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Scheduling delegate's final decisions: ACMS, October 2014

Scheduling medicines and poisons

23 October 2014

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

2. New chemical entities - medicines for human therapeutic use

2.1 Bemdamustine

Scheduling proposal

The delegate considered the scheduling of bendamustine, a new chemical entity (a human therapeutic medicine).

Scheduling status

Bendamustine is the Internationally Nonproprietary Name (INN) and it is not specifically scheduled in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). A related compound, mustine, is listed in the SUSMP No. 3 as follows:

Schedul 4

MUSTINE (nitrogen mustard)

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 scheduling factors
  • The TGA evaluation report
  • The advice of the Advisory Committee on Prescription Medicines
  • The new drug application.
Delegate's final decision

The delegate has made a final decision to amend the SUSMP to include bendamustine in Schedule 4, with an implementation date of 1 February 2015.

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 bendamustine; (b) the purpose and the extent of use of bendamustine; (c) the toxicity of bendamustine; d) the dosage, formulation, labelling, packaging and presentation of bendamustine; (e) the potential for abuse of bendamustine.

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

  • This is a new chemical entity with limited clinical experience in Australia. The TGA has found a positive benefit-risk balance for bendamustine for specific uses.
  • Recommended use is limited to specified haemato-oncology indications.
  • Toxicity has been factored into the TGA appraisal of benefit - risk balance and is consistent with S4 scheduling.
  • These factors have been considered in the TGA appraisal of benefit - risk balance and are consistent with S4 scheduling.

The potential for abuse of bendamustine is unlikely.

Schedule entry
Schedule 4 - New entry

BENDAMUSTINE.

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2.2 Bosutinib

Scheduling proposal

The delegate considered the scheduling of bosutinib, a new chemical entity (a human therapeutic medicine).

Scheduling status

Bosutinib monohydrate is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons.

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 scheduling factors
  • The TGA evaluation report
  • The advice of the Advisory Committee on Prescription Medicines
  • The new drug application.
Delegate's final decision

The delegate has made a final decision to amend the SUSMP to include bosutinib in Schedule 4, with an implementation date of 1 February 2015.

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 bosutinib; (b) the purpose and the extent of use of bosutinib; (c) the toxicity of bosutinib; d) the dosage, formulation, labelling, packaging and presentation of bosutinib; and (e) the potential for abuse of bosutinib.

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

  • This is a new chemical entity with limited clinical experience in Australia. The TGA has found a positive benefit-risk balance for bosutinib for specific uses.
  • Recommended use is limited to specified haemato-oncology indications.
  • Toxicity has been factored into the TGA appraisal of benefit - risk balance and is consistent with S4 scheduling.
  • These factors have been considered in the TGA appraisal of benefit - risk balance and are consistent with S4 scheduling.
  • The potential for abuse of bosutinib is unlikely.
Schedule entry
Schedule 4 - New entry

BOSUTINIB.

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2.3 Brentuximab

Scheduling proposal

The delegate considered the scheduling of brentuximab vedotin, a new chemical entity (a human therapeutic medicine).

Scheduling status

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

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 scheduling factors
  • The TGA evaluation report
  • The advice of the Advisory Committee on Prescription Medicines
  • The new drug application.
Delegate's final decision

The delegate has made a final decision to amend the SUSMP to include brentuximab vedotin in Schedule 4, with an implementation date of 1 February 2015.

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 brentuximab vedotin; (b) the purpose and the extent of use of brentuximab vedotin; (c) the toxicity of brentuximab vedotin; d) the dosage, formulation, labelling, packaging and presentation of brentuximab vedotin; (e) the potential for abuse of brentuximab vedotin.

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

  • This is a new chemical entity with limited clinical experience in Australia. The TGA has found a positive benefit-risk balance for brentuximab vedotin for specific uses.
  • Recommended use is limited to specified haemato-oncology indications.
  • Toxicity has been factored into the TGA appraisal of benefit - risk balance and is consistent with S4 scheduling.
  • These factors have been considered in the TGA appraisal of benefit - risk balance and are consistent with S4 scheduling.

The potential for abuse of brentuximab vedotin is unlikely.

Schedule entry
Schedule 4 - New entry

BRENTUXIMAB VEDOTIN.

