You are here

Scheduling delegate's final decisions: ACMS, November 2015

Scheduling medicines and poisons

18 November 2015

Book pagination

Part B - Final decisions on matters not referred to an expert advisory committee (2)

2. New Chemical Entities – medicines for human therapeutic use

2.1 Armodafinil

Scheduling proposal

The delegate considered an application from the TGA for the scheduling of armodafinil, a new chemical entity for a human therapeutic medicine.

Armodafinil - Modafinil is a racemic mixture of the enantiomers R-modafinil and S-modafinil with the stereogenic centre at the sulphur atom. Armodafinil is R-modafinil only.

Modafinil/armodafinil are oral wakefulness promoting agents, but pharmacologically different from other stimulants (including sympathomimetic amines). The exact mechanism of action is unknown.

Armodafinil is indicated:

  • to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy
  • to treat excessive sleepiness associated with moderate to severe chronic shift work sleep disorder where nonpharmacological interventions are unsuccessful or inappropriate
  • as an adjunct to continuous positive airways pressure (CPAP) in obstructive sleep apnoea/hypopnoea syndrome in order to improve wakefulness.

The delegate decided to make a delegate-only decision to include this to Schedule 4. The ACMS was not consulted.

Scheduling status

Armodafinil is not specifically scheduled and is not captured by any entry in the SUSMP No. 9.

Armodafinil 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.
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • Scheduling factors9.

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 armodafinil 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 a substance; (b) the purpose and the extent of use of a substance; (c) the toxicity 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/marketing] experience in Australia.
  • It has been proposed for the treatment of conditions that require the medical supervision.
  • It is anticipated to have a toxicity/ risk profile similar to the racemic mixture of which this active is a component. The racemic mixture is currently on the SUSMP.
  • This substance has a moderate likelihood of abuse but not of dependency.

The delegate has decided that the wording for the schedule entry will be as follows:

Schedule entry
Schedule 4 - New entry

ARMODAFINIL

2.2 Asfotase alfa

Scheduling proposal

The delegate considered an application from the TGA for the scheduling of asfotase alfa, a new chemical entity for a human therapeutic medicine.

Asfotase alfa is a human recombinant tissue-nonspecific alkaline phosphatase (TNSALP)-Fc-deca-aspartate fusion protein with enzymatic activity, produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture.

Asfotase alfa is indicated for long-term enzyme replacement therapy in patients with paediatric-onset hypophosphatasia.

The delegate decided to make a delegate-only decision to include this to Schedule 4. The ACMS was not consulted.

Scheduling status

Asfotase alfa is not specifically scheduled and is not captured by any entry in the SUSMP No. 9.

Asfotase alfa 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.
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • Scheduling factors10.

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 asfotase alfa 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 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.
  • Asfotase alfa is indicated for long-term enzyme replacement therapy in patients with paediatric-onset hypophosphatasia.
  • 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 be initiated by a physician experienced in the management of patients with metabolic or bone disorders.
  • Asfotase alfa is a first in class human recombinant tissue-nonspecific alkaline phosphatase (TNSALP)-Fc-deca-aspartate fusion protein.
  • 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 entry
Schedule 4 - New entry

ASFOTASE ALFA

2.3 Nintedanib

Scheduling proposal

The delegate considered an application from the TGA for the scheduling of nintedanib, a new chemical entity for a human therapeutic medicine.

Nintedanib esilate is a triple angiokinase inhibitor blocking vascular endothelial growth factor receptors (VEGFR 1-3), platelet-derived growth factor receptors (PDGFR α and β) and fibroblast growth factor receptors (FGFR 1-3) kinase activity.

Nintedanib esilate is indicated, in combination with docetaxel, for the treatment of patients with locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after failure of first line chemotherapy. OFEV is also indicated for the treatment of Idiopathic Pulmonary Fibrosis (IPF).

The delegate decided to make a delegate-only decision to include this to Schedule 4. The ACMS was not consulted.

Scheduling status

Nintedanib is not specifically scheduled and is not captured by any entry in the SUSMP No. 9.

Nintedanib 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.
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • Scheduling factors11.

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 nintedanib 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 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:

  • Nintedanib is a new chemical entity with no marketing experience in Australia.
  • The benefits and risks of nintedanib have been considered in the TGA evaluation process.
  • Toxicity of the substance has been taken into account in the TGA evaluation process.
  • The dosage, formulation, labelling, packaging and presentation of the substance has been taken into account in the TGA evaluation process.

The delegate has decided that the wording for the schedule entry will be as follows:

Schedule entry
Schedule 4 - New entry

NINTEDANIB

2.4 Sacubitril

Scheduling proposal

The delegate considered an application from the TGA for the scheduling of sacubitril, a new chemical entity for a human therapeutic medicine.

Sacubitril in combination with valsartan, is a first-in-class angiotensin receptor neprilysin (neutral endopeptidase 24.11; NEP) inhibitor (ARNI).

Sacubitril, in combination with valsartan, is indicated for the treatment of adults with chronic heart failure (NYHA class II-IV) in patients with reduced ejection fraction.

The delegate decided to make a delegate-only decision to include this to Schedule 4. The ACMS was not consulted.

Scheduling status

Sacubitril is not specifically scheduled and is not captured by any entry in the SUSMP No. 9.

Sacubitril 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.
  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • Scheduling factors12.

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 sacubitril 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 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.
  • Sacubitril, in combination with valsartan, is indicated for the treatment of adults with chronic heart failure (NYHA class II-IV) in patients with reduced ejection fraction.
  • 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.
  • Sacubitril, in combination with valsartan, is a first-in-class angiotensin receptor neprilysin inhibitor. Sacubitril is a neprilysin (neutral endopeptidase) inhibitor.
  • The medicine has risks that require medical intervention, evaluation and monitoring by a medical practitioner.
  • It is contraindicated in pregnancy.
  • 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 entry
Schedule 4 - New entry

SACUBITRIL


Footnotes

Book pagination