Scheduling delegate's final decisions. ACMS/ACCS, December 2015

Scheduling medicines and poisons

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8 December 2015

2.1 Tofacitinib

Part B - Final decisions on matters not referred to an expert advisory committee

2. New Chemical Entities – Medicines for human therapeutic use

2.1 Tofacitinib

Scheduling proposal

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

Tofacitinib is a JAK1, 2 and 3 kinase inhibitor with some limited inhibitory activity against tyrosine kinase 2 (TyK2).

Tofacitinib is indicated for the treatment of the signs and symptoms of moderate to severe active rheumatoid arthritis in adults who have had an inadequate response or are intolerant to methotrexate. Tofacitinib can be used alone or in combination with nonbiological DMARDs, including methotrexate.

Therapy with tofacitinib should be initiated and monitored by a rheumatologist or specialist physician with expertise in the management of rheumatoid arthritis.

The delegate decided to make a delegate-only decision in including tofacitinib to Schedule 4. The Advisory Committee on Medicines Scheduling (ACMS) was not consulted.

Scheduling status

Tofacitinib is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

Tofacitinib is not classified in New Zealand.

Delegate's considerations

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

  • The new drug application.
  • The TGA evaluation report.
  • The advice of the Advisory Committee on Prescription Medicines.
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • The Scheduling Policy Framework scheduling factors.
Delegate's final decision

The delegate has made a final decision to amend the SUSMP to include tofacitinib in Schedule 4, with an implementation date of 1 February 2016.

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; (b) the purposes and the extent of use; (c) the toxicity of; and (e) the potential for abuse of tofacitinib.

The delegate decided that the reasons for the final decision comprise of the following.

  • Tofacitinib is a new chemical entity with no clinical experience in Australia.
  • The risks and benefits of the medicine have been considered and are outlined in the Product Information, Delegate's Request for ACPM advice and the TGA evaluation reports.
  • The indication is for the treatment of the signs and symptoms of moderate to severe active rheumatoid arthritis in adults who have had an inadequate response or are intolerant to methotrexate. Tofacitinib can be used alone or in combination with nonbiological DMARDs, including methotrexate. Therapy with tofacitinib should be initiated and monitored by a rheumatologist or specialist physician with expertise in the management of rheumatoid arthritis.
  • Experience of its use is limited in Australia.
  • It is proposed for use in the community.
  • The drug has specific toxicities related to its immunosuppressive effect (infection, malignancy) and other concerns which are discussed in the Product Information. It has been placed in Pregnancy Category D as preclinical studies indicated teratogenic effects and there is limited experience in pregnant women.
  • The medicine has risks that require medical intervention, evaluation and monitoring by a medical practitioner.
  • Treatment with tofacitinib should be initiated and monitored by a rheumatologist or specialist physician with expertise in the management of rheumatoid arthritis.
  • Labelling needs to comply with the requirements for a prescription only medicine. Medicine is packed as 5 mg film-coated tablets in blisters and bottles.
  • It does not appear to produce dependency and the abuse potential appears to be low.
Schedule entry
Schedule 4 – New Entry

TOFACITINIB.

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