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2.4 Carglumic acid

Scheduling proposal

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

Scheduling status

Carglumic acid is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons.

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 scheduling factors
  • The TGA evaluation report
  • The advice of the Advisory Committee on Prescription Medicines
  • The new drug application.
Delegate's final decision

The delegate has made a final decision to amend the SUSMP to include carglumic acid in Schedule 4 with an implementation date of 1 February 2015.

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; 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/marketing] experience in Australia.
  • The proposed therapeutic use relates to conditions requiring specialist care including acute care settings.
  • Labelling needs to comply with requirements of a prescription-only medicine.
Schedule entry
Schedule 4 - New entry

CARGLUMIC ACID (N-carbomoyl-L-glutamic acid).

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2.5 Elosulfase alfa

Scheduling proposal

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

Scheduling status

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

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 scheduling factors
  • The TGA evaluation report
  • The advice of the Advisory Committee on Prescription Medicines
  • The new drug application.
Delegate's final decision

The delegate has made a final decision to amend the SUSMP to include elosulfase alfa in Schedule 4, with an implementation date of 1 February 2015.

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 purpose and the extent of use of; (c) the toxicity of; 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 or marketing experience in Australia.
  • It has no previous experience of use in Australia but has recently been approved for use overseas.
  • Elosulfase alfa is indicated for the treatment of mucopolysaccharidosis type IVA (MPS IVA; Morquio A).
  • It is proposed for hospital use and home based use.
  • The risks and benefits of the medicine have been considered and are outlined in the Product Information.
  • Treatment should be supervised by a physician or healthcare provider experienced in the management of patients with MPS IVA or other inherited metabolic disorders.
  • The use of the medicine requires medical intervention, adjunctive therapy, 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.
Schedule entry
Schedule 4 - New entry

ELOSULFASE ALFA.

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2.6 Macitentan

Scheduling proposal

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

Macitentan is a dual endothelin A and B receptor antagonist.

Macitentan, as monotherapy or in combination with approved PAH treatments (phosphodiesterase-5 inhibitors or inhaled prostanoids), is indicated for the treatment of:

  • idiopathic pulmonary arterial hypertension
  • heritable pulmonary arterial hypertension
  • pulmonary arterial hypertension associated with connective tissue disease
  • pulmonary arterial hypertension associated with congenital heart disease with repaired shunts in patients with WHO Functional class II, III or IV symptoms.

The delegate decided to make a delegate-only decision to include this to Schedule 4. The Advisory Committee on Medicines Scheduling (ACMS) was consulted due to the pregnancy Category X status of macitentan. The delegate has considered the committee's recommendation and macitentan is to be included in Appendix D and Appendix L (see Part A 1. Scheduling proposals referred to the July 2014 meeting of the Advisory Committee on Medicines Scheduling (ACMS# 12) of this document).

Scheduling status

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

Macitentan is not classified in New Zealand.

Delegate's consideration

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.
Delegates' final decision

The delegate has made a final decision to amend the SUSMP to include macitentan in Schedule 4, with an implementation date of 1 February 2015.

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 purpose and the extent of use of; (c) the toxicity of; d) the dosage, formulation, labelling, packaging and presentation of; and (e) the potential for abuse of macitentan.

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

  • Macitentan is a new chemical entity with no clinical experience in Australia.
  • Macitentan has risks and benefits which are outlined in the Product Information.
  • It is indicated for the treatment of pulmonary arterial hypertension in certain subgroups as either monotherapy or in combination with other treatments and in patients with specific WHO functional classes.
  • Experience of its use is limited.
  • The drug has specific toxicities related to embryo-fetal risk and therefore is a category X drug and contraindicated in pregnancy or in women who may become pregnant.
  • Treatment with macitentan should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension. The use of the medicine requires medical intervention 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.

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2.7 Riociguat

Scheduling proposal

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

Riociguat is a stimulator of soluble guanylate cyclase, an enzyme in the cardiopulmonary system, and increases production of the second messenger cyclic guanosine monophosphate (cGMP).

