Extended indication

Extension of indication in combination with ipilimumab to include treatment of adult patients with m

Therapeutic value

No estimate possible yet

Total cost

6,350,000.00

Registration phase

Registered

Product

Active substance

Nivolumab

Domain

Oncology and Hematology

Reason of inclusion

Indication extension

Main indication

Colon cancer

Extended indication

Extension of indication in combination with ipilimumab to include treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer (CRC) for combination treatment with Opdivo and Yervoy;

Proprietary name

Opdivo

Manufacturer

BMS

Mechanism of action

PD-1 / PD-L1 inhibitor

Route of administration

Intravenous

Therapeutical formulation

Intravenous drip

Budgetting framework

Intermural (MSZ)

Registration

Registration route

Centralised (EMA)

Submission date

December 2020

Expected Registration

June 2021

Orphan drug

No

Registration phase

Registered

Additional comments
Positieve CHMP-opinie in mei 2021. Voor nivolumab is er een financieel arrangement afgesloten met het Ministerie van VWS (lopend tot 1 januari 2024). Het verlengde financieel arrangement voor nivolumab heeft mede betrekking op alle (toekomstige) bewezen effectieve indicaties van nivolumab.

Therapeutic value

Therapeutic value

No estimate possible yet

Substantiation

Op dit moment loopt de fase 3 studie nog. De fase 2 data is gepubliceerd in 2018. Hierin werd geconcludeerd dat nivolumab plus ipilimumab mogelijk effectiever is dan monotherapie.

Frequency of administration

2 times every 2 weeks

Dosage per administration

3mg/kg

References
J Clin Oncol 2018 Mar 10;36(8):773-779; NCT02060188

Expected patient volume per year

Patient volume

127

Market share is generally not included unless otherwise stated.

References
NKR 2018; Poynter et al. Cancer Epidemiol Biomarkers Prev. 2008 Nov;17(11):3208-15.; Zhaohui Jin. Prognostic and Predictive Values of Mismatch Repair Deficiency in Non-Metastatic Colorectal Cancer. Cancers 2021.
Additional comments
In 2018 waren er 1.929 patiënten met een coloncarcinoom en 622 patiënten met een rectum carcinoom in stadium 4. Dit zijn in totaal 2.551 patiënten. Er wordt verwacht dat ongeveer 5% hiervan in aanmerking zal komen voor behandeling. Dit betekent dat er naar verwachting 127 patiënten per jaar behandeld zullen worden.

Expected cost per patient per year

Cost

40,000.00 - 60,000.00

References
G-standaard
Additional comments
Nivolumab 10mg/ml flacon, 4 ml (40mg): €405,03; Nivolumab 10mg/ml flacon, 10ml (100mg): €1.012,56; Nivolumab 10mg/ml flacon, 24ml (240mg): €2.430,15; Z-index, 1 april 2021, exclusief btw. Prijs is ingeschat in lijn met andere indicaties. Voor alle indicatie van nivolumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis lopend tot 1 januari 2024.

Potential total cost per year

Total cost

6,350,000.00

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.