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Scheduling delegate's final decisions, January 2018

Scheduling medicines and poisons

25 January 2018

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1.21. Tipiracil

Scheduling proposal

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

Substance summary

Tipiracil (as tipiracil hydrochloride) is a thymidine phosphorylase inhibitor which increases the bioavailability of trifluridine when co-administered.

Tipiracil (as tipiracil hydrochloride), in combination with trifluridine, is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with, or are not considered candidates for fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.

Scheduling status

Tipiracil (as tipiracil hydrochloride) is not specifically scheduled and is not captured by any entry 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)).

International regulations

Tipiracil (as tipiracil hydrochloride) is not classified in New Zealand and Canada. Tipiracil is listed as a prescription only medicine in the United States of America and the European Union.

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 advice of the Advisory Committee on Prescription Medicines; and
  • 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 tipiracil (as tipiracil hydrochloride) 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

TIPIRACIL.

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; (e) the potential for abuse; and (f) any other matters that the Secretary considers necessary to protect public health.

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

  • Tipiracil is an NCE with no marketing experience in Australia.
  • The potential for abuse of tipiracil (as tipiracil hydrochloride) is unlikely.
  • All matters under subsections 52E(1) have been considered as part of the evaluation and approval process.

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