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


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 route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date March 2023
Expected Registration September 2024
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Current treatment options Enkel chemotherapie
Therapeutic value No estimate possible yet
Substantiation Uit de fase 3 studie blijkt dat serplulimab de algehele overleving (OS) verlengt ten opzichte van enkel chemotherapie. Serplulimab is de eerste pdl-1 remmer die voor deze indicatie op de markt zal komen. De verwachting is dat de PASKWIL-criteria gehaald zullen worden.
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 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 GIP-databank, 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


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.