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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 palbociclib 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
- 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
- Palbociclib is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: an aromatase inhibitor as initial endocrine-based therapy; or Fulvestrant in patients who have received prior therapy. Therefore use is relatively limited.
- the toxicity of a substance
- While palbociclib has distinct toxicities, these are well characterised and (given the benefits conferred in the target population) are consistent with scheduling as an Schedule 4 medicine.
- the dosage, formulation, labelling, packaging and presentation of a substance
- The dosage, formulation, labelling, packaging and presentation of palbociclib have been considered and none of these aspects precludes scheduling as a Schedule 4 medicine.
- the potential for abuse of a substance
- The potential for abuse was considered low.
The delegate of the Secretary proposed to amend the Poisons Standard with respect to palbociclib.
Palbociclib 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; (d) the dosage, formulation, labelling, packaging and presentation of a substance; and (e) the potential for abuse of a substance.