Diabetes management products

Medicines

Decision

What we’re doing

We’re pleased to announce the approval of a new sole supply arrangement with Pharmaco (NZ) Limited for an expanded range of CareSens self-monitoring diagnostic test meters and associated test strips from 1 February 2018 until 30 June 2022.

The decision will result in:

  • Widened access to a blood ketone meter (CareSens Dual), so that funded blood ketone testing products will be available for all people:
    • with Type 1 diabetes;
    • with permanent neonatal diabetes;
    • who have undergone a pancreatectomy;
    • with cystic fibrosis related diabetes; and
    • with metabolic disease or epilepsy under the care of a paediatrician, neurologist or metabolic specialist.
  • From 1 August 2018 the following diabetes management products will not be funded:
    • the CareSens II meter and its associated test strips;
    • the Freestyle Optium meter and its associated test strips; and
    • the Accu-Chek Performa blood glucose test strips.
  • To keep using a funded meter and test strips, approximately 3,000 people will need to change from their current brand of meter, and approximately 15,000 people will need to upgrade their current CareSens meter.
  • People that need to change will have a choice of four CareSens funded meters.
  • There will 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. During this period:
    • Pharmacists will be able to initiate a change of meter for eligible people;
    • Patients will not need to pay any co-payment for a new meter; and
    • Pharmacies will be able to claim a Brand Switch Fee when they’ve supported a person to change funded meters.
  • PHARMAC will be talking with diabetes healthcare professionals over the next few months to finalise the criteria and a process to allow some people, who have specific clinical circumstances, to maintain funded access to their existing meter and test strips. We intend to release further information regarding this process before April 2018.

More information about what this decision will mean for you is available on our diabetes webpage, which will be regularly updated.

We are grateful for all the consultation feedback we received about new and emerging diabetes technologies. For the avoidance of doubt, the sole supply agreement with Pharmaco would not prevent the funding of continuous blood glucose monitoring systems (CGMS) and other hybrid systems during its exclusivity term. PHARMAC is interested in new diabetes management technology and we are currently assessing funding applications for two different CGMS systems. We will assess such technology and devices for funding using our standard process, which includes seeking specialist clinical advice.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 25 July 2017, amended 4 August 2017, and having carefully considered consultation feedback, we have made the following changes:

  • The CareSens and KetoSens brands will be listed in Section H (Hospital Medicines List) but Hospital Sole Supply will not be awarded.
  • Prescriptions for dual blood glucose and blood ketone diagnostic test meters written by metabolic specialists will be funded.
    • Patients will be able to change their meter by visiting their local pharmacy and patient co-payments will be waived on all four CareSens meters during the transition period.
    • Pharmacists will be able to initiate a funded change of meter, should they wish to, for those people who need to change and who are entitled to a new funded meter.
    • Pharmacies will be able to claim a Brand Switch Fee for dispensings of CareSens meters during the transition period.Prescriptions for dual blood glucose and blood ketone diagnostic test meters written by metabolic specialists will be funded.

Who we think will be most interested

  • All people living with diabetes, their caregivers and consumer groups representing people living with diabetes who need to monitor blood glucose/blood ketones.
  • All health care professionals who support people who need to monitor blood glucose/blood ketones.
  • Suppliers and wholesalers.

Detail about this decision

The following changes will occur in Section B and Part III of Section H of the Pharmaceutical Schedule.

Section B changes

From 1 February 2018:

  • The following new products will be listed:
    • 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.

with restrictions, at the price and subsidies (ex-man., ex-GST) set out in the table below:

Pharmaceutical Presentation Brand Pack size Price & subsidy
Blood glucose diagnostic test meter Meter with 50 lancets, a lancing device and 10 blood glucose diagnostic test strips CareSens N 1 OP $10.00
CareSens N POP 1 OP $10.00
CareSens N Premier 1 OP $20.00
Blood glucose diagnostic test strip Test strip CareSens N 50 test OP $10.56
CareSens PRO 50 test OP $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 $20.00
Blood ketone diagnostic test strip Test strip KetoSens 10 strip OP $15.50
Please note – All the subsidies are subject to a confidential rebate. Further details on the CareSens meters can be found on Pharmaco’s webpage(external link).
  • Funding restrictions will be replaced with the following, including widening access for people with Type 1 diabetes to the dual meter:

BLOOD GLUCOSE DIAGNOSTIC TEST METER 

a) Maximum of 1 pack per prescription

b) Up to 1 pack available on a PSO

c) 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 2 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 or CareSens N meter are not eligible for a new meter, unless they meet the criteria for a dual blood glucose and blood ketone diagnostic test meter.

