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Scheduling delegate's final decisions: ACCS/ACMS, April 2014

Scheduling medicines and poisons

14 April 2014

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Part B - Final decisions on matters not referred to an expert advisory committee - 5.1-5.8

5. New chemical entities - medicines for human therapeutic use

5.1 Collagenase clostridium histolyticum

Scheduling proposal

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

Collagenase Clostridium histolyticum is indicated for the treatment of Dupuytren's contracture in adult patients with palpable cord.

Collagenase Clostridium histolyticum is an enzyme produced by the bacterium Clostridium histolyticum that dismantles excessive collagen by disrupting its chemical structure. Reducing the accumulation of collagen improves movement of the affected fingers.

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

Scheduling status

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

Collagenase Clostridium histolyticum 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 collagenase Clostridium histolyticum in Schedule 4, with an implementation date of 27 March 2014.

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 collagenase Clostridium histolyticum.

The delegate decided that the reasons for the final decision comprise of the following.

  • Collagenase Clostridium histolyticum is a new biological entity with no clinical experience in Australia.
  • It is indicated for the treatment of Dupuytren's contracture in adult patients with a palpable cord.
  • Experience of its use is limited.
  • The use of Collagenase Clostridium histolyticum requires medical intervention by doctors who are experienced in the diagnosis and surgical management of Dupuytren's disease and who have undergone a prescriber education and training program.
  • Toxicity is mainly confined to the treated limb but there is potential for distal effects.
  • It is only to be administered in a setting with the ability to monitor vital signs and treat allergic reactions.
  • It is presented as 0.9 mg lyophilised powder for injection by local administration into the cord.
  • It does not appear to produce dependency.
  • There is potential for usage beyond the approved indication.
Schedule 4 - New entry

COLLAGENASE CLOSTRIDIUM HISTOLYTICUM.

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5.2 Empagliflozin

Scheduling proposal

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

Empagliflozin is a selective inhibitor of sodium-glucose co-transporter 2.

Ronjoli (empagliflozin) tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

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

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

Empagliflozin 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.

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 empagliflozin in Schedule 4, with an implementation date of 8 April 2014.

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 empagliflozin.

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 4 - New entry

EMPAGLIFLOZIN.

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5.3 Febuxostat

Scheduling proposal

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

Febuxostat is a non-purine selective inhibitor of xanthine oxidase that inhibits the formation of uric acid from xanthine and therefore decreases serum uric acid.

Febuxostat is proposed to be used in adults with chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of tophus and/or gouty arthritis).

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

Scheduling status

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

Febuxostat is classified as a prescription medicine 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.
  • 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 febuxostat in Schedule 4, with an implementation date of 27 March 2014.

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 febuxostat.

The delegate decided that the reasons for the final decision are comprised of the following.

  • Febuxostat 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 adults with chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of tophus and/or gouty arthritis).
  • Experience of its use is limited in Australia but it has been used overseas since 2008.
  • The drug has potential for cardiovascular effects, hypersensitivity reactions and hepatic safety.
  • Medicine is packed as film-coated tablets in blister packs.
  • It does not appear to produce dependency and the abuse potential appears to be low.
Schedule 4 - New entry

FEBUXOSTAT.

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5.4 Normal human immunoglobulin

Scheduling proposal

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

Normal Human Immunoglobulin is a human immunoglobulin G.

Normal Human Immunoglobulin is indicated in adults and children for replacement therapy in:

  • Primary Immunodeficiency Disease (PID) and
  • Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.

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

Normal Human Immunoglobulin is not specifically scheduled in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), but is captured by the following group/class entry:

Schedule 4

IMMUNOGLOBULINS for human parenteral use except when separately specified in these Schedules.

Normal Human Immunoglobulin is not classified in New Zealand.

Delegate's consideration

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

  • 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.

Delegate's final decision

The delegate has made a final decision to amend the SUSMP to include Normal Human Immunoglobulin in Schedule 4, with an implementation date of 8 April 2014.

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 Normal Human Immunoglobulin.

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

  • Normal Human Immunoglobulin is a new biological entity with no clinical/marketing experience in Australia.
  • The product is used to treat serious medical conditions: Primary Immunodeficiency Disease (PID) and Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.
  • The possible side effects include hypersensitivity, embolic and thrombolic events, aseptic meningitis syndrome etc.
  • Hizentrashould only be administered subcutaneously.
  • The dose may need to be individualised for each patient dependent on the clinical response and serum IgG trough levels.
  • No potential for abuse of a substance.
Schedule 4 - New Entry

NORMAL HUMAN IMMUNOGLOBULIN.

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5.5 Serelaxin

Scheduling proposal

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

Serelaxin is a recombinant human relaxin-2, a vasoactive peptide hormone.

Serelaxin is proposed for use in patients with acute heart 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

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

Serelaxin 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.
  • 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 serelaxin in Schedule 4, with an implementation date of 8 April 2014.

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 serelaxin.

