Pharmacy Daily | Drug/test feedback wanted

THE Department of Health and Ageing is seeking feedback on new Draft Information Requests for Assessing Co-Dependent Technologies. The move follows the rise of “codependent and hybrid technologies,” and in particular the pairing of proposed tests with proposed drugs. A number of new medications, particularly for cancer, have been shown to be effective in certain patient groups with particular genetic markers, and the draft assessment process aims to look at whether tests and the associated drugs should be subsidised under the PBS and MBS. The document is based on advice received from Adelaide Health Technology Assessment which is based at the University of Adelaide, and sais that the focus on pairing a proposed test with a proposed drug with reference to a specific genetic DNA biomarker “is only an important first step and so does not comprehensively engage the full range of possible co-dependent and hybrid technology combinations”. The proposed process would see test and drug sponsors working together to integrate a full information package, providing details on test technology along with normal drug assessment requirements. It also covers so-called “double randomised trials” which would add the use of the genetic test to any drug trial protocol. The department is seeking feedback on the proposals by 17 Dec to hta@health.gov.au. The draft document can be viewed by clicking HERE.

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