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 for an alternative version or a copy to be sent to you.