This presentation on AFAO's submission regarding rapid testing and the TGA Review of Medicines and Devices Regulation was given by Ben Wilcock, AFAO Health promotion Officer, at the AFAO Members Forum – May 2015.
2. Overview
TGA Review of Medicines and Devices Regulation
TGA review on the Proposed Performance Requirements
and Risk Mitigation Strategies for HIV Tests
Rapid HIV tests currently being assessed by TGA
MBS listing for rapid HIV testing
National HIV Testing Policy
3. TGA Review of Medicines and Medical
Devices Regulation
Large independent review examining TGA’s regulatory framework and
processes
– First stage:
Prescription medicines
Over-the-counter (OTC) medicines
Medical devices
– Second stage:
Complementary medicines
Recommendations the review will make include areas such as:
– Ensuring an appropriate balance between risk and benefit
– Simplifying and streamlining approval processes (fast tracking approvals,
opportunities for working with overseas regulators)
– Process improvements that make navigation of regulatory system easier
4. TGA Review of Medicines and Medical
Devices Regulation
First stage (prescription, OTC, medical devices):
– AFAO limited its submission to medical devices chapter –
specifically relating to rapid tests
– Submissions closed 5 January 2015
– Report provided to government by 31 March 2015
Second stage (complementary medicines)
– Submissions closed 8 April 2015
– Recommendations to government mid-2015
5. TGA review on the Proposed
Performance Requirements and Risk
Mitigation Strategies for HIV Tests
Smaller consultation by the TGA proposing the performance
requirements and risk mitigation strategies for HIV tests:
– Laboratory HIV tests
– Rapid HIV tests used at point-of-care
– Rapid HIV tests used for self-testing
AFAO made no comment on laboratory testing and
concentrated its submission on rapid HIV tests, both for point-of-
care and self-testing use.
6. TGA review on the Proposed
Performance Requirements and Risk
Mitigation Strategies for HIV Tests
Submissions closed 30 January 2015
TGA’s document was published on their website in March 2015
Overall, a very good step in the right direction
– Importantly, it identifies the different needs for specific types of tests
(eg rapid HIV tests) in different settings (eg both at point of care and
self-testing)
– Performance requirements (sensitivity and specificity) appear
reasonable
– Issue of what constitutes “supervision” seems now to be suitable for
models of AFAO’s state member organisations’ testing services
direct and indirect
7. Rapid HIV tests currently being assessed
by the TGA
Trinity Uni-Gold test:
– Original application was knocked back
– Sponsor appealed – appeal on hold for TGA review
– Outcome expected soon
Orasure
– Original application also knocked back, also appealed
No application has yet been made by a manufacturer for a rapid
HIV test for self-testing
8. MBS listing for rapid HIV testing
Alere (manufacturer of currently only TGA-approved rapid HIV test,
Determine HIV Combo test) made an application to MSAC (Medical
Services Advisory Committee) in mid 2014
– the final protocol published on MSAC website early 2015.
Alere’s original application included a limitation on the listing to
antigen/antibody combo tests (Determine is currently the only one
on the market).
– AFAO’s and other organisations’ letters of support to the original
application supported an MBS listing for rapid HIV tests including
combo and antibody only tests.
– Encouragingly this limitation doesn’t seem to appear in the final
protocol document.
9. MBS listing for rapid HIV testing
Feedback from Alere earlier this year is unfortunately we are still some way
from a decision.
A couple of processes/meetings as part of the MSAC process before the
final MSAC meeting
– Next MSAC meetings on end of July and end of November
Alere doesn’t think those processes will have everything ready in time for
the June MSAC meeting – much more likely to be reviewed in November.
If successful, MSAC then makes a recommendation to the Government and
then if the Government decides to act on that recommendation it could take
say 6 months for the Medicare schedule to be updated.
10. National HIV Testing Policy
Several planned amendments that were being incorporated in the
latest review of the National HIV Testing Policy (eg the need to
remove regulatory restrictions to allow HIV self-testing) occurred
during the drafting of the latest version.
The National HIV Testing Policy Expert Reference Group is
meeting in late May to finalise the revised policy.
It will then be circulated to all jurisdictions and organisations for
their endorsement.
– Intended agenda item for a draft briefing at the next BBVSS meeting in
mid June.
– Then a briefing and final version sent to the Commonwealth, BBVSS
and MACBBVS for endorsement by all by August 2015.
Editor's Notes
Quick update for some
Quick recap for others – might know some of this
We have already shared updates on most of this over the last little while, but thought it would be useful to do a quick recap of the together today.
Just giving an overview, to allow time for Q&A at the end of this session – but of course feel free to come an have a chat afterwards if you’d like more detail.
Medical devices – includes testing devices and kits, such as rapid HIV tests
AFAO and many of you made submissions.
Provided to the Minister for Health by 31 March (copied to PM, the assistant Minister for Health, and the Parliamentary Secretary to the PM responsible for deregulation)
We are checking with timeframes from the government
AFAO and many of you made submissions
Overall, a very good step in the right direction
In terms of AFAO’s submission, although some of the points in our submission (and no doubt from your submissions) weren’t included (eg statements about not being suitable for use in workplaces, mandatory testing, not suitable for low prevalence populations etc), many were included
Clarifies a lot of issues AFAO and its (particularly its state/territory) members have raised
AFAO distributed a briefing covering the details of the document, and noting issues raised in AFAO’s submission that seem to not have been addressed in the final TGA document.
Performance requirements
We would expect Trinity and Orasure (previously knocked back) to meet these requirements – though this is clearer with Trinity at the moment, I’ll explain that on the next slide
Rapid tests
Sensitivity – 99.5% (whole blood), 99% (oral fluid)
Specificity – 99%
Self-tests the same, plus usability studies (acknowledging that the same level of sensitivity and specificity may not be achieved in a self-testing environment)
Sensitivity
How many of true positive samples will give a positive result
Lower sensitivity = more false negatives
Specificity
Proportion of positive results that are true positive results
Lower specificity = more false positives
Trinity Uni-Gold
Original application was knocked back
Knocked back about the time the review of performance requirements and risk mitigations for HIV tests.
Sponsor appealed and was agreed by all parties put on hold while the review was done – with the view to approve if met the new requirements without a second full application
Outcome expected soon
As I said, we would expect the Trinity test to meet the performance requirements from the new TGA document, so we are hopeful on the outcome
We have heard possibly in the next couple of months - but not official (end June?)
Orasure
Trying to get information from Orasure about where the process is up to for them hasn’t been as easy, so not sure if the same position as Trinity
UK recently approved their first test – Biosure
Encouragingly this limitation doesn’t seem to appear in the final protocol document.
Though the application name is still “Rapid point of care combined Antigen/Antibody HIV test to aid in the diagnosis of HIV infection”
Feedback from Alere.
The next steps towards an MBS listing:
the Health Technology Assessment (HTA) group putting together the Assessment document – this should take about 6 months.
this then goes to the Evaluation Sub Committee (ESC) for review, then on to MSAC.
the next MSAC meetings are at the end of July and end of November.