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Scheduling delegate's final decisions, January 2017

Scheduling medicines and poisons

16 January 2017

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2.1. Ocrelizumab

Final decisions on matters not referred to an expert advisory committee

2. New Chemical Entities – medicines for human therapeutic use

2.1. Ocrelizumab

Scheduling proposal

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

Substance summary

Ocrelizumab is a humanised monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage.

Ocrelizumab is indicated for the treatment of patients with relapsing forms of multiple sclerosis (RMS) to suppress relapses and disease progression (clinical and subclinical disease activity). Ocrelizumab is indicated for the treatment of patients with primary progressive multiple sclerosis (PPMS) to delay disease progression and reduce deterioration in walking speed. The delegate decided to make a delegate-only decision. The Advisory Committee on Medicines Scheduling was not consulted.

Scheduling status

Ocrelizumab is not specifically scheduled in the current Standard for the Uniform Scheduling of Medicines and Poisons.

Ocrelizumab is captured in the current Standard for the Uniform Scheduling of Medicines and Poisons under the following group entry:

Schedule 4

MONOCLONAL ANTIBODIES for therapeutic use except:

  1. in diagnostic test kits; or
  2. when separately specified in these Schedules.
International regulations

Ocrelizumab is not classified in New Zealand.

Delegate's consideration

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; and
  • The new drug application.

The delegate noted that currently there are no issues of concern that require additional control other than by inclusion in Schedule 4.

Delegate's final decision

The delegate has made a final decision to amend the Poisons Standard to include ocrelizumab 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

OCRELIZUMAB.

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; and (d) the dosage, formulation, labelling, packaging and presentation of a substance

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

  • It is a new chemical entity with no clinical experience in Australia.
  • It is an immune suppressant and use of which will require regular monitoring.
  • Strong and fairly specific immune suppressant for treatment of Multiple Sclerosis.
  • It is a strong immune suppressant, requires intravenous infusion and observation following infusion to reduce adverse effects of any infusion reactions.
  • Must be infused intravenously.

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