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LYNPARZA - Pancreas (olaparib)
Reason for request
- Key points
Favourable opinion for inclusion in both the hospital formulary list and the retail formulary list of reimbursed proprietary medicinal products approved for use only in the subpopulation of patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen and who are not suitable for continuation of platinum-based chemotherapy.
Unfavourable opinion for inclusion in both the hospital formulary list and the retail formulary list of reimbursed proprietary medicinal products approved for use in the rest of the MA population: patients suitable for continuation of platinum-based chemotherapy, in the absence of any available specific data.
What therapeutic improvement?
No clinical added value in the therapeutic strategy.
Role in the care pathway?
According to the European ESMO and American NCCN recommendations, patients with metastatic pancreatic cancer with an ECOG performance score of 0-2 are suitable for systemic chemotherapy. The FOLFIRINOX (5-FU/LV/irinotecan/oxaliplatin) protocol or nab-paclitaxel/gemcitabine combination are recommended.
In the presence of known BRCA 1/2 mutations, the favoured treatment protocols are FOLFIRINOX or modified FOLFIRINOX or Gemcitabine + cisplatin.
The first-line treatment is administered until progression or significant toxicity.
Role of LYNPARZA (olaparib) in the care pathway:
LYNPARZA is a maintenance option for a very limited number of patients. Indeed, in view of the available data, it is only intended for patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen and who are not suitable for continuation of platinum-based chemotherapy. In patients who are responding, it is preferable to maintain chemotherapy until disease progression or inacceptable toxicity. Outside these precise situations, treatment with LYNPARZA has no role in the absence of data.
Clinical Benefit
| Moderate |
The Committee deems that the clinical benefit of LYNPARZA (olaparib) is moderate in the MA subpopulation represented by patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen and who are not suitable for continuation of platinum-based chemotherapy. |
| Insufficient |
The Committee deems that the clinical benefit of LYNPARZA (olaparib) is insufficient to justify public funding cover in the rest of the MA population: patients suitable for continuation of platinum-based chemotherapy, in the absence of any available specific data.
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Clinical Added Value
| no clinical added value | null |
| Not applicable |
Considering:
but,
the Committee considers that LYNPARZA (olaparib) provides no clinical added value (CAV V) in the MA subpopulation represented by patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen and who are not suitable for continuation of platinum-based chemotherapy.
In the rest of the MA population, the CAV is not applicable.
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