You are here

Scheduling delegate's final decisions, January 2017

Scheduling medicines and poisons

16 January 2017

Book pagination

2.6. Dermatophagoides pteronyssinus and Dermatophagoides farinae extract

Final decisions on matters not referred to an expert advisory committee

2. New Chemical Entities – medicines for human therapeutic use

2.6. Dermatophagoides pteronyssinus and Dermatophagoides farinae extract

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of Dermatophagoides pteronyssinus and Dermatophagoides farinae extract (American & European house dust mites (HDM) extract), a NCE for a human therapeutic medicine.

Substance summary

Dermatophagoides pteronyssinus and Dermatophagoides farinae extract (American & European HDM extract) is a standardised allergen extract (50%) of the American HDM and the European HDM species, Dermatophagoides pteronyssinus and Dermatophagoides farinae.

In patients with a positive test of house dust mite sensitisation (skin prick test and/or specific IgE), Dermatophagoides pteronyssinus and Dermatophagoides farinae extract is indicated for the treatment of moderate to severe HDM-allergic rhinitis despite use of symptom-relieving medication, and HDM-allergic asthma not responsive to inhaled corticosteroids in adults.

ABN – American house dust mite extract

ABN – European house dust mite extract

Scheduling status

Dermatophagoides pteronyssinus and Dermatophagoides farinae extract is not specifically scheduled and is not captured by any entry in the current Poisons Standard.

International regulations

Dermatophagoides pteronyssinus and Dermatophagoides farinae extract is not classified in New Zealand.

Delegate's consideration

The delegate made a delegate-only decision, hence the Advisory Committee on Medicines Scheduling was not consulted.

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 (2015) scheduling factors; and
  • The TGA evaluation report;
  • The advice of the Advisory Committee on Prescription Medicines; 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 Poisons Standard to include Dermatophagoides pteronyssinus and Dermatophagoides farinae extract in Schedule 4, with an implementation date of 1 February 2017.

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

Schedule 4 – New Entry

DERMATOPHAGOIDES PTERONYSSINUS AND DERMATOPHAGOIDES FARINAE EXTRACT.

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 (f) any other matters that the Secretary considers necessary to protect public health.

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

  • It is a NCE with no clinical experience in Australia.
  • Dermatophagoides pteronyssinus and Dermatophagoides farinae extract is indicated for the treatment of adults diagnosed with:
    • HDM allergic rhinitis not well controlled despite use of symptom relieving medication; or
    • HDM allergic asthma not well controlled by inhaled corticosteroids;
  • When treated with D. pteronyssinus and D. farinae extract the patient is exposed to the allergen that causes the allergic symptoms. Therefore local allergic reactions are to be expected during the treatment period. The use of anti-allergic medication (e.g. antihistamines) should be considered for any potential significant local adverse reactions to the D. pteronyssinus and D. farinae extract;
  • Need a medical doctor to prescribe to the right patient group; and
  • D. pteronyssinus and D. farinae extract is not recommended for use in children below 18 years of age due to insufficient data on safety and efficacy in this population.

Book pagination