VELTASSA (patiromer)

Key points

Approval of reimbursement for the treatment of hyperkalaemia in adults.

Therapeutic improvement?

No therapeutic improvement.

Role in therapeutic strategy?

For the long-term treatment of hyperkalaemia or in cases in which gradual blood potassium reduction is possible, a low-potassium diet, thiazide diuretics or loop diuretics, gastrointestinal potassium exchange resins and/or where applicable, reduction or discontinuation of potassium-elevating medicinal products (RAAS inhibitors) are recommended. The aim of long-term treatment is to prevent recurrences of hyperkalaemia by correcting modifiable underlying causes (such as sources of potassium intake or metabolic acidosis), and by controlling the serum potassium concentration.

Role of VELTASSA (patiromer) in the therapeutic strategy:

The new data submitted based essentially on exploratory analyses and on observational studies are not likely to modify the Committee’s previous assessment of VELTASSA (patiromer) (see CT opinion of 20/02/2019).

VELTASSA (patiromer) is a first-line treatment for hyperkalaemia, in the same way as the other cation-exchange resins available.

The Committee upholds its opinion that, although VELTASSA (patiromer) may have a different taste to other cation-exchange resins, no comparative clinical study has been carried out to demonstrate its superiority over these alternatives in terms of improving compliance or quality of life. In addition, VELTASSA (patiromer) proprietary medicinal products contains sorbitol as part of the counterion complex (4 g per 8.4 g of patiromer). It should be noted that the other cation-exchange resins available (KAYEXALATE and RESIKALI) have been the subject of warnings and precautions for use when associated with sorbitol (to prevent constipation) due to rare cases of onset of intestinal necrosis. No cases of colonic necrosis have been reported in clinical studies with VELTASSA (patiromer). The duration of the studies (not more than 52 weeks), and the number of patients included are insufficient to rule out this risk given the rareness of this complication; however, international pharmacovigilance data have not demonstrated any new signals to date.