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Reason for request
Key points
Favourable opinion for reimbursement in combination with a nonsteroidal aromatase inhibitor and an LHRH agonist as initial hormone therapy in premenopausal women with HR-positive/HER2-negative locally advanced or metastatic breast cancer without any symptomatic and short-term life-threatening organ involvement.
What therapeutic improvement?
Therapeutic improvement compared to hormone therapy used alone.
Role in the care pathway?
In the absence of short-term life-threatening symptomatic organ metastases, the therapeutic strategy is based on hormone therapy.
According to the guidelines, tamoxifen is a first-line option in premenopausal women, in the absence of prior treatment with an antioestrogen at the advanced-stage, i.e., with cancer diagnosed at the metastatic stage or with late relapse following adjuvant treatment with tamoxifen. Other hormone therapies may also be used at the advanced stage, depending on the clinical situation and the treatments previously received by the patient.
Role of the medicinal product in the care pathway
Given the now demonstrated superiority of the addition of KISQALI (ribociclib) to hormone therapy combined with an LHRH agonist compared to hormone therapy alone in terms of overall survival, co-administration of KISQALI with letrozole or anastrozole and an LHRH agonist is the treatment option to be favoured in premenopausal women with HR-positive/HER2-negative locally advanced or metastatic breast cancer without any symptomatic and short-term life-threatening organ involvement.
The decision to prescribe KISQALI (ribociclib) must take into consideration its hepatic, cardiac and haematological safety profile.
Clinical Benefit
| Substantial |
Le service médical rendu par KISQALI (ribociclib) reste important chez les femmes non ménopausées ayant un cancer du sein localement avancé ou métastatique, RH+/HER2-, en association à un inhibiteur de l’aromatase non stéroïdien (létrozole ou anastrozole) et à un agoniste de la LH-RH comme traitement initial à base d’hormonothérapie, en l’absence d’atteinte viscérale symptomatique menaçant le pronostic vital à court terme. |
Clinical Added Value
| minor |
Compte tenu :
et malgré :
la Commission considère que l’ajout de KISQALI au létrozole ou à l’anastrozole et à un agoniste de la LH-RH apporte une amélioration du service médical rendu mineure (ASMR IV) par rapport à une hormonothérapie seule dans le traitement du cancer du sein localement avancé ou métastatique, RH+/HER2-, chez la femme non ménopausée sans atteinte viscérale symptomatique menaçant le pronostic vital à court terme. |
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