Fighting Our Corner

We are fortunate to have only ever lived in countries with universal health care systems, so in theory no-one should be denied the care they need. However, there is only ever so much money available in a health budget and the need is seemingly endless. Decisions need to be made about what the health budget is spent on, what facilities to provide, what treatments to fund, what devices to supply. When it comes to medicines and medical devices in New Zealand the people entrusted with those decisions are Pharmac, the Pharmaceutical Management Agency.

With limited budgets and limitless ways to spend them, tough decisions have to be made and I believe in general they try to do the best they can with what they've got. But sometimes they get it wrong, and it's up to us as advocates for our children to ensure they put right any mistakes they make.

Recently Pharmac released two proposals relating to diabetes.

The first was to stop funding the existing subsidised brands of glucose meters used by almost all diabetics in NZ; Accu-check Performa, Optium Exceed, Freestyle Lite, On Call Advanced, and leave us with a sole supplier, iSens, who supply the demonstrably inferior CareSens range. The plan is to save NZ$10 million from their budget, although as many have pointed out, this is likely to result in far greater increases to other areas of the health budget resulting from poorer control of diabetes.

This proposal was met with horror by diabetics and resulted in over 3000 submissions to Pharmac, including mine, which we hope will make them reverse their plans but time will tell.

The second proposal was to fund insulin pumps and consumables. On the face of it this is good news as currently pumps are not funded nationally but on a piecemeal basis by various district health boards around the country, so the chances of getting one have really come down to luck, or considerable personal expense. That they will now be funded is great news. But that's where the good news ends.

They are only going to fund one pump, the Animas 2020. By chance that happens to be the one Finlay is currently on but for many others that is not the case. Pharmac seems to have a one-size-fits-all approach to diabetes. If only diabetes would reciprocate!

Another aspect to the proposal that alarms me is that they are only going to fund pumps for type 1s, or from our point of view, NOT FINLAY!!

So I have been back on the computer and sent a second submission within two days to Pharmac in time for yesterday's close of consultation. Although this proposal will affect many diabetics across New Zealand I have stuck mainly to issues specific to our case. For this I make no apology. When it comes to fighting for the health and wellbeing of my son, any of my sons, the gloves are off.

So here is my submission. Hopefully it, along with many others will bear fruit:

Dear XXXX,

Thank you for the opportunity to offer feedback on Pharmac's recent proposal to fund insulin pumps and consumables. While I am pleased that Pharmac has seen the need to fund these devices I am left with a number of concerns.

As I wrote in my submission on the proposal for funding changes for glucose testing equipment, in 2008 my son was born with a rare condition called pancreatic agenesis, where the entire pancreas failed to form, along with an absent gall bladder and multiple cardiac defects. Among other effects this left him an insulin-dependent diabetic. He was born with severe intrauterine growth restriction, weighing less than 1.4kg. Due to the lack of pancreas he failed to thrive in the early days and, following confirmation of his diagnosis he was put on an insulin pump, becoming one of the youngest and smallest children in the world to use the technology, a notable achievement for the New Zealand health system.

The tiny amounts of insulin that could be delivered via the pump were fundamental to his progress, allowing him to reach growth and developmental milestones far earlier than could have been achieved, if at all, with conventional insulin injections. Open-heart surgery that was required at 6 months of age was successful, an outcome that would have been far less likely had pump therapy not been an option. A measure of the importance of modern medical technology is that 2 decades ago there were no survivors among children with my son’s condition anywhere in the world.

After reading the proposal I am alarmed to read the criteria set out for Special Authority for subsidy for insulin pumps:

Special Authority for Subsidy for insulin pump

Initial application only from a relevant specialist. Approvals valid for three months for applications

meeting the following criteria:
1. Patient has type 1 diabetes; and
2. Either
2.1. has adhered to an intensive MDI regimen using analogue insulin’s for at least three
months but still has either:
2.1.1. four severe unexplained recurrent hypoglycaemic episodes over a six month
period either due to hypoglycaemic unawareness or to nocturnal hypoglycaemia; or
2.1.2. unpredictable and significant variability in blood glucose including significant
hypoglycaemia affecting the ability to reduce HbA1c and in the opinion of the
treating clinician, HbA1c could be reduced by at least 11 mmol/mol (1.0%) using
insulin pump treatment; and
2.1.3. has been evaluated by the multidisciplinary team for their suitability for insulin
pump therapy, or
2.2. is already on pump treatment prior to xx date (date Special Authority is initiated) and
met criteria 2.1 at the time of initiating that pump treatment and continues to benefit from
pump treatment

Both criteria 1 & 2 are required for Special Authority yet my son meets neither. He is not type 1 and as he was never treated with MDI he cannot meet criterion 2.

A similar scenario was included in the criteria for subsidising pump consumables where my son fitted neither criterion:

Special Authority for Subsidy for insulin pump consumables

Initial application only from a relevant specialist. Approvals valid for nine months for applications
meeting the following criteria:
1. Patient has had a valid Special Authority approval for an insulin pump approved under SA xxx
Renewal only from a relevant specialist. Approvals valid for two years for applications meeting the
following criteria:
Patient is continuing to derive benefit from insulin pump therapy as defined by:
1. Either
1.1. a reduction of hypoglycaemic events compared with pre-pump frequency by at least
50%; or
1.2. is maintaining a reduction of 11 mmol/mol (1%) HbA1c from baseline;

My son does not have any pre-pump data to compare as he has been on a pump since shortly after diagnosis and, similarly, any baseline measurements of HbA1c would be irrelevant.

