Extended indication Advanced Hepatocellular Carcinoma
Therapeutic value No judgement
Total cost 7,900,000.00
Registration phase Registration application pending

Product

Active substance Cabozantinib
Domain Oncology and Hematology
Main indication Liver cancer
Extended indication Advanced Hepatocellular Carcinoma
Proprietary name Cabometyx / Cometriq
Manufacturer Ipsen
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks Inhibitor of specific receptor tyrosine kinases.

Registration

Registration route Centralised (EMA)
Particularity Indication extension
Submission date March 2018
Expected Registration November 2018
Orphan drug No
Registration phase Registration application pending
Additional remarks Scrip pipeline watch 19 januari 2018: Updated Phase III Results. CELESTIAL; improved overall survival, PFS.

Therapeutic value

Current treatment options Sorafenib
Therapeutic value No judgement
Frequency of administration 1 times a day
Dosage per administration 60 mg
References NCT01908426

Expected patient volume per year

Patient volume

< 158

Market share is generally not included unless otherwise stated.

References NKR
Additional remarks Totaal aantal patiënten in 2016 met hepatocellulair carcinoom stadium 4 betreft 158.

Expected cost per patient per year

Cost 50,000.00
References Medicijnkosten.nl; Farmacotherapeutisch Kompas
Additional remarks Inschatting op basis van kosten SORAFENIB TABLET 200MG (€ 34,80) en behandelschema FK. Kosten van Cabozantinib 6784 euro voor 30 stuks (20MG / 40 MG / 60 MG).

Potential total cost per year

Total cost

7,900,000.00

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

Indication extension Yes
Indication extensions Prostate Cancer, Carcinoid Tumor
References Clinicaltrials.gov

Other information

There is currently no futher information available.