Sugemalimab

Extended indication	Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma.
Therapeutic value	No estimate possible yet
Total cost	24,575,000.00
Registration phase	Clinical trials

Product

Active substance	Sugemalimab
Domain	Oncology
Reason of inclusion	Indication extension
Main indication	Oncology other
Extended indication	Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma.
Manufacturer	CStone
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)
ATMP	No
Submission date	2025
Expected Registration	2026
Orphan drug	No
Registration phase	Clinical trials
Additional remarks	In mei 2024 is geadviseerd aan VWS om sugemalimab in de sluis te plaatsen, voor zover verstrekt in het kader van geneeskundige behandelingen.

Therapeutic value

Current treatment options	Pdl-1 remmers.
Therapeutic value	No estimate possible yet
Substantiation	Er zijn nog geen resultaten bekend.
Frequency of administration	1 times every 3 weeks
Dosage per administration	1200mg
References	NCT04187352

Expected patient volume per year

Patient volume	447 - 536 Market share is generally not included unless otherwise stated.
References	NKR2021; Epidemiology of Esophageal Squamous Cell Carcinoma. Christian C. Abnet.;
Additional remarks	In 2021 zijn in Nederland 1.787 patiënten met stadium 3 en 4 slokdarmkanker gediagnosticeerd. In ongeveer 25 tot 30% van de gevallen zal het een plaveisel carcinoom betreffen.

Patient volume

447 - 536

Market share is generally not included unless otherwise stated.

References

NKR2021; Epidemiology of Esophageal Squamous Cell Carcinoma. Christian C. Abnet.;

Additional remarks

In 2021 zijn in Nederland 1.787 patiënten met stadium 3 en 4 slokdarmkanker gediagnosticeerd. In ongeveer 25 tot 30% van de gevallen zal het een plaveisel carcinoom betreffen.

Expected cost per patient per year

Cost	40,000.00 - 60,000.00
Additional remarks	Afhankelijk van de studieresultaten wordt er verwacht dat de kosten van deze behandeling in lijn liggen met andere PD-L1 remmers

Potential total cost per year

Total cost	24,575,000.00 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

24,575,000.00

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.