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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 siltuximab 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
- Siltuximab is indicated for use in some patients with Multicentric Castleman's disease. In this use the benefits are considered to outweigh risks at a population level.
- the purposes for which a substance is to be used and the extent of use of a substance
- Siltuximab is indicated for the treatment of patients with Multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. Accordingly, the extent of use is relatively very small.
- the toxicity of a substance
- Siltuximab has its own distinct toxicities but these have been addressed within the benefit/risk consideration noted above.
- the dosage, formulation, labelling, packaging and presentation of a substance
- The dose regimen, formulation, labelling, packaging and presentation of siltuximab have been considered and none of these aspects precludes scheduling of Siltuximab as Schedule 4.
The delegate of the Secretary proposed to amend the Poisons Standard with respect to siltuximab.
Siltuximab is not specifically scheduled in the Poisons Standard, but as a monoclonal antibody, it is captured by the Schedule 4 entry for monoclonal antibodies as follows:
MONOCLONAL ANTIBODIES for therapeutic use except:
- in diagnostic test kits; or
- when separately specified in these Schedules.
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.