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.

DUAL BLOOD GLUCOSE AND BLOOD KETONE DIAGNOSTIC TEST METER

a) Maximum of 1 pack per prescription

b) Up to 1 pack available on a PSO

c) Subsidy by endorsement

A dual blood glucose and blood ketone diagnostic test meter is subsidised for a patient who 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, neurologist or metabolic specialist.

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).

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 KETONE DIAGNOSTIC TEST STRIP

a) Maximum of 20 strips per prescription

b) Up to 10 strips available on a PSO

c) Not on a BSO

Subsidy by endorsement

Patient has any of the following:

  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, neurologist or metabolic specialist

The prescription must be endorsed accordingly.

  • A six-month transition period will start on 1 February 2018 and end on 31 July 2018, during which the following fees, notes and rules will apply:
    • A Brand Switch Fee ($4.50) will be available to be claimed on dispensing by pharmacies, once per patient, for any of the four CareSens meters.
    • The following will be able to be provided by a pharmacist under the non-prescribing Practitioners rules in Part III of Section A:
      • Blood glucose diagnostic test meter; and
      • Dual blood glucose and blood ketone diagnostic test meter.
  • The “No patient co-payment payable” restriction will be applied to the dispensing of the four CareSens meters.

From 1 August 2018:

  • The following products will be delisted and their Special Authorities (where relevant) deleted, 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.
    • The following products will have Sole Supply Status until 30 June 2022:
      • CareSens – blood glucose diagnostic test meters, dual blood glucose and blood ketone diagnostic test meters, blood ketone diagnostic test meters and blood glucose test strips; and
      • KetoSens – blood ketone test strips

Section H (Hospital Medicines List) changes

From 1 February 2018:

  • The following products will be listed (or remain listed) at the prices (ex-man., ex. GST) set out in the table below:
    • CareSens N Premier blood glucose diagnostic test meter;
    • CareSens PRO blood glucose diagnostic test strips;
    • CareSens Dual blood glucose and blood ketone dual testing meter;
    • KetoSens blood ketone test strips;
    • CareSens N blood glucose diagnostic test meter;
    • CareSens N POP blood glucose diagnostic test meter; and
    • CareSens N blood glucose diagnostic test strips.
Pharmaceutical Presentation Brand Pack size Price
Blood glucose diagnostic test meter Meter with 50 lancets, a lancing device and 10 blood glucose diagnostic test strips CareSens N 1 $10.00
CareSens N POP 1 $10.00
CareSens N Premier 1 $20.00
Blood glucose diagnostic test strip Test strip CareSens N 50 test $10.56
CareSens PRO 50 test $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 $20.00
Blood ketone diagnostic test strip Test strip KetoSens 10 test $15.50
Please note – All the prices will be subject to a confidential rebate

From 1 August 2018:

  • All other brands will 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.

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. The main themes raised in feedback, our responses and changes we have made after listening to you are summarised in the table below. 

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz; or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.

Theme PHARMAC response
Supportive of the proposal

Supportive of the proposal, noting:

  • That the majority of people did not have to change meters

  • The choice of 4 funded meters, including a dual meter for people with Type 1 diabetes

  • Widened access to ketone testing for all people with Type 1 diabetes

Noted.

Meters and strips functionality

Concerns about technical aspects of the CareSens meters and strips, including:

  • 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.

CareSens meters meet ISO standards. The standard allows for +/- 15% variation compared to a laboratory test, therefore variations are to be expected.

Electronic devices including all blood glucose meters are designed to work within a certain temperature range. Most meters wouldn't work in very low temperatures. 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.

Bluetooth and smartphone apps are not new technologies internationally. SmartLog, the CareSens operating system, has been extensively tested and Pharmaco will provide support to users via its customer service channels.

Comments on the physical aspects of the meters and strips, including:

  • the packaging of the strips in a bottle;

  • the lancet;

  • the ease with which the battery can be removed;

  • meter port location;

  • functionality;

  • robustness; and

  • limited information on the CareSens Dual.

PHARMAC engaged with health professionals and consumers to seek feedback on the meters shortlisted via the RFP including how any change in meter brand should be supported. As part of this process meter functionality was carefully considered and we took this feedback into account when making our decision.

We recognise the CareSens Dual is new to the NZ market and patients will not be familiar with it. It has received high ratings in the healthcare professional and consumer feedback and a summary of these reports are published on our website.

We are also aware that Pharmaco intends to publish more information about the Dual meter on its website(external link).

Concerns about the software, including previous issues with CareSens meters in terms of downloading data and date/time slippage; and compatability of the CareSens Dual meter with DiaSend software, which is used by diabetes clinicians to monitor meter and pump data.

