- Date 09 March 2022
- Documents : 7
- Economic analysis
- History
Listen
Reason for request
Key points
Favourable opinion for reimbursement in the treatment of adult patients with advanced gastrointestinal stromal tumour (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib.
What therapeutic improvement?
Therapeutic improvement in the management of GIST as fourth-line treatment in adults.
Role in the care pathway?
According to national and international guidelines (Thésaurus national de cancérologie digestive [French National Thesaurus of Gastrointestinal Oncology], ESMO and NCCN), the standard of care for unresectable or metastatic GIST is based on imatinib (GLIVEC), which is the reference first-line treatment. The tolerability of imatinib is dose-dependent. In the event of disease progression following resistance or intolerance to imatinib, the second-line treatment is sunitinib (SUTENT) and the third-line treatment is regorafenib (STIVARGA). Currently, no standard treatment is recommended for fourth and later-line therapy.
Role of the medicinal product in the care pathway
QINLOCK (ripretinib) is the only fourth or later-line treatment with an MA and for which the benefit has been established in adult patients with advanced gastrointestinal stromal tumour (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib.
It is a novel tyrosine kinase inhibitor that inhibits KIT proto-oncogene receptor tyrosine kinase and PDGFRA kinase, including wild type mutations.
Clinical Benefit
| Substantial |
The Committee deems that the clinical benefit of QINLOCK (ripretinib) is substantial in the MA indication. |
Clinical Added Value
| moderate |
Considering: - demonstration of the superiority of ripretinib 150 mg/d compared to placebo in terms of progression-free survival (27.6 weeks (CI95% [20.0; 29.9]) with ripretinib and 4.1 weeks (CI95% [4.0; 7.3]) with placebo, HR = 0.15; CI95% [0.09; 0.25]) in a study of good methodological quality (controlled, randomised, double-blind), - the favourable safety profile of ripretinib, and - the unmet medical need in fourth and later-line treatment, But taking into account:
the Transparency Committee considers that QINLOCK (ripretinib) provides a moderate clinical added value (CAV III) in the treatment of unresectable or metastatic GIST as fourth-line therapy. The Transparency Committee highlights the clinical development efforts implemented to assess the clinical benefit in this rare disease at this stage of its progression. |
Avis économique
Ce produit a fait l'objet d'un avis économique rendu par la Commission d'évaluation économique et de santé publique le 19 juillet 2022.
L’évaluation porte sur une indication superposable à celle de l’AMM obtenue le 18/11/2021 en procédure centralisée.
L’efficience du produit n’est pas démontrée sur la population pour laquelle une ASMR II est revendiquée en raison d’une réserve majeure relative à la méthode d’estimation de la survie globale du traitement évalué.
Selon les termes de l’accord cadre du 5 mars 2021 conclu entre le CEPS et le Leem, lorsque le CA prévisionnel en 2e année de commercialisation est estimé inférieur à 50 millions d’euros HT, le choix d’intégrer dans le dossier une analyse d’impact budgétaire est laissé à la libre appréciation de l’industriel. Dans le cadre de ce dossier, aucune analyse d’impact budgétaire n’a été fournie par l’industriel.
> QINLOCK - Avis économique (pdf)
