Extended indication Libtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or met
Therapeutic value No estimate possible yet
Total cost 910,000.00
Registration phase Positive CHMP opinion


Active substance Cemiplimab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Skin cancer
Extended indication Libtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (laBCC or mBCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI).
Proprietary name Libtayo
Manufacturer Sanofi
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments PD-1 receptor antagonist


Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date September 2020
Expected Registration July 2021
Orphan drug No
Registration phase Positive CHMP opinion
Additional comments Positieve CHMP-opinie in mei 2021.

Therapeutic value

Current treatment options Geen geregistreerde behandeling voorhanden in tweedelijn na hedgehog inhibitor therapie.
Therapeutic value No estimate possible yet
Frequency of administration 1 times every 3 weeks
References NCT03132636

Expected patient volume per year

Patient volume


Market share is generally not included unless otherwise stated.

References Oncoline; De Freitas et al. Case Rep Med. 2017; 2017: 8929745. Basset-Seguin et al EJC 2017;86:334-348
Additional comments In 2017 zijn 480.000 mensen in Nederland gediagnosticeerd met een basaalcelcarcinoom (BCC) van de huid. Het BCC metastaseert zelden, schattingen lopen uiteen van 0,0028%-0,55%. Deze patiënten komen in aanmerking voor de hedgehog inhibitor vismodegib. Dit zijn ongeveer 20 patiënten per jaar. Een deel daarvan is/wordt resistent tegen vismodegib en zou dan in aanmerking kunnen komen voor cemiplimab. In de literatuur is de schatting dat de responsrate voor locally advanced BCC 68.5% is en voor metastatic BCC 36.8%. Gemiddeld komt dat neer op 50% wat 10 patiënten zou betekenen.

Expected cost per patient per year

Cost 91,000.00
References Lijstprijs op basis van G-standaard.
Additional comments Verwachte prijs in lijn met andere PD-1(L)-receptor antagonisten.

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 Cervixcarcinoom, niet kleincellig longcarcinoom (NSCLC)
References Sanofi.com

Other information

There is currently no futher information available.