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Scheduling delegate's final decisions: NCEs, April 2016

Scheduling of medicines and poisons

28 April 2016

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1.3 Alirocumab

Final decisions on matters not referred to an expert advisory committee

1. New Chemical Entities - medicines for human therapeutic use

1.3 Alirocumab

Scheduling proposal

The proposal is to include alirocumab, a new chemical entity for a human therapeutic medicine, in Schedule 4 of the SUSMP.

Scheduling application

The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of alirocumab, a new chemical entity for a human therapeutic medicine. The Advisory Committee on Medicines Scheduling was not consulted.

Substance summary

Alirocumab is a fully human monoclonal antibody (IgG1 isotype) that targets PCSK9. Alirocumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture.

Alirocumab is indicated as an adjunct therapy to diet, for long-term use in adult patients with primary hypercholesterolaemia (non-familial and heterozygous familial) to reduce low-density lipoprotein cholesterol (LDL-C). Alirocumab is indicated in combination with a statin (HMG-CoA reductase inhibitor), with or without other lipid-modifying therapy (LMT), in patients not appropriately controlled with a statin. Alirocumab (Praluent) is indicated as monotherapy, or as add-on to other non-statin LMT, in patients who cannot tolerate statins.

Scheduling status

Alirocumab is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons.

Alirocumab is not classified in New Zealand.

Delegate's consideration

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 scheduling factors
  • The TGA evaluation report
  • The advice of the Advisory Committee on Prescription Medicines
  • 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 SUSMP to include alirocumab in Schedule 4, with an implementation date of 1 June 2016.

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; d) the dosage, formulation, labelling, packaging and presentation of a substance and (e) the potential for abuse.

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

  • It is a new chemical entity with no clinical experience in Australia apart from clinical trials.
  • The risks and benefits of the medicine have been considered and are outlined in the Product Information, and the TGA evaluation reports.
  • Alirocumab is indicated for the treatment of patients with primary hypercholesterolaemia to reduce LDL-C cholesterol.
  • It has no previous experience of use in Australia outside the clinical trial setting but has recently been approved overseas.
  • It is proposed for use in the hospital and community.
  • Alirocumab is a fully human monoclonal antibody (IgG1) isotype that targets proprotein converase subtilisin kexin type 9 (PCSK9) and is given by subcutaneous injection.
  • Labelling needs to comply with the requirements for an injectable prescription only medicine.
  • It does not appear to produce dependency and the abuse potential appears low.

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

Schedule entry

Schedule 4 - New Entry


Implementation date: 1 June 2016.

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