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Scheduling delegate's final decisions: NCEs, April 2016

Scheduling of medicines and poisons

28 April 2016

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1.6 Idarucizumab

Final decisions on matters not referred to an expert advisory committee

1. New Chemical Entities - medicines for human therapeutic use

1.6 Idarucizumab

Scheduling proposal

The proposal is to include idarucizumab, 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 idarucizumab, a new chemical entity for a human therapeutic medicine.

The Advisory Committee on Medicines Scheduling was not consulted.

Substance summary

Idarucizumab binds specifically to dabigatran and reverses its anticoagulant effect. It will not reverse the effects of other anticoagulants.

Idarucizumab is indicated for the patients treated with dabigatran etexilate when rapid reversal of the anticoagulant effects of dabigatran is required:

  • For emergency surgery/urgent procedures
  • In life-threatening or uncontrolled bleeding.
Scheduling status

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

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 idarucizumab 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 marketing experience in Australia. There have been patients enrolled in a clinical trial in Australia.
  • The risks and benefits of the medicine have been considered and are outlined in the Product Information and the TGA Evaluation reports.
  • Idarucizumab is indicated in patients treated with dabigatran etexilate when rapid reversal of the anticoagulant effects of dabigatran is required:
    • For emergency surgery/urgent procedures
    • In life-threatening or uncontrolled bleeding
  • It has no previous us in Australia outside the clinical trial setting but has recently been approved overseas for the same indication.
  • It is proposed for use in the hospital.
  • Idarucizumab is a humanised antibody fragment (Fab) molecule derived from an IgG1 isotype molecule directed against the direct thrombin inhibitor dabigatran.
  • The medicine has risks that require medical intervention, evaluation and monitoring by a medical practitioner.
  • Labelling needs to comply with the requirements for an injectable prescription only medicine.
  • It does not appear to produce dependency and the abuse potential is low.

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

Schedule entry

Schedule 4 - New Entry

IDARUCIZUMAB

Implementation date: 1 June 2016.

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