Under the proposal as it stands my son would not qualify for subsidy for either a pump or pump consumables yet I consider the insulin pump an absolute necessity for his continued care.

Despite the multiple facets of my son’s condition, we as parents, working closely with our clinical teams, have managed to keep him remarkably healthy. Despite the severity of his condition, inpatient hospital stays have become a rarity and the insulin pump has been an integral part of this success.

I see from the PTAC Diabetes Subcommittee report from December 2011 that the subsidising of pumps to small groups such as neonatal diabetics such as my son, CF patients and pancreatectomy patients was raised but this issue was not resolved due to reasons that were not elaborated on in the report. The issue was not mentioned at all in last month’s proposal document.

In my view the relatively small cost of subsidising pumps and consumables for the small number of patients in these groups would be very cost-effective as they will prevent multiple expensive hospital admissions of these complex and potentially high cost patients.

The second issue I have is that the proposal appears to imply pumps will be supplied through a sole supplier. Limiting options to one brand of insulin pumps may not be in the best interests of individual patients. When my son was first put on a pump, an Animas 1200, it was the only one suitable for him at the time as it allowed delivery of the smallest increments of insulin which was critical for good growth in a very small child, particularly as we were trying to strengthen him for his imminent cardiac surgery. Had we been restricted to another brand there would likely have been serious, possibly life-threatening consequences. While our son’s condition was/is unusual, I believe he is a good illustration of how we should not adopt a one-size-fits-all approach to insulin pumps. There are inevitably going to be other patients for whom the optimal pump is denied due to a sole supplier status. The large initial outlay in purchasing a pump and continuing cost of consumables will make self-funding of alternatives an impossible burden for many families.

There are a range of insulin pumps, each having their own pros and cons. Different patients have different needs and while the Animas 2020 may be the best option for some, it will not be for others. Also, whereas the Animas 2020 my son currently has is serving him well, he is a pre-schooler. Whether it will be the best option for him as he grows through puberty and into adulthood is something that should be decided when the time arises, by clinical criteria, not by the stroke of a pen years earlier.

I thank you for the opportunity to comment on your proposal and hope that you will consider my comments prior to finalising any policy.

The Rollercoaster Rides On.....

We knew it was coming but the reality still hits hard.

 Yesterday we had an appointment with the cardiologist. It was all over in a few minutes. In fact it was all over by the time I joined them at the hospital after getting the older boys to school. The result is we will be getting an appointment for a cardiac catheter in the next few months. What this means is that Finlay will fly up to Auckland on the North Island of New Zealand with Vicky and spend a few days at the hospital. All the paediatric cardiac specialists in the country are based in Auckland.

We’ve been waiting for this for a while but the realisation of another imminent operation still fills us with dread. He had open heart surgery at 6 months old but only some of his problems were fixed. For the rest we adopted a wait-and-see approach. We’ve done the waiting, this next op is the seeing! The main problem left with his heart is that the right ventricle (the one that pumps blood to his lungs) is too small. This op will let the surgeons see whether it has grown sufficiently in relation to the rest of the heart for them to do a quick patch up job and send us on our way or whether there will need to be some major replumbing to take the strain off his small right ventricle.

Next year, Finlay will turn five. In New Zealand children start school on their fifth birthday, whenever it is during the year. Quite a nice way of doing it, each child having their special day. For us it’s more than the start of his journey through school: it’s a line in the sand for his heart. The cardiologists want to have his heart sorted before he starts school. They see little benefit in waiting longer and they don’t want his schooling to be disrupted by major heart surgery. So we’ve always known that cardiac surgery would happen sometime in the next year.

So what will happen is he will be put under general anaesthetic while a catheter is pushed up a vein from his groin all the way into his heart. Finlay has a hole between the right and left atria that was left open during his previous surgery to relieve the pressure on his small ventricle. Once the catheter gets into his heart they will stick a balloon in the hole to block it and measure the pressures within the heart. If all is well then they’ll schedule an op to close up the hole and all should be well. If, as seems likely, things aren’t so good, then a more complex surgery will be needed to take some of the blood returning from the body and redirect it straight to the lungs bypassing the heart, thereby easing the pressure on the heart.

The catheter operation is about as simple as heart surgery gets but is still far from a walk in the park. There will be a general anaesthetic which is never nice. We will have the fun and games of nil-by-mouth prior to surgery with a diabetic while trying to deliver him to the surgeons with his sugars at a good figure. In a different hospital all the staff will have to get to know his case. With him being the only one with his condition in the country only those that saw him three and half years ago will ever have seen a case like him. Hopefully those that do remember will be able to make it clear that his mother knows what she is doing when it comes to his diabetes and she should be listened to. Back at home his brothers are old enough to understand why he won’t be at home and they’ll have to suffer my cooking for a few days – we all suffer for this disease!

A year from now our son will have his heart fixed, perhaps not 100% but hopefully to a level where he will be able to live a full, productive life doing all the things he wants to. We’ve always been determined that diabetes shouldn’t hold him back, the surgeons can hopefully ensure his heart doesn’t either.

So the upcoming operations are a positive step, another milestone on the path to beating his disease, but it’s only natural to be nervous. The necessary suffering he will endure and the inherent risks, all the risks. He’s so small. He shouldn’t have to go through all this.

Blissfully unaware of what's coming

So for now we carry on with the day-to-day, waiting for the letter……the rollercoaster rides on…..