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Serplulimab

Extended indication Treatment of extensive-stage small cell lung cancer (ES-SCLC)
Therapeutic value No estimate possible yet
Total cost 27,000,000.00
Registration phase Registration application pending

Product

Active substance Serplulimab
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Lung cancer
Extended indication Treatment of extensive-stage small cell lung cancer (ES-SCLC)
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 April 2024
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet
Frequency of administration 1 times every 3 weeks
Dosage per administration 300 mg
References NCT05353257

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 patientvolume is sterk afhankelijk van precieze indicatie. De inschatting is dat er uiteindelijk 500-700 patiënten in aanmerking kunnen komen voor deze behandeling.

Expected cost per patient per year

Cost 30,000.00 - 60,000.00
References GIP-databank, Horizonscan
Additional remarks Gegeven de andere PD1 remmers binnen dit indicatiegebied is de verwachting dat de kosten 30.000-60.000 euro pppj 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.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Fase 3: Oesophageal cancer Gastric cancer Colorectal cancer Cervical cancer
References Adis Insight, Clinicaltrials.gov

Other information

There is currently no futher information available.