Expand all sections

Cemiplimab

Libtayo

Extended indication Monotherapy treatment of adult patients with metastatic or locally advanced cutaneous squamous cell
Therapeutic value Possible added value
Total cost € 5,000,000.00
Registration phase Registered

Product

Active substance Cemiplimab
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Skin cancer
Extended indication Monotherapy treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.
Proprietary name Libtayo
Manufacturer Sanofi
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Concentrate for solution for infusion
Budgetting framework Intermural (MSZ)
Additional comments PD-1 receptor antagonist

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date March 2018
Expected Registration June 2019
Orphan drug No
Registration phase Registered
Additional comments Positieve CHMP-opinie april 2019. Geregistreerd in juni 2019.

Therapeutic value

Current treatment options Chemotherapie met cisplatin en (continue) 5FU.
Therapeutic value Possible added value
Substantiation Chemotherapie met cisplatin en (continue) 5FU is het alternatief en dat is beperkt effectief en behoorlijk toxisch. Wel is de vraag of het veilig toegediend kan worden gezien plaveiselcelcarcinoom vaak voorkomt bij orgaantransplantatiepatiënten.
Duration of treatment Median 32.7 week / weeks
Frequency of administration 1 times every 2 weeks
Dosage per administration 3 mg/kg
References Migden MR, Rischin D, Schmults CD, et al. PD-1 blockade with cemiplimab in advanced cutaneous squamous-cell carcinoma. N Engl J Med.
Additional comments Fase II studie loopt nog. Bovenstaande gegevens komen uit het gemetastaseerd cohort patiënten met Q2W 3 mg/kg schema. Naast dit cohort ook nog een tweede cohort in lokaalgevorderde patiënten (3 mg/kg Q2W) en een derde cohort in gemetastaseerde patiënten met een ander doseringsschema (350 mg driewekelijks, fixed dose).

Expected patient volume per year

Patient volume

< 100

Market share is generally not included unless otherwise stated.
References Fabrikant; Hollestein et al. European Journal of Cancer (2012) 48, 2.046-2.053; Roozeboom et al. Acta Derm Venereol (2013) 93, 417-421; NKR.
Additional comments Schatting van het patiëntenaantal geschikt voor behandeling met een anti-PD1 in deze indicatie: 100 patiënten.

Expected cost per patient per year

Cost € 40,000.00 - € 60,000.00
References Fabrikant
Additional comments Prijs in lijn met andere PD-1(L)-receptor antagonisten.

Potential total cost per year

Total cost

€ 5,000,000.00

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

Off label use No

Indication extension

Indication extension Yes
Indication extensions Niet kleincellig longcarcinoom (NSCLC), cervixcarcinoom, lymfomen.
References Fabrikant

Other information

There is currently no futher information available.