Pharmaco confirmed that this was an issue in 2012 however it was resolved with the current software (SmartLog). Pharmaco will work with primary and secondary care to integrate with their software and ensure that the CareSens meters are compatible with Diasend software.

Access to other products

Preferences for another product, including:

Freestyle Optium. Reasons given included:

  • trust in this product,

  • it is a dual meter; and

  • some people considered they have a lifetime Special Authority number.

Freestyle Libre. A number of respondents, who have purchased this product privately, expressed a desire to retain funded access to the Freestyle Optium blood glucose and ketone test strips because these are compatible with the FreeStyle Libre. Respondents suggested that the Freestyle Libre is useful as it shows glucose trends which help with better diabetes management and children don't have to be woken to test glucose. Respondents suggested it could be funded via special authority for the following diabetic groups:

  • paediatrics with Type 1 diabetes;

  • Maori and pacific people; and

  • people with developmental or mental health issues.

Continuous blood glucose monitoring. Respondents considered that funding this technology would lead to better health outcomes, save money on test strips and reduce hospital admissions. Some responders noted that there is funding for CGMS in Australia.CareSens II. Some responders indicated that it would be difficult to change meters, however, expressed the view that a change would be easier given that they would be changing to another CareSens meter.

As part of the RFP process we considered feedback from consumers & health professionals on all the shortlisted products; the CareSens meters have been assessed by NZ laboratory(s) and they meet ISO standards. PHARMAC consider that the CareSens meters/strips will meet the needs of people with diabetes including those that need a meter that tests both blood glucose and blood ketones. We know there may be some clinical reasons where people may have difficulty changing meters. PHARMAC will be talking with diabetes healthcare professionals over the next few months to finalise the criteria and a process to allow some people, who have specific clinical circumstances, to maintain funded access to their existing meter and test strips. We intend to release further information regarding this process before April 2018.

Some special authority approvals for funded access to pharmaceuticals are issued without need for renewal – however this is not a ‘lifetime approval’ for funding for a specific brand of medicine or medical device, rather it is an approval for funded access to a particular chemical or type of device.

We are grateful for all the consultation feedback we received about new and emerging diabetes technologies. For the avoidance of doubt, the sole supply agreement with Pharmaco would not prevent the funding of continuous blood glucose monitoring systems (CGMS) and other hybrid systems are not during its exclusivity term. PHARMAC is interested in new diabetes management technology and we are currently assessing funding applications for two different CGMS systems. We will assess such technology and devices for funding using our standard process, which includes seeking specialist clinical advice.

Sole supply

Many responders considered that there were limitations with a sole supply arrangement, including:

  • lack of choice of alternative brands; one brand of blood glucose test meter does meet the needs of all people with diabetes;

  • creating a monopoly;

  • no contingency if the supply chain was to be disrupted;

  • the length of the exclusivity period is being too long to keep up with new technology; and

  • the environmental waste from discarded meters.

This decision ensures that a range of four different meters will be listed to suit different user’s needs. PHARMAC will be talking with diabetes healthcare professionals over the next few months to finalise the criteria and a process to allow some people, who have specific clinical circumstances, to maintain funded access to their existing meter and test strips. We intend to release further information regarding this process before April 2018.

The sole supply status is a fixed duration and we will run a commercial process again at the end of the exclusivity period. Having one supplier allows for greater surety of supply. Pharmaco is contractually obliged to hold a minimum of four months stock in New Zealand. As such, we consider that there would be sufficient stock in the chain to switch to an alternative product if that was required. The agreement allows for upgrades in technology.

We will be advising on the appropriate way to dispose of old meters prior to the transition period.

Savings

Some responders mentioned the savings related to this proposal, including:

  • the potential increase in costs of hospitalisations due to patients changing brands would offset forecasted savings;

  • asking what the potential savings generated would be invested in and suggesting that any potential savings should be reinvested into people with diabetes;

  • that the degree of savings was the only factor in making this decision; and

  • suggesting that the subsidy for the CareSens meters and strips should be able to be used to offset the charge of an alternative product and any additional charge could be managed as a part charge.

Following the 2012/13 transaction for diabetes management products, we commissioned an independent report to evaluate the clinical impacts of the decision. [PDF, 1.1 MB]

This report indicated that it is uncertain whether changing brands of meters impacted the rates of hospitalisations for diabetes.

Savings will be reinvested according to PHARMAC’s view of the next best spend on pharmaceuticals which is determined using the Factors for Consideration, as with all of our decisions.

