Serplulimab

Extended indication	Serplulimab in combination with carboplatin-etoposide for first line treatment of small cell lung cancer extensive stage in adults and elderly.
Therapeutic value	No estimate possible yet
Total cost	27,000,000.00
Registration phase	Positive CHMP opinion

Product

Active substance	Serplulimab
Domain	Oncology
Reason of inclusion	New medicine (specialité)
Main indication	Lung cancer
Extended indication	Serplulimab in combination with carboplatin-etoposide for first line treatment of small cell lung cancer extensive stage in adults and elderly.
Manufacturer	Shanghai Henlius Biotech
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)
Type of trajectory	Normal trajectory
ATMP	No
Submission date	March 2023
Expected Registration	January 2025
Orphan drug	Yes
Registration phase	Positive CHMP opinion
Additional remarks	EMA-indiening in maart 2023. Positieve CHMP-opinie in september 2024.

Therapeutic value

Current treatment options	Chemotherapie
Therapeutic value	No estimate possible yet
Substantiation	Er is nog enkel data van uit een interim analyse bij 12 maanden beschikbaar. De HR van de algehele overleving was 0,63. Verdere resultaten moeten nog afgewacht worden.
References	NCT04063163 (ASTRUM-005); NCT05468489 (ASTRIDE)

Expected patient volume per year

Patient volume	500 - 700 Market share is generally not included unless otherwise stated.
References	IKNL, expert opinie
Additional remarks	In 2020 werden er 1.157 diagnoses stadium 4 SCLC geregistreerd. Inschatting patiëntvolume is sterk afhankelijk van precieze indicatie. De inschatting is dat er uiteindelijk 500 tot 700 patiënten in aanmerking kunnen komen voor deze behandeling.

Patient volume

500 - 700

Market share is generally not included unless otherwise stated.

References

IKNL, expert opinie

Additional remarks

In 2020 werden er 1.157 diagnoses stadium 4 SCLC geregistreerd. Inschatting patiëntvolume is sterk afhankelijk van precieze indicatie. De inschatting is dat er uiteindelijk 500 tot 700 patiënten in aanmerking kunnen komen voor deze behandeling.

Expected cost per patient per year

Cost	30,000.00 - 60,000.00
References	GIPdatabank, Horizonscan
Additional remarks	Gegeven de andere PD1-remmers binnen dit indicatiegebied is de verwachting dat de kosten €30.000 tot €60.000 per patiënt per jaar zullen bedragen.

Potential total cost per year

Total cost	27,000,000.00 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

27,000,000.00

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.