Proposed changes to blood glucose meter provisionin 2018 - how dothese changesaffect you?

25 July 2017

What Pharmac isproposing

PHARMAC is seeking feedback on a proposal to enter into a new sole supply arrangement with Pharmaco (NZ) Limited for an expanded range of CareSens self-monitoring diagnostic test meters and associated test strips, in both the community and hospital settings, from 1 February 2018 until 30 June 2022.

Most people who use a blood glucose testing meter (approximately 100,000 people) would not need to change their diabetes management products.

The proposal would result in the following:

  • A choice of four CareSens funded meters and their associated test strips, including a dual meter that tests both blood glucose and ketones:
  • CareSens N;
  • CareSens N POP;
  • CareSens N Premier; and
  • CareSens Dual.
  • Widened access to a blood ketone meter (CareSens Dual), so that funded blood ketone testing products would be available for all people:
  • with Type 1 diabetes;
  • with permanent neonatal diabetes;
  • who have undergone a pancreatectomy; and
  • with cystic fibrosis related diabetes
  • with metabolic disease or epilepsy under the care of a paediatrician or neurologist
  • The CareSens II meter and its associated test strips would no longer be funded.
  • The Freestyle Optium meter and its blood glucose and ketone test strips would no longer be funded and Special Authorities removed.
  • The Accu-Chek Performa blood glucose test strips would no longer be funded and Special Authorities removed.
  • We would create a process to enable people to keep funded access to their existing meter if their clinical circumstances mean they require it. We are keen to hear feedback on this aspect of the proposal.
  • There are approximately 3,000 people who would need to change from their current brand of meter to keep using a funded meter and test strips, and approximately 15,000 people who would need to upgrade their current CareSens meter.
  • There would be a six-month transition period from 1 February 2018 – 31 July 2018 for these people to change brands or upgrade to a newer CareSens meter.

More information about what this proposal would mean for you at the end of this consultation letter and on our diabetes webpage, which will be updated throughout the consultation period if required.

We welcome your feedback on this proposal. Consultation closes at onFriday, 25 August 2017and can be emailed .

What would the effect be?

For patients

  • People using CareSens N and CareSens N POP meters and test strips would not need to change meters. We estimate there are approximately 100,000 people using the CareSens N and CareSens N POP meter.
  • From 1 February 2018 people with Type 1 diabetes who are currently using two meters (a blood glucose meter and a blood ketone meter) would be able to access a funded CareSens Dual meter which tests both blood glucose and blood ketones.
  • People on CareSens II meters would need to upgrade to an alternate funded CareSens meter before 1 August 2018. We estimate there are approximately 15,000 people using the CareSens II meter.
  • People currently using a Freestyle Optium meter to test blood glucose and/or ketones would need to change to a funded CareSens meter before 1 August 2018.
  • The CareSens Dual meter would be the funded blood ketone meter, and can also test blood glucose. We estimate there are approximately 3,000 people using the Freestyle Optium meter.
  • People currently using a funded Accu-Chek Performa meter and strips to test blood glucose would need to change to a funded CareSens meter before 1 August 2018.
  • No change for visually impaired people who use funded test strips for the Sensocard meter.

There would be a six-month transition period from 1 February – 31 July 2018 for people to change meters if required. Detailed information about whether you would need to change your meter can be found at the end of this consultation letter.

For community pharmacies

We’re proposing that community pharmacy would be able to manage any change of meters that may be required for some people.

A Brand Switch Fee may apply to support the change.

For hospital pharmacies

There would be minimal impact of this proposal for hospital pharmacies.

For prescribers

As most people (85%) would not need to change or upgrade their meters, we anticipate the proposal would result in minimal administrative workload. Some patients would need to change meters during the 6-month transition period from 1 February 2018 to 31 July 2018.

We are proposing to create a process to enable people to keep funded access to their existing meter if their clinical circumstances mean they require it. In order to develop nationally consistent criteria that would apply, we would like your feedback on what clinical circumstances we should consider to enable people to keep funded access to their existing meter.

