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Since 2017, kidney transplant patients have had to deal with the shortage of Belatacept, an anti-rejection treatment. They must therefore resort to other less suitable treatments. What is this shortage due to? What are the consequences for patients?
This is bad news for all patients who have benefited from a transplanted kidney. Nujolix (belatacept) is always hard to find. A shortage, which leads to significant loss of chances for patients.
A beneficial drug in more ways than one
Belatacept, marketed by the BMS laboratory, has long been proven with transplant patients.
It would indeed improve the function of the transplanted kidneys, would reduce the risks of arterial hypertension and diabetes, would prevent the formation of antibodies directed against the graft… and contrary to the other anti-rejection treatments sold in France, it would not be toxic for the kidney.
It is administered by infusion, lasting 30 minutes, every four weeks.
A shortage that has persisted since 2017
As early as 2017, “supply tensions” appeared and persisted when they were only supposed to last a few months. Therefore, a dose quota was put in place.
With the Covid crisis, since May 2020, the drug can be administered at the patient’s home and is covered by Health Insurance. On the other hand, when it is administered in the hospital, it remains the responsibility of the establishment. Result: prescriptions increased as the benefits of the drug were confirmed by several studies. A change in formulation led to a request from the European drug authorities to increase the monthly maintenance dose of the product, leading to an increase in consumption of around 20% and therefore an aggravation of the shortage.
Restricted indications and no new patients put on treatment
Since August 2022, a temporary cessation of this treatment has been decided. New initiations can only be done if other patients stop treatment Priority indications are more restrictive:
- Non-primary function: situation of a kidney which has just been transplanted and which does not restart or very badly
- Thrombotic microangiopathies: acute disease which alters the small vessels of the transplanted kidney and which is aggravated by other anti-rejection treatments
For other indications, patients remain deprived of this drug which could nevertheless be useful to them, in particular for patients who have received a poor quality graft, and those whose graft function is chronically impaired by the toxicity of other drugs. anti-rejection. According to the Renaloo association, “The associated loss of opportunity is already major, grafts that should have been “saved” or improved will continue to deteriorate or will be lost“.
Barely more than 10% of patients can access treatment
The promises of greater imports from the USA and a gradual increase in production do not reassure the association, which is asking for more transparency on the reasons for this shortage, a precise assessment of the loss of chances, accountability of the health authorities. European and French so that the production is in accordance with the needs of the patients…
According to Renaloo, 2,269 people who have received a kidney transplant are currently on belatacept in France, while 20,000 patients could benefit from this treatment (ie 50% of all kidney transplant patients in France).