Burosumab

[MAF] Burosumab (Crysvita) Solution For Injection 10 mg/mL, 20 mg/mL, and 30 mg/mL

1. Additional clinical criteria applies
   
   Treatment of X-linked hypophosphataemia (XLH) in adults and children 1 year of age and older.

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04/06/2024 Burosumab for treating X-linked hypophosphataemia

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

[R] 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.

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This section displays recommendation from the MOH Drug Advisory Committee for subsidy and appropriate use of the drug as extracted from the Agency for Care Effectiveness (ACE) Drug Guidances. As this website is updated monthly, please refer to the ACE website for the most updated information.