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Scheduling delegate's final decisions, January 2017

Scheduling medicines and poisons

16 January 2017

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2.8. Sarilumab

Final decisions on matters not referred to an expert advisory committee

2. New Chemical Entities – medicines for human therapeutic use

2.8. Sarilumab

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of sarilumab, a new biological entity for a human therapeutic medicine.

Substance summary

Sarilumab is a fully human monoclonal antibody targeting interleukin-6 receptor alpha (IL-6Rα).

Sarilumab, in combination with non-biologic Disease-Modifying Anti-Rheumatic Drugs (DMARDs), is indicated for the treatment of moderate to severe Rheumatoid Arthritis in adult patients who have had an inadequate response or intolerance to one or more DMARDs.

ABN – Sarilumab

Scheduling status

Sarilumab is not specifically scheduled and is not captured by any entry in the current Poisons Standard.

International regulations

Sarilumab is not classified in New Zealand, Canada or the USA.

Delegate's consideration

The delegate made a delegate-only decision; hence the Advisory Committee on Medicines Scheduling was not consulted.

The delegate considered the following in regards to this application for scheduling:

  • Subsection 52E(1) of the Therapeutic Goods Act 1989;
  • The Scheduling Policy Framework (2015) scheduling factors;
  • The TGA evaluation report; and
  • The new drug application.
Delegate's final decision

The delegate has made a final decision to amend the Poisons Standard to include sarilumab in Schedule 4, with an implementation date of 1 February 2017.

The delegate has decided that the wording for the schedule entry will be as follows:

Schedule 4 – New Entry

SARILUMAB.

The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are: (a) the risks and benefits of the use of a substance; (b) the purpose 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.

The delegate decided that the reasons for the final decision comprise the following:

  • Sarilumab is a new biological entity with no clinical experience in Australia;
  • Sarilumab is a fully human monoclonal antibody targeting interleukin-6 receptor alpha (IL-6Rα);
  • Sarilumab, in combination with non-biologic Disease-Modifying Anti-Rheumatic Drugs (DMARDs), is indicated for the treatment of moderate to severe Rheumatoid Arthritis in adult patients who have had an inadequate response or intolerance to one or more DMARDs;
  • Sarilumab is proposed for use in the hospital and community;
  • Sarilumab has risks that require medical intervention, evaluation and monitoring by a medical practitioner experienced in the diagnosis and treatment of rheumatoid arthritis and use of biological medicines; and
  • The labeling of sarilumab needs to comply with the requirements for a prescription only medicine.

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