Kaliumcitraat / kaliumwaterstofcarbonaat Medicine 12 June 2018 Extended indication Adults and Children Suffering from distal Renal Tubular Acidosis (dRTA) Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Kaliumcitraat / kaliumwaterstofcarbonaat Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) Main indication Metabolic diseases Extended indication Adults and Children Suffering from distal Renal Tubular Acidosis (dRTA) Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Advicenne Portfolio holder Mechanism of action Other Route of administration Oral Therapeutical formulation Granulate Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Kaliumcitraat / kaliumwaterstofcarbonaat heeft een alkaliserende werking zodat de zuurtegraad in de patiënt wordt teruggebracht. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity New therapeutical formulation ATMP Unknown Submission date 2019 Expected Registration 2020 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Alkaliserende middelen om de zuurtegraad van het lichaam in stand te houden zoals natriumbicarbonaat, natriumcitraat en kaliumcitraat. Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Huidige behandeling moet iedere 4-6 uur worden ingenomen. Deze formulering werkt 12 uur en hoeft dus maar 2 maal per dag te worden ingenomen en is smaakloos. Met name gericht op kindvriendelijke toediening. Duration of treatment Frequency of administration 2 times a day Dosage per administration References Scrip Additional remarks Expected patient volume per year Patient volume < 4,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References EMA Additional remarks At the time of designation, distal renal tubular acidosis affected approximately 2.1 in 10,000 people in the European Union (EU). Dit zou neerkomen op 3.570 patiënten in Nederland 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 Unknown Indication extensions References Additional remarks Other information Additional remarks