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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 selexipag, 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 selexipag. The Advisory Committee on Medicines Scheduling was not consulted.
Selexipag is a selective non-prostanoid prostacyclin IP receptor agonist.
Selexipag is indicated for the treatment of idiopathic pulmonary arterial hypertension, heritable pulmonary arterial hypertension, pulmonary arterial hypertension associated with connective tissue disease and pulmonary arterial hypertension associated with congenital heart disease with repaired shunts and pulmonary arterial hypertension associated with drugs and toxins in patients with WHO functional class II, III or IV symptoms.
Selexipag is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons.
Selexipag is classified as a prescription medicine in New Zealand.
Selexipag has not been previously considered for scheduling; therefore, scheduling history is not available.
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 factors1
- The TGA evaluation report
- The advice of the Advisory Committee on Prescription Medicines
- 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 selexipag 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.
- Selexipag is indicated for the treatment of idiopathic pulmonary arterial hypertension, heritable pulmonary arterial hypertension, pulmonary arterial hypertension associated with connective tissue disease and pulmonary arterial hypertension associated with congenital heart disease with repaired shunts and pulmonary arterial hypertension associated with drugs and toxins in patients with WHO functional class II, III or IV symptoms.
- It has no previous experience of use in Australia but has recently been approved for use overseas.
- It is proposed for use in the hospital and community.
- Treatment should only be initiated and monitored by a physician experienced in the treatment of Pulmonary arterial Hypertension (PAH).
- Selexipag is an oral, selective non-prostanoid prostacyclin receptor (IP receptor) agonist.
- 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.