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Scheduling delegate's final decisions, January 2018

Scheduling medicines and poisons

25 January 2018

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1.16. Recombinant varicella zoster virus glycoprotein E antigen

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of recombinant varicella zoster virus glycoprotein E antigen, a new chemical (biological) entity (NCE) for a human therapeutic medicine.

Substance summary

Recombinant varicella zoster virus glycoprotein E antigen is a varicella zoster virus antigen based on recombinant technology and will be presented as powder for suspension for injection 50 micrograms.

Recombinant varicella zoster virus glycoprotein E antigen is indicated for the prevention of herpes zoster (HZ) and HZ-related complications, such as post-herpetic neuralgia (PHN), in adults 50 years of age or older.

Scheduling status

Recombinant varicella zoster virus glycoprotein E antigen is not specifically scheduled but is captured by the Schedule 4 class entry for vaccines in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) – the Poisons Standard that was in effect at the time the decision was made (Poisons Standard October 2017 (SUSMP No. 18)) as follows:

Schedule 4

VACCINES.

International regulations

Recombinant varicella zoster virus glycoprotein E antigen is classified as a biological product in Canada and a prescription medicine in New Zealand.

Delegate’s consideration

The delegate decided to make a delegate-only decision. The Advisory Committee on Medicines Scheduling was not consulted.

The delegate considered the following in regards to this application for scheduling:

  • Subsection 52E(1) of the Therapeutic Goods Act 1989;
  • The Scheduling Policy Framework (2015) scheduling factors; and
  • The TGA evaluation report.
  • The new drug application

The delegate noted that currently there are no issues of concern that require additional control other than by inclusion in Schedule 4.

Delegate’s final decision

The delegate has made a final decision to amend the Poisons Standard to include recombinant varicella zoster virus glycoprotein E antigen in Schedule 4, with an implementation date of 1 February 2018.

The delegate has decided that the wording for the schedule entry will be as follows:

Schedule 4 – New Entry

RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN.

The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are: (a) the risks and benefits of the use of a substance; (b) the purpose and the extent of use of a substance; (c) the toxicity of a substance; and (d) the dosage, formulation, labelling, packaging and presentation of a substance.

The delegate decided that the reasons for the final decision comprise the following:

  • Recombinant varicella zoster virus glycoprotein E antigen is an NCE with no clinical or marketing experience in Australia.
  • Active immunisation against herpes zoster.
  • Usage needs to be based on clinical assessment.
  • Presentation will be in compliance with the prescription medicines labelling requirements.

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