Saturday, March 17, 2012

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.


  1. Your son does have type 1 diabetes by the definition that type 1 diabetes is any diabetes caused by an inability to make insulin. It's just not the commoner type 1a diabetes- it's not autoimmune.

    Anyways, I am very sorry to hear about these changes. I hope the policy changes very soon.

    1. Thanks for the comment. Hopefully we'll hear something soon but they've had a LOT of submissions to work through so it could be a while.

      My son's condition doesn't come under type 1. This table from the ADA is a few years old now but shows most causes of diabetes, Type 1 is diabetes resulting from destruction of specifically the beta cells, either by the immune system (1A) or some other reason (1B).
      Pancreatic agenesis doesn't appear anywhere on that list but then it doesn't appear on many lists!

      As if diabetes needed to be more complicated!

      Thanks for reading the blog.

  2. I couldn't imagine. Good luck!!