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RENVELA (sévélamer (carbonate de))

New indication
Opinions on drugs - Posted on Mar 12 2020

Reason for request

New indication

  • Key points

Favourable opinion for reimbursement only as second-line treatment for the control of hyperphosphataemia in paediatric patients (>6 years of age and a body surface area (BSA) of >0.75 m2) with chronic kidney disease. RENVELA should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.

  • What therapeutic improvement?

No clinical added value in its indication.

 

  • Role in the care pathway?

The treatment of hyperphosphataemia in chronic kidney disease (CKD) requires a combination of several measures: dietary control of phosphorus intake, dialysis and, usually, treatment with a phosphorus chelating agent. In practice, a calcium salt is generally prescribed as first-line treatment (off-label), as in adults, and used in the context of pharmacy compounded preparations.

Role of the medicinal product in the care pathway

RENVELA (sevelamer carbonate) is a second-line phosphorus chelating agent to be used preferentially in the event of adverse effects such as hypercalcaemia following the use of a calcium-based chelating agent as first-line treatment.

  • Special recommendations

The 2.4 g sachet packaging form is not appropriate for the prescribing conditions in this indication and in accordance with the dosage and treatment duration. The SPC specifies that “if a dose of 0.4 g is to be administered, please use the dedicated 0.8 g powder presentation with dosing spoon”. However, given that the contents of the sachet must be used within 30 minutes following dilution and cannot be stored, this leads to substantial product losses.

In practice, in children, sevelamer is usually started at a dose of 800 mg two to three times daily, it being possible to increase this dose up to 1,600 mg per day. Therefore this presentation is not suitable for young children. In young children, the RENVELA 0.8 g sachets presentation, also available, is more appropriate.


Clinical Benefit
Substantial

The clinical benefit of RENVELA 2.4 g powder for oral suspension in sachets is substantial only as second-line treatment in the indication “for the control of hyperphosphataemia in paediatric patients (>6 years of age and a body surface area (BSA) of >0.75 m2) with chronic kidney disease”.

Clinical Added Value
no clinical added value

Considering:

  • the demonstrated superiority of sevelamer carbonate (RENVELA) on the reduction of blood phosphorus levels after 2 weeks compared to placebo in a randomised, double-blind trial in children - mainly adolescents - with hyperphosphataemia associated with chronic kidney disease,
  • the limited clinical relevance of the result for this primary outcome measure, assessed in the very short term (2 weeks) in this chronic disease,
  • the limited interest of the exploratory results of the additional, non comparative follow-up study with only 27% of the children demonstrating normalisation of phosphorus levels at 6 months,
  • the lack of any demonstrated impact on the quality of life of the children,
  • the absence of demonstration of an impact on morbidity and mortality, the study duration not enabling this to be assessed,
  • and the absence of comparative data versus another phosphorus chelating agent containing a calcium salt (carbonate, acetate),

the Transparency Committee considers that RENVELA provides no clinical added value (CAV V) as second-line treatment for the control of hyperphosphataemia in paediatric patients (>6 years of age and a body surface area (BSA) of >0.75 m2) with chronic kidney disease.

 

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