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Slow-release potassium bicarbonate–potassium citrate for treating distal renal tubular acidosis

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1 Recommendations

1.1 Slow-release potassium bicarbonate–potassium citrate is not recommended, within its marketing authorisation, for treating distal renal tubular acidosis in people 1 year and over.

1.2 This recommendation is not intended to affect treatment with slow-release potassium bicarbonate–potassium citrate that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop. For children and young people, this decision should be made jointly by them, their clinician, and their parents or carers.

Why the committee made these recommendations

Standard care for distal renal tubular acidosis is alkalinising therapy used outside its UK marketing authorisation.

The clinical trials of slow-release potassium bicarbonate–potassium citrate were short, small, not done in the UK and provided no head-to-head data, so the results are highly uncertain. Because of this uncertainty, it is not possible to tell whether slow-release potassium bicarbonate–potassium citrate is more effective than standard care.

There are also limitations with the economic model including issues with its structure and the sources of evidence used to inform it. Because of these limitations and the uncertainty in the clinical evidence, the cost-effectiveness estimates are uncertain. Also, the most likely estimates are much higher than what NICE usually considers an acceptable use of NHS resources. So, slow-release potassium bicarbonate–potassium citrate is not recommended.