Diabetes management products - AMENDED, 4 August

Medicines

Consultation Closed

Amendment - 4 August 2017

PHARMAC released a consultation on Tuesday 25 July 2017 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.

We have received early feedback on the proposed changes to Section H (Hospital Medicines List); namely the proposal that the CareSens and KetoSens brands 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.

Following consideration of this feedback, we can confirm that we made an error in the consultation, contrary to our intent. Please disregard the previous consultation solely as it relates to the proposal to award Hospital Sole Supply.  Below is the corrected proposal, which we seek your feedback on.  Differences to the 25 July 2017 proposal are indicated by deletions in strikethrough and appear in the section of this document headed Section H (Hospital Medicines List) proposed changes.

See the amended portion of the consultation

What we’re proposing

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 on Friday, 25 August 2017 and can be emailed to diabetesfeedback@pharmac.govt.nz.

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 [link no longer available]. 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 Premier blood glucose diagnostic test meter;
    • CareSens PRO blood glucose diagnostic test strips; and
    • CareSens Dual blood glucose and blood ketone meter and KetoSens blood ketone test strips.
  • The following products would remain listed, with some changes to the restrictions, at the subsidies set out in the table below:
    • CareSens N, CareSens N POP blood glucose diagnostic test meters and CareSens N blood 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 CareSens N 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 Premier blood glucose diagnostic test meter,
    • CareSens PRO blood glucose diagnostic test strips;
    • CareSens Dual dual blood glucose and blood ketone meter; and
    • KetoSens blood ketone test strips.
  • The following products would remain listed, at the prices set out in the table below:
    • CareSens N, CareSens N POP blood glucose diagnostic test meters and CareSens N blood 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
CareSens N 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

Send us an email: diabetesfeedback@pharmac.govt.nz by 25 August 2017.

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

Black meter with 3 buttons, labelled Caresens N.Long and narrow black meter with 2 buttons.

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

White meter with 2 buttons placed vertically.

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

Off-white and black meter with 3 buttons, labelled FreeStyle Optium.Black meter with 2 buttons.

You either:

Have access to blood glucose test strips through a Special Authority because you were using insulin and 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)

White and red meter with 2 buttons.

You would have access to this meter through a Special Authority because you were using an Accu-Chek Combo insulin pump 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.

The CareSens Dual meter tests for both blood glucose and ketones.

Sensocard Blood Glucose test strips, testing for glucose for the visually impaired.

White meter with one button.

You are using funded SensoCard test strips with your voice meter.

There would be no change for you as a result of this proposal.

CareSens meters proposed for funding

(New table - 22 August 2017)

Meters proposed for funding Meter features

CareSens N (currently funded)

Black meter with 3 buttons, labelled Caresens N.

  • 1.1 – 33.3 mmol/L measurement range
  • 1000 test memory capacity
  • 5 second test time
  • 1-, 7-, 14-, 30- and 90-day averaging function
  • Alarms
  • Battery life ~3000 tests
  • 2 X CR2032 batteries

CareSens N POP (currently funded)

Long and narrow black meter with 2 buttons.

  • Back light
  • 1.1 – 33.3 mmol/L measurement range
  • 1000 test memory capacity
  • 5 second test time
  • 1-, 7-, 14-, 30- and 90-day averaging function
  • Alarms
  • Battery life ~2000 tests
  • 2 X CR2032 batteries

CareSens N Premier (proposed for funding)

Long and narrow black metter with straight sides and 3 buttons.

  • Bluetooth connectivity (to SmartLog app)
  • Backlight
  • 1.1 – 33.3 mmol/L measurement range
  • 1000 test memory capacity
  • 5 second test time
  • 1-, 7-, 14-, 30- and 90-day averaging function
  • Alarms
  • Battery life ~1000 tests
  • 2 x CR2032 batteries

CareSens Dual (proposed for funding)

Long and narrow black metter with incurved sides and 3 buttons.

  • Able to test for both glucose and ketones
  • Bluetooth connectivity (to SmartLog app)
  • Backlight
  • 1.1 – 33.3 mmol/L measurement range
  • 1000 test memory capacity
  • 5 second test time
  • 1-, 7-, 14-, 30- and 90-day averaging function
  • Alarms
  • Battery life ~1000 tests
  • 2 x CR2032 batteries

Answers to your questions

Questions for consumers

1. Which meters are proposed for funding?

The proposal is to fund four meters from the CareSens range. This would mean that only CareSens meters would be funded until at least 2022. The four funded meters would be:

  • CareSens N (currently funded)
  • CareSens N POP (currently funded)
  • CareSens N Premier (not currently funded)
  • CareSens Dual (not currently funded).

