Added benefit of sucroferric oxyhydroxide is not proven

G-BA specifies appropriate comparator therapy

If the kidney cannot regulate the salt, water and acid-base balance anymore, phosphate, among other substances, accumulates in the blood (hyperphosphataemia). Phosphate binders aim to help bind the phosphate ingested with the food before it enters the blood stream and reduce complications such as cardiovascular disease.

The Federal Joint Committee (G-BA) distinguished between patients with and without contraindication to calcium-based phosphate binders: If calcium-based phosphate binders are not an option, sucroferric oxyhydroxide was to be compared with sevelamer or lanthanum carbonate. If there is no contraindication, these two drugs as well as calcium-based phosphate binders are available as comparator therapy.

Drug was over- or underdosed in the studies

In one of the two studies presented (PA-CL-03A), the appropriate comparator therapy (sevelamer) was not used in compliance with the approval, and the starting dose was exceeded in more than half of the patients (approximately 64%). Furthermore, individual dose adjustment, as recommended by the approval, was not allowed in the sevelamer treatment or in the sucroferric oxyhydroxide treatment. It was also not ensured that additional calcium supplements, vitamin D3 derivatives or their analogues were given to control the development of renal bone disease. However, this is part of the multiple therapeutic approach, which should be applied when administering sucroferric oxyhydroxide according to the approval.

In the second study (PA-CL-05A/05B), the starting dose of both drugs was not in compliance with the approval. This resulted in an underdosing in all patients in the sucroferric oxyhydroxide arm, and in an overdosing in roughly half of the patients (approximately 51%) in the sevelamer arm. Hence none of the studies presented is suitable for assessing the added benefit of sucroferric oxyhydroxide versus the appropriate comparator therapy.