Download opinion
Add to my selection
Quote this publication Print

PLUVICTO (lutetium (177Lu) vipivotide tetraxetan) - Prostate cancer

Opinions on drugs - Posted on May 25 2023

Reason for request

Inclusion

First assessment.

 

Key points

Favourable opinion for reimbursement “in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition 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 chemo-therapy”.

 

Role in the care pathway?

PLUVICTO (lutetium [177Lu] vipivotide tetraxetan) in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition is a third-line treatment for progressive prostate-specific membrane antigen (PSMA)-positive mCRPC, i.e. following the failure of AR pathway inhibition and taxane-based chemotherapy.


Clinical Benefit
Substantial

The clinical benefit of PLUVICTO (lutetium [177Lu] vipivotide tetraxetan) is substantial in the MA indication.

Clinical Added Value
moderate

Considering:

  • demonstration of the superiority of PLUVICTO (lutetium [177Lu] vipivotide tetraxetan) plus best standard of care versus best standard of care alone, in a randomised, open-label phase-3 study, in terms of:
    • radiographic progression-free survival with a difference in median of 5.3 months and an HR=0.4 (CI2% = [0.29; 0.57]; p < 0.001), and overall survival with a difference in median of 4 months and an HR=0.62 (CI95% = [0.52; 0.74]; p < 0.001) (alternative primary efficacy endpoints);
    • response rate of 29.8% in the experimental group versus 1.7% in the comparator group (OR = 24.99; CI95% = [6.05; 103.24]; p<0.001) and time to first symptomatic skeletal event with a difference in median of 4.7 months (HR = 0.5; CI95% = [0.4; 0.62]; p<0.001) (ranked secondary endpoints with management of the alpha risk);
  • the safety profile, which is deemed to be acceptable,

the Committee deems that PLUVICTO (lutetium [177Lu] vipivotide tetraxetan) 1,000 MBq/mL solution for injection/infusion provides a moderate clinical added value (CAV III) in the care pathway.

Avis économique

Ce produit a fait l'objet d'un avis économique rendu par la Commission d'évaluation économique et de santé publique le 18 juillet 2023. 

L’évaluation porte sur une indication superposable à l’indication de l’AMM obtenue le 09/12/2022 en procédure centralisée. 

La CEESP a été en mesure de conclure sur le niveau d’efficience du produit, avec un RDCR de 355 002 €/QALY versus cabazitaxel + BSOC, au prix de vente en vigueur et sur un horizon temporel de 5 ans.  

Au prix public de Pluvicto, et selon les parts de marchés prévisionnelles envisagées par l’industriel, la mise à disposition de Pluvicto dans la nouvelle indication revendiquée représente une augmentation des dépenses de l’assurance maladie de 147% dans cette indication, pour une population cible de 28 375 patients cumulés sur 5 ans.

> PLUVICTO - Avis économique (pdf)

Documents

 

Economic analysis

English version

Contact Us

Évaluation des médicaments
All our publications