RESUMO
The real-world study of data from the Système National des Données de Santé (French System of Health Data) in relation to therapeutic indications that give entitlement to having Assurance Maladie (Health-Insurance Fund) pay for, or reimburse the cost of, inhibitors of cyclin-dependent kinases 4 and 6 (iCDK4/6) shows that the target population defined by the Haute Autorité de santé (HAS-National Health Authority) has been significantly exceeded ; in addition, there is a gap with respect to reimbursable indications and therapeutic strategy. The HAS has set the upper limit of the eligible population at 5 320 new patients per year, but in 2019, Assurance Maladie reimbursed iCDK4/6-related costs for 10 894 patients, i.e. double the number. Therapeutic strategies are found that do not comply with the opinions of the commission de la transparence (transparency commission) in 30 % of cases, and that do not comply with reimbursable therapeutic indications in 22 % of cases. Patient profiles are not in line with reimbursable indications in terms of age (women aged under 50 and, a priori, non-menopausal) and sex (men) in 14 % of cases. Furthermore, treatment seems to be started at an advanced stage of the disease, based on the number of deaths observed after treatment is started: 13% of patients died in the year following the start of treatment, including 26 % in the first three months. There is a significant volume of treatment being started, but there is also a significant volume of stoppage. One third of patients for whom treatment was started in 2019 had their treatment stopped after less than one year, including half after less than three months.
