Diabetes management products

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.

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.

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.

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.

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.

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.

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.

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