn relatief veel bijwerkingen. Verdere studieresultaten dienen nog wel afgewacht te worden. Duration of treatment Frequency of administration Dosage per administration References NCT03626688 (ROR-PH-301, ADVANCE OUTCOMES); NCT03683186 (ROR-PH-303) Additional remarks Expected patient volume per year Patient volume 288 - 522 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Informatie voor de huisarts over Pulmonale Hypertensie. Stichting PAH Nederland et al. 2016 (1). Additional remarks De prevalentie van PAH in Nederland is ongeveer 16 tot 29 per miljoen inwoners (1). Expected cost per patient per year Cost € 31,000.00 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 Additional remarks Kosten op basis van IHSI-inschatting, afgeleid van de mediane kosten van dezelfde ATC-klasse (B01AC) geneesmiddelen in Nederland (exclusief heparine). Potential total cost per year Total cost € 12,555,000.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks