Extended indication Chemotherapy-Induced Neutropenia
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Efbemalenograstim alfa
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Breast cancer
Extended indication Chemotherapy-Induced Neutropenia
Manufacturer Evive Biotech
Mechanism of action Other, see general comments
Route of administration Intravenous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional comments Granulocyte colony-stimulating factor replacement.

Registration

Registration route Centralised (EMA)
Submission date 2021
Expected Registration 2022
Orphan drug No
Registration phase Clinical trials
Additional comments Verwacht indieningsdatum op basis van primary completion datum in september 2019.

Therapeutic value

Current treatment options Pegfilgrastim en lipegfilgrastim
Therapeutic value No estimate possible yet
Substantiation Op dit moment zijn er nog geen studies gepubliceerd.
Frequency of administration 2 times every 3 weeks
Dosage per administration 20 mg
References NCT03252431; persbericht Evive Biotech
Additional comments 20mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.

Expected patient volume per year

Patient volume

< 7,721

Market share is generally not included unless otherwise stated.

References GIPdatabank
Additional comments In 2019 waren er 2.650 gebruikers van pegfilgrastim en 5.071 gebruikers van lipegfilgrastim. Afhankelijk van de therapeutische waarde en plaats in de behandelrichtlijn van efbemalenograstim zal een deel van deze patiënten hiervoor in aanmerking kunnen komen.

Expected cost per patient per year

References GIPdatabank
Additional comments Voor pegfilgrastim en lipegfilgrastim werd in 2019 respectievelijk €3.452 en €3.049 per patiënt vergoed. De prijs van efbemalenograstim zal sterk afhankelijk zijn van de concurrentiepositie.

Potential total cost per year

There is currently nothing known about the possible total cost.

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.