Last week I wrote about the announced expansion to the NDSS CGM Subsidy. If you haven’t read that article yet, please do before continuing.
There’s still some time to go before we find out for sure what will happen, but some things are getting clearer. I’m not sure the Health Department and NDSS necessarily know all the details yet either: post-election we don’t even officially have a Health Minister yet!
Timeframes
We’re obviously interested in fundamental details like “When will I have CGM in my hands”. And we would like to imagine we might have them from the 1st of July. Especially if that means we don’t need to buy more between now and then!
However it seems much more likely that if the 1st of July date comes true, that will only mean the forms will be available then. And then the processes can start rolling.
It does seem highly likely that we will have to get doctors to sign off on paperwork, just like with the current NDSS CGM Subsidy.
Sure, NDSS already knows if we have Type 1 diabetes (as long as those details are correct: some people initially misdiagnosed with T2 find their NDSS records not updated!).
So surely we shouldn’t have to fill out more paperwork? But we did have to get extra paperwork signed off when the NDSS subsidy of Insulin Pump Consumables was introduced. So there seems to be precedent.
It also does seem likely that we will have to nominate which CGM system we will be using. Of course this can be changed later, but it seems unlikely at this point that we’ll be able to just get a box of a different system to trial it on a whim.
So I’m working on the assumption that we will have to involve doctors or DEs after the first of July and submit forms before we can eventually get our hands on supplies.
On a related note, apparently the NDSS HCP interface may be going “online” in late June (so forms can be submitted electronically). It would be nice to think that this means things will run quickly and smoothly and we get access to CGM faster.
I do hope the system implementation goes well and doesn’t run into hiccups in those first weeks before July kicks in! New IT systems always get implemented smoothly, right?
CGM providers
Abbott (behind the FreeStyle Libre2), AMSL (behind the Dexcom G6 and the Tandem pump), and Medtronic have all been sending emails to existing customers. Obviously setting up to reinforce and build their market shares.
As suggested in the previous article, Medtronic seems to be offering to upgrade all in-warranty pumps (back to the 640G) to the latest 780G. As long as you register for the compatible Medtronic CGM through NDSS of course. Note that pump warranty would not be extended by that upgrade.
AMSL has been taking the opportunity to remind people that the Tandem pump can be upgraded at no cost to Basal-IQ and Control-IQ. The emails have been making a big point about “Urgent Product Defect Correction”. Apparently this even applies to people with out-of-warranty Tandems with the old firmware.
Not surprising really, as the old G5-compatible Tandem firmware lost its TGA approval in early 2021 due to issues such as battery instability. Some people have been sticking with their old G5 pumps because they have a pile of sensors and can’t justify the cost of G6 CGM. The subsidy will change that equation…
Don’t get caught out
Hopefully as we get further into June things may become clearer. But I won’t be surprised if it’s still suppositions right up to July.
My advice is to try to not be that person counting on getting access to CGM gear on Friday the 1st. That would seem very risky!
Personally I have a telehealth appointment organised with my endocrinologist for early July. That way we have a chance of getting the appropriate forms updated. Hopefully my current stash of sensors will last long enough.
Thanks for the update David. I really appreciate all the time spent and research you’ve done and continue to do.
I’m certainly receiving daily emails from Medtronic/AMSL/Abbott and giving them the quick once over, with my Endo booked 4th July.
Daily emails…. I’ve not had one yet.. Doesn’t bother me.. I bought 6 months supply in March as I’m travelling round Europe.. Hopefully some clarity by the time I’m back in September!
Thanks for the update! Do you know if this change needs to go through parliament? It’s looking like parliament isn’t going to sit until July.
I don’t think so. I hope not: that would involve extra delays, and I’m sure Parliament will have a lot on its plate.
I don’t believe any part of the functions of NDSS are legislated, so a ministerial direction to DOH is all that’s required. The actual spending allocation would have been in the budget as part of the billions of pork barrelling dollars counted as “decisions taken but not yet announced”.
Thanks David for all the great information you share with the Type 1 Community.
Well written David! Thank you ?
Thanks David. Can you advise where you sourced the information about Medtronic upgrading all pumps to the 780? That would be amazing.
