Fiasp again – time to act!

The 2023 Fiasp supply dramas are entering a new phase.

We have an opportunity to contribute to the process in the next week. Scroll on and you’ll find details. But first, some background. Or jump ahead if you’re in a hurry….

History recap

In June 2019 Fiasp was added to the Australian Pharmaceutical Benefits Scheme (PBS). Fiasp is “faster insulin aspart”, and has a greatly accelerated action time compared to the usual insulin aspart (NovoRapid). Insulin lispro (Humalog) and insulin glulisine (Apidra) are the other rapid insulins currently available in Australia, and they have very similar timing to NovoRapid. Fiasp is the only “ultra-rapid” insulin that has been available to Australians.

Managing insulin injections/pumping, and lining up the action time of the insulin with that of food and exercise is a balance that we are constantly working with.

In the years since, Fiasp has allowed many people to keep that balance on track, making life much easier. In 2023 we were told that about 15,000 people were relying on Fiasp.

In February 2023 we heard that Fiasp was about to be delisted from PBS. The March PBS update showed it was to become unavailable on April 1.

This was apparently due to a price dispute between the Australian Government and Novo. Essentially, PBS was reducing how much they wanted to pay for insulins, and even apparently lowered their offer for Fiasp even further than NovoRapid. There’s evidence of discussion at PBAC (the PBS Advisory Committee) that basically indicated it wouldn’t matter if Fiasp wasn’t available, as it was essentially “just another insulin aspart”.

Those of us who’ve used Fiasp know that it’s usually significantly different in speed of action compared to NovoRapid, and that this speed can have a significant impact on us.

In mid-March 2023 the Federal Health Minister issued a Supply Order to Novo, resulting in Fiasp being in “Supply Only” state for 6 months (up until the end of September 2023). This means that new PBS prescriptions for it could not be written after March, but existing prescriptions could still be filled.

The current setup has no access for many people at the moment, and no access for anyone by October 2023!

So who does this affect?

So currently there are multiple populations:

• People who have current Fiasp prescriptions and are able to access it (until they use up those prescriptions or October runs around).
  These people are obviously worried about what their options will be at that point.
• People who were using Fiasp but were not able to get new prescriptions in the few weeks of warning we had. Not everyone is watching this stuff all the time.
  These people are now either just using up their remaining supply, or are already having to step back to slower insulins to manage their diabetes.

As mentioned above, that’s about 15,000 people. But sadly, there are also people who didn’t know that Fiasp existed until it was taken away.

There are of course people who tried Fiasp and found it didn’t work for them, and people who have been simply sticking with their older insulins (there are many understandable reasons behind this). Apart from anything else, there can be a lot of “inertia” involved in managing a chronic condition like diabetes.

Fiasp formats

Yesterday’s article about insulin containers (“Re-usable insulin pens”) is relevant here. Please read it now if you haven’t already.

One of the things we moaned about in 2019 was the fact that Fiasp was not available in Penfill format. Only in vials and in disposable pens. But we coped.
But those formats have this year been subject to unsuccessful PBS price negotiations (see above). Now, there may be a new hope.

The agenda for the upcoming July meeting of the PBAC (Pharmaceutical Benefits Advisory Committee) was updated this month with a few new items. One in particular looks interesting:

It seems as though there’s a chance that Fiasp in Penfill form could be added to PBS. I don’t know all the departmental negotiation over prices and politics around this, but it does for example seem to open up the possibility of access without needing someone to reverse a previous decision. Fiasp in Penfill form was submitted to PBAC years ago, so this would just be re-opening that case.

Using Penfills

You may not have used Penfills before, but as explained in yesterday’s article they can be easily used for both pen injections and for filling pumps. If we end up only being able to access Fiasp in Penfill format that might not be ideal for everyone, but it’s a whole lot better than not being able to access it at all!

What we can do to help!

PBAC is currently accepting comments and submissions on the items on the July agenda. Submissions close on May 24, which means we have just over a week available to us!

As consumers it can’t hurt the process to make PBAC conscious of the impact Fiasp has for us. Then we can just hope that our submissions add to the evidence that the committee will be considering, and that a useful outcome will appear before October!