We are aware that people with metabolic conditions or epilepsy may need to test for ketones if they are on a ketogenic diet. We would like your feedback on whether there are any other clinical circumstances where people may need access to ketone testing.

For DHBs

The proposal would generate savings in excess of $10 million over 5 years (NPV) for the Combined Pharmaceutical Budget. PHARMAC would be able to use this money to invest and improve access to other funded medical devices and medicines.

Who we think will be interested

Feedback from a wide range of stakeholders over recent years has been invaluable in developing this proposal.

This proposal will be of interest to:

  • All people living with diabetes and consumer groups representing people living with diabetes who use the diabetes management products in this proposal.
  • All health care professionals who support people who need to monitor blood glucose/blood ketone testing.
  • Suppliers and wholesalers.

Why we’re proposing this

The sole supply and subsidy protection period for CareSens, the currently funded brand of blood glucose meters and test strips, ended on 30 June 2015.

Following the 2012/13 decision that required over 100,000 people to change their funded brand of blood glucose meter,PHARMAC conducted an evaluation of the change. This current process has ensured that key recommendations of that evaluation have been considered and addressed including:

  1. Seeking feedback from people on our proposed approach, including identifying key functions of a blood glucose meter;
  2. Seeking both healthcare professional and consumer feedback on possible meters for funding; and
  3. Ensuring all meters had met international standards and had completed New Zealand based laboratory testing before being considered for funding.

During this process we also sought feedback from the Diabetes Subcommittee of PTAC about clinical requirements of blood glucose and ketone testing, and it considered that all people with Type 1 diabetes (and similar conditions) should have access to a blood ketone meter without the requirement to have experienced ketoacidosis.

The feedback that we received helped PHARMAC to formulate a Request for Proposals (RFP) for the supply of funded diabetes management products that was released in August 2016.

Following the RFP PHARMAC has entered into a provisional agreement with Pharmaco (NZ) Limited and feedback to this consultation will help us decide if the agreement should be finalised.

Details about our proposal - mainly for Healthcare Professionals, suppliers and wholesalers

Section B proposed changes

From 1 February 2018:

  • The following new products would be listed, with restrictions, at the subsidies set out in the table below:
  • CareSens N Premierblood glucose diagnostic test meter;
  • CareSens PROblood glucose diagnostic test strips; and
  • CareSens Dualblood glucose and blood ketone meter andKetoSensblood ketone test strips.
  • The following products would remain listed, with some changes to the restrictions, at the subsidies set out in the table below:
  • CareSensN,CareSens N POPblood glucose diagnostic test meters andCareSens Nblood glucose diagnostic test strips.

Pharmaceutical / Presentation / Brand / Pack size / Current price & subsidy
(ex-man., ex. GST) / Proposed price & subsidy
(ex-man., ex. GST)
Blood glucose diagnostic test meter / Meter with 50 lancets, a lancing device and 10 blood glucose diagnostic test strips / CareSensN / 1 OP / $20.00 / $10.00
CareSens N POP / 1 OP / $20.00 / $10.00
CareSens N Premier / 1 OP / N/A / $20.00
Blood glucose diagnostic test strip / Blood glucose test strip / CareSens N / 50 test OP / $10.56 / $10.56
CareSens PRO / 50 test OP / N/A / $10.56
Dual blood glucose and blood ketone diagnostic test meter / Meter with 50 lancets, a lancing device and 10 blood glucose diagnostic test strips / CareSens Dual / 1 OP / N/A / $20.00
Blood ketone diagnostic test strip / Test strip / KetoSens / 10 strip OP / N/A / $15.50

Please note– All the proposed subsidies would be subject to a confidential rebate

  • Restrictions would be replaced with the following, including widening access for people with Type 1 diabetes to the dual meter:

Blood glucose diagnostic test meter & Dual blood glucose and blood ketone diagnostic test meter

Maximum of 1 pack per prescription

Up to 1 pack available on a PSO

Subsidy by endorsement

A diagnostic blood glucose test meter is subsidised for a patient who:

1. is receiving insulin or sulphonylurea therapy; or

2. is pregnant with diabetes; or

3. is on home TPN at risk of hypoglycaemia or hyperglycaemia; or

4. has a genetic or an acquired disorder of glucose homeostasis, excluding type 1 or type diabetes and metabolic syndrome.

