Extended indication Monotherapy for the treatment of adult patients with Merkel Cell Carcinoma with distant metastatic d
Therapeutic value No estimate possible yet
Total cost 625,000.00
Registration phase Registration application pending

Product

Active substance Retifanlimab
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Oncology other
Extended indication Monotherapy for the treatment of adult patients with Merkel Cell Carcinoma with distant metastatic disease or recurrent advanced locoregional disease not amenable to surgery or radiation
Manufacturer Incyte
Mechanism of action Proteasome inhibitor
Route of administration Intravenous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks Retifanlimab is a humanized, anti–programmed cell death protein-1 (PD-1) monoclonal antibody

Registration

Registration route Centralised (EMA)
Type of trajectory Conditional marketing authorisation
ATMP No
Submission date March 2023
Expected Registration May 2024
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Current treatment options Chemotherapie: cisplatin of carboplatin/etoposide met of zonder RT. Nu met name avelumab bij irresectabel stadium iii-IV MCC.
Therapeutic value No estimate possible yet
Substantiation Er is enkel een inidrecte vergelijking met avelumab mogelijk. De PODIUM 201 trial liet een ORR van 52% zien voor retifanlimab. Avelumab liet een ORR van 40% zien. Daarnaast was er een complete respons % 18.5 (retifanlimab) versus16,4 (avelumab). Dit ging om chemo-naïeve MCC patiënten. Het bijwerkingenprofiel van retifanlimab is vergelijkbaar met andere anti PD (L)-1's. Een voordeel is daarnaast dat retifanlimab minder frequent toegediend hoeft te worden.
Frequency of administration 1 times a month
Dosage per administration 500 mg
References POD1UM-201: A Phase 2 Study of Retifanlimab(INCMGA00012) in Locally Advanced or Metastatic Merkel Cell Carcinoma,European Society for Medical Oncology Virtual Congress 2020 September 19–21, 2020, P1089, G. Grignani et al (Javelin-220 trial: Ott PA, et al. Ann Oncol. 2017;28:1036-41 https://clinicaltrials.gov/ct2/show/NCT03599713

Expected patient volume per year

Patient volume

10 - 15

Market share is generally not included unless otherwise stated.

References (1) A. Van Akkooi, Nederlands Tijdschrift voor Dermatologie en Venereologie | jaargang 31 | nummer 8 | september 2021; (2) IKNL2021; Expertopinie(3);
Additional remarks Incidentie MCC (alle stadia) stijgt, inmiddels circa150 tot 200 per jaar in Nederland (1). In 2021 waren er 43 diagnoses in stadium III en 10 diagnoses stadium IV. Het systemisch behandelen van MCC komt in vier centra voor en betreft 10 tot 15 incidente patiënten per jaar (3).

Expected cost per patient per year

Cost 40,000.00 - 60,000.00
Additional remarks Vergelijkbare kosten met andere PD-1 remmers. Mogelijk tussen de €40.000 en €60.000 per jaar.

Potential total cost per year

Total cost

625,000.00

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 Endometrial cancer; Non-small cell lung cancer
References Adis insight

Other information

There is currently no futher information available.