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Scheduling delegate's final decisions: NCEs, April 2016
Scheduling of medicines and poisons
Final decisions on matters not referred to an expert advisory committee
1. New Chemical Entities - medicines for human therapeutic use
The proposal is to include vorapaxar, a new chemical entity for a human therapeutic medicine, in Schedule 4 of the SUSMP.
The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of vorapaxar, a new chemical entity for a human therapeutic medicine. The Advisory Committee on Medicines Scheduling was not consulted.
Vorapaxar is an inhibitor of the PAR-1 receptors on platelets that are activated by thrombin.
Vorapaxar is indicated for the reduction of atherothrombotic events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD).
Vorapaxar is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons.
Vorapaxar is not classified in New Zealand.
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 scheduling factors
- The TGA evaluation report
- 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 SUSMP to include vorapaxar in Schedule 4, with an implementation date of 1 June 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 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; and (e) the potential for abuse.
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.
- 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.
- Vorapaxar, an antagonist of the protease activated receptor-1 (PAR-1), is indicated for the reduction of atherothrombotic events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD).
- It has no previous experience of use in Australia but has been approved for use overseas.
- It is proposed for use in the hospital and community.
- Vorapaxar is an inhibitor of the PAR-1 receptors on platelets that are activated by thrombin. It has risks mainly related to bleeding but there is also concern about retinal changes.
- The medicine has risks that require medical intervention, evaluation and monitoring by a medical practitioner.
- Labelling needs to comply with the requirements for a prescription only medicine.
- It does not appear to produce dependency and the abuse potential appears to be low.
The delegate has decided that the wording for the schedule entry will be as follows:
Schedule 4 - New Entry
Implementation date: 1 June 2016.