Nivolumab

Extended indication	Opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy
Therapeutic value	No estimate possible yet
Total cost	23,550,000.00
Registration phase	Registered and reimbursed

Product

Active substance	Nivolumab
Domain	Oncology
Reason of inclusion	Indication extension
Main indication	Oncology other
Extended indication	Opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy
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	January 2021
Expected Registration	July 2021
Orphan drug	No
Registration phase	Registered and reimbursed
Additional remarks	Positieve CHMP-opinie in juni 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

Current treatment options	De mediane follow-up tijd was 24,4 maanden onder de 532 patiënten die nivolumab toegediend kregen, de mediane ziektevrije overleving was 22,4 maanden, ten opzichte van 11 maanden onder de 262 patiënten die placebo kregen.
Therapeutic value	No estimate possible yet
References	CheckMate 577 (NCT027434940)

Expected patient volume per year

Patient volume	< 471 Market share is generally not included unless otherwise stated.
References	NKR
Additional remarks	In 2019 waren er 471 patiënten met slokdarm- of GEJ/cardia carcinoom die neo-adjuvante chemoradiatie en chirurgische resectie hebben ondergaan en residuele ziekte (gedefinieerd als geen ypT0 en ypN0) hadden.

Patient volume

< 471

Market share is generally not included unless otherwise stated.

References

NKR

Additional remarks

In 2019 waren er 471 patiënten met slokdarm- of GEJ/cardia carcinoom die neo-adjuvante chemoradiatie en chirurgische resectie hebben ondergaan en residuele ziekte (gedefinieerd als geen ypT0 en ypN0) hadden.

Expected cost per patient per year

Cost	40,000.00 - 60,000.00
References	Horizonscan Geneesmiddelen.
Additional remarks	Kosten verwacht in lijn met andere indicaties van nivolumab.

Potential total cost per year

Total cost	23,550,000.00 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.

Total cost

23,550,000.00

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.