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LYNPARZA - Pancreas (olaparib)

Opinions on drugs - Posted on Dec 23 2020

Reason for request

New indication

  • 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.

 


Clinical Added Value

no clinical added value null
Not applicable

Considering:

  • demonstration of an increase in median progression-free survival (primary endpoint) of +3.6 months in favour of the olaparib group compared to placebo (7.4 months versus 3.8 months (HR = 0.531 CI95% [0.346; 0.815]) in a randomised double-blind study,
  • the inadequately met medical need in this cancer with a very poor prognosis,

but,

  • the absence of demonstration of an increase in overall survival, a ranked secondary endpoint (median overall survival between the olaparib group and the placebo group: 18.9 months versus 18.1 months, HR = 0.906; CI95% [0.563; 1.457]; NS,
  • the choice of comparator group in the study: absence of treatment (placebo) after a limited number of first-line chemotherapy cycles, highly debatable since, in practice, treatment is continued until disease progression or intolerance,
  • the choice of primary endpoint (progression-free survival), the clinical relevance of which can be criticised in the context of metastatic pancreatic cancer,
  • the safety profile of this treatment as maintenance therapy (around one in three patients (39.6%) had grade ≥ 3 adverse events),

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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