LIBTAYO 350 mg (cémiplimab) (CBNPC)

Key points

Favourable opinion for reimbursement as monotherapy for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (in ≥ 50% tumour cells), with no EGFR, ALK or ROS1 aberrations, who have locally advanced NSCLC and who are not candidates for definitive chemoradiation, or metastatic NSCLC.

 What therapeutic improvement?

No clinical added value in the current therapeutic strategy including pembrolizumab.

Role in the care pathway?

The current first-line management for metastatic non-small cell lung cancer expressing PD-L1 (in ≥ 50% tumour cells), in the absence of molecular abnormalities (EGFR mutations, or ALK or ROS-1 rearrangements), is based on immunotherapy, for eligible patients.

Pembrolizumab is a first-line treatment:

• as monotherapy,
• in combination with chemotherapy (irrespective of PD-L1 expression status):
  • in combination with pemetrexed and platinum chemotherapy 
  • in non-squamous NSCLC,
  • in combination with carboplatin and paclitaxel (or nab-paclitaxel) chemotherapy,
  • in squamous NSCLC.

In the event of contraindication to immunotherapy, or to one of the chemotherapy drugs combined with pembrolizumab, chemotherapy is indicated. This involves dual therapy combining a platinum (cisplatin or carboplatin) with one of the following substances: vinorelbine, gemcitabine, docetaxel, paclitaxel or pemetrexed (only in non-squamous NSCLC for the latter), irrespective of PD-L1 expression status. The nivolumab/ipilimumab can be combined with two cycles of chemotherapy in the absence of contraindications in metastatic NSCLC, irrespective of PD-L1 expression status. In non-squamous NSCLC, bevacizumab can be added to the dual chemotherapy regimen, in the absence of contraindications; and atezolizumab can be combined with bevacizumab + paclitaxel + carboplatin, irrespective of PD-L1 expression status.

Role of the medicinal product in the care pathway

LIBTAYO (cemiplimab) as monotherapy is a first-line treatment option for adult patients with non-small cell lung cancer expressing PD-L1 (in ≥ 50% tumour cells), with no EGFR, ALK or ROS1 aberrations, who have locally advanced NSCLC and who are not candidates for definitive chemoradiation, or metastatic NSCLC.

However, the Committee regrets the absence of data enabling the role of LIBTAYO (cemiplimab) to be positioned compared to the current standard of care therapy, i.e., pembrolizumab as monotherapy, only if PD-L1 ≥ 50%. Consequently, as knowledge currently stands, the role of cemiplimab as monotherapy compared to pembrolizumab monotherapy is not known.

Avis économique

Ce produit a fait l'objet d'un avis économique rendu par la Commission d'évaluation économique et de santé publique le 14 décembre 2021. 

La CEESP a été en mesure de conclure sur le niveau d’efficience du produit, avec un ratio différentiel coût-résultat (RDCR) de 61 866€/QALY versus les chimiothérapies et une dominance versus le pembrolizumab, au prix unitaire revendiqué.  

Selon les termes de l’accord cadre du 5 mars 2021 conclu entre le CEPS et le Leem, lorsque le CA prévisionnel en 2e année de commercialisation est estimé inférieur à 50 millions d’euros HT, le choix d’intégrer dans le dossier une analyse d’impact budgétaire est laissé à la libre appréciation de l’industriel. Dans le cadre de ce dossier, aucune analyse d’impact budgétaire n’a été fournie par l’industriel. 

> LIBTAYO - Avis économique (pdf)