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Abicipar

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)
Manufacturer Allergan
Route of administration Intravitreal
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks Vascular endothelial growth factor A (VEGF-A) inhibitor, based on proprietary Designed Ankyrin Repeat Protein (DARPin®) technology.

Registration

Registration route Centralised (EMA)
Submission date 2019
Expected Registration 2020
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Aflibercept, ranibizumab, bevacizumab (en in de toekomst: brolucizumab)
Therapeutic value Possible equal value
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.
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.
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
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

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.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.