- Date 02 February 2022
- Documents : 6
- Economic analysis
- History
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Reason for request
Key points
Favourable opinion for reimbursement of KISPLYX (lenvatinib) in combination pembrolizumab in the first-line treatment of advanced purely clear-cell renal cell carcinoma (RCC) or with a clear-cell component.
Unfavourable opinion for reimbursement 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 KISPLYX (lenvatinib) in combination with pembrolizumab compared to sunitinib, in the same way as the pembrolizumab/axitinib and nivolumab/cabozantinib combinations 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 KISPLYX/KEYTRUDA (lenvatinib/pembrolizumab) or KEYTRUDA/INLYTA (pembrolizumab/axitinib) or CABOMETYX/OPDIVO (cabozantinib/nivolumab) combinations including immunotherapy [1A/1B] (level of evidence 1 and recommendation grade A or B) are 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).
Tyrosine kinase inhibitors (TKIs) with SUTENT (sunitinib) and VOTRIENT (pazopanib) are also recommended as therapeutic alternatives in these new recommendations
- in intermediate or poor prognosis situations:
The same combinations as those mentioned above: KISPLYX/KEYTRUDA (lenvatinib/pembrolizumab), 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).
Tyrosine kinase inhibitors (TKIs) with SUTENT (sunitinib) and VOTRIENT (pazopanib) are also recommended as therapeutic alternatives according to the recommendations.
AVASTIN (bevacizumab) in combination with interferon and an 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
KISPLYX (lenvatinib) in combination with pembrolizumab 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 this combination compared to the other available combinations:
- KEYTRUDA/INLYTA (pembrolizumab/axitinib) and OPDIVO/CABOMETYX (nivolumab/cabozantinib) 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 KISPLYX (lenvatinib) in combination with pembrolizumab, 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 KISPLYX (lenvatinib) in combination with pembrolizumab is substantial only in the first-line treatment of advanced clear-cell renal cell carcinoma (RCC) or with a clear cell component.
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| Insufficient |
The Committee deems that the clinical benefit of KISPLYX (lenvatinib) in combination with pembrolizumab 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.
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Clinical Added Value
| moderate |
Considering:
despite:
the Transparency Committee considers that combination of KISPLYX (lenvatinib) - pembrolizumab, like the pembrolizumab/axitinib combination and the nivolumab/cabozantinib, 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 5 juillet 2022.
L’évaluation porte sur une indication plus restreinte que l’AMM à savoir le traitement des adultes atteints d’un cancer rénal avancé à cellules claires, en association avec le pembrolizumab, en traitement de première ligne
L’efficience du produit n’est pas démontrée sur la population pour laquelle une ASMR III versus sunitinib est revendiquée en raison d’une réserve majeure.
Selon les termes de l’accord cadre du 5 mars 2021 conclu entre le CEPS et le Leem, lorsque le CA prévisionnel en 2e année de commercialisation est estimé inférieur à 50 millions d’euros HT, le choix d’intégrer dans le dossier une analyse d’impact budgétaire est laissé à la libre appréciation de l’industriel. Dans le cadre de ce dossier, aucune analyse d’impact budgétaire n’a été fournie par l’industriel.
> KISPLYX - Avis économique (pdf)
