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Lutetium (177lu) vipivotide tetraxetan

Pluvicto

Extended indication

Pluvicto in combination with androgen deprivation therapy (ADT) with or without androgen receptor (A

Therapeutic value

Possible equal value
Total cost

123,000,000.00
Registration phase

Registered

Product

Active substance

Lutetium (177lu) vipivotide tetraxetan
Domain

Oncology
Reason of inclusion

New medicine (specialité)
Main indication

Prostate cancer
Extended indication

Pluvicto in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition is indicated for the treatment of adult patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with AR pathway inhibition and taxane based chemotherapy.
Proprietary name

Pluvicto
Manufacturer

Advanced Accelerator Applications
Portfolio holder

Novartis
Mechanism of action

Other
Route of administration

Intravenous
Therapeutical formulation

Injection
Budgetting framework

Intermural (MSZ)
Additional remarks 
Mechanism of Action (MoA) is Radio Ligand Therapy (RLT).

Registration

Registration route

Centralised (EMA)
Type of trajectory

Normal trajectory
ATMP

No
Submission date

October 2021
Expected Registration

December 2022
Orphan drug

No
Registration phase

Registered
Additional remarks 
Positieve CHMP opinie ontvangen oktober 2022. 

Met deze wijziging van de Regeling zorgverzekering is  lutetium (177Lu) vipivotide tetraxetan (merknaam: Pluvicto) in de sluis geplaatst.

Therapeutic value

Current treatment options

mCRPC (Metastatic disease treatment) treatments currently available in third line and beyond: abiraterone acetate, enzalutamide, radium-233 dichloride, cabazitaxel.
Therapeutic value

Possible equal value
Substantiation

Resultaten van de VISION trial laten zien dat door behandeling met 177Lu-PSMA de OS en PFS significant verbeteren. Hierdoor is de verwachting dat er een positief CieBOM advies zal volgen. 177Lu-PSMA kan momenteel zelf door ziekenhuizen bereid worden.
Duration of treatment

Median 7 month / months
Frequency of administration

1 times every 6 weeks
Dosage per administration

7.4GBq (200 mCi)
References 
NCT03392428; NCT03511664.
Sartor et al; NEJM DOI: 10.1056/NEJMoa2107322
Additional remarks 
De mediane behandelduur met Pluvcito is 6,9 maanden.
Vision posology study dose was 7.4 GBq +/- 10%.

Expected patient volume per year

Patient volume

1,193 - 1,267

Market share is generally not included unless otherwise stated.
References 
(1) IKNL data 2019 ; (2) Sartor et al 2021 NEJM (3) Hofman et al 2021 Lancet
Additional remarks 
In 2019 waren er 13.557 patiënten waarbij prostaatkanker werd geconstateerd (1). Van deze groep behoorden 4.474 mannen tot de palliatieve setting. Van deze groep behoort ongeveer 33% tot de hoog risico gemetastaseerde setting. Dit komt overeen met 1.491 mannen. Uit literatuur blijkt dat 80% tot 85% van deze groep voldoende PSMA expressie heeft om de behandeling effectief te laten zijn (2,3). Dat zijn 1.193 tot 1.267 mannen.

Expected cost per patient per year

Cost

100,000.00
References 
Fabrikant
Additional remarks 
Fabrikant geeft aan dat de kosten per vial €20.000 bedragen. Per behandeling wordt1 vial volledig gebruikt, want de behandeling wordt per patiënt bereid. De mediane behandelduur staat gelijk aan 5 behandelingen waarmee de prijs per patiënt neerkomt op €100.000.

Potential total cost per year

Total cost

123,000,000.00

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

There is currently nothing known about off label use.

Indication extension

Indication extension

Yes
Indication extensions

1) PSMAfore 2) PSMAddition
References 
1)  NCT04689828
2)  NCT04720157

Other information

There is currently no futher information available.