Extended indication Extension of Indication to include Cyramza indicated as monotherapy for the treatment of adult patie
Therapeutic value No judgement
Total cost 532,000.00
Registration phase Registration application pending

Product

Active substance Ramucirumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Liver cancer
Extended indication Extension of Indication to include Cyramza indicated as monotherapy for the treatment of adult patients with hepatocellular carcinoma who have an alpha fetoprotein (AFP) of ≥ 400 ng/mL, after prior sorafenib therapy.
Proprietary name Cyramza
Manufacturer Eli Lilly
Mechanism of action Angiogenesis inhibitor
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments Monoclonaal antilichaan gericht tegen VEGF2. Ramucirumab blokkeert de binding van VEGF aan VEGFR2 en remt zo de angiogenese.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date August 2018
Expected Registration August 2019
Orphan drug No
Registration phase Registration application pending
Additional comments Lilly geeft aan dat de indiening mid 2018 zal plaatsvinden.

Therapeutic value

Current treatment options Regorafenib
Therapeutic value No judgement
Substantiation Patiënten met AFP-High hebben een verbetering van de mediane OS van 3,1 maand.
Duration of treatment Median 3 month / months
Frequency of administration 1 times every 2 weeks
Dosage per administration 8 mg/kg
References 2018 ASCO annual meeting abstract #4003; NCT02435433; Zhu et al. Lancet Oncol. 2019 Jan 18.
Additional comments 8 mg/kg ramucirumab wordt toegediend via IV op dag 1 van iedere cyclus van 14 dagen.

Expected patient volume per year

Patient volume

20 - 50

Market share is generally not included unless otherwise stated.

References NKR
Additional comments Totaal aantal patiënten in 2016 met hepatocellulair carcinoom stadium 4 betreft 158. Verwacht wordt dat ongeveer 20-50 patiënten hiervan in de tweede lijn zullen worden behandeld.

Expected cost per patient per year

Cost 15,200.00
References Fabrikant; Zhu et al. Lancet Oncol. 2019 Feb;20(2):282-296. G-standaard
Additional comments AIP mei 2019: €453,46 voor een flacon van 100 mg. Voor een patiënt van 70 kg worden 5,6 flacons per cyclus gebruikt (€2.539,38). Het mediaan aantal cycli bedraagt 6 dus de totale kosten zijn €15.236,26.

Potential total cost per year

Total cost

532,000.00

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.