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French health authorities will now reimburse the cost of Sibnayal, a medication used to treat distal renal tubular acidosis (dRTA), a rare kidney disorder, as of February 13, 2026. The decision, announced earlier this month, extends coverage to both public and private healthcare settings, with a reimbursement rate of 30% for the medication and approval for use within public healthcare systems, according to official statements.
Sibnayal, which combines potassium citrate and potassium hydrogen carbonate, was initially approved by the European Medicines Agency (EMA) in April 2021 and by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in June 2021. The medication is available in two dosages – 8 mEq and 24 mEq – in the form of prolonged-release granules administered in sachets. Prior to this month, however, it had not been covered by French national health insurance.
The French Transparency Committee (Comité de la Transparence, CT) issued a favorable opinion on reimbursement in December 2021, assigning Sibnayal a “moderate” service medical rendu (SMR), indicating a worthwhile clinical benefit. The committee determined that Sibnayal offered a “minor” improvement (ASMR IV) over existing treatments for dRTA, which typically involve compounded medications prepared by pharmacists.
Sibnayal is indicated for use in adults, adolescents, and children aged one year and older. The prolonged-release formulation is designed to provide therapeutic effect over a 12-hour period. The granules are intended to be taken orally, preferably with meals, and can be administered directly into the mouth with a full glass of water. Alternatively, for patients who have difficulty swallowing, the granules can be mixed with small amounts of soft foods like applesauce or yogurt, provided the mixture is consumed immediately and not chewed.
Dosage is determined based on a patient’s age and weight, and is incrementally adjusted to achieve optimal control of metabolic acidosis, as measured by plasma bicarbonate levels. Initiating doses range from 1 mEq/kg/day for adults and adolescents to 4 mEq/kg/day for children aged one to three years. When switching patients from other alkalizing therapies, treatment with Sibnayal should initiate at the previously used dosage, with titration as needed.
Patients have been advised not to mix the granules with hot liquids or alcohol, nor to chew or crush them, as this could compromise the prolonged-release mechanism and potentially lead to adverse effects. The presence of undissolved granules in stool is considered normal and does not affect the medication’s efficacy.
The medication is classified as a List I drug in France. A box of 60 sachets of Sibnayal 8 mEq has a public price of 71.46 euros, while a box of 60 sachets of the 24 mEq formulation costs 213.41 euros. Both formulations are subject to the 30% reimbursement rate. Sibnayal is marketed by Advicenne S.A.
