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Scheduling delegate's final decisions: ACMS, July 2014

Scheduling of medicines & poisons

3 July 2014

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Part B - Final decisions on matters not referred to an expert advisory committee (New chemical entities)

3. New chemical entities - medicines for human therapeutic use

3.1 Insulin glargine

Scheduling proposal

The new chemical entities delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of insulin glargine, a new chemical entity for a human therapeutic medicine.

Insulin glargine is an insulin analogue.

Insulin glargine is indicated for once-daily subcutaneous administration in the treatment of type 1 diabetes mellitus in adults and children and type 2 diabetes mellitus in adults who require insulin for the control of hyperglycaemia.

The delegate decided to make a delegate-only decision to include this to Schedule 4. The Advisory Committee on Medicines Scheduling was not consulted.

Scheduling status

Insulin glargine is not specifically scheduled in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) but may be captured by the following group/class entry:

Schedule 4

INSULINS.

Insulins are classified as a prescription medicine in New Zealand but not insulin glargine.

Delegate's consideration

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

  • The new drug application.
  • The TGA evaluation report.
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors.
Delegate's final decision

The delegate has made a final decision to amend the SUSMP to include insulin glargine in Schedule 4, with an implementation date of 1 October 2014.

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 of a substance.

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

  • It is a new chemical entity and a biosimilar of insulin glargine with no clinical/marketing experience in Australia.
  • Insulin glargine is an insulin analogue indicated for once-daily subcutaneous administration in the treatment of type 1 diabetes mellitus in adults and children and type 2 diabetes mellitus in adults who require insulin for the control of hyperglycaemia.
  • The toxicity profile of the substance meets the factors in the SPF for Schedule 4.
  • The product contains an insulin glargine 100 IU/mL solution for injection presented as cartridges. The cartridges conventional glass cartridges, contain 3mL of injection solution, have a proposed 28 day open shelf life, and are supplied in packs of 1, 2, 5, and 10.
  • Insulin glargine is an insulin analogue with a peakless glucose lowering profile and a prolonged duration of action that permits once daily dosing.
  • The product containing insulin glargine is for individual patient use only, is given subcutaneously once a day and is not intended for intravenous administration.
  • The substances does not appear to produce dependence.
Schedule entry

Schedule 4 - New entry

INSULIN GLARGINE.

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3.2 Nalmafene

Scheduling proposal

The new chemical entities delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of nalmafene, a new chemical entity for a human therapeutic medicine.

Nalmafene is an opioid antagonist.

Nalmefene has been proposed for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high Drinking Risk Level (DRL), without physical withdrawal syndrome and who do not require immediate detoxification. The product should be prescribed in conjunction with psychosocial support focused on treatment adherence and reducing alcohol consumption.

The delegate decided to make a delegate-only decision to include this to Schedule 4. The Advisory Committee on Medicines Scheduling was not consulted.

Scheduling status

Nalmafene is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

Nalmafene is not classified in New Zealand.

Delegate's consideration

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

  • The new drug application.
  • The TGA evaluation report round 1.
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors.
Delegate's final decision

The delegate has made a final decision to amend the SUSMP to include nalmafene in Schedule 4, with an implementation date of 1 October 2014.

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; and (b) the purpose and the extent of use of a substance.

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

  • It is a new chemical entity with no clinical or marketing experience in Australia.
  • The proposed indication requires that individuals taking nalmafene be under medical supervision.
Schedule entry

Schedule 4 - New entry

NALMAFENE.

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