Pimavanserin Medicine 09 January 2018 Extended indication Hallucinations and delusions associated with Parkinson's disease. Therapeutic value Possible equal value Total cost Registration phase Unknown Product Active substance Pimavanserin Domain Neurological disorders Reason of inclusion Main indication Parkinson's Extended indication Hallucinations and delusions associated with Parkinson's disease. Current proprietary name Already available biosimilars / generics Proprietary name Nuplazid Manufacturer Acadia Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Werkingsmechanisme: 'Selective serotonin 5-HT2A inverse agonist'. Hierbij is de claim dat het geen effect heeft op D2-receporen. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Nuplazid is in april 2016 geregistreerd door FDA. Therapeutic value Current treatment options Clozapine of Quetiapine. Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Het is nog onduidelijk wat de toegevoegde waarde is t.o.v. Clozapine en Quetiapine. Een mogelijke gelijke waarde lijkt te veronderstellen met de huidige informatie Duration of treatment Frequency of administration 1 times a day Dosage per administration 34 mg References Cummings J. et al. Lancet. 2014 Feb 8;383(9916):533-40. doi: 10.1016/S0140-6736(13)62106-6. Bozymski KM et al.Ann Pharmacother. 2017 Jun;51(6):479-487. doi: 10.1177/1060028017693029. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207318lbl.pdf, DUITS JH. et al.Tijdschr Psychiatr. 2017;59(9):528-536. 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 € 25,000.00 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 Gemiddeld in de VS $2,478.21 voor 60 tabletten van 17mg. $29.738,52 p.p.p.j. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Yes Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Indicatie-uitbreiding: andere psychose gerelateerd aan dementie of neuropsychiatrische beelden References Clinicaltrials.gov. Additional remarks Other information Additional remarks