Version 1

Avelumab

Medicine

Extended indication Treatment of adult patients with ovarian cancer (OC) 2L/1L.
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Avelumab
Domain Oncology and Hematology
Main indication Ovarian cancer
Extended indication Treatment of adult patients with ovarian cancer (OC) 2L/1L.
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
Additional remarks Indicatie-uitbreiding

Therapeutic value

Current treatment options Bevacizumab
Therapeutic value No judgement

This assessment does not indicate any potential inclusion in the package.
Substantiation De fase III studie Javelin Ovarian 200 wordt uitgevoerd. Nog geen resultaten bekend.
Frequency of administration 2 times a month
Dosage per administration 182 mg
References NCT02718417
Additional remarks 1 keer per 2 weken behandeling met Avelumab als monotherapie, en 1 keer per 3 weken in combinatie met Paclitaxel en carboplatin.

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.
References NKR
Additional remarks Totaal aantal patientien met eierstok en eileiderkanker betreft volgens NKR 2016: 1717, gezien alleen epitheliale eierstokkanker wordt geincludeerd in de studie zal het gaan om maximaal 1096 patienten die in aanmerking zouden komen voor de behandeling. Hiervan valt nog een deel van de patienten af gezien het alleen om platinum resistant/refractory patienten gaat.

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 patient jaar (kosten op basis van 1 jaar behandeling 1x per 3 weken voor een patient van 70 kg en de prijs € 327,40 voor 25 mg/ml fl 4 ml).

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Yes
Indication extensions 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 Treatment of adult patients with renal cell carcinoma (RCC) 1L. Advanced, unresectable, in combination with axitinib.
References SPS

Other information