Burosumab for treating X-linked hypophosphataemia

Published on 04 Jun 2024
Last Updated on 04 Jun 2024

Guidance Recommendations

The Ministry of Health’s Drug Advisory Committee has recommended:

• Burosumab 10 mg/mL, 20 mg/mL and 30 mg/mL solution for injection for treating X-linked hypophosphataemia (XLH) in adults and children 1 year of age and older, in line with the following criteria:

  • Patient must have a documented confirmation of PHEX pathogenic variant; or

  • Patient must have a confirmed diagnosis of XLH demonstrated by the presence of all of the following:

    • a serum phosphate concentration below the age adjusted lower limit of normal;

    • current or historical (for those with growth plate fusion) radiographic X-ray evidence of rickets;

    • renal phosphate wasting demonstrated by a ratio of tubular maximum reabsorption rate of phosphate to glomerular filtration rate (TmP/GFR) according to age specific normal ranges using the second morning urine void and paired serum sample measuring phosphate and creatinine; and

  • Patient must be treated by, or in consultation with, a specialist physician experienced in the diagnosis and management of XLH.

Funding status

Burosumab 10 mg/mL, 20 mg/mL and 30 mg/mL solution for injection are recommended for inclusion on the Medication Assistance Fund (MAF) for the abovementioned indication from 1 August 2024.

Burosumab for treating X-linked hypophosphataemia (Published 4 Jun 24) [PDF, 130 KB]

PES Burosumab for X-linked hypophosphataemia (Published 4 Jun 24) [PDF, 100 KB]

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