The prescription must be endorsed accordingly. Pharmacists may annotate the prescription as endorsed where there exists a record of prior dispensing of insulin or sulphonylureas.

Only 1 meter per patient will be subsidised (no repeat prescriptions).

Patients already using the CareSens N POP meter and CareSens N meter are not eligible for a new meter, unless they have:

  1. type 1 diabetes; or
  2. permanent neonatal diabetes; or
  3. undergone a pancreatectomy; or
  4. cystic fibrosis-related diabetes.

CareSens Dual (blood glucose and blood ketone diagnostic meter) will only be subsidised for patients who have:

  1. type 1 diabetes; or
  2. permanent neonatal diabetes; or
  3. undergone a pancreatectomy; or
  4. cystic fibrosis-related diabetes, or
  5. metabolic disease or epilepsy under the care of a paediatrician or neurologist.

For the avoidance of doubt patients who have previously received a funded meter, other than CareSens, are eligible for a funded CareSens meter.

From 1 February 2018 – 31 July 2018 patients who have used a CareSens II blood glucose diagnostic meter and associated strips, as their only blood glucose diagnostic testing meter and strips, are eligible for a new CareSens meter provided they meet the funding criteria.

Blood glucose diagnostic test strips

Up to 50 strips available on a PSO.

The number of strips available on a prescription is restricted to 50 unless:

  1. Prescribed for a patient on insulin or a sulphonylurea and endorsed accordingly. Pharmacists may annotate the prescription as endorsed where there exists a record of prior dispensing of insulin or sulphonylurea; or
  2. Prescribed on the same prescription as insulin or a sulphonylurea in which case the prescription is deemed to be endorsed; or
  3. Prescribed for a pregnant woman with diabetes and endorsed accordingly; or
  4. Prescribed for a patient on home TPN at risk of hypoglycaemia or hyperglycaemia and endorsed accordingly; or
  5. Prescribed for a patient with a genetic or an acquired disorder of glucose homeostasis excluding type 1 or type 2 diabetes and metabolic syndrome and endorsed accordingly.

Blood ketone diagnostic test strips

Maximum of 20 strips per prescription

Up to 10 strips available on a PSO

Not on a BSO

Subsidy by endorsement

Any of the following:

Patient has:

  1. type 1 diabetes; or
  2. permanent neonatal diabetes; or
  3. undergone a pancreatectomy; or
  4. cystic fibrosis-related diabetes; or
  5. metabolic disease or epilepsy under the care of a paediatrician or neurologist

The prescription must be endorsed accordingly.

  • A six month transition period would start on 1 February 2018 and end on 31 July 2018.

From 1 August 2018:

  • The following products would be delisted and their Special Authorities (where indicated) removed, including:
  • CareSens II – blood glucose diagnostic test meter;
  • Accu-Chek Performa, Freestyle Optium and CareSens – blood glucose diagnostic test strips; and
  • Freestyle Optium Neo – blood ketone diagnostic test meter.
  • CareSens and KetoSens would have Sole Supply Status for blood glucose diagnostic test meters, dual blood glucose and blood ketone diagnostic test meters, blood ketone diagnostic test meters, blood glucose test strips and blood ketone test strips respectively, until 30 June 2022.

Section H (Hospital Medicines List) proposed changes

From 1 February 2018:

  • The following products would be listed at the prices set out in the table below:
  • CareSens N Premierblood glucose diagnostic test meter,
  • CareSens PROblood glucose diagnostic test strips;
  • CareSens Dualdual blood glucose and blood ketone meter; and
  • KetoSensblood ketone test strips.
  • The following products would remain listed, at the prices set out in the table below:
  • CareSens N,CareSens N POPblood glucose diagnostic test meters andCareSens Nblood glucose diagnostic test strips.

