New Chemical Entities - medicines for human therapeutic use
1.18 Secukinumab
On this page: Delegate's final decision | Scheduling proposal | Scheduling status | Delegate's consideration
Delegate's final decision
Final decision:
The delegate's final decision is to amend the Poisons Standard to include secukinumab in Schedule 4 as follows:
Schedule 4 - New Entry
SECUKINUMAB.
Implementation date: 1 June 2018
Reasons:
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
- Secukinumab is an antibody against interleukin-17A, initially approved for use in some psoriasis patients, with use subsequently expanded to some patients with psoriatic arthritis and ankylosing spondylitis. In these uses 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
- Secukinumab was initially approved for use in some psoriasis patients (adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy), with use subsequently expanded to some patients with psoriatic arthritis and ankylosing spondylitis. Accordingly, the extent of use of the product is relatively limited.
- the toxicity of a substance
- Secukinumab 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 secukinumab have been considered and none of these aspects precludes scheduling of Secukinumab as Schedule 4.
Scheduling proposal
The delegate of the Secretary proposed to amend the Poisons Standard with respect to secukinumab.
Scheduling status
Secukinumab 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:
Schedule 4
MONOCLONAL ANTIBODIES for therapeutic use except:
- in diagnostic test kits; or
- when separately specified in these Schedules.
Delegate's consideration
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.