Patiromer (1) – Veltassa®
Hyperkalemia
Characteristics
| Start date | 01.04.2018 – Marketing authorisation: 19.07.2017 |
|---|---|
| Resolution | 20.09.2018 |
| INN | Patiromer |
| Brand name | Veltassa® |
| Pharm. company | Fresenius Medical Care Nephrologica Deutschland GmbH |
| G-BA Procedure ID | D-351 |
| ATC code | V03AE09 Drugs for treatment of hyperkalemia and hyperphosphatemia (V03AE) |
| DDD | 8.4 g O |
| Therapeutic area | Metabolic diseases |
| Reason for procedure | Initial assessment |
Studies and Results
- Clinical trials
- The benefit assessment is based on the OPAL-HK study submitted by the pharmaceutical manufacturer.
Adult patients with hyperkalaemia
- An additional benefit is not proven.
- On balance, therefore, an additional benefit is not proven.
- Overall assessment
- The randomised, placebo-controlled part of the OPAL-HK study, with a study duration of 8 weeks, was submitted for the benefit assessment.
- The study is not suitable for demonstrating any additional benefit of patiromer compared with the appropriate comparator therapy, as patients in the comparator arm were not treated as part of a patient-individually optimised therapy.
- Consequently, the appropriate comparator therapy has not been implemented.
- Furthermore, the 8-week study duration of the randomised part of the study is considered too short for the chronic treatment situation under assessment.
Courtesy translation only, please refer to the German original.
Associated procedures
| Patiromer (2) | Veltassa® | Fresenius Medical Care Nephrologica Deutschland GmbH | Hyperkalaemia, ≥ 12 to < 18 years | 370–790 | 100% additional benefit not proven | |
| Patiromer (1) | Veltassa® | Fresenius Medical Care Nephrologica Deutschland GmbH | Hyperkalemia | 61,700 | 100% additional benefit not proven |
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