- Date 12 October 2022
- Documents : 6
- Economic analysis
- History
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OPDIVO (nivolumab) - Cancer de l’œsophage
Reason for request
Key points
Approval of reimbursement for the first-line treatment of adult patients with unresectable, recurrent or metastatic oesophageal squamous cell carcinoma, with PD-L1 tumour cell expression ≥1%, in combination with fluoropyrimidine- and platinum-based combination chemotherapy.
OPDIVO (nivolumab) provides therapeutic improvement with respect to chemotherapy (fluoropyrimidine- and platinum-based), as a first-line treatment for adult patients with unresectable, recurrent or metastatic oesophageal squamous cell carcinoma, with PD-L1 tumour cell expression ≥1%.
Role in therapeutic strategy?
For patients with unresectable (if radiotherapy is contraindicated) locally advanced or metastatic oesophageal squamous cell carcinoma or adenocarcinoma, referral for systemic treatment (palliative chemotherapy) is the conventional treatment. The main chemotherapy drugs used are a fluoropyrimidine associated with a platinum derivative. Other regimens such as FOLFOX associating fluorouracil-oxaliplatin-folinic acid are sometimes used as a treatment option.
Since 2021, KEYTRUDA (pembrolizumab) in association with a chemotherapy regimen based on platinum salts and fluoropyrimidine is a first-line treatment for adult patients with unresectable locally advanced or metastatic, type I only (Siewert classification) HER-2-negative gastro-oesophageal junction adenocarcinoma or oesophageal cancer, with PD-L1 tumour expression where CPS ≥ 10 based on the findings of the KEYNOTE 590 study (including approximately 70% squamous cancer patients).
Role of OPDIVO (nivolumab) in the therapeutic strategy:
OPDIVO (nivolumab) in combination with fluoropyrimidine- and platinum-based combination chemotherapyis a first-line treatment option for the treatment of adult patients with unresectable, recurrent or metastatic oesophageal squamous cell carcinoma, with PD-L1 tumour cell expression ≥1%. Given the lack of comparative data, it is not possible to determine its role in the therapeutic strategy with respect to KEYTRUDA (pembrolizumab).
Clinical Benefit
| Substantial |
The Committee deems that the clinical benefit of OPDIVO (nivolumab) when associated with a chemotherapy regimen is significant in the marketing authorisation indication. |
Clinical Added Value
| moderate |
Considering: the evidence in a phase III, randomised, open-label study of the superiority of OPDIVO (nivolumab) in combination with fluoropyrimidine- and platinum-based combination chemotherapy versus chemotherapy alone among patients with PD-L1 tumour cell expression ≥1% in terms of:
despite:
the Transparency Committee deems that OPDIVO (nivolumab) in combination with fluoropyrimidine- and platinum-based combination chemotherapy provides moderate clinical added value (CAV III) versus chemotherapy alone, as a first-line treatment, for the treatment of adult patients with unresectable, recurrent or metastatic oesophageal squamous cell carcinoma, with PD-L1 tumour cell expression ≥1%. |
Avis économique
Ce produit a fait l'objet d'un avis économique rendu par la Commission d'évaluation économique et de santé publique le 8 novembre 2022.
L’évaluation porte sur une indication superposable à l’indication de l’AMM obtenue le 01/04/2022 en procédure centralisée.
La CEESP a été en mesure de conclure sur le niveau d’efficience de la stratégie nivolumab + 5-FU-cisplatine, avec un RDCR de 134 706 €/QALY versus un comparateur composite « mixte de chimiothérapies », au prix de vente en vigueur et sur un horizon temporel de 7 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 273% dans cette indication, pour une population cible de 3006 patients cumulés sur 3 ans.
> OPDIVO - Avis économique (pdf)
