Patiromer (2) – Veltassa®

Young people aged 12 to 17 with hyperkalaemia

• For adolescents aged 12 to 17 with hyperkalaemia, the additional benefit of patiromer compared with the appropriate comparator therapy is not proven.
• No relevant studies comparing patiromer with the appropriate comparator therapy were identified for the assessment of the additional benefit of patiromer in the treatment of adolescents aged 12 to 17 with hyperkalaemia.
• Nor are there any data available that allow an indirect comparison of the active ingredient under assessment with polystyrene sulphonates.
• In the age cohort of 12- to 17-year-olds relevant to the benefit assessment, the efficacy and safety of patiromer were investigated in 14 study participants over a total period of 28 weeks.
• As no comparison with the specified appropriate comparator therapy was carried out in the single-arm registration study EMERALD, the study is not suitable for the present benefit assessment of patiromer.
• In accordance with the pharmaceutical manufacturer’s assessment, the additional benefit of patiromer compared with the appropriate comparator therapy is therefore considered not to be proven.
• Summary of the assessment
  • No comparative data are available for Patiromer against the appropriate comparator therapy for the target population under consideration.
  • Furthermore, in the EMERALD registration study submitted by the pharmaceutical manufacturer, no comparison with a polystyrene sulphonate (CaPSS or NaPSS) was carried out due to the single-arm study design.
  • Consequently, no conclusions regarding the additional benefit of Patiromer compared with the appropriate comparator therapy can be drawn from the study.
  • An additional benefit is therefore not proven.

Courtesy translation only, please refer to the German original.