Pharmaceutical / Presentation / Brand / Pack size / Current price(ex-man., ex. GST) / Proposed price (ex-man., ex. GST)
Blood glucose diagnostic test meter / Meter with 50 lancets, a lancing device and
10 blood glucose diagnostic test strips / CareSensN / 1 / $20.00 / $10.00
CareSens N POP / 1 / $20.00 / $10.00
CareSens N Premier / 1 / N/A / $20.00
Blood glucose diagnostic test strip / Test strip / CareSens N / 50 test / $10.56 / $10.56
CareSens PRO / 50 test / N/A / $10.56
Dual blood glucose and blood ketone diagnostic test meter / Meter with 50 lancets, a lancing device and 10 blood glucose diagnostic test strips / CareSens Dual / 1 / N/A / $20.00
Blood ketone diagnostic test strip / Test strip / KetoSens / 10 test / N/A / $15.50

Please note– All the proposed subsidies would be subject to a confidential rebate

  • A six month transition period would start on 1 February 2018 and end on 31 July 2018.

From 1 August 2018:

  • All other brands would be delisted, including:
  • CareSens II, Accu-Chek Performa, Freestyle Lite and On Call Advanced – blood glucose diagnostic test meters;
  • Accu-Chek Performa, Freestyle Optium, Freestyle Lite, On Call Advanced and CareSens – blood glucose diagnostic test strips;
  • Freestyle Optium Neo – blood ketone diagnostic test meter.
  • CareSens and KetoSens would be awarded Hospital Sole Supply for blood glucose diagnostic meters, dual blood glucose and blood ketone diagnostic test meters, blood glucose test strips and blood ketone test strips respectively, with a 1% DV Limit for hospitals, until 30 June 2022.

To provide your feedback to this proposal

Feel free to contact Pharmac directly
by25 August 2017 alternatively, email with your concerns or questions and we will do our best to represent members and supporters of Diabetes Help Tauranga and Diabetes Help Tauranga Youth.

We would like your feedback on all aspects of the proposal, and in particular:

  • What clinical circumstances we should consider to enable people to keep funded access of their existing meter?
  • In what other clinical circumstances do people need to test for ketones?

All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal.

Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our obligations under the OIA. Anyone providing feedback, where on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld. PHARMAC will give due consideration to any such request.

What would this proposal mean for you?

What meter are you currently using? / What medication are you taking for diabetes? / What does this proposal mean for you?
CareSens N or CareSens N POP, testing for glucose
/ Insulin and/or sulphonylurea tablets (ie glibenclamide, gliclazide or glipizide) / There would be no change for you as a result of this proposal.
Metformin or any other medication / There would be no change for you as a result of this proposal.
CareSens II, testing for glucose
/ Insulin and/or sulphonylurea tablets (eg glibenclamide, gliclazide and glipizide) / You would have 6 months from 1 February 2018 to change your meter and test strips. You would have a choice of funded meters.
If you have Type 1 diabetes and are testing for blood ketones, you may be eligible to switch to a CareSens Dual meter and test strips.
Metformin or any other medication / You are unable to access a funded meter.
You would need to purchase a meter to continue to access up to 50 funded blood glucose test strips per prescription.
Freestyle Optium/ Freestyle Optium Neo, testing for glucose and/or ketones
/ You either:
Have access to blood glucose test strips through a Special Authority because you were usinginsulinand testing for ketones prior to 1 June 2012. / You would have 6 months from 1 February 2018 to change to another funded meter for blood glucose and/or blood ketone testing.
or
You are using this meter for ketone testing and/or are using a CareSens meter for blood glucose testing. / The CareSens Dual meter tests for both blood glucose and ketones.
Accu-Chek Performa, testing for glucose (currently on a Special Authority)
/ You would have access to this meter through a Special Authority because you were using an Accu-Chek Comboinsulin pumpprior to 1 June 2012. / You would have 6 months from 1 February 2018 to change to another funded meter for blood glucose and/or blood ketone testing.
The CareSens Dual meter tests for both blood glucose and ketones.
Sensocard Blood Glucose test strips, testing for glucose for the visually impaired.
/ You are using funded SensoCard test strips with your voice meter. / There would be no change for you as a result of this proposal.

For more information go to :