- Date 14 September 2022
- Documents : 8
- Economic analysis
- History
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KEYTRUDA (pembrolizumab) - Cancer du col de l’utérus
Reason for request
Key points
Positive opinion for the reimbursement of KEYTRUDA (pembrolizumab) in combination with chemotherapy with or without bevacizumab, in the treatment of adult patients with persistent, recurrent or metastatic cervical cancer, whose tumours express PD-L1 with a CPS ≥ 1.
Therapeutic improvement?
Therapeutic improvement in the care pathway.
Role in therapeutic strategy?
In persistent, recurrent or metastatic cervical cancer, management is based on palliative chemotherapy with the aim of relieving symptoms and improving quality of life. The recommended first-line treatment by the European Society for Medical Oncology (ESMO) (2017) and the National Comprehensive Cancer Network (NCCN) (2022) is cisplatin (or carboplatin in case of impaired renal function), paclitaxel and bevacizumab.
The use of topotecan (HYCAMTIN) instead of platinum salt is considered when the patient is not eligible for cisplatin or carboplatin (NCCN recommendation 2A).
In its opinion of 6 July 2016, the Committee listed the ACB of AVASTIN (bevacizumab) as substantial and assessed its CAV at level IV compared to paclitaxel and cisplatin chemotherapy (or topotecan in case of platinum salt ineligibility) based on a 4-arm randomised phase III study that showed an overall survival gain of 3.9 months (median of 16.8 months versus 12.9 months).
The 2022 NCCN guidelines included pembrolizumab as a first-line treatment for persistent, recurrent and metastatic cervical cancer when a CPS of 1 or more is found, in combination with dual or triple therapy with platinum salt, paclitaxel ± bevacizumab.
Role of the medicinal product:
KEYTRUDA (pembrolizumab) in combination with chemotherapy with or without bevacizumab, is a first-line treatment for persistent, recurrent or metastatic cervical cancer with tumours expressing PD-L1 with a CPS ≥ 1.
Clinical Benefit
| Substantial |
The Committee deems that the actual clinical benefit of KEYTRUDA (pembrolizumab) is substantial in the marketing authorisation indication. |
Clinical Added Value
| moderate |
Considering:
and despite the lack of formal conclusions that can be drawn from the quality-of-life results, KEYTRUDA, in combination with chemotherapy, provides moderate clinical added value (CAV III) in the first-line treatment of adult patients with persistent, recurrent or metastatic cervical cancer whose tumours express PD-L1 with a CPS ≥ 1.
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Avis économique
Ce produit a fait l'objet d'un avis économique rendu par la Commission d'évaluation économique et de santé publique le 11 octobre 2022.
L’évaluation porte sur une indication superposable à l’indication de l’AMM obtenue le 25/04/2022 en procédure centralisée.
La CEESP a été en mesure de conclure sur le niveau d’efficience de la stratégie pembrolizumab + chimiothérapie ± bévacizumab avec un RDCR de 168 076 €/QALY versus la chimiothérapie ± bévacizumab sur un horizon temporel de 7 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 285% dans cette indication, pour une population cible de 2 205 patientes cumulés sur 3 ans.
> KEYTRUDA - Avis économique (pdf)
