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OPDIVO 10 mg/ml / YERVOY 5 mg/ml (nivolumab en association à l’ipilimumab, cancer colorectal métastatique)
Reason for request
Key points
Favourable opinion for reimbursement in adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy, only in patients who have received no prior immunotherapy.
Unfavourable opinion for reimbursement in patients having received prior immunotherapy.
Role in the care pathway?
In metastatic colorectal cancer without the presence of mismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H), in the event of failure of first-line fluoropyrimidine-based combination chemotherapy (+/- targeted therapy),a change of chemotherapy ± targeted therapy protocol is recommended. The medicinal products used as second-line therapy are 5-FU chemotherapies (FOLFOX, FOLFIRI), irinotecan/oxaliplatin, anti-VEGF therapy (bevacizumab, aflibercept, ramucirumab), anti-EGFR therapy (panitumumab, cetuximab), STIVARGA (regorafenib), LONSULF (trifluridine/tipiracil) and BRAFTOVI (encorafenib) in BRAF V600E mutation-positive patients.
In patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer, apart from first-line treatment with pembrolizumab (KEYTRUDA), the treatments used as second-line therapy are identical to those recommended in the absence of the MSI-H/dMMR genome abnormality.
Role of the medicinal product in the care pathway
The OPDIVO/YERVOY (nivolumab/ipilimumab) combination is a treatment alternative in adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy, only in patients who have received no prior immunotherapy.
Considering the absence of direct comparative data and the absence of an indirect comparison of good methodological quality, its role in the care pathway cannot be specified compared to the chemotherapy protocols used as second or later-line treatments.
Clinical Benefit
| Moderate |
The Committee deems that the clinical benefit of the OPDIVO/YERVOY (nivolumab/ipilimumab) combination is moderate in the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy, only in patients who have received no prior immunotherapy. |
| Insufficient |
The Committee deems that the clinical benefit of the OPDIVO/YERVOY (nivolumab/ipilimumab) combination is insufficient to justify public funding cover in all other clinical situations (patients having received prior immunotherapy).
|
Clinical Added Value
| no clinical added value |
Considering:
and despite:
the Transparency Committee considers, that as the dossier currently stands, the OPDIVO/YERVOY (nivolumab/ipilimumab) combination provides no clinical added value (CAV V) in the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy who have received no prior immunotherapy. |
