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Scheduling delegate's final decisions: ACMS, March 2015

Subtitle: ACMS Meeting - 18 November 2014

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

3. New chemical entities - medicines for human therapeutic use

3.1 Pembrolizumab

Scheduling proposal

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

Pembrolizumab is a potent and highly-selective humanized monoclonal antibody (mAb) of the Immunoglobulin G4 (IgG4)/kappa isotype directed to the programmed cell death-1 (PD-1) receptor and designed to directly block the interaction between the receptor and its ligands, PD-L1 and PD-L2. The PD-1 pathway represents a major immune control switch which may be engaged by tumour cells to overcome active T-cell immune surveillance.

Pembrolizumab is indicated as monotherapy for the treatment of unresectable or metastatic melanoma 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

Pembrolizumab is not specifically scheduled, but as it is a monoclonal antibody pembrolizumab is captured by monoclonal antibodies under Schedule 4. However, the delegate has decided to specifically list pembrolizumab in Schedule 4.

Pembrolizumab 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, and
  • 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 pembrolizumab 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 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 benefit / risk profile has been considered in the evaluation of the NCE application.
  • The proposed indication is: treatment of unresectable or metastatic melanoma in adults.
  • Toxicity has been considered in the benefit / risk evaluation of the NCE application.
  • Dosage, formulation, labelling, packaging and presentation have been considered in the benefit / risk evaluation of the NCE application.

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

Schedule entry
Schedule 4 - New entry

PEMBROLIZUMAB

3.2 Ledipasvir

Scheduling proposal

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

Ledipasvir is a new chemical entity and inhibits hepatitis C virus (HCV) replication through NS5A. It has a high potency and selectivity in multiple cell-based replicon assays and specificity exclusively for HCV.

Ledipasvir is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection 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

Ledipasvir is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons No. 6.

Ledipasvir is not currently 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 reports,
  • Subsection 52E(1) of the Therapeutic Goods Act 1989, and
  • 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.

Delegate's final decision

The delegate has made a final decision to amend the SUSMP to include ledipasvir 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; (b) the purpose and the extent of use of; (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.
  • The fixed dose combination of ledipasvir and sofosbuvir is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults.
  • Reported adverse events from clinical trials include fatigue, headache, insomnia, nausea and arthralgia. Drug-drug interactions can occur when ledipasvir and sofosbuvir is co-administered with other medicines.
  • Ledipasvir and Sofosbuvir, the fixed dose combination tablets 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

LEDIPASVIR

3.3 Asunaprevir

Scheduling proposal

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

Asunaprevir is an inhibitor of the NS3 serine protease of HCV, and subsequent viral RNA replication. Asunaprevir competitively inhibits the binding of substrate to NS3/4A protease complex, binding directly and reversibly to the protease, with Ki 0.24 to 1.0 nM, depending on the genotype strain employed.

Asunaprevir is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults with compensated liver disease (including cirrhosis) in combination with:

  • daclatasvir, an NS5A replication complex inhibitor, for patients with HCV genotype 1b infection.
  • daclatasvir, peginterferon alfa, and ribavirin for patients with HCV genotype 1 or 4 infection.

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

Asunaprevir is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons No. 6.

Asunaprevir 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 reports,
  • Subsection 52E(1) of the Therapeutic Goods Act 1989, and
  • 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.

Delegate's final decision

The delegate has made a final decision to amend the SUSMP to include asunaprevir 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; (b) the purpose and the extent of use of; (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 and marketing experience in Australia.
  • asunaprevir is indicated for the treatment of chronic hepatitis C virus infection in adults with compensated liver disease (including cirrhosis) in combination with:
    • daclatasvir, an NS5A replication complex inhibitor, for patients with HCV genotype 1b.
    • daclatasvir, peginterferon alfa, and ribavirin for patients with HCV genotype 1 or 4 infection.
    • asunaprevir may cause liver toxicity. As asunaprevir is to be used in combination with other medicines, there could be adverse events caused by the concomitant medicines. Drug-drug interactions can occur when asunaprevir is co-administered with other medicines.
  • Pregnancy category B1 is acceptable for asunaprevir. When used in combination with daclatasvir (B3), or daclatasvir and peginterferon alfa and ribavirin (category X), the most restrictive category is applicable.
  • asunaprevir 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 recommended dosing regimens.
Schedule entry
Schedule 4 - New entry

ASUNAPREVIR

3.4 Daclatasvir

Scheduling proposal

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

Daclatasvir is an inhibitor of the hepatitis C virus non-structural protein 5a (NS5A) replication complex. NS5A is a multifunctional protein with key functions in both HCV replication and modulation of cellular signalling pathways.

Daclatasvir is indicated, when in combination with other agents, for the treatment of chronic hepatitis C virus (HCV) infection in adults with compensated liver disease (including 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

Daclatasvir is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons No. 6.

Daclatasvir 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 reports,
  • Subsection 52E(1) of the Therapeutic Goods Act 1989, and
  • 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.

Delegate's final decision

The delegate has made a final decision to amend the SUSMP to include daclatasvir 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; (b) the purpose and the extent of use of; (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 and marketing experience in Australia.
  • Daclatasvir is indicated, in combination with other medicinal products, for the treatment of chronic hepatitis C virus (HCV) infection in adults with compensated liver disease (including cirrhosis).
  • Daclatasvir is to be used for a medical condition (chronic hepatitis C virus infection) that requires careful diagnosis and management by medical professionals. Drug-drug interactions can occur when daclatasvir is co-administered with other medicines.
  • Pregnancy Category B3 is proposed.
  • There are side effects associated with the use of Daclatasvir, such as diarrhoea, nausea and headache, hypersensitivity reactions, drug-induced liver toxicity, etc.
  • Daclatasvir 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

DACLATASVIR

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