I’ve seen copies of emails they’ve been sending to 640G and 670G owners.
Mind you, there are a bunch of people who have not yet got the emails, and it won’t be actionable until we can eventually register for the NDSS Subsidy.
So there doesn’t seem to be a hurry on sorting it out.
Just got the email from Medtronic ?
Abbott has received FDA approval for the Libre 3 in the USA:
https://abbott.mediaroom.com/2022-05-31-Abbotts-FreeStyle-Libre-R-3-Receives-U-S-FDA-Clearance-Features-Worlds-Smallest,-Thinnest-and-Most-Accurate-14-Day-Glucose-Sensor
This looks similar to the Libre 2 rollout which was approved in June 2020 in the USA. Australia followed 10 months later with TGA approval in April 2021. Availability in Australia took another 3-4 months from the approval.
If timetable follows this time can expect Libre 3 available in Australia in about 12months or so. Notably the Abbott CEO did say they are trying to speed the rollout this time so see if that has any effect
Another way of looking at the Libre approvals is that Libre2 was approved in Europe in early 2018, and it took 3 years for it to be approved in Australia.
Libre 3 was approved in Europe in late 2020 (but seems to have only recently started rolling out beyond some trial deployments). So maybe late 2023 in AU?
It is quite hard to extrapolate timelines from previous products…
As part of the press release Abbott said:
“The FreeStyle Libre 3 sensor will be available at participating pharmacies later this year.”
The lack of a specific launch date sounds like at a few months at least. The USA is a very big market to fill, so seems very unlikely will be able to provide anything to Australia this year.
Not sure if is still true but previously Abbott used to do all their prototyping, testing and setup for Libre in Wiesbaden Germany before transitioning to the Witney factory in the UK for production. That’s a long way from Australia, so much cheaper to sell the initial product in Europe nearby as they are now doing in UK, France and Germany.
On the plus side though was looking at the Libre 3 circuit board in the FCC submission here:
https://fccid.io/QXS-LIB03S/Internal-Photos/Int-5514479
It’s only one chip! The Libre 2 had 2 chips(a much bigger TI one that was also on Libre 1) and would probably be more expensive to manufacture than the Libre 3. Hopefully that encourages them to speed the transition this time.
Knowing how long you seem to manage to get your sensors to last David…I’m confident your stash of sensors will, indeed, last!!!
Thanks for all your information sharing…you’ve been a life saver for me and have helped many others. Thanks
The NDSS has issuing a short notice here:
https://www.ndss.com.au/news/eligibility-expansion-for-all-people-with-type-1-diabetes-to-access-subsidised-cgm-and-flash-gm-products-through-the-ndss/
It’s dated June 10 and talks of contacting all newly eligible registrants with details in the coming weeks.
Not sure how they plan to do this ie letter, email, phone call etc Does anyone know if there is anywhere online you can check your current NDSS registration details?
Your best place to check your details is to ring the NDSS Hotline.
Of course “the coming weeks” could include up into July…
Thanks David, i called the NDSS Hotline (1800 637 700) and they confirmed details correct.
Can also do it at the Pharmacy although think need to fill out a NDSS form and email or the online version here:
https://www.ndss.com.au/about-the-ndss/manage-your-registration/update-your-details/
Still can’t find anything about how the expanded scheme will work yet.
In the form for under 21 people it requires people to say they have either frequent low blood sugar events or unawareness or fear of low blood sugars. This is really bad, as it pressurizes the Doctor to make a declaration that’s not true or exaggerated to get a benefit for their patient.
The Doctor then potentially has to sign off on drivers license medical forms for the same patients saying the opposite is true.
(See here:https://www.ndss.com.au/about-the-ndss/cgm-initiative/type-1-diabetes-aged-under-21-years/)
That first registration is to make sure you’re set up in NDSS. Which should have been done when you were diagnosed with diabetes.
The registration for CGM will we presume need another step. You’ve linked to the setup for one of the current categories, but as you say we haven’t seen sign of the new forms yet. Yes the original (several years ago) registration did lead to people needing hospitalisation before they become eligible. But everyone with T1 and under 21 can be written up as eligible at the moment.