- Date 22 September 2021
- Documents : 5
- Economic analysis
- History
Listen
OPDIVO 10 mg/ml (nivolumab) (carcinome à cellules rénales avancé, en association cabozantinib)
Reason for request
Key points
Favourable opinion for reimbursement of OPDIVO (nivolumab) in combination with cabozantinib in the first-line treatment of advanced purely clear-cell renal cell carcinoma (RCC) or with a clear-cell component.
Unfavourable opinion for reimbursement of OPDIVO (nivolumab) in combination with cabozantinib in the first-line treatment of advanced renal cell carcinoma (RCC) with a histological type other than clear-cell in the absence of data.
What therapeutic improvement?
Therapeutic improvement for OPDIVO (nivolumab) in combination with cabozantinib compared to sunitinib in the first-line treatment of advanced purely clear-cell renal cell carcinoma (RCC) or with a clear-cell component.
Role in the care pathway?
Today, with the introduction of immunotherapy treatments, the European (EAU 2021, ESMO 2021) and American (NCCN 2021) guidelines recommend the following treatments as first-line therapy in patients with advanced clear-cell renal cell carcinoma, depending on the prognostic risk:
- in good prognosis situations:
The KEYTRUDA/INLYTA (pembrolizumab/axitinib) or CABOMETYX/OPDIVO (cabozantinib/nivolumab) combination including immunotherapy [1A/1B] (level of evidence 1 and recommendation grade A or B) is recommended.
The BAVENCIO/INLYTA (avelumab/axitinib) combination is not cited in these guidelines, given its lower level of evidence (moderate clinical benefit and CAV V, granted by the Transparency Committee in 2020).
- in intermediate or poor prognosis situations:
The same combinations including immunotherapy as those mentioned above - KEYTRUDA/INLYTA (pembrolizumab/axitinib) or CABOMETYX/OPDIVO (cabozantinib/ nivolumab) - as well as the OPDIVO/YERVOY (nivolumab/ipilimumab) combination are recommended as category [1A/1B] (level of evidence 1 and recommendation grade A or B). The superiority of the OPDIVO/YERVOY combination has been established versus SUTENT (sunitinib) in terms of overall survival only in intermediate or high-risk patients.
Tyrosine kinase inhibitors (TKIs) with SUTENT (sunitinib) and VOTRIENT (pazopanib) are also recommended, irrespective of prognosis, as therapeutic alternatives.
AVASTIN (bevacizumab) in combination with interferon, and the use of interleukin-2 (IL-2) can be used in certain clinical situations.
In the same way, in patients with a poor prognosis only, TORISEL (temsirolimus) is now considered to be a treatment option in patients with advanced renal cell carcinoma with at least 3 out of the 6 prognostic risk factors.
Role of the medicinal product in the care pathway
OPDIVO (nivolumab) in combination with cabozantinib is a new treatment option in the first-line treatment of advanced purely clear-cell renal cell carcinoma (RCC) or with a clear-cell component. The available data does not enable definition of the role of the CABOMETYX (cabozantinib) and OPDIVO (nivolumab) combination compared to the other available combinations:
KEYTRUDA/INLYTA (pembrolizumab/axitinib) irrespective of prognosis, and
OPDIVO/YERVOY (nivolumab/ipilimumab) in the subpopulation of patients with an intermediate or poor prognosis.
Consequently, the Committee proposes that the choice of treatment should be made in the context of the proposal made following a multidisciplinary team meeting, based on the safety profile of these medicinal products and patients’ preferences.
In the absence of available data, the role of OPDIVO (nivolumab) in combination with cabozantinib, like that of the other combinations including an immunotherapy currently available, has not been established in the first-line treatment of advanced renal cell carcinoma with a histological type other than clear-cell.
Clinical Benefit
| Substantial |
The Committee deems that the clinical benefit of the CABOMETYX/OPDIVO (cabozantinib/nivolumab) combination is subsstantial only in the first-line treatment of advanced clear-cell renal cell carcinoma (RCC) or with a clear cell component.
|
| Insufficient |
The Committee deems that the clinical benefit of the CABOMETYX/OPDIVO (cabozantinib/nivolumab) combination is insufficient to justify public funding cover in the first-line treatment of advanced renal cell carcinoma with a histological type other than clear-cell given the absence of data.
|
Clinical Added Value
| moderate |
Considering:
despite:
the Committee considers that the combination of OPDIVO (nivolumab) with cabozantinib, like the pembrolizumab/axitinib combination, provides a moderate clinical added value (CAV III) compared to sunitinib in the first-line treatment of advanced clear-cell renal cell carcinoma (RCC) or with a clear-cell component.
|
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. L’avis économique porte sur une indication superposable à celle demandée au remboursement, à savoir le nivolumab en association à cabozantinib dans le traitement de 1re ligne, au stade avancé du carcinome rénal à cellules claires ou comportant un contingent de cellules claires.
Au prix revendiqué, l’association nivolumab + cabozantinib est dominée (plus chère et moins efficace) par l’association nivolumab + ipilimumab sur la population pour laquelle une ASMR III est revendiquée.
L’impact budgétaire associé à l’introduction du nivolumab + cabozantinib représente une augmentation des dépenses de l’assurance maladie dans l’indication de + 2,38%, pour une population cible de 3 729 patients cumulés sur 3 ans.
> OPDIVO - Avis économique (pdf)
