Extended indication Cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults
Therapeutic value Possible added value
Total cost 3,950,000.00
Registration phase Registered and reimbursed

Product

Active substance Cabozantinib
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Liver cancer
Extended indication Cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.
Proprietary name Cabometyx
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)
Submission date March 2018
Expected Registration November 2018
Orphan drug No
Registration phase Registered and reimbursed
Additional remarks Scrip pipeline watch 19 januari 2018: Updated Phase III Results. CELESTIAL; improved overall survival, PFS. Positieve CHMP-opinie september 2018. Geregistreerd in november 2018.

Therapeutic value

Current treatment options Sorafenib
Therapeutic value Possible added value
Substantiation Langere OS en PFS versus placebo na resistentie tegen sorafenib.
Duration of treatment Average 3.8 month / months
Frequency of administration 1 times a day
Dosage per administration 60 mg
References NCT01908426; Abou-Alfa et al. N Engl J Med. 2018 Jul 5;379(1):54-63

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 25,000.00
References Medicijnkosten.nl; Farmacotherapeutisch Kompas
Additional remarks Op basis van de gemiddelde behandelduur van 3,8 maanden zal de patiënt gemiddeld 114 tabletten verbruiken. Dit komt neer op een totaal van €24.320 per patiënt per jaar.

Potential total cost per year

Total cost

3,950,000.00

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.