- Date 14 December 2022
- Documents : 7
- Economic analysis
- History
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KEYTRUDA (pembrolizumab) - Cancer du sein triple négatif
Reason for request
Key points
Approval of reimbursement of KEYTRUDA (pembrolizumab) in combination with chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment after surgery, for the treatment of adult patients with locally advanced, or early-stage triple-negative breast cancer at high risk of recurrence.
Therapeutic improvement?
Therapeutic improvement in the care pathway.
Role in therapeutic strategy?
Due to the aggressive nature of the triple-negative breast cancer subtype, administration of a neoadjuvant chemotherapy regimen has been recommended for over 10 years for patients with a large tumour (≥ 2 cm in the current ESMO European guidelines) and/or with lymph node involvement. The objective of treatment at the operable stage is to limit disease progression as early as possible, even before surgery, by reducing tumour size before the procedure and improving the complete histological response rate, in order to maximize chances of recovery and prevent recurrence or metastatic onset. Chemotherapy regimens combine a taxane (generally paclitaxel), and an anthracycline (doxorubicin or epirubicin + cyclophosphamide) used sequentially. Chemotherapy combinations without anthracycline appear to be inferior for triple-negative type tumours. Adding carboplatin to chemotherapy regimens with anthracycline and taxanes has shown an improvement in the probability of complete response for triple-negative type tumours.
Role of KEYTRUDA (pembrolizumab) in the therapeutic strategy:
KEYTRUDA (pembrolizumab), in combination with chemotherapy as neoadjuvant, and then continued as monotherapy as adjuvant treatment after surgery is the preferred treatment for locally advanced or early-stage triple-negative cancer with a high risk of recurrence.
Clinical Benefit
| Substantial |
The Committee deems that the actual clinical benefit of KEYTRUDA (pembrolizumab) is significant in the new marketing authorisation indication. |
Clinical Added Value
| minor |
Considering evidence in a randomised double-blind study:
the Committee deems that, based on the data currently available, KEYTRUDA (pembrolizumab) provides minor clinical added value (CAV IV) for the neoadjuvant and subsequently adjuvant treatment of adult patients with locally advanced or early-stage triple-negative breast cancer at high risk of recurrence. |
Avis économique
Ce produit a fait l'objet d'un avis économique rendu par la Commission d'évaluation économique et de santé publique le 25 avril 2023.
L’évaluation porte sur une indication superposable à l’indication de l’AMM obtenue le 19/05/2022 en procédure centralisée.
La CEESP a été en mesure de conclure sur le niveau d’efficience du produit, avec un RDCR de 49 007 €/QALY versus CPAC, au prix de vente en vigueur et sur un horizon temporel de 40 ans.
Au prix public du pembrolizumab, et selon les parts de marchés prévisionnelles envisagées par l’industriel, la mise à disposition du pembrolizumab dans la nouvelle indication revendiquée représente une augmentation des dépenses de l’assurance maladie de 167% dans cette indication, pour une population cible de 34 400 patients cumulés sur 5 ans.
> KEYTRUDA - Avis économique (pdf)
