This is the second time MSAC have knocked back HPV DNA testing. The first submission was recieved way back in 2001 and rejected on the basis of lack of evidence. This time around
"MSAC finds that, in comparison to the Papanicolaou (Pap) test, LBC is safe, is at least as effective, but is not cost effective at the price requested. MSAC advises that LBC not be supported for public funding."
As the second submission was made in 2007, six years of clinical data was required in order to convince MSAC that HC2 was safe and effective.
Reducing the cost will be a must in any further applications for public reimbursement of alternates to traditional Pap testing. If QIAGEN drop the price and get public funding I'd call curtains on any other test trying to get funding.
The idea GBI will be able to simply drop it's cost to $40-50 and then apply for funding in early 2010 is a little optimistic. MSAC assessments require volumes of evidence relating to a products safety and clinical effectiveness and the study published to date won't even come close to satisfying the levels of evidence required (study design with MSAC Evidence level IV). Further, results from any comparative studies of PapType and HC2 will yield results with Evidence level III-2/3, depending on the study design. These are the lowest rating of Evidence levels given in MSAC assessments. IMO a submission to MSAC with a cost of 1c and those levels of evidence would still have no chance of getting funding.
Profrazer, you seem to be on good terms with the CEO of GBI. Next time you call him perhaps ask what advice he has received from Prof Suzanne Garland about trial designs to generate sufficient evidence to satisfy MSAC assessments. She served on the on the assessment committee that just rejected public funding for HC2 so would be able to give you the good oil on the process.
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