EVRENZO (roxadustat) - Anémie symptomatique

Key points

Favourable opinion for maintenance of reimbursement in the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) only in adult patients not already treated with an erythropoiesis-stimulating agent (ESA), not on dialysis or on dialysis for less than 4 months.

Unfavourable opinion for reimbursement in the other MA populations, i.e.:

• all patients already receiving ESA treatment, regardless of whether they are on dialysis or not,
• patients on dialysis for at least 4 months not previously treated with an ESA.

What therapeutic improvement?

No therapeutic improvement compared to erythropoiesis-stimulating agents (ESA).

Role in the care pathway?

Chronic kidney disease (CKD) causes anaemia, the prevalence and seriousness of which increases with the severity of the CKD.
Correcting haemoglobin levels should avoid the need for blood transfusions, limit the cardiovascular complications of anaemia, improve quality of life and prolong survival.
In any patients with chronic kidney disease and haemoglobin levels ≤ 10 g/dL on two assays performed five days apart, it is recommended to:

• Investigate for an extra-renal cause of anaemia, with the main cause being iron deficiency;
• Treat the iron deficiency, if present;

Treatment with an erythropoiesis-stimulating agent (ESA: epoietin alfa, beta or delta, or darbepoeitin
alfa) should only be proposed:

• after verifying the absence of a curable cause for anaemia other than kidney disease and, if applicable, only if iron supplementation therapy is inadequately effective
• and only if the anaemia is symptomatic (asthenia, dyspnoea, angina). Reduced haemoglobin levels alone are not sufficient.

The administered dose should be individually tailored in order to maintain haemoglobin levels within the target range of 10 to 12 g/dL in adults and 9.5 to 11 g/dL in children (European SPC for erythropoietins).

Increasing haemoglobin levels to above 12 g/dL should be avoided. That is because haemoglobin levels > 13 g/dL under ESA areassociated with increased risks of myocardial infarction, hospitalisation for heart failure, stroke and thrombosis of the arteriovenous dialysis fistula, without providing any additional symptomatic benefit.

Transfusions should be avoided as far as possible in patients with chronic kidney disease and, in particular, patients awaiting transplantation (risk of allo-immunisation).

Resistance to erythropoietin may be suspected if the target haemoglobin level is not achieved despite a dose of > 300 IU/kg of epoietin per week or > 1.5 μg/kg of darbepoeitin per week, or if these doses are continuously necessary to maintain the target level.

Role of the medicinal product in the care pathway

• Treatment of symptomatic anaemia associated with chronic kidney disease (CKD) only in adult patients not already treated with an erythropoiesis-stimulating agent (ESA), not on dialysis or on dialysis for less than 4 months.
• 
  EVRENZO (roxadustat) is a first-line treatment, in the same way as ESA, for symptomatic anaemia associated with chronic kidney disease (CKD) in adult patients not already treated with an erythropoiesis-stimulating agent (ESA), not on dialysis or on dialysis for less than 4 months.

Given uncertainties concerning the existence of an additional risk of cardiovascular events and mortality in non-dialysed patients in comparison with placebo, the decision to treat these patients with roxadustat should be based on similar criteria to those that would be applied before ESA therapy.

It is necessary to investigate for any other causes of anaemia and verify that iron reserves are sufficient before initiating treatment with roxadustat.

•  Other clinical situations

EVRENZO (roxadustat) has no role in the care pathway for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in:

• all patients already receiving ESA treatment, regardless of whether they are on dialysis or not,
• patients on dialysis for at least 4 months not previously treated with an ESA.