Extended indication Extension of indication to use Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum
Therapeutic value Possible added value
Total cost 19,500,000.00
Registration phase Registration application pending

Product

Active substance Nivolumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Stomach cancer
Extended indication Extension of indication to use Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-based combination chemotherapy, in first-line treatment of adult patients with advanced or metastatic gastric, gastro-oesophageal junction (GEJ) or oesophageal adenocarcinoma.
Proprietary name Opdivo
Manufacturer BMS
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intracavernous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments PD-1 antilichaam.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date December 2020
Expected Registration October 2021
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options FOLFOX of XELOX
Therapeutic value Possible added value
Substantiation In de CHECKMATE-649 studie (NCT02872116), was een verbetering van de overall survival (OS) en progressie-vrije overleving (PFS) van nivolumab/chemotherapie in vergelijking met enkel chemotherapie. Er is een verbetering van de OS aangetoond van 11,1 naar 14,4 maanden. De cieBOM zal nog een advies uitbrengen.
Frequency of administration 1 times every 2 weeks
Dosage per administration 3 mg/kg
References ASCO 2020
Additional comments Toedieningsfrequentie 1 maal per 2 weken 240mg of 1 maal per 3 weken 360mg.

Expected patient volume per year

Patient volume

< 300

Market share is generally not included unless otherwise stated.

References NKR
Additional comments In 2018 waren er 525 diagnoses stadium IV maagcarcinoom. In de studie had 60% van de patiënten een CPS score van hoger dan 5%. De verwachting is dat er maximaal 300 patiënten in aanmerking zullen komen.

Expected cost per patient per year

Cost 65,000.00
References medicijnkosten.nl
Additional comments €1.036 voor 10ml van 10mg/ml en €414,30 voor 4ml van 10mg/ml. Uitgaande van de toedieningsfrequentie zoals hierboven beschreven zou dat op jaarbasis gaan om zo'n €5.000 per patiënt per jaar. Voor alle indicaties van nivolumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis (lopend tot eind 2023).

Potential total cost per year

Total cost

19,500,000.00

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 No
References Fabrikant

Other information

There is currently no futher information available.