Reason for request

Indication extension

Summary of opinion  

Favourable opinion for reimbursement within a restricted scope: patients with metastatic colorectal cancer (ECOG score 0-1) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, an anti-VEGF biologic therapy, and, in the event of a RAS wild type gene, an anti-EGFR agent.  


Clinical Benefit

Moderate

The Committee deems that the clinical benefit of LONSURF in combination with bevacizumab is moderate in the restricted indication: patients with metastatic colorectal cancer (ECOG score 0-1) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, an anti-VEGF biologic therapy, and, in the event of a RAS wild type gene, an anti-EGFR agent. In the rest of the MA scope, the clinical benefit is insufficient to justify public funding. 

Insufficient

Clinical Added Value

no clinical added value

Considering:

  • data from a comparative study having demonstrated a superiority of the bevacizumab/LONSURF combination versus LONSURF monotherapy in terms of overall survival and progression-free survival (difference in median of around 3 months for each of the endpoints),
  • limitations with respect to interpretation of the results of this study due to the fact that more than a quarter of the patients (28%) in the comparator group had not been treated with bevacizumab during previous treatment lines, despite this already being recommended in clinical practice,
  • the absence of data in the population with an ECOG score > 1,
  • the impossibility of drawing a conclusion with respect to quality of life (exploratory endpoint),
  • comparative data from the SUNLIGHT study showing a benefit of adding bevacizumab to LONSURF but, in no case, the contribution of the latter in this context,
  • the absence of robust comparative data versus regorafenib, 

the Committee considers that, as the dossier currently stands, LONSURF in combination with bevacizumab provides no clinical added value (CAV V) in the current 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 15 octobre 2024. L’avis économique porte sur une indication superposable à celle demandée au remboursement, à savoir en association au bévacizumab chez les adultes atteints d’un cancer colorectal métastatique (CCRm) précédemment traités par deux protocoles de traitement comprenant les chimiothérapies à base de fluoropyrimidine, d’oxaliplatine et d’irinotecan, les agents anti-VEGF et/ou les agents anti-EGFR. 

Au prix retenu dans la modélisation et sous les hypothèses retenues par l’industriel, le RDCR de LONSURF en association au bevacizumab versus STIVARGA est de 100 396 €/QALY (et de 87 161 €/AVG), sur un horizon temporel de 5 ans. 

L’introduction de ce produit engendrerait une hausse d’environ 48% des dépenses de l’Assurance Maladie dans cette indication sur 5 ans. 

> LONSURF - Avis économique (pdf)

 

Contact Us

Évaluation des médicaments