Extended indication Adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously recei
Therapeutic value No estimate possible yet
Total cost 5,904,093.75
Registration phase Registration application pending

Product

Active substance Enfortumab vedotin
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Bladder cancer
Extended indication Adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting (3L).
Proprietary name Padcev
Manufacturer Astellas
Mechanism of action Antibody-drug conjugate
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments Tubulin polymerisation inhibitor.

Registration

Registration route Centralised (EMA)
Type of trajectory Accelerated assessment
Submission date March 2021
Expected Registration December 2021
Orphan drug No
Registration phase Registration application pending
Additional comments Fabrikant verwacht registratie in december 2021. SPS UK scan: "Mar 21 · EMA accept MAA for accelerated assessment".

Therapeutic value

Current treatment options Huidige behandelopties in de derde lijn zijn chemotherapie (docetaxel, paclitaxel or vinflunine), immunotherapie (indien niet gegeven in 2e lijn), klinische studie of Best Supportive Care.
Therapeutic value No estimate possible yet
Frequency of administration 3 times every 4 weeks
References https://www.bioworld.com/articles/431921-fda-grants-accelerated-approval-for-padcev-to-treat-urothelial-cancer. NCT03474107.
Additional comments Behandelduur verwacht 4-5 maanden.

Expected patient volume per year

Patient volume

50 - 75

Market share is generally not included unless otherwise stated.

References NKR; Moderate or severe LUTS is associated with increased recurrence of non - muscle - invasive urothelial carcinoma of the bladder. Austin Lunney. Department of Urology, Texas Tech University Health Sciences Center, Lubbock, TX, USA. http://dx.doi.org/10.1590/s1677-5538.ibju.2018.0068
Additional comments In 2016 waren er in totaal 3.337 patiënten met blaascarcinoom, hiervan waren 975 patiënten gediagnosticeerd met stadium III/IV. Hiervan zullen er naar verwachting uiteindelijk ongeveer 250-500 een tweedelijns behandeling krijgen. De verwachting is dat er in derde lijn hooguit 50-75 patiënten in aanmerking zullen komen voor deze behandeling.

Expected cost per patient per year

Cost 90,358.00 - 98,573.00
References https://www.bioworld.com/articles/431921-fda-grants-accelerated-approval-for-padcev-to-treat-urothelial-cancer
Additional comments Kosten in de Verenigde Staten verwacht tussen de $110.000 en $120.000 per patiënt. Dit komt neer op een bedrag van €90.358 tot €98.573. Kosten van geneesmiddelen zijn in Europa (inclusief Nederland) over het algemeen lager dan in de Verenigde Staten.

Potential total cost per year

Total cost

5,904,093.75

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 Enfortumab Vedotin and Pembrolizumab, With or Without Chemotherapy, versus Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer (EV-302).
References NCT04223856
Additional comments 1e lijns combinatie studie, registratie verwacht medio 2024.

Other information

There is currently no futher information available.