Extended indication LIBTAYO as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic
Therapeutic value Possible added value
Total cost 7,280,000.00
Registration phase Registered

Product

Active substance Cemiplimab
Domain Oncology
Reason of inclusion Indication extension
Main indication Cervical cancer
Extended indication LIBTAYO as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.
Proprietary name Libtayo
Manufacturer Sanofi
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Infusion fluid
Budgetting framework Intermural (MSZ)
Additional comments PD-1 receptor antagonist

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date November 2021
Expected Registration November 2022
Orphan drug No
Registration phase Registered
Additional comments Positieve CHMP opinie ontvangen oktober 2022.

Therapeutic value

Current treatment options Bevacizumab, chemotherapie.
Therapeutic value Possible added value
Substantiation De resultaten uit het artikel in de NEJM 2022 voldoen aan de PASKWIL criteria van CieBOM. In de populatie patiënten was de mediane algehele overleving langer in de cemiplimab groep dan in de chemotherapie groep (12,0 maanden versus 8,5 maanden; hz, 0.69; 95% confidence interval [CI], 0.56 to 0.84; two-sided P<0.001).
Frequency of administration 1 times every 3 weeks
Dosage per administration 350 mg
References NCT03257267

Expected patient volume per year

Patient volume

< 80

Market share is generally not included unless otherwise stated.

References NKR 2020(1); Expert opinie(2);
Additional comments Het cervixcarcinoom wordt in Nederland in 2020 bij ongeveer 806 vrouwen vastgesteld. Er wordt verwacht dat er 70-80 patiënten in aanmerking zullen komen voor eerstelijnsbehandeling met pembrolizumab in combinatie met chemo(2). Voor de tweedelijns monotherapie cemiplimab komt hierdoor naar verwachting een deel van deze groep in aanmerking.

Expected cost per patient per year

Cost 91,000.00
References Lijstprijs zoals vermeld in de G-Standaard van Z-Index
Additional comments 1 maal per 3 weken €5.721,10 inclusief btw dus €5.248,72 exclusief btw. Uitgaande van een heel behandeljaar zouden de kosten maximaal zo'n €91.000 betreffen.

Potential total cost per year

Total cost

7,280,000.00

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 NSCLC
References Fabrikant

Other information

There is currently no futher information available.