Valbenazine Medicine 09 January 2018 Extended indication Tardieve dyskinesie. Therapeutic value Possible added value Total cost Registration phase Clinical trials Product Active substance Valbenazine Domain Neurological disorders Reason of inclusion Main indication Muscular diseases Extended indication Tardieve dyskinesie. Current proprietary name Already available biosimilars / generics Proprietary name Ingrezza Manufacturer Neurocrine Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Het werkingsmechanisme is nog onbekend, mogelijk is het aangrijpingspunt op het dopamine systeem: “The vesicular monoamine transporter 2 (VMAT2) inhibitor in Ingrezza regulates monoamine uptake from the cytoplasm to the synaptic vesicle for storage and release. The drug causes reversible reduction of dopamine release.” Registration Registration route Unknown Type of trajectory Unknown Particularity New medicine ATMP Unknown Submission date Expected Registration Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Ingrezza is in april 2017 door de FDA geregistreerd. Therapeutic value Current treatment options Geen duidelijke comparator. Behandeling bestaat uit stoppen/switchen/verlagen van antipsychotica. Ook antcholinerge midden in sommige gevallen. Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Tardieve Dyskinesie kan wisselend uitingen hebben van relatief geringe tot beperkende gevolgen. Mogelijke meerwaarde t.o.v. de “standaard” behandeling, maar dat zal waarschijnlijk niet gemakkelijk en eenduidig kunnen worden aangetoond. Duration of treatment Frequency of administration 1 times a day Dosage per administration 40 mg, na een week 80 mg References Barquero N. Drugs Today (Barc). 2016 Dec;52(12):665-672. doi: 10.1358/dot.2016.52.12.2570977. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209241lbl.pdf Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Verwachting aantal patiënten honderden / duizenden. Expected cost per patient per year Cost € 100,000.00 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 GoodRx Additional remarks Verwachting is dat het meerkosten gaat opleveren. In de VS ongeveer $5.500 voor 30 capsules van 40 mg, $132.000 p.p.p.j. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Indicatie-uitbreiding: mogelijk bij andere bewegingsstoornissen References Additional remarks Other information Additional remarks