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PBS Prescribing

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Approved product information

PBS codes

  • 13275Q VOSORITIDE, vosoritide 400 microgram injection [10 vials] (&) inert substance diluent [10 x 0.5 mL syringes], 1 pack (VOXZOGO®)
  • 13274P VOSORITIDE, vosoritide 560 microgram injection [10 vials] (&) inert substance diluent [10 x 0.7 mL syringes], 1 pack (VOXZOGO®)
  • 13270K VOSORITIDE, vosoritide 1.2 mg injection [10 vials] (&) inert substance diluent [10 x 0.6 mL syringes], 1 pack (VOXZOGO®)

Prescriber

  • Must be treated by a medical specialist, experienced in the management of achondroplasia; OR
  • Must be treated by a paediatrician in consultation with a medical specialist experienced in the management of achondroplasia.

Clinical criteria – initial treatment

  • Patient must have a diagnosis of achondroplasia, confirmed by appropriate genetic testing. Appropriate genetic testing constitutes testing for FGFR3 gene mutation. AND
  • Patient must not have evidence of growth plate closure demonstrated by at least one of the following:
    i bilateral lower extremity X-rays (proximal tibia, distal femur). X-rays and dates (date commenced treatment and date of X-ray) must be documented in the patient’s medical records.
  • In patients where puberty has not commenced, X-rays must be taken within 2 years of commencing treatment with vosoritide. Additional radiographic evidence is not required until patient has begun puberty.
  • In patients where puberty has commenced, X-rays must be taken within 6 months of completing an authority application.
    ii 1.5 cm/year as assessed over a period of at least 6 months.

Quantity

  • 30 vials + 5 repeats
  • request the appropriate strength, based on the weight of the patient, according to the specified dosage in the approved Product Information (PI).

Continuing treatment

  • As above AND
  • Patient must have received PBS subsidised vosoritide treatment previously.

Grandfather treatment (transition from non-PBS subsidised treatment) clinical criteria

  • As above AND
  • Patient must have received non-PBS subsidised vosoritide treatment for this condition prior to 1 May 2023.
    This grandfather restriction will cease to operate after 30 April 2024.