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Avelumab

Medicine

Extended indication Treatment of adult patients with renal cell carcinoma (RCC) 1L. Advanced, unresectable, in combination with axitinib.
Therapeutic value No judgement yet
Total cost € 33,900,000.00
Registration phase Clinical trials

Product

Active substance Avelumab
Domain Oncology and Hematology
Main indication Kidney cancer
Extended indication Treatment of adult patients with renal cell carcinoma (RCC) 1L. Advanced, unresectable, in combination with axitinib.
Proprietary name Bavencio
Manufacturer Merck
Mechanism of action Unknown
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Monoklonaal anitlichaam anti PD-L1. Betreft een samenwerking tussen Merck en Pfizer.

Registration

Registration route Centralised (EMA)
Type of trajectory Unknown
Particularity Indication extension
ATMP Unknown
Submission date 2018
Expected Registration 2019
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Bevacizumab
Therapeutic value No judgement yet

This assessment does not indicate any potential inclusion in the package.
Frequency of administration 1 times every 2 weeks
Dosage per administration 10 mg/kg
Additional remarks 1 keer per 2 weken behandeling met Avelumab

Expected patient volume per year

Patient volume < 565

Market share is generally not included unless otherwise stated.
References NKR
Additional remarks 565 patiënten in 2016 gediagnosticeerd met stadium 4 niercarcinoom. Een deel hiervan zal in aanmerking komen voor een behandeling.

Expected cost per patient per year

Cost € 60,000.00

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.
References Medicijnkosten.nl
Additional remarks €979,72 per 20 mg/ml voor 10 ml flacon. Vergelijkbare behandeling: bevacizumab maximaal 60.000 euro per patiënt per jaar (kosten op basis van 1 jaar behandeling 1x per 2 weken voor een patiënt van 70 kg en de prijs €327,40 voor 25 mg/ml fl 4 ml).

Potential total cost per year

Total cost € 33,900,000.00

Off label use

Off label use Unknown

Indication extension

Indication extensions Yes
Indication extensions Ovarian cancer, Urothelial cancer, unresectable locally advanced or metastatic transitional cell carcinoma - second-line; Gastric cancer - first-line; Gastric cancer - third-line; Head and neck (or upper airways tract) cancers, locally advanced - first-line; Non-small cell lung cancer (NSCLC) - PD-L1-positive, first-line & second-line.
References SPS

Other information