Independent Review Report for Imiquimod
The following page includes the Independent Review Report for Imiquimod
Page last updated: 03 July 2009
The Independent Review (PBS) was established as part of
Australia’s implementation of the pharmaceutical provisions
of the Australia-United States Free Trade Agreement (AUSFTA).
From 1 January 2005, Independent Review has been available to any
applicant whose submission to the Pharmaceutical Benefits Advisory
Committee (PBAC) has not resulted in a recommendation to list the
drug on the Pharmaceutical Benefits Scheme (PBS). From the July
2006 meeting, Independent Review has also been available where the
PBAC has declined to recommend an extension of the listing of an
already listed drug.
At its July 2008 meeting, the PBAC rejected a request to extend the
PBS listing of imiquimod to include field therapy of multiple
clinically evident solar keratosis because of uncertain evidence of
effectiveness and safety over the comparator, 5-flurouracil gel,
and the resulting uncertain cost-effectiveness.
Following the July 2008 rejection by the PBAC, the sponsor sought
an Independent Review.
The purpose of this Independent Review was to assess the efficacy
and cost-effectiveness of 5% imiquimod cream (Aldara®) for the
treatment of solar keratosis of the face and scalp.
PDF printable version of Independent Review Report for Imiquimod (PDF 1767 KB)
If you are having difficulty downloading the PDF document, please
contact pbd webmaster@health.gov.au for an alternative version or a copy to
be sent to you.