Abicipar Medicine 13 December 2018 Extended indication Neovascular (wet) age-related macular degeneration (AMD) Therapeutic value Possible equal value Total cost € 11,400,000.00 Registration phase Clinical trials Product Active substance Abicipar Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Eye disorders Extended indication Neovascular (wet) age-related macular degeneration (AMD) Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Allergan Portfolio holder Mechanism of action Unknown Route of administration Intravitreal Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Vascular endothelial growth factor A (VEGF-A) inhibitor, based on proprietary Designed Ankyrin Repeat Protein (DARPin®) technology. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2019 Expected Registration 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Aflibercept, ranibizumab, bevacizumab (en in de toekomst: brolucizumab) Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Abicipar heeft veel bijwerkingen, de vraag is of het geregistreerd gaat worden. Primaire eindpunten zijn gehaald in een non-inferiority studie in vergelijking met ranibizumab. Duration of treatment Frequency of administration Dosage per administration 2 mg References NCT02462928, NCT02462486 Additional remarks In klinische studies wordt het volgende behandelschema aangehouden: "Abicipar pegol 2 mg administered to the study eye by intravitreal injection on day 1, week 4, and week 8, followed by injections every 8 weeks through week 96. A sham procedure to the study eye will be performed every 4th week that an injection of abicipar pegol is not performed." & "Abicipar pegol 2 mg administered to the study eye by intravitreal injection on day 1, week 4, and week 12, followed by injections every 12 weeks through week 96. A sham procedure to the study eye will be performed every 4th week that an injection of abicipar pegol is not performed." Expected patient volume per year Patient volume 640 - 2,400 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References volksgezondheidenzorg.nl; Incidence of Late-Stage Age-Related Macular Degeneration in American Whites: Systematic Review and Meta-analysis; AJO 2015, Opendis data, NZa Additional remarks Incidentie en prevalentie cijfers wisselen sterk. De gerefereerde studie beschrijft een incidentie van 1,8 op 1.000, dit komt overeen met 30.000 patiënten in Nederland. In totaal ongeveer 24.000 patiënten bekend bij de huisarts. Incidentie: 6.400 nieuwe patiënten per jaar met AMD. Gezien het gaat om natte AMD, komen er maximaal 640-2.400 patiënten in aanmerking voor deze behandeling. In 2016 hebben ong. 60.000 patiënten intravitreale injecties gehad, voor alle indicaties (dus AMD, DME , RVO en andere (kleinere) indicaties). 14.000 patiënten hebben Lucentis of Eylea gehad in 2016. Afhankelijk van de waarde t.o.v. deze bestaande middelen zal een deel van deze patiënten abicipar gaan krijgen. Expected cost per patient per year Cost € 5,000.00 - 10,000.00 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 Additional remarks Prijs per patient per jaar verwacht vergelijkbaar met Brolucizumab (5.000 - 10.000 euro). Potential total cost per year Total cost € 11,400,000.00 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