2023-10-13 17:08:36
✅ Access to belatacept (Nulojix) is a historic battle for renaloo, which seems to be coming to an end.
For more than ten years, we have regularly mobilized to enable the treatment of this anti-rejection medication., which was slow to be reimbursed in France. It remained the responsibility of the hospitals, most of which refused to finance it and therefore refuse to use it.
???? Belatacept has important benefits for patients who can benefit from it:
1. It is not toxic to the kidney, unlike most other older anti-rejection drugs (cyclosporin, tacrolimus). It would thus allow an improvement in the function of the transplanted kidney, an extension of the survival of the graft, but also of the survival of the patient.
2. It helps limit the appearance of donor-specific anti-HLA antibodies (DSA)which contribute to chronic rejection, the leading cause of graft loss.
3. He has fewer side effects than traditional anti-rejections:
It reduces cardiovascular and metabolic complications (arterial hypertension, diabetes, dyslipidemia, hyperuricemia, etc.) which are today the leading cause of mortality following kidney transplantation.It reduces post-transplant diabetes (which concerns 20 to 40% of patients on tacrolimus) is associated with an increase of more than 30% in mortality.It is not neurotoxicunlike ciclosporin and tacrolimus, and helps avoid associated symptoms (tremors, sleep, concentration or mood problems).
4. It is administered intravenously once a month. An infusion lasts approximately 30 minutes. This helps avoid forgetting to take which is the cause of rejection episodes, even if it remains necessary to take other oral medications every day.
As if these financing difficulties were not enough, “supply tensions”, which appeared from 2017, linked to the manufacturing conditions of the drug, have gradually made its access even more complex.
✅ Reimbursement issues were largely resolved in 2020, and belatacept might finally be administered in patients’ homes.
But supply tensions gradually increased and led to a dramatic situation in 2022.where any new initiation of treatment was first prohibited, then limited to cases of extreme emergency.
???????? We also noted at the beginning of 2022 that access to treatment seemed much easier in other countries than in France. We alerted the ANSM to this unequal situation.
Belatacept was finally added to the list in February 2022, allowing hospitals to no longer have it at their expense. Its prescription conditions have slowly been relaxed until summer 2023.
✅ A few days ago, the BMS laboratory, which markets belatacept, wrote to all transplant teams in France to inform them that there are now no more restrictions on its prescription.
???? All patients who need it can now receive it.
This is of course very good news, and hopefully the end of a long fight.
The fact remains that belatacept is currently only used by a minority of French transplant teams, which poses important questions of access to innovation for patients who might or should benefit from it. Now that there is no longer any obstacle to its prescription, we will be very vigilant as to the evolution of this situation.
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#Belatacept #shortage #finally
