VELTASSA (patiromer) - Hyperkalaemia

The Committee deems that the clinical benefit of VELTASSA 8.4 g and 16.8 g (patiromer) powder for oral suspension is substantial in “the treatment of hyperkalaemia in adults”.

Considering:

• evidence of efficacy on the reduction and normalisation of serum potassium levels and the prevention of hyperkalaemia recurrences compared to placebo (Transparency Committee opinion of 2019);
• new data in favour of an effect of VELTASSA versus a non-active comparator (placebo) on control of serum potassium levels in heart failure patients with impaired LVEF treated with RAAS inhibitors, but a modest effect size with debatable clinical relevance in the DIAMOND study for the primary endpoint;
• new comparative data, again versus placebo, demonstrating the capacity of VELTASSA to facilitate the continuation of spironolactone in chronic kidney disease patients with resistant hypertension, after 12 weeks of treatment;
• comparative palatability data versus clinically relevant comparators, suggesting the possibility of better compliance with VELTASSA treatment compared to the available alternatives (KAYEXALATE / RESIKALI);
• a safety profile deemed to be acceptable due to the absence of sodium in the composition of VELTASSA, in favour of a better safety in terms of salt and fluid retention; but, nonetheless, a calcium content of the medicinal product that requires monitoring of treatment, and uncertainties with respect to the long-term safety data related to rare but serious digestive complications (possible class effect observed with other potassium chelators, particularly in combination with sorbitol);
• the medical need for effective and better-tolerated new cation-exchange resins;

and:

• the absence of robust comparative data versus the active treatments available demonstrating a superior efficacy of VELTASSA;
• the lack of evidence of an impact on morbidity and mortality and on quality of life;

the Committee deems that VELTASSA 8.4 g and 16.8 g (patiromer) powder for oral suspension provides a minor clinical added value (CAV IV) in the current care pathway for the treatment of hyperkalaemia in adults, in the same way as LOKELMA.