Adempas (riociguat) has the following indications:

Pulmonary arterial hypertension

Adempas, as monotherapy or in combination with approved PAH treatments (endothelin receptor antagonists or inhaled or subcutaneous prostanoids), is indicated for the treatment of:

  • idiopathic pulmonary arterial hypertension
  • heritable pulmonary arterial hypertension
  • pulmonary arterial hypertension associated with connective tissue diseases or
  • pulmonary arterial hypertension associated with congenital heart disease in adult patients with WHO functional Class II, lll or IV symptoms
Chronic thromboembolic pulmonary hypertension

Adempas is indicated for the treatment of:

  • persistent or recurrent chronic thromboembolic pulmonary hypertension (CTEPH) after surgical treatment or
  • inoperable CTEPH in adult patients with WHO functional Class II, III or IV symptoms.

The delegate decided to make a delegate-only decision to include this to Schedule 4. The Advisory Committee on Medicines Scheduling (ACMS) was consulted on the requirement for a sedation warning. The delegate has considered the committee's recommendation and riociguat is to be included in Appendix D and Appendix L (see Part A 1. Scheduling proposals referred to the July 2014 meeting of the Advisory Committee on Medicines Scheduling (ACMS# 12) of this document).

Scheduling status

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

Riociguat is not classified in New Zealand.

Delegate's consideration

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 riociguat in Schedule 4, with an implementation date of 1 February 2015.

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 purpose and the extent of use of; (c) the toxicity of; d) the dosage, formulation, labelling, packaging and presentation of; and (e) the potential for abuse of riociguat.

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

  • Riociguat is a new chemical entity with no clinical experience in Australia.
  • The risks and benefits are outlined in the Product Information, Delegate's Request for ACPM advice and the TGA evaluation reports.
  • It is proposed to be used in adult patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension in certain subgroups as either monotherapy or in combination with other treatments and in patients with specific WHO functional classes.
  • Experience of its use is limited.
  • The use of riociguat requires medical intervention, adjunctive therapy and evaluation.
  • The drug has specific toxicities related to use in pregnancy and is proposed as a category X drug and contraindicated in pregnancy. It also has safety concerns with hypotension and bleeding and concomitant use with nitrates, nitric oxide donors and PDE-5 inhibitors.
  • Treatment with riociguat should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension.
  • The use of riociguat requires monitoring by a medical practitioner to minimize the risk of using it.
  • Medicine is packed as 0.5, 1.0, 1.5, 2.0 and 2.5 mg film-coated tablets in blister packs.
  • It does not appear to produce dependency and the abuse potential appears to be low.
Schedule entry
Schedule 4 - New entry

RIOCIGUAT.

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2.8 Simoctocog alfa

Scheduling proposal

The delegate considered the scheduling of simoctocog alfa, a new chemical entity (a human therapeutic medicine).

Scheduling status

Simoctocog alfa is not specifically scheduled in the Standard for the Uniform Scheduling of Medicines and Poisons.

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 scheduling factors
  • The TGA evaluation report
  • The advice of the Advisory Committee on Prescription Medicines
  • The new drug application.
Delegate's final decision

The delegate has made a final decision that simoctocog alfa falls under Appendix A - General Exemptions under Human Blood Products as it is an equivalent recombinant alternative to a plasma-derived clotting factor.

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2.9 Suvorexant

Scheduling proposal

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

Suvorexant is a dual orexin receptor antagonist.

Suvorexant was proposed to be indicated for the treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance.

The delegate decided to make a delegate-only decision to include this to Schedule 4. The Advisory Committee on Medicines Scheduling (ACMS) was consulted on the requirement for a sedation warning. The delegate has considered the committee's recommendation and suvorexant is to be included in Appendix K (see Part A 1. Scheduling proposals referred to the July 2014 meeting of the Advisory Committee on Medicines Scheduling (ACMS# 12) of this document).

Scheduling status

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

Suvorexant is not classified in New Zealand.

Delegate's consideration

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

  • The new drug application.
  • 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 suvorexant in Schedule 4, with an implementation date of 1 February 2015.

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 suvorexant.

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

  • Suvorexant is a new chemical entity with no clinical or marketing experience in Australia.
  • The substance is intended to cause drowsiness and its effects are additive with alcohol.
  • The delegate made an initial decision to reject registration of suvorexant.
Schedule entry
Schedule 4 - New entry

SUVOREXANT.

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