Version 5

Enfortumab vedotin

Medicine

Extended indication Enfortumab vedotin in combination with pembrolizumab indicated for the first-line treatment of unresectable or metastatic urothelial carcinoma in adu
Therapeutic value Possible added value
Registration phase Registered

Product

Active substance Enfortumab vedotin
Domain Oncology
Reason of inclusion Indication extension IND
Main indication Bladder cancer
Extended indication Enfortumab vedotin in combination with pembrolizumab indicated for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults who are eligible for platinum-containing chemotherapy.
Proprietary name PADCEV
Manufacturer Astellas
Portfolio holder Astellas
Mechanism of action Antibody-drug conjugate
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Unknown
Particularity Unknown
ATMP No
Submission date January 2024
Expected Registration September 2024
Orphan drug No
Registration phase Registered
Additional remarks Positieve CHMP opinie juli 2024 en EC decision in augustus 2024. Deze indicatieuitbreiding voldoet aan het sluiscriterium van meer dan €20.000.000 per jaar. Zorginstituut Nederland beoordeelt of enfortumab vedotin (Padcev®) in combinatie met pembrolizumab (Keytruda®) vergoed kan worden. Start beoordeling dossier in maart 2025.

Therapeutic value

Current treatment options Platinum-based chemotherapy and/or checkpoint inhibitor (PDL-1 positive).
Therapeutic value Possible added value

This assessment does not indicate any potential inclusion in the package.
Substantiation Het geneesmiddel is geregistreerd voor de eerstelijnsbehandeling van gemetastaseerd urotheelcarcinoom. Overall survival: (median, 31.5 months versus 16.1 months; hazard ratio for death, 0.47; 95% CI, 0.38 to 0.58; P<0.001). Voldoet daarmee aan PASKWIL-criteria.
Frequency of administration 2 times every 3 weeks
References NCT04223856 (EV-302); Powles et al. N Engl J Med. 2024.

Expected patient volume per year

Patient volume < 713

Market share is generally not included unless otherwise stated.
References NKR2021 (1);
Additional remarks In 2021 waren er 754 patiënten met een stadium 3 en 459 patiënten met een stadium 4 carcinoom. In totaal 1.213 patiënten. In dat jaar zijn 713 patiënten behandeld met chemotherapie. (1)

Expected cost per patient per year

References medicijnkosten.nl
Additional remarks Padcev infusiepoeder flacon 20mg enfortumab vedotine Astellas Pharma €707,05 per stuk (inclusief BTW). Padcev infusiepoeder flacon 30mg enfortumab vedotine Astellas Pharma €1.060,57 per stuk (inclusief BTW).

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Yes
Indication extensions MIBC
References fabrikant

Other information