- Date 30 June 2021
- Documents : 6
- Economic analysis
- History
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VENCLYXTO (vénétoclax) (Leucémie Aiguë Myéloïde)
Reason for request
Key points
Favourable opinion for reimbursement only in combination with azacitidine, for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.
Unfavourable opinion for reimbursement in combination with a hypomethylating agent other than azacitidine.
What therapeutic improvement?
Therapeutic improvement compared to azacitidine.
Role in the care pathway?
The objective of treatment in patients with AML is to achieve complete remission via an induction treatment (to restore bone marrow function and thereby limit the risk of potentially life-threatening infection and/or bleeding), then to limit the risk and increase the time to relapse via consolidation therapy. The type of treatment is based on eligibility for intensive chemotherapy and potential allogeneic haematopoietic stem cell transplantation. Management is therefore determined by weighing up the objectives and risks, which themselves depend on the characteristics of the patient (general condition, age, comorbidities), the disease (cytogenetic risk group, treatment line) and the availability of a donor.
In subjects who are not eligible for induction chemotherapy, the use of hypomethylating agents (azacitidine and decitabine) or low-dose cytarabine is recommended.
Role of the medicinal product in the care pathway
Considering demonstration of a clinically relevant benefit compared to azacitidine as monotherapy in terms of overall survival, the Transparency Committee considers that VENCLYXTO (venetoclax) in combination with azacitidine is a first-line treatment in adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy.
Given the lack of direct comparative data and the methodological limitations of indirect comparative data, the role of the venetoclax + azacitidine combination versus low-dose cytarabine cannot be determined.
In the absence of data, the combination of VENCLYXTO (venetoclax) with a hypomethylating agent other than azacitidine has no role in the care pathway.
Clinical Benefit
| Substantial |
The Committee deems that the clinical benefit of VENCLYXTO (venetoclax) is substantial in combination with azacitidine for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy; |
| Insufficient |
The Committee deems that the clinical benefit of VENCLYXTO (venetoclax) is insufficient in combination with a hypomethylating agent other than azacitidine to justify public funding cover. |
Clinical Added Value
| moderate |
Considering:
and despite:
the Committee considers that VENCLYXTO (venetoclax) in combination with azacitidine provides a moderate clinical added value (CAV III) compared to azacitidine as monotherapy in the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy.
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AVIS ECONOMIQUE
Ce produit a fait l'objet d'un avis économique validé par la Commission d'évaluation économique et de santé publique le 29 septembre 2021. L’avis économique porte sur la même indication que celle demandée au remboursement mais restreinte par rapport au libellé de l’AMM, à savoir le vénétoclax en association avec l’azacitidine pour le traitement de la leucémie aigüe myéloïde nouvellement diagnostiquée chez des sujets adultes inéligibles à une chimiothérapie intensive.
La CEESP a été en mesure de conclure sur le niveau d’efficience du produit, avec un ratio différentiel coût-résultat (RDCR) de 161 780 €/QALY versus l’azacitidine seule, au prix revendiqué.
L’impact budgétaire associé à l’introduction de l’association vénétoclax + azacitidine représente une augmentation des dépenses de l’assurance maladie dans l’indication de 70% cumulé sur 3 ans. Cette estimation est marquée par une forte incertitude liée à l’intensité de la dose prise de vénétoclax en vie réelle.
> VENCLYXTO - Avis économique (pdf)
