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Lenvatinib

Lenvima

Extended indication Lenvima is indicated as monotherapy for the treatment of adult patients with advanced or unresectabl
Therapeutic value Possible equal value
Total cost 5,372,000.00
Registration phase Registered and reimbursed

Product

Active substance Lenvatinib
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Liver cancer
Extended indication Lenvima is indicated as monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy
Proprietary name Lenvima
Manufacturer Eisai
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date July 2017
Expected Registration September 2018
Registration phase Registered and reimbursed
Additional remarks Positieve opinie juni 2018. Geregistreerd in augustus 2018.

Therapeutic value

Current treatment options Sorafenib
Therapeutic value Possible equal value
Substantiation Non-inferior versus sorafenib
Duration of treatment Median 5.7 month / months
Frequency of administration 1 times a day
Dosage per administration 12 mg
References Kudo et al. Lancet. 2018 Mar 24;391(10126):1163-1173.

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. Zal de competitie aan moeten gaan met sorafenib.

Expected cost per patient per year

Cost 34,000.00
References Medicijnkosten.nl
Additional remarks 12 mg (3 maal een tablet van 4 mg) kost €195,08. Bij een behandelduur van 5,7 maanden resulteert dit in €33.359,27 per patiënt per jaar.

Potential total cost per year

Total cost

5,372,000.00

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.