KEYTRUDA (pembrolizumab) - Clear cell renal cell carcinoma

Opinions on drugs - Posted on Feb 06 2023

Reason for request

Indication extension

New indication.

Key points

Favourable opinion for reimbursement of KEYTRUDA (pembrolizumab) in the adjuvant treatment of adults with clear cell renal cell carcinoma only, at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

Unfavourable opinion for reimbursement of KEYTRUDA (pembrolizumab) in the adjuvant treatment of adults with renal cell carcinoma with a histological type other than clear cell.

What therapeutic improvement?

Therapeutic improvement in the care pathway for clear cell renal cell carcinoma.

No therapeutic improvement in the care pathway for renal cell carcinoma with a histological type other than clear cell.

Role in the care pathway?

KEYTRUDA (pembrolizumab) is an adjuvant treatment in adults with clear cell renal cell carcinoma, at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

Clinical Benefit

Substantial	The clinical benefit of KEYTRUDA (pembrolizumab) is substantial in clear cell renal cell carcinoma.
Insufficient	Considering the absence of data in these histological subtypes, the Committee deems that the clinical benefit of KEYTRUDA (pembrolizumab) is insufficient in non-clear cell renal cell carcinoma (chromophobe and papillary).

Clinical Added Value

minor

Considering:

evidence of superiority of pembrolizumab versus placebo on the primary endpoint, investigator-assessed recurrence-free survival, with HR=0.68 (CI95%: [0.53 - 0.87]), p= 0.0010;
the lack of evidence of superiority of the pembrolizumab group versus the placebo group in terms of overall survival (p=NS) and the currently immature data;
an increased toxicity in the pembrolizumab group, marked in particular by adverse events of grade 3 or more (32.2% versus 17.7%) and serious adverse events (20.7% versus 11.5%);
the absence of a demonstrated impact on quality of life (exploratory endpoint);

the Committee considers that as the dossier currently stands, KEYTRUDA (pembrolizumab) provides a minor clinical added value (CAV IV) as monotherapy in the adjuvant treatment of adults with clear cell renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

Not applicable

Avis économique

Ce produit a fait l'objet d'un avis économique rendu par la Commission d'évaluation économique et de santé publique le 28 mars 2023. L’avis économique porte sur une indication superposable à celle demandée au remboursement, à savoir le traitement adjuvant en monothérapie des patients adultes atteints d’un carcinome à cellules rénales à risque accru de récidive post néphrectomie, ou après une néphrectomie et une résection des lésions métastatiques.

Au prix retenu dans la modélisation et sous les hypothèses retenues par l’industriel, le RDCR de pembrolizumab versus la surveillance active est de 29 342 €/QALY (et de 23 355 €/AVG), sur un horizon temporel de 30 ans.

L’introduction de ce produit engendrerait une hausse d’environ 24% des dépenses de l’Assurance Maladie dans cette indication.

> KEYTRUDA - Avis économique (pdf)

Documents

Economic analysis

English version

KEYTRUDA_18012023_SUMMARY_CT20032

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