Temporary listing of ganciclovir eye gel

Medicines

Decision

PHARMAC has decided to temporarily list ganciclovir 0.15% eye gel on the Pharmaceutical Schedule from 1 January 2015 until aciclovir 3% eye ointment (Zovirax) supply resumes in New Zealand.

Zovirax supply has been interrupted by an international manufacturing issue. 

Details of the decision

  • Ganciclovir eye gel 0.15% (Virgan) will be listed in Section B of the Pharmaceutical Schedule from 1 January 2015 as follows (price ex-manufacturer, excluding GST):
Chemical Formulation Brand Pack size Price and subsidy
Ganciclovir Eye gel 0.15% Virgan 5 g OP $37.53
  • Ganciclovir eye gel 0.15% will be listed in Part II of Section H of the Pharmaceutical Schedule from 1 January 2015.
  • Note that ganciclovir eye gel 0.15% (Virgan) is not a Medsafe-approved medicine and will be supplied in accordance with section 29 of the Medicines Act 1981.

Background

The supplier of Zovirax, GlaxoSmithKline, has informed PHARMAC that there is no stock of this treatment in New Zealand and it will not be re-supplied for a number of months because of an international manufacturing issue. Given the clinical need for an alternative funded treatment, PHARMAC has decided to list ganciclovir eye gel 0.15% (Virgan) which is a potential treatment alternative for some patients.

Virgan is not a Medsafe-approved medicine and will be supplied in accordance with section 29 of the Medicines Act 1981.  Despite looking, PHARMAC has not been able to identify alternative brands or treatments which are Medsafe-approved.

Information on medical practitioner’s obligations when prescribing or dispensing unapproved medicines can be found on the Medsafe website at http://www.medsafe.govt.nz/profs/riss/unapp.asp(external link).

The ganciclovir eye gel 0.15% (Virgan) stock being listed has Ukrainian labelling. However, English datasheets for the product can be found on various websites. PHARMAC is pursuing options to over-label the stock with English labels but this will not be available before February 2015.

We recommend that ophthalmologists are consulted prior to patients beginning treatment with Virgan.

As Virgan will be supplied in accordance with section 29 of the Medicines Act 1981 (which enables supply on the request of a medical practitioner only), optometrists will be unable to prescribe this product for their patients.

Pharmacists presented with prescriptions written for aciclovir eye ointment (Zovirax) will not be able to substitute, dispense and claim a subsidy for ganciclovir eye gel 0.15% (Virgan).

The listing of ganciclovir eye gel 0.15% (Virgan) on the Pharmaceutical Schedule will be temporary until aciclovir eye ointment 3% (Zovirax) supply resumes. We will inform the market when this occurs.

More information

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.