Version 3

Cemiplimab

Medicine

Extended indication Monotherapy treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surg
Therapeutic value Possible added value
Total cost € 5,000,000.00
Registration phase Positive CHMP opinion

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 remarks PD-1 receptor antagonist

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Unknown
ATMP Unknown
Submission date March 2018
Expected Registration June 2019
Orphan drug No
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP-opinie april 2019.

Therapeutic value

Current treatment options chemotherapie met cisplatin en (continue) 5FU
Therapeutic value Possible added value

This assessment does not indicate any potential inclusion in the package.
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 remarks 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, 2046-2053; Roozeboom et al. Acta Derm Venereol (2013) 93, 417-421; NKR.
Additional remarks 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

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.
References Fabrikant
Additional remarks Prijs in lijn met andere PD-1(L)-receptor antagonisten.

Potential total cost per year

Total cost € 5,000,000.00

Off label use

Off label use No

Indication extension

Indication extensions Yes
Indication extensions Basaalcelcarcinoom van de huid (cBCC), niet kleincellig longcarcinoom (NSCLC), cervixcarcinoom, lymfomen
References Fabrikant

Other information