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Scheduling delegate's final decisions: ACMS, May 2015

Scheduling medicines and poisons

5 May 2015

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

1. Delegate only decision - medicines for human therapeutic use

1.1 Allergens

Scheduling proposal

The delegate has initiated an amendment to the current allergens entry so that it will only capture allergens for therapeutic use. Currently, the Schedule 4 entry for allergens covers substances in products not intended for therapeutic use and as such there is potential for substances included in other Schedules, or not scheduled, to be inadvertently captured by the current allergens entry in Schedule 4.

Scheduling status
Schedule 4

ALLERGENS

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.
Delegate's final decision

The final decision is that the Schedule 4 entry for allergens is to be amended to include "for therapeutic use".

The reason for the decision is that it clarifies that the Schedule 4 entry only applies to allergens used in therapeutic circumstances.

Schedule entry
Schedule 4 - Amendment

ALLERGENS for therapeutic use.

The implementation date of this decision will be 1 June 2015.

1.2 Apremilast

Scheduling proposal

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

Apremilast is a small molecule, acting to inhibit phosphodiesterase 4, which acts intracellularly to modulate various pro-inflammatory and anti-inflammatory mediators.

Apremilast is indicated for:

  • The treatment of the signs and symptoms of active psoriatic arthritis in adult patients
  • The treatment of adult patients with moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy.

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

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

Apremilast 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.

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 apremilast in Schedule 4, with an implementation date of 1 June 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 the substance; (b) the purpose and the extent of use of the substance; (c) the toxicity of the substance; d) the dosage, formulation, labelling, packaging and presentation of the substance; and (e) the potential for abuse of the 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 treatment of signs and symptoms of active psoriatic arthritis in adult patients.
  • The treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
  • The substance has specific toxicities related to the pharmacological mechanism of action. Diarrhoea, nausea and headache, occurred particularly during initial up-titration.
  • There may be an increased background risk of depression/suicidal ideation in the indicated conditions, which may be worsened by apremilast therapy.
  • A substantial proportion of patients experienced weight loss while taking apremilast.
  • It has been placed in Pregnancy Category B3 (as recommended by the non-clinical evaluator) as preclinical studies demonstrated vasculitis-like changes. There is no experience of apremilast use in pregnancy; indeed, the FDA has mandated a pregnancy-exposure registry.
  • A two-week titration pack (4 x 10 mg, 4 x 20 mg and 5 x 30 mg for the first week for dose titration and 14 x 30 mg tablets for the second week).
  • A four-week pack (56 x 30 mg tablets)
  • A 12 week pack (168 x 30 mg tablets)
  • It does not appear to produce dependency and the abuse potential appears to be low.
Schedule entry
Schedule 4 - New entry

APREMILAST

1.3 Dasabuvir

Scheduling proposal

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

Dasabuvir is a hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor.

Dasabuvir is an active ingredient in the products VIEKIRA PAK-RBV and VIEKIRA PAK, both of which are indicated for the treatment of genotype 1 chronic hepatitis C infection, including patients with cirrhosis.

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

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

Dasabuvir 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.

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 dasabuvir in Schedule 4, with an implementation date of 1 June 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 the substance; (b) the purpose and the extent of use of the substance; (c) the toxicity of the substance; and d) the dosage, formulation, labelling, packaging and presentation of the 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.
  • Dasabuvir is to be given as part of the composite packs VIEKIRA PAK-RBV and VIEKIRA PAK.
  • Dasabuvir is indicated for the treatment of genotype 1 chronic hepatitis C infection, including patients with compensated cirrhosis.
  • Dasabuvir is to be used for a medical condition that requires careful diagnosis and management by medical professionals.
  • There are many contraindications proposed due to possible drug interactions when co-administered with other medicines.
  • Pregnancy category B1 is proposed. Please note that for the composite pack 'VIEKIRA PAK RBV', ribavirin is classified as pregnancy category X. Ritonavir as part of the composite packs VIEKIRA PAK and 'VIEKIRA PAK RBV' is currently classified as pregnancy category B3.
  • There are side effects associated with the use of dasabuvir such as fatigue, nausea, pruritis.
  • Dasabuvir should be prescribed by medical professionals who are familiar with the management of chronic liver diseases. The patients need to be instructed to follow the dosing regimens.
Schedule entry
Schedule 4 - New entry

DASABUVIR.

