Selumetinib Medicine 13 December 2018 Extended indication Differentiated thyroid cancer - first-line with radioactive iodine Therapeutic value No judgement Total cost Registration phase Withdrawn Product Active substance Selumetinib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Thyroid cancer Extended indication Differentiated thyroid cancer - first-line with radioactive iodine Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer AstraZeneca Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Anti MAPK kinase (MEK) Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date Expected Registration Orphan drug No Registration phase Withdrawn Reimbursement Medicine sluice Additional remarks De ASTRA trial heeft zijn primaire eindpunten niet gehaald. Therapeutic value Current treatment options Geen toevoeging RAI behandeling Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Median 5 week / weeks Frequency of administration 2 times a day Dosage per administration 5 mg References NCT02393690 Additional remarks Behandelduur maximaal 5 weken Expected patient volume per year Patient volume < 114 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks 114 diagnoses schildklierkanker stadium 4. Doordat het echter onduidelijk is in welke lijn dit middel ingezet gaat worden is het lastig om een reëel patiëntaantal in te schatten. Het zal naar verwachting een klein deel van deze patiëntengroep bedragen. Expected cost per patient per year Cost References Additional remarks 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 No Indication extensions References Additional remarks Other information Additional remarks