- Date 22 September 2021
- Documents : 5
- Economic analysis
- History
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CABOMETYX 20 - 40 mg (cabozantinib) (carcinome à cellules rénales avancé, en association au nivolumab)
Reason for request
Key points
Favourable opinion for reimbursement of CABOMETYX (cabozantinib) in combination with nivolumab in the first-line treatment of advanced clear-cell renal cell carcinoma (RCC) or with a clear cell component.
Unfavourable opinion for reimbursement of CABOMETYX (cabozantinib) in combination with nivolumab 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, in the same way as the pembrolizumab/axitinib combination, for the cabozantinib/nivolumab combination compared to sunitinib only in the first-line treatment of advanced 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 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
CABOMETYX (cabozantinib) in combination with nivolumab is a new treatment option in the first-line treatment of advanced 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 review meeting, based on the safety profile of these medicinal products and patients’ preferences.
In the absence of available data, the role of CABOMETYX (cabozantinib) in combination with nivolumab, 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 substantial 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 |
The Committee considers that combination of CABOMETYX (cabozantinib) with nivolumab, 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.
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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 14 décembre 2021. L’avis économique porte sur une indication plus restreinte que celle de la demande d’AMM et superposable à celle de la demande de remboursement, à savoir le cabozantinib en association au nivolumab dans le traitement de 1re ligne, au stade avancé du carcinome rénal à cellules claires ou comportant un contingent de cellules claires.
La CEESP n’a pas été en mesure de conclure sur le niveau d’efficience du produit en raison d’une incertitude globale majeure.
L’impact budgétaire associé à l’introduction du cabozantinib en association au nivolumab représente une augmentation des dépenses de l’assurance maladie dans l’indication de 2%, sur la base des hypothèses retenues par le laboratoire.
> CABOMETYX - Avis économique (pdf)
