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 overall survival 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.