1.4 Ombitasvir

Scheduling proposal

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

Ombitasvir is a hepatitis C virus NS5A inhibitor.

Ombitasvir is an active ingredient in the products VIEKIRA PAK-RBV and VIEKIRA PAK, both of which are indicated for the treatment of genotype 1 chronic hepatitis C infection, including patients with cirrhosis.

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

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

Ombitasvir 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.

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 ombitasvir in Schedule 4, with an implementation date of 1 June 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 the substance; (b) the purpose and the extent of use of the substance; (c) the toxicity of the substance and d) the dosage, formulation, labelling, packaging and presentation of the 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.
  • Ombitasvir is to be given as part of the composite packs VIEKIRA PAK-RBV and VIEKIRA PAK.
  • Ombitasvir is indicated for the treatment of genotype 1 chronic hepatitis C infection, including patients with compensated cirrhosis.
  • Ombitasvir is to be used for a medical condition that requires careful diagnosis and management by medical professionals.
  • Pregnancy category B1 is proposed. Please note that for the composite pack 'VIEKIRA PAK RBV', ribavirin is classified as pregnancy category X. Ritonavir as part of both VIEKIRA PAK and VIEKIRA PAK RBV is currently classified as pregnancy category B3.
  • There are side effects associated with the use of ombitasvir including fatigue, nausea and pruritis.
  • There are many contraindications proposed due to possible drug interactions when co-administered with other medicines.
  • Ombitasvir should be prescribed by medical professionals who are familiar with the management of chronic liver diseases. The patients need to be instructed to follow the dosage regimens.
Schedule entry
Schedule 4 – New entry

OMBITASVIR.

1.5 Paritaprevir

Scheduling proposal

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

Paritaprevir is a hepatitis C virus NS3/4A protease inhibitor.

Paritaprevir is an active ingredient in the products VIEKIRA PAK-RBV and VIEKIRA PAK, both of which are indicated forthe treatment of genotype 1 chronic hepatitis C infection, including patients with cirrhosis.

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

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

Paritaprevir 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.

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 paritaprevir in Schedule 4, with an implementation date of 1 June 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 the substance; (b) the purpose and the extent of use of the substance; (c) the toxicity of; and d) the dosage, formulation, labelling, packaging and presentation of the 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.
  • Paritaprevir is to be given as part of the composite packs VIEKIRA PAK-RBV and VIEKIRA PAK.
  • Paritaprevir is indicated for the treatment of genotype 1 chronic hepatitis C infection, including patients with compensated cirrhosis.
  • Paritaprevir is to be used for a medical condition that requires careful diagnosis and management by medical professionals.
  • Pregnancy category B1 is proposed. Please note that for the composite pack 'VIEKIRA PAK RBV', ribavirin is classified as pregnancy category X. Ritonavir as part of both VIEKIRA PAK and VIEKIRA PAK RBV is currently classified as pregnancy category B3.
  • There are side effects associated with the use of paritaprevir including fatigue, nausea and pruritis.
  • There are many contraindications proposed due to possible drug interactions when co-administered with other medicines.
  • Paritaprevir should be prescribed by medical professionals who are familiar with the management of chronic liver diseases. The patients need to be instructed to follow the dosage regimens.
Schedule entry

Schedule 4 - New entry

PARITAPREVIR

1.6 Ulipristal

Scheduling proposal

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

Ulipristal is an orally-active synthetic selective progesterone receptor modulator that acts via high affinity binding to the human progesterone receptor. When used for emergency contraception the mechanism of action is inhibition or delay of ovulation via suppression of the lutenising hormone (LH) surge.

Ulipristal is indicated for emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.

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

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

Ulipristal 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.

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 ulipristal in Schedule 4, with an implementation date of 1 June 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 the substance.

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.
Schedule entry
Schedule 4 – New entry

ULIPRISTAL.

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