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

  • Serelaxin is a new biological entity with no clinical experience in Australia.
  • The risks and benefits are outlined in the Product Information and the TGA evaluation reports.
  • A significant risk is hypotension.
  • Serelaxin is proposed for use in patients with acute heart failure.
  • The use of serelaxin requires medical intervention, adjunctive therapy and evaluation.
  • The use of serelaxin requires monitoring by a medical practitioner to minimize the risk of using it.
  • It has no previous experience of use in Australia or overseas. It is proposed for hospital only use.
  • The medicine's main toxicity is hypotension.
  • It is presented as a pack containing 1 single-use vial containing 3.5 mg serelaxin in 3.5 mL of solution.
  • It does not appear to produce dependency and the abuse potential appears to be low.
Schedule 4 - New entry

SERELAXIN.

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5.6 Simeprevir

Scheduling proposal

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

Simeprevir is hepatitis C virus NS3/4A protease inhibitor.

The proposed indication for simeprevir for the treatment of chronic hepatitis C (CHC) genotype 1 or genotype 4 infection, in combination with peginterferon alfa and ribavirin, in adults with compensated liver disease (including cirrhosis) with or without human immunodeficiency virus-1 (HIV-1) co-infection who are treatment-naïve or who have failed previous interferon therapy (pegylated or non-pegylated) with or without ribavirin.

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

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

Simeprevir is not classified/is classified in New Zealand.

Delegate's consideration

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

  • The TGA evaluation report.
  • 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.

Delegate's final decision

The delegate has made a final decision to amend the SUSMP to include simeprevir in Schedule 4, with an implementation date of 8 April 2014.

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 simeprevir.

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

  • Simeprevir is a new chemical entity with no clinical/marketing experience in Australia.
  • Simeprevir is for the treatment of chronic hepatitis C (CHC) genotype 1 or genotype 4 infection, in combination with peginterferon alfa and ribavirin, in adults with compensated liver disease.
  • As simeprevir is to be used in combination with peginterferon and ribavirin, extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients while taking this combination. Women of childbearing potential and their male partners should not receive ribavirin unless they are using effective contraception (two reliable forms) during treatment with ribavirin and for 6 months after treatment.
  • Use with Ribavirin and Peginterferon Alfa: Ribavirin may cause birth defects and fetal death and animal studies have shown interferons have abortifacient effects; avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to initiating therapy, use at least two effective methods of contraception during treatment, and undergo monthly pregnancy tests.
  • Photosensitivity: Serious photosensitivity reactions have been observed during combination therapy with Simeprevir, peginterferon alfa and ribavirin. Use sun protection measures and limit sun exposure.
  • Rash has been observed during combination therapy with Simeprevir, peginterferon alfa and ribavirin.
  • It is capsule form and to be taken once daily with food.
  • The potential for abuse of this substance is unlikely.
Schedule 4 - New entry

SIMEPREVIR.

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5.7 Sofosbuvir

Scheduling proposal

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

Sofosbuvir is hepatitis C virus nucleotide analogue NS5B polymerase inhibitor.

The proposed indication for sofosbuvir (SOVALDI) is indicated in combination with other agents for the treatment of chronic hepatitis C (CHC) in adults. The proposed use is to be used with ribavirin for Genotype 2 and 3 hepatitis C and to be used with peginterferon alfa and ribavirin for Genotype 1 and 4 hepatitis C.

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

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

In the Medsafe committee meeting held on 18 December 2013: Sofosbuvir should be classified as Prescription Medicine (see http://www.medsafe.govt.nz/profs/class/Minutes/201...).

Delegate's consideration

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

  • The TGA evaluation report.
  • 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.

Delegate's final decision

The delegate has made a final decision to amend the SUSMP to include sofosbuvir in Schedule 4, with an implementation date of 8 April 2014.

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 sofosbuvir.

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

  • Sofosbuvir is a new chemical entity with no clinical/marketing experience in Australia.
  • Sofosbuvir (SOVALDI) is indicated in combination with other agents for the treatment of chronic hepatitis C (CHC) in adults As sofosbuvir is to be used in combination with peginterferon and ribavirin, extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients while taking this combination. Women of childbearing potential and their male partners should not receive ribavirin unless they are using effective contraception (two reliable forms) during treatment with ribavirin and for 6 months after treatment.
  • Use with Ribavirin and Peginterferon Alfa: Ribavirin may cause birth defects and fetal death and animal studies have shown interferons have abortifacient effects; avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to initiating therapy, use at least two effective methods of contraception during treatment, and undergo monthly pregnancy tests.
  • Drugs that are potent P-gp inducers in the intestine (e.g., rifampin, St. John's wort) may significantly decrease sofosbuvir plasma concentration leading to reduced therapeutic effect of sofosbuvir. Rifampin and St. John's wort should not be used with sofosbuvir.
  • It is a tablet.
  • The recommended dose of SOVALDI tablets is 400 mg once daily taken orally with or without food.
  • The potential for abuse of this substance is unlikely.
Schedule 4 - New entry

SOFOSBUVIR.

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5.8 Umeclidinium

Scheduling proposal

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

  • Umeclidinium (as bromide) is a long-acting muscarinic receptor antagonist.

Anoro Ellipta containing umeclidinium (as bromide) and vilanterol (as trifenatate) is indicated as a long-term once daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

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

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

Umeclidinium (as bromide) 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.

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 umeclidinium in Schedule 4, with an implementation date of 8 April 2014.

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 umeclidinium.

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

  • Umeclidinium is a new chemical entity with no clinical/marketing experience in Australia.
Schedule 4 - New entry

UMECLIDINIUM.

6. Editorials and errata

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