Someone’s making this harder than it needs to be

The standard process to provide feedback is straightforward: they have a web form to fill out. One of the fields is a pull-down list of which medicine you wish to comment on.

However, “INSULIN ASPART” can not be selected! At least one other medicine on this agenda has a similar issue.
The Department has not responded to repeated requests to have the form fixed. So the web form seems to be useless for us.

How to make submissions

We can make submissions by email (to commentsPBAC@health.gov.au). But this is a free-form process, so you need to be careful to submit all the required information. Essentially we need to reproduce the web form:

Your name
Your email address
Your phone number
What state you live in
Consent	That you consent to the content of your submission being published (discussed further below).
The medicine you’re commenting on	“INSULIN ASPART (Fiasp)”
Your category. One of:	Individual who would like to access the medicine to treat own health condition Individual who has used this medicine for own health condition Parent, partner or another person directly caring for an individual from the above two groups Consumer group/organisation There are some more categories spelt out on the web form, but those would not apply to most of us.
How did you find out about the consultation	Feel free to drop this website name, but “Community advocacy” seems quite an appropriate answer.
Your comments, answering these 5 questions. Try to follow these guidelines from the department.	Q1: Outline your experience with diabetes. “What is the impact of your health condition on your life? Try to be as specific as possible including impacts on your everyday activities, work, family, friends, mental and emotional health.“
	Q2: How is the medical condition currently treated? What is the effect of your current treatment on your health condition? Are there any symptoms which cannot be controlled with the current treatment? What side-effects have you experienced with current treatments? Are these manageable?
	Q3: What do you see as the advantages of this proposed medicine for you? What are the specific positive impacts that you hope this treatment will have on your health condition? What impact would you like it to have on your quality of life? (for example, enabling you to return to work) If you have used this medicine what was your experience? What changed for you? Are there advantages in the way the medicine is delivered? After you’ve spelt out the advantages for you of Fiasp, I would think that retaining access to any format of Fiasp would be a significant advantage of the item being discussed by the committee!
	Q4: What do you see as the main disadvantages of this proposed medicine? Are there disadvantages in how you can access the medicine? If you have used this medicine, what did you consider to be the disadvantages?
	Q5: Any additional comments.
Conflicts of interest	Presumably do you not own shares in Novo Nordisk, but whatever your situation you do need to make a declaration.

You can attach a PDF or Microsoft Word document to your submission if it helps. As long as it’s no larger than 25 MB.

The department actually provides a Word document template to make things a little easier. You can download it, insert “INSULIN ASPART (Fiasp)”, and start filling in details.

Make your submission count!

The above details may seem like a long process, but please don’t ask for a sample set of answers for you to submit.
The department is strict about things that are not acceptable.

If you just copy someone else’s submission and put in a form letter, it will be rejected.

Other things to consider when writing

This is quoting from the web form:

• All input from individuals will be made available in summary form to the sponsor of the application and the PBAC.
• No identifying information about individuals or third parties will be included in the summary. This type of information will be removed by the Department.
• The PBAC may also have access to de-identified individual responses.
• All input from groups or organisations will be provided in full to both the PBAC and its subcommittees and the sponsor of the medicine. Any identifying information relating to third parties detected will be removed prior to distribution.
• In addition, all input received will be noted in the relevant Public Summary Document. Public Summary Documents are available approximately four (4) months after the PBAC meeting and outline the PBAC discussion and advice.

You should confirm in your submission that you consent to your submission being used that way.

So:

1. As individuals your submissions will be summarised. Make it concise and sweet, folks!
2. Don’t include identifying personal details (except for the name/email/phone items). Give them less to delete.
3. Four months after the July meeting would be November. While there’s a chance that even if the PBAC’s recommendations are positive then it might not be enacted until after the current Fiasp arrangement expires, but somehow I doubt that the Health Minister (Mark Butler) would make that political mistake. We hope that if he receives a positive recommendation from PBAC that he will act on it promptly.
   It would not be setting a new precedent for the government to enact things before they documented them…

Speak up now, or…

You only have until May the 24th to get your voice added to the official record. Don’t delay!