Octreotide Medicine 03 June 2025 Extended indication Oczyesa is indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues Therapeutic value No estimate possible yet Total cost Registration phase Positive CHMP opinion Product Active substance Octreotide Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Metabolic diseases Extended indication Oczyesa is indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues Current proprietary name Already available biosimilars / generics Proprietary name Oczyesa Manufacturer Camurus Portfolio holder Mechanism of action Hormonal therapy Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Betreft de goedkeuring van een maandelijks subcutaan depot voor acromegalie. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New therapeutical formulation ATMP No Submission date May 2024 Expected Registration June 2025 Orphan drug Yes Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in april 2025. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a month Dosage per administration 20 mg References NCT04076462 (ACROINNOVA 1); NCT04125836 (ACROINNOVA 2) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Horizonscan Geneesmiddelen octreotide. Additional remarks Voor acromegalie is de incidentie 3 tot 4 patiënten per miljoen inwoners en de prevalentie bedraagt 60 per miljoen inwoners (in totaal 51 tot 68 en 1.020 patiënten in Nederland). Tot 50% van hen heeft een geneesmiddel niet nodig omdat chirurgie volstaat. Expected cost per patient per year Cost € < 8,400.00 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 Medicijnkosten.nl Additional remarks De prijs van octreotide 20mg is ongeveer €700. Dit komt neer op €8.400 per jaar. 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