Evaluation of the proposals we received was a considered process taking into account feedback from consumers, health professionals, and public consultation. All the Factors for Consideration were taken into account when making the decision.

A sole supply arrangement prevents part funding of any other products.

Schedule changes

Some responders gave specific feedback on the proposed restriction criteria, including:

  • wanting more than one funded meter;

  • having one meter every 5 years, rather than over a lifetime;

  • funding the CareSens N Voice meter for people with impaired vision;

  • ketone testing may also be clinically indicated in rare forms of Youth onset Type 2 diabetes, in atypical presentations of diabetes, in anorexia nervosa and Type 2 diabetes using SGLT-2 inhibitors;

  • the addition of metabolic specialist as prescribers and a request that the maximum number of strips is increased;

  • feedback on patients whose clinical circumstances are such that they should continue on their existing meter: behavioural concerns, severe mental illness or developmental delay, children and young people (inaccuracy data in this population does not exist); and

  • widening of access for people with type 2 diabetes that don't currently qualify for a funded meter, to help with self-management.

We do not consider that more than one meter needs to be funded.

The restriction on meter numbers would be reviewed during the next RFP for these products (in 4-5 years) and this decision does not affect funding of existing products listed for people who are visually impaired.

We are grateful for this feedback and the ketone testing strips restriction has been modified so that those who only test for ketones (that currently have funded access) would retain this. Prescribers who have patients with exceptional circumstances would be able to apply for funding via NPPA.

We have added metabolic specialists to the prescriber type able to access funded ketone test strips. The claiming software does not enable us to have different quantity restrictions for a specific group of patients so we have not changed this. We note that urine ketone test strips are also funded.

We will be using feedback on patients with specific clinical circumstances that might need to maintain funded access to their existing meter and test strips when developing our alternative brand access criteria.

Clinical advice is that people with type 2 diabetes who are not taking medicines that increase their risk of hypoglycaemia, do not need to test for blood glucose for clinical management.

Procurement process

Respondents commented on the process that has been undertaken, including:

  • expressing uncertainty whether the meters have been NZ laboratory tested for their ability to monitor glucose and ketones in paediatric populations;

  • the lack of available results from consumer testing of the CareSens products;

  • lack of publicly available data on the CareSens Dual, concern that it may not have been tested in New Zealand or Australia, and questions regarding the planned switch to the Dual meter;

  • the perceived underrepresentation of patients with Type 1 diabetes in focus groups;

  • requests for the data showing accuracy/consistency of the blood glucose to lab testing of the meters; and

  • responses which considered the needs of people with Type 1 diabetes differed from those with Type 2 diabetes and considered that the two should be differentiated by PHARMAC.

We passed on this feedback to Pharmaco. It advised that it is unaware of specific age related physiological factors that would require self-testing blood glucose monitoring systems to be tested for paediatric populations. We note that there are no international standards for ketone testing, however the CareSens Dual and KetoSens test strips are CE marked.

Diabetes New Zealand (DNZ) was contracted to run focus groups to obtain feedback on all shortlisted meters to help consider how any change to the meters would best be implemented and how to support people with change. These groups included a range of people living with Type 1 diabetes; young children and their parents/caregivers, older children/youth and adults. You can find a summary of the DNZ consumer feedback report (as it relates to the CareSens meters) here.

We note that CareSens Dual is a new product for the New Zealand market. All meters in this proposal were tested in NZ laboratories as part of our assessment and the protocol and the CareSens meter reports were provided to consultation respondents that sought copies. We will be supporting change for people who require it.

We have engaged with people with Type 1 and Type 2 diabetes during our decision-making process. We acknowledge that there may be differences in the disease and treatment and these differences have been taken into account.

Implementation

Responders commented on how the proposed changes would take effect, including:

  • this transaction would be an opportunity to increase education and awareness about diabetic ketoacidosis;

  • that the cost of changing meters (including training health professionals, education and support) is underestimated;

  • that there would be a significant increase in workload for all clinicians in paediatric and adolescent services;

  • whether people who need to change meters should return the meter they are currently using to prevent comparisons between readings from each meter; and

  • that Pharmaco should work with paediatric services to develop appropriate resources for this population and to facilitate implementation face-to-face.

A relatively small number of patients who use diabetes management products would need to change compared with the change that occurred in 2012. Across NZ there will be 3000 people that will need to change brands and 15,000 people will need to upgrade their current CareSens meter.

We recognise that this change will have an impact on the health sector and those patients and that there is an emotional and resource cost in managing change. We are committed to doing what we can to support health care professionals with educational material to help them with the change.

Pharmaco is also committed to supporting this change and has advised that it would be happy to collaborate with clinical grou