Calcifediol (1) – Rayaldee®
Secondary hyperparathyroidism in chronic renal failure
Characteristics
| Start date | 01.02.2022 – Marketing authorisation: 18.08.2020 |
|---|---|
| Resolution | 21.07.2022 |
| INN | Calcifediol |
| Brand name | Rayaldee® |
| Pharm. company | Fresenius Medical Care Nephrologica Deutschland GmbH |
| G-BA Procedure ID | D-767 |
| ATC code | H05BX05 Other anti-parathyroid agents (H05BX) |
| ICD-10 codes (AIS) | N25.8Other disorders resulting from impaired renal tubular function |
| Alpha-ID codes (AIS) | I16639Secondary renal hyperparathyroidism |
| DDD | 30 mcg O |
| Therapeutic area | Metabolic diseases Secondary hyperparathyroidism (sHP) |
| Reason for procedure | Initial assessment – New data exclusivity (known INN) |
| Specialty | ACT change |
| Therapeutic indication of the resolution |
|---|
|
Rayaldee is indicated for the treatment of secondary hyperparathyroidism (sHPT) in adults with stage 3 chronic kidney disease (CKD) and vitamin D deficiency or 4 and vitamin D deficiency. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adult secondary hyperparathyroidism (sHPT) patients with chronic kidney disease stage 3 or 4 and vitamin D deficiency | Paricalcitol |
Studies and Results
|
No. of studies
(best subpopulation) |
2 (CTAP-CL-3001, CTAP-CL-3002) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. non-ACT + no ITC |
|
Meta analysis
(best subpopulation) |
no |
| ACT change | 15.02.2020 – vor Dossiereinreichung |
- Clinical trials
- The CTAP-CL-3001 and CTAP-CL-3002 trials included adult patients with secondary hyperparathyroidism who had stage 3 or 4 chronic kidney disease and were vitamin D-deficient.
Adults with secondary hyperparathyroidism (sHPT) and stage 3 or 4 chronic kidney disease and vitamin D deficiency
- For adults with secondary hyperparathyroidism (sHPT) who have stage 3 or 4 chronic kidney disease and vitamin D deficiency, additional benefit is not proven with calcifediol compared with the appropriate comparator therapy.
- For the assessment of the additional benefit of calcifediol in the treatment of adults with secondary hyperparathyroidism (sHPT) with stage 3 or 4 chronic kidney disease and vitamin D deficiency, the pharmaceutical manufacturer did not submit any suitable data for comparison with the appropriate comparator therapy determined by the G-BA.
- The studies CTAP-CL-3001 and CTAP-CL-3002 are, in line with the pharmaceutical manufacturer’s assessment, not suitable for evaluating the additional benefit of calcifediol compared with the appropriate comparator therapy, as the appropriate comparator therapy was not implemented.
- Overall assessment
- On the basis of the studies submitted, no conclusions can be drawn regarding the additional benefit of calcifediol compared with the appropriate comparator therapy. An additional benefit is therefore not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Calcifediol (1) | Rayaldee® | Fresenius Medical Care Nephrologica Deutschland GmbH | Secondary hyperparathyroidism in chronic renal failure | 146,700–184,300 | 100% additional benefit not proven |
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