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Scheduling delegates' final decisions: NCEs, May 2018
Scheduling medicines and poisons
New Chemical Entities - medicines for human therapeutic use
Delegate's final decision
The delegate's final decision is to amend the Poisons Standard to include pegaspargase in Schedule 4 as follows:
Schedule 4 - New Entry
Implementation date: 1 June 2018
The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate include:
- the risks and benefits of the use of a substance
- Pegaspargase is a new chemical entity with relatively little experience of use in Australia.
- The risks and benefits have been considered with the view reached that benefits outweighed risks at a population level in the proposed indication.
- the purposes for which a substance is to be used and the extent of use of a substance
- Pegaspargase is used as a component of antineoplastic combination therapy in patients with acute lymphoblastic leukaemia, so use is relatively limited.
- the toxicity of a substance
- While pegaspargase has distinct toxicities, these are well characterised and (given the benefits conferred in the target population) are consistent with scheduling as a Schedule 4 medicine.
- the dosage, formulation, labelling, packaging and presentation of a substance
- The dosage, formulation, labelling, packaging and presentation of pegaspargase have been considered and none of these aspects precludes scheduling as a Schedule 4 medicine.
The delegate of the Secretary proposed to amend the Poisons Standard with respect to pegaspargase.
Pegaspargase is not specifically scheduled and is not captured by any entry in the Poisons Standard.
The delegate considered the following in regards to this scheduling:
- Advice on the place in therapy of this medicine;
- Scheduling Policy Framework (SPF 2018); and
- Section 52E(1) of the Therapeutic Goods Act 1989 in particular: (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; and (d) the dosage, formulation, labelling, packaging and presentation of a substance.