Difelikefalin (1) – Kapruvia®
Pruritus in chronic kidney disease (CKD), haemodialysis patients
Characteristics
| Start date | 01.10.2022 – Marketing authorisation: 25.04.2022 |
|---|---|
| Resolution | 06.04.2023 |
| Limitation date | 15.10.2023 limitation repealed |
| INN | Difelikefalin |
| Brand name | Kapruvia® |
| Pharm. company | Fresenius Medical Care Nephrologica Deutschland GmbH |
| G-BA Procedure ID | D-854 |
| ATC code | V03AX04 Other therapeutic products (V03AX) |
| ICD-10 codes (AIS) | L29.8Other pruritus |
| Alpha-ID codes (AIS) | I131199Uremic pruritus |
| Therapeutic area | Skin diseases Pruitus / Prurigo nodularis |
| Reason for procedure | Initial assessment |
| Specialty | ACT change |
| Therapeutic indication of the resolution |
|---|
|
Kapruvia is indicated for the treatment of moderate to severe pruritus associated with chronic kidney disease in adult hemodialysis patients. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adult hemodialysis patients with moderate to severe pruritus associated with chronic kidney disease (CKD-aP). | Best Supportive Care |
Studies and Results
|
No. of studies
(best subpopulation) |
2 (KALM-1, KALM-2) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. non-ACT + no ITC |
|
Meta analysis
(best subpopulation) |
yes |
| ACT change | 21.03.2023 – Stellungnahme der Fachgesellschaften |
- Clinical trials
- The KALM-1 and KALM-2 studies were submitted for the assessment of the additional benefit of difelikefalin in the treatment of adult haemodialysis patients with moderate to severe pruritus associated with chronic kidney disease (CKD-aP).
- The KALM-1 and KALM-2 studies have a similar study design. In both studies, the double-blind, randomised, head-to-head treatment phase lasted a total of 12 weeks.
Adult haemodialysis patients with moderate to severe pruritus associated with chronic kidney disease (CKD-aP)
- An additional benefit is not proven
- The study duration of just 12 weeks is considered too short within the context of the randomised comparative study phase for the early benefit assessment in a chronic condition.
- Overall assessment
- In summary, the studies submitted by the pharmaceutical manufacturer are not suitable for demonstrating an additional benefit of difelikefalin compared with the appropriate comparator therapy (BSC).
- The study duration of only 12 weeks is considered too short within the context of the randomised comparative study phase for early benefit assessment in a chronic condition. An additional benefit is therefore not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Difelikefalin (1) | Kapruvia® | Fresenius Medical Care Nephrologica Deutschland GmbH | Pruritus in chronic kidney disease (CKD), haemodialysis patients | 3,500–22,000 | 100% additional benefit not proven |
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