- Date 02 February 2022
- Documents : 6
- Economic analysis
- History
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OPDIVO (nivolumab) - Cancer œsophage ou jonction œso-gastrique
Reason for request
Key points
Favourable opinion for reimbursement only as monotherapy in the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy and complete surgical resection (R0 post-surgery) within 4 to 16 weeks.
Unfavourable opinion for reimbursement in other situations.
What therapeutic improvement?
Therapeutic improvement in the management of the disease.
Role in the care pathway?
The management of oesophageal or gastro-oesophageal junction cancer depends on the stage of the disease at the time of diagnosis.
Surgery alone is reserved for stage I and II oesophageal or gastro-oesophageal junction cancers.
The curative treatment for stage II or III oesophageal and gastro-oesophageal junction cancers is surgery preceded by radiochemotherapy combining carboplatin and paclitaxel or FOLFOX. In the event of locally advanced tumours or a health status unfavourable to surgery, curative treatment may also consist of radiochemotherapy (RCT) alone, potentially supplemented by salvage surgery in the event of an incomplete response.
Despite RCT and surgery, residual disease persists in some patients. These patients are considered to be at “high risk” of recurrences. To date, there is no adjuvant treatment recommended by the European guidelines.
Role of the medicinal product in the care pathway
OPDIVO (nivolumab) is an adjuvant treatment for adult patients with oesophageal or gastro-oesophageal junction cancer and who have residual pathologic disease following prior neoadjuvant chemoradiotherapy and complete surgical resection (R0 post-surgery) within 4 to 16 weeks.
The Committee highlights the fact that, in adjuvant situations, the maximum duration of treatment with OPDIVO indicated in the SPC is 12 months.
To date, the superiority of OPDIVO (nivolumab) compared to placebo has only been demonstrated in terms of disease-free survival. The Committee is awaiting overall survival data from the CheckMate 577 study (provisional date for availability of results: 2024).
Clinical Benefit
| Substantial |
The Committee deems that the clinical benefit of OPDIVO (nivolumab) is Substantial only as monotherapy in the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy and complete surgical resection (R0 post-surgery) within 4 to 16 weeks.
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| Insufficient |
The Committee deems that the clinical benefit of OPDIVO (nivolumab) is Insufficient to justify public funding cover in all other adjuvant situations, in the absence of data.
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Clinical Added Value
| minor |
Considering:
and despite:
The Transparency Committee considers that OPDIVO (nivolumab), as adjuvant treatment, provides a minor clinical added value (CAV IV) compared to the current care pathway for the treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy and complete surgical resection (R0 post-surgery) within 4 to 16 weeks.
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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 15 mars 2022.
L’évaluation porte sur une indication plus restreinte que l’AMM à savoir nivolumab en monothérapie dans le traitement adjuvant des patients adultes atteints de CO ou de la JOG, présentant des traces de maladie résiduelle et ayant eu une résection complète après une RCT néoadjuvante.
La CEESP a été en mesure de conclure sur le niveau d’efficience du produit, avec un RDCR de 49 572 €/QALY versus la surveillance seule, au prix de vente en vigueur et sur un horizon temporel de 15 ans.
Au prix public du nivolumab, et selon les parts de marchés prévisionnelles envisagées par l’industriel, la mise à disposition du nivolumab dans la nouvelle indication revendiquée représente une augmentation des dépenses de l’assurance maladie de 256% dans cette indication.
> OPDIVO - Avis économique (pdf)
