Extended indication Extension of indication to include adjuvant treatment of adult patients with resected oesophageal, o
Therapeutic value No estimate possible yet
Total cost 23,550,000.00
Registration phase Registration application pending

Product

Active substance Nivolumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Other oncology
Extended indication Extension of indication to include adjuvant treatment of adult patients with resected oesophageal, or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy for OPDIVO.
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 October 2021
Orphan drug No
Registration phase Registration application pending
Additional comments 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 comments 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 comments 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.

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.