- Date 30 March 2022
- Documents : 8
- Economic analysis
- History
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KEYTRUDA (pembrolizumab) - Cancer de l’endomètre
Reason for request
Key points
Favourable opinion for reimbursement in the indication extension: KEYTRUDA, in combination with lenvatinib, is indicated in the treatment of adult patients with advanced or recurrent endometrial carcinoma (EC) who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and are not candidates for curative surgery or radiation.
What therapeutic improvement?
Therapeutic improvement compared to single-agent chemotherapy with doxorubicin or paclitaxel in the second-line treatment of advanced endometrial carcinoma.
Role in the care pathway?
In patients with advanced or recurrent disease, who have disease progression on or following prior treatment with a platinum-containing therapy, there is no treatment/protocol considered to be the standard care. The treatment options are:
- Platinum-containing dual-agent chemotherapy, to be favoured in patients having had a platinum-free interval of more than 6 months,
- single-agent chemotherapy with doxorubicin, paclitaxel, oxaliplatin or ifosfamide. There is no solid data enabling single-agent chemotherapies to be ranked in the event of progression following platinum-containing chemotherapy.
Role of the medicinal product in the care pathway
KEYTRUDA (pembrolizumab), in combination with lenvatinib (LENVIMA), is a second-line treatment in adult patients with advanced or recurrent endometrial carcinoma (EC) who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and are not candidates for curative surgery or radiation.
Clinical Benefit
| Substantial |
The Committee deems that the clinical benefit of KEYTRUDA in the context of its combination with lenvatinib is substantial in the MA indication. |
Clinical Added Value
| moderate |
Considering:
and despite:
the Transparency Committee considers that KEYTRUDA in combination with LENVIMA (lenvatinib) provides a moderate clinical added value (CAV III) compared to single-agent chemotherapy with doxorubicin or paclitaxel in the second-line treatment of adult patients with advanced or recurrent endometrial carcinoma (EC) who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and are not candidates for curative surgery or radiation.
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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 (CEESP) le 10 mai 2022. L’avis économique porte sur une indication superposable à l’AMM.
La CEESP a été en mesure de conclure sur le niveau d’efficience du produit, avec un ratio différentiel coût-résultat (RDCR) de 126 247 €/QALY versus la chimiothérapie par doxorubicine ou paclitaxel sur un horizon temporel de 10 ans. Ces résultats reposent sur un choix méthodologique faiblement étayé, non pertinent au vu des données disponibles et des alternatives envisageables, et favorable à l'association évaluée. Ainsi, le résultat produit est associé à une forte incertitude.
L’introduction du pembrolizumab en association au lenvatinib conduit à une multiplication par 10 des dépenses de l’assurance maladie dans cette indication.
> KEYTRUDA - avis économique (pdf)
