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Scheduling delegate's final decisions, June 2017

Scheduling medicines and poisons

29 June 2017

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4.6 Rurioctocog alfa pegol

Part B - Final decisions on matters not referred to an expert advisory committee

New Chemical Entities – medicines for human therapeutic use

4.6 Rurioctocog alfa pegol

Scheduling proposal

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

Substance summary

Rurioctocog alfa pegol is a full-length recombinant factor VIII conjugated to polyethylene glycol.

Rurioctocog alfa pegol is indicated in haemophilia A (congenital factor VIII deficiency) patients for:

  • the control and prevention of bleeding episodes;
  • routine prophylaxis to prevent or reduce the frequency of bleeding episodes; and
  • perioperative management (surgical prophylaxis).

Nomenclature

ABN – Rurioctocog alfa pegol

Scheduling status

Rurioctocog alfa pegol is not specifically scheduled in the current Poisons Standard. However, as a recombinant clotting factor, rurioctocog alfa pegol is exempt from scheduling as it is captured by the Appendix A entry for HUMAN BLOOD PRODUCTS, (iv) clotting factors.

International regulations

Rurioctocog alfa pegol is not specifically classified by Medsafe New Zealand, however may be captured by the entry ‘Blood clotting factors' classified for general sale.

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;
  • The TGA evaluation report; and
  • The new drug application.
Delegate's final decision

The delegate has made a final decision that rurioctocog alfa pegol is exempt from scheduling as it falls under Appendix A – General Exemptions under HUMAN BLOOD PRODUCTS.

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:

  • The potential for abuse of rurioctocog alfa pegol is unlikely.

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