From August next year people with diabetes will only have access to the CareSens range of glucose meters, despite some users still expressing a lack of trust in the meters’ accuracy.

Pharmac today announced it had negotiated a sole supplier agreement with Pharmco to supply four fully-funded CareSens meters – two of them not currently funded.  Also from August 1 it will stop funding the Freestyle Optimum and Accu-Check Performa meters and test strips currently used by about 3000 people.

Dr Bryan Betty, Pharmac deputy medical director, says blood glucose meters are used every day by about 120,000 New Zealanders and most won’t have to change the meter they currently use.

Pharmac estimates that the deal will save more than $10 million over five years – similar savings to those signalled when Pharmac signed its contract with Pharmaco in 2012 that led to more than 100,000 people having to change their funded brand of blood glucose meter.

That massive transition was controversial, with many users expressing concern at the accuracy of the blood glucose readings from their new meters and anger at funding not continuing for their existing meters.

The concerns prompted Pharmac to commission a study which showed a “small increase” in both hyper- and hypoglycaemia hospitalisations during the changeover period in 2012-13 but found hospitalisations returned to baseline levels in 2014.

Dr Betty said in today’s announcement that Pharmac had made sure that the CareSens meters funded met international standards for blood glucose meters and tests strips.

“The meters were also tested by New Zealand laboratories before they were considered for funding,” he said.

As part of the deal Pharmac will also discontinue funding the CareSens II but says users of that meter may be eligible to upgrade to one of the other funded meters.

Dr Betty said that it had engaged with stakeholders throughout the funding process and drew heavily on feedback received, including people supportive that the contract meant the majority of people did not have to change meters, and that it would include a dual meter for people with Type 1 diabetes.

But the consultation feedback on the Pharmac website also showed that a number of submissions were received expressing concern about the sole provider contract. Technical concerns expressed about the CareSens meters and strips included:

  • the accuracy of blood glucose readings, discrepancies between repeat tests and between different meters, leading to a lack of trust in the meters;
  • meters not working in cold temperatures; and
  • potential teething problems from introducing new technology such as the Bluetooth and smartphone app which are available with the CareSens Dual meter.

Pharmac’s response was that the CareSens meters met ISO standards which allow for 15 per cent variations compared to a laboratory test – therefore variations were to be expected. It also said it would be working with health professionals to develop education material on how patients can make best use of their meter including keeping it a working temperature range. Plus the SmartLog app operating system used by CareSens had been extensively tested and Pharmaco would be providing customer support.

Submissions also asked for continued funding for the Freestyle strips, that are compatible with FreeStyle Libre meters, or at least continuing with special authority funding for some groups, particularly children. Pharmac said it was aware there may be some clinical reasons for people having difficulties changing meters and it would be consulting with health professionals over a process to allow some people to retain funded access to their existing meter and test strips.

There were also calls for continuous blood glucose monitoring systems (CGMS) to be funded, as they were in Australia.  Pharmac said the sole supply agreement with Pharmac would not prevent the funding of CGMS and it was currently assessing funding applications for two different CGMS systems.

The four meters to be funded from February 1 2018 are:

  • CareSens N – currently funded
  • CareSens N Pop – currently funded
  • CareSens N Premier – not currently funded
  • CareSens Dual – not currently funded.

TIMELINE

1 February 2018

  • Transition period begins.
  • CareSens N Premier and CareSens Dual meters are listed on the Pharmaceutical Schedule.

31 July 2018

  • Transition period ends.
  • CareSens II meters and CareSens strips, Freestyle Optium/Neo meters and Freestyle Optium blood glucose and ketone test strips, and Accu-Chek Performa strips no longer funded.
  • Special Authorities for these strips no longer valid after 31 July 2018.

1 August 2018

  • CareSens are the only funded meters and test strips for blood glucose and ketones.

3 COMMENTS

  1. ISO standards stipulate that clinical trials on meters are to be undertaken at 23 deg C. This eliminates a major source of error – temperature. Enzymes (which are used in the strip reactions) are very temperature-sensitive. Most of the good manufacturers ended up putting temp sensors into their strips directly to deal with this. The CareSens system uses only a temp sensor inside the meter casing itself, which can take over an hour to reach equilibrium with the surroundings. This design flaw is masked by the flawed ISO test standards. Pharmac have been told about all of this years ago, and even though the CTO of iSens wrote to me saying that meters must be allowed to reach thermal equilibrium, these instructions still are not in the user guide for the meter. You get what you pay for.

    • Yes saw on Pharmac consultation feedback that people pointed out temperature issue as a problem. Pharmac’s response is “We will be working with healthcare professionals to develop educational material to focus on making the most of your meter. In the meantime users should seek advice from their healthcare professional on how to keep their meter at a working temperature range.”
      I take it that you think a better answer is to have an option of other meters that aren’t as temperature sensitive?

      • Meter choice is critical for people with Type 1 Diabetes. We can’t wait an hour for our meter to reach equilibrium. We could be dead by then.

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