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Scheduling delegate's final decisions: ACMS and NCEs, July 2015

23 July 2015

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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 Netupitant

Scheduling proposal

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

Netupitant is a neurokinin-1 receptor antagonist. 

Netupitant is indicated in adult patients, in combination with palonosetron (as part of a fixed dose combination product), for the:

  • Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy; and
  • Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.

The delegate decided to make a delegate-only decision to include this to Schedule 4. The Advisory Committee on Medicines Scheduling was not consulted.

Scheduling status

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

Netupitant is not classified in New Zealand.

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.

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 netupitant in Schedule 4, with an implementation date of 1 October 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; (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 marketing experience in Australia.
  • The benefits are considered to outweigh the risks at a population level.
  • It is also noted that netupitant is currently proposed for use in a fixed dose combination with palonosetron, and benefit / risk has been assessed in this context.
  • The purpose and extent of use is reflected in the indication, i.e. use in adults for:
    • Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy; and
    • Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
  • The potential for abuse of netupitant is unlikely.
Schedule entry
Schedule 4 – New Entry

NETUPITANT

2.2 Ibrutinib

Scheduling proposal

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

Ibrutinib is a first-in-class, orally-administered, potent, covalently-binding inhibitor of Bruton's tyrosine kinase (BTK).  Ibrutinib inhibits B-cell antigen receptor and chemokine-receptor signalling pathways in malignant B cells, disrupts integrin-dependent B-cell migration and adhesion in vitro and promotes egress of malignant  cells from tissues and prevents homing of these cells to tissues in patients without clinically adverse effects on levels of normal B cells. 

Ibrutinib is indicated for the treatment of patients with:

  • Mantle Cell Lymphoma (MCL) who have received at least one prior therapy; and
  • Chronic Lymphocytic Leukaemia/Small Lymphocytic Lymphoma (CLL/SLL) who have received at least one prior therapy, or as first line in patients with CLL with 17p deletion. 

The delegate decided to make a delegate-only decision to include this to Schedule 4. The Advisory Committee on Medicines Scheduling was not consulted.

Scheduling status

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

Ibrutinib is not classified in New Zealand.

Delegate's consideration

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

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

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

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 ibrutinib in Schedule 4, with an implementation date of 1 October 2015.

The delegate decided that the reason for the final decision comprised the following:

  • It is a new chemical entity with no marketing experience in Australia.
Schedule entry
Schedule 4 – New Entry

IBRUTINIB

2.3 Cholic Acid

Scheduling proposal

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

Cholic acid is a bile acid and used in patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders.  

Cholic acid is indicated for the treatment of inborn errors of bile acid synthesis responsive to treatment with cholic acid.

The delegate decided to make a delegate-only decision to include this to Schedule 4. The Advisory Committee on Medicines Scheduling was not consulted.

Scheduling status

Cholic 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 new drug application.
Delegate's final decision

The delegate has made a final decision to amend the SUSMP to include cholic acid in Schedule 4, with an implementation date of 1 October 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; and (b) the purpose and the extent of use 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.
  • This cholic acid is a synthetic version of a naturally occurring bile acid.  It has a relatively good safety profile.
  • Cholic acid is intended to be used in the management of certain inborn errors of bile acid synthesis that, if untreated, result in liver failure.  It's use will be in the context of long-term management of patients with a serious medical condition that requires ongoing assessment.
Schedule entry
Schedule 4 – New Entry

CHOLIC ACID

2.4 Levomilnacipran

Scheduling proposal

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

Levomilnacipran is a selective serotonin and noradrenaline reuptake inhibitor (SNRI). It is reported to inhibit both the norepinephrine (NE) and 5-hydroxytryptamine (5-HT, serotonin) reuptake with an approximate two fold more potent inhibition of NE reuptake than 5-HT reuptake transporters. It is the more active enantiomer of the racemate milnacipran. 

Levomilnacipran is indicated for the treatment of Major Depressive Disorder (MDD) in adults.

The delegate decided to make a delegate-only decision to include this to Schedule 4. The Advisory Committee on Medicines Scheduling was not consulted.

Scheduling status

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

Levomilnacipran is not classified in New Zealand.

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 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 levomilnacipran in Schedule 4, with an implementation date of 1 October 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 (c) the toxicity 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.
  • This active may cause increases in heart rate and blood pressure as well as nausea, vomiting and dizziness.  Less frequent adverse effects may also occur that may require assessment and management by a medical doctor.
  • It is intended for the treatment of depression, a medical condition that requires management by a healthcare professional.
  • It has side effects that may require management by a doctor.

2.5 Naloxegol

Scheduling proposal

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

Naloxegol is a PEGylated derivative of the mu-opioid receptor antagonist naloxone.

Naloxegol is indicated for the treatment of opioid-induced constipation (OIC). 

The delegate decided to make a delegate-only decision to include this to Schedule 4. The Advisory Committee on Medicines Scheduling was not consulted.

Scheduling status

Naloxegol is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons No.8.

Naloxegol is not classified as a prescription medicine in New Zealand.

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 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.

Delegates' final decision

The delegate has made a final decision to amend the SUSMP to include Naloxegol in Schedule 4, with an implementation date of 1 October 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 (c) the toxicity 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.
  • This active can cross the blood brain barrier in certain medical conditions and interacts with many other medications via CYP metabolism pathways
  • Naloxegol is intended for the treatment of opioid induced constipation.It is a new chemical entity.
  • While naloxegol when used as intended has a good safety profile it can interfere with the action of other medicines and must not be given where there is a possibility of bowel obstruction.  A medical assessment should be performed prior to its initial use and where there is significant abdominal pain.

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

Schedule entry
Schedule 4 – New Entry

NALOXEGOL

2.6 Milnacipran

Scheduling proposal

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

Milnacipran is a balanced, specific, dual reuptake inhibitor of noradrenaline (NA) and serotonin (5-hydroxytryptamine [5 HT]), inhibiting noradrenaline uptake with greater potency than serotonin.

Milnacipran is indicated for the treatment of fibromyalgia.

The delegate decided to make a delegate-only decision to include this to Schedule 4. The Advisory Committee on Medicines Scheduling was not consulted.

Scheduling status

Milnacipran is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons No.8.

Milnacipran is not classified as a prescription medicine in New Zealand.

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 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.

Delegates' final decision

The delegate has made a final decision to amend the SUSMP to include milnacipran in Schedule 4, with an implementation date of 1 October 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 (c) the toxicity of a substance.

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

  • It is a new chemical entity.
  • This active may cause increases in heart rate and blood pressure as well as nausea, vomiting and dizziness.  Less frequent adverse effects may also occur that may require assessment and management by a medical doctor.   It is intended for the treatment of depression, a medical condition that requires management by a healthcare professional.
  • It is intended for the treatment of a chronic pain condition that requires management by a healthcare professional.
  • It has side effects that may require management by a doctor

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

Schedule entry
Schedule 4 – New Entry

MILNACIPRAN

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