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

Registered

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

Registered

Additional comments
Positieve CHMP-opinie (september 2021).

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.