Version 2

Cemiplimab

Medicine

Extended indication Libtayo as monotherapy is indicated for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation.
Therapeutic value Possibly no place in the treatment regimen
Registration phase Positive CHMP opinion

Product

Active substance Cemiplimab
Domain Oncology
Reason of inclusion Indication extension IND
Main indication Skin cancer
Extended indication Libtayo as monotherapy is indicated for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation.
Proprietary name LIBTAYO
Manufacturer Regeneron
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 April 2025
Expected Registration December 2025
Orphan drug No
Registration phase Positive CHMP opinion
Medicine sluice Broadly excluded
Additional remarks Positieve CHMP-opinie in oktober 2025.

Therapeutic value

Current treatment options Geen
Therapeutic value Possibly no place in the treatment regimen

This assessment does not indicate any potential inclusion in the package.
Substantiation In de fase-III-studie C-POST bedroeg de geschatte ziektevrije overleving na 24 maanden 87,1% met cemiplimab versus 64,1% met placebo, met een hazard ratio van 0,32 (68% minder risico op recidief of overlijden), maar cemiplimab ging gepaard met meer ernstige bijwerkingen (23,9% versus 14,2%) en vaker voortijdig stoppen (9,8% versus 1,5%). Er lijken tot nu toe geen aanwijzingen te zijn voor een verbetering van de totale overleving.
References NCT03969004 (C-POST); Rischin et al. NEJM. 2025; Expertopinie

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.
Additional remarks Mogelijk is er geen plaats in de behandeling voor dit middel.

Expected cost per patient per year

References medicijnkosten.nl
Additional remarks Gemiddelde prijs per flacon Libtayo, 7ml concentraat voor oplossing voor infusie 50mg/ml is € 5.918,82.

Potential total cost per year

Off label use

Indication extension

Other information