All four of the funded meters test glucose levels. CareSens N Premier has blue tooth connectivity as does CareSens Dual, which also tests both glucose and ketones levels.

2. Do I have to change meters?

Most people don’t have to change the meter they’re using. People using a CareSens II meter or a Freestyle Optium meter would need to change. Take a look here to see if you would need to change meters.

3. I use a Freestyle Optium to test for blood ketones – do I need to change?

Yes – you would be able to change to the CareSens Dual meter which tests for both blood glucose and blood ketones. You would also be able to use this meter to test for blood glucose which means you would only need to carry one meter instead of two.

4. If I have to change meters, when would I have to make the change by?

You can change from 1 February 2018 and there would be a 6-month transition period, through to 1 August 2018.

5. If I have to change meters, who would help me make the change?

If you need to change meters, your diabetes nurse, general practitioner, diabetes specialist or community pharmacist would be able to help you.

6. Can I change to an ‘upgraded’ meter?

You can change meters and upgrade if you meet the criteria to change to another meter – for example, if you have Type 1 diabetes, you would be able to access a CareSens Dual meter. Your health professional would know if you meet criteria to upgrade to another funded meter.

You cannot change to another funded meter just because you want to.

7. Do the meters accurately measure my blood glucose levels?

All the meters meet the international standard for testing: ISO standard ISO15197:2013. This standard means they are accurate to within plus or minus 15% of what a laboratory test would show. All meters were tested by New Zealand laboratories before they were considered for funding.

8. Who has PHARMAC engaged with throughout this process?

Our approach to this proposal was shaped by the feedback we received in 2012/13. You can find the feedback we received here. Consumer and health professional input has been sought to support our decision making to reach this proposal.

This proposal changes the number and type of meters we fund, including funding of a dual meter.

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; and,
  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 they recommended that all people with Type 1 diabetes (and some other conditions) should have access to a blood ketone meter without the requirement to have experienced ketoacidosis.

9. What about continuous glucose monitoring?

PHARMAC has not received a funding application for a continuous glucose monitoring system. PHARMAC would be open to receiving a funding application for a continuous glucose monitoring system – anyone can submit a funding application.

Glucose continuous monitoring systems use different technology to that of diabetes and ketone meters and test strips and would not have been eligible in this recent procurement process of glucose and ketone meters and test strips.

Questions for prescribers

10. What would be the funded meters?

The proposal is to fund four meters from the CareSens range. This would mean that only CareSens meters would be funded until at least 2022. The four funded meters would be:

  • CareSens N (currently funded)
  • CareSens N POP (currently funded)
  • CareSens N Premier (not currently funded)
  • CareSens Dual (not currently funded).

All four of the funded meters test glucose levels. CareSens N Premier has blue tooth connectivity as does CareSens Dual, which tests both glucose and ketones levels.

11. Do these meters connect with IT systems?

Yes, all the meters are able to connect with IT systems. The results from all proposed CareSens meters can be downloaded to computers on Windows and Mac platforms using SmartLog software and a CareSens USB cable. All DHB clinics have access to SmartLog software and the software has also been installed in 61% of medical practices.

Both the CareSens N Premier and CareSens Dual meters have Bluetooth connectivity to the SmartLog app on compatible IPhone and Android smartphones.

Questions for pharmacists

12. Would I be able to change meters for people who come to pharmacy?

Yes. If people are entitled to a funded meter (they are on insulin or sulphonylurea therapy) and they are using a CareSens II meter, or a Freestyle Optium meter, you would be able to make the change for these people.

13. Would I be able to provide an upgraded meter to people?

If people are entitled to a funded meter (they are on insulin or sulphonylurea therapy) and are using a CareSens II meter, or a Freestyle Optium, they could be upgraded to an appropriate meter for their needs.

People could also choose to pay for an upgraded meter.

14. Would I get a brand-switch fee for a meter change?

We are proposing that if people are entitled to a funded meter (they are on insulin or sulphonylurea therapy) and they are using a CareSens II meter, or a Freestyle Optium meter, and pharmacy makes that change, that pharmacy would be able to receive a brand-switch fee for the meter change.

There would be no brand-switch fee for people who choose to pay for an upgraded meter.