1.14 Palbociclib

Final decision:

The delegate's final decision is to amend the Poisons Standard to include palbociclib in Schedule 4 as follows:

Implementation date: 1 June 2018

Reasons:

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate include:

1. 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.
2. 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.
3. 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.
4. 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.
5. the potential for abuse of a substance
   • The potential for abuse was considered low.