Decision to fund continuous glucose monitors, insulin pumps, and insulin pump consumables

Many responses were supportive of the proposal. Many people shared their personal experiences with type 1 diabetes from various perspectives including as an individual with diabetes, caregiver, family member or friend. These stories highlighted:

• that this proposal will make a meaningful difference to the lives of people, their whānau, friends, and caregivers.
• the clinical benefits of diabetes technologies including marked improvements in glycaemic control as measured by HbA1c and time in range, reductions in hypoglycaemic events, and a reduction in hospitalisations.
• the increased quality of life access to diabetes technologies would provide, including reduced anxiety, improved productivity, reduced mental load associated with managing diabetes, improved sleep, and being able to “live a normal life”.
• that CGMs are superior to finger-prick testing as they show trends in glucose levels compared to glucose levels at one point in time.
• that diabetes technologies empower users to manage their diabetes more confidently.
• the long-term health benefits of diabetes technologies, including reduced rates of hospitalisation and diabetes-related complications.

We are grateful to those who took the time to provide feedback on this proposal.

We are pleased that this decision will improve the health outcomes of people with type 1 diabetes. This feedback is in line with the advice we have received and what we have heard from individuals, their whānau, and the wider health sector.

This proposal will help to reduce inequities in diabetes management between those who can afford to self-fund CGMs and AID systems, and those who cannot.

This proposal will significantly reduce the financial burden on individuals, their whānau, caregivers and/or friends who currently self-fund CGMs.

Many supportive responders requested that the proposal be implemented as soon as possible.

We acknowledge the delay to decision making has been extremely disappointing. The delay has provided additional time for us to consider all the issues identified during the consultation and seek further information from key stakeholders including consumers, clinicians, suppliers and government agencies. This has helped us to make necessary amendments to ensure the decision will be able to be implemented.

Some responders who were supportive of the proposal acknowledged that Medtronic insulin pump users will be unhappy with the proposal. However, these responders considered that the advantages of the proposal outweigh the disadvantages and that the overall proposal will benefit the majority of people living with type 1 diabetes.

We appreciate the decision will require a change for existing Medtronic insulin pump users. We acknowledge this is not the outcome that some people were hoping for. To make the transition from Medtronic insulin pump easier for people, we have extended the initially proposed 12-month transition period to 2 years. This is to ensure people who are using Medtronic insulin pumps have enough time to transition to one of the proposed funded pumps, NZMS (Tandem pump), or Pharmaco (Ypsopump).

Support for the proposed increase in the annual funded limit of insulin pump consumables. This is important for people on high daily doses of insulin and those who require more frequent infusion set changes. Some people currently use their infusion sets past their recommended life because they are worried about exceeding their funded amount.

We understand that the current limits do not work for all people, and we are pleased to hear that the increase in the annual limit of funded consumables will have a positive impact on people currently using insulin pumps.

Disappointed it has taken so long for CGMs and AID systems to be funded in New Zealand when they have been funded, or partially funded, in other countries such as Australia and the UK for several years.

We appreciate that it has taken time to be able to fund these technologies, and we appreciate the patience shown by the diabetes community as we have worked this through.

This decision represents a significant investment, while some diabetes technology may be available in other countries, the funding and reimbursement systems are often not comparable.

Supportive of proposal but highlighted that blood glucose meters should still be funded even if CGMs are funded.

Blood glucose meters will remain funded.

Excitement that the YpsoPump with CamAPS-FX algorithm has been selected as one of the proposed options.

We are pleased to have selected an option that will be positively received by some of the diabetes community.

Pharmac should allow suppliers to launch newer models of insulin pumps and CGMs during the Dual Supply Period so that New Zealanders aren’t stuck with old, obsolete technology. 

Our contracts with preferred suppliers allow replacement or supplementation of their listed products with newer technology as it becomes available, at Pharmac’s discretion. Replacement or supplementary products will be required to have equivalent or greater functionality and compatibility to the currently available products.

Tubeless insulin pumps (e.g. Omnipod and Medtrum Nano) should be funded alongside the two proposed insulin pump options.

Highlighted that tubeless insulin pumps have significant suitability benefits including:

• more discreet
• lower risk of pump being disconnected as there are no tubes which can get caught in the environment
• easier to lead an active lifestyle
• lack of tubes may reduce stigma associated with insulin pump therapy

The competitive process we ran allowed for suppliers to bid with tubeless pump options.

Tubeless pumps were not included in the preferred proposals that were selected to progress for funding. We acknowledge this may be disappointing for some people who were hoping to have tubeless insulin pumps funded.

Tandem has previously experienced delays to the launch of technological updates or improvements.

Historically, Tandem has promised updates to software or hardware but the launches of these have either been late, problematic or have not happened at all.

We have discussed this feedback with the supplier (NZMS) and Tandem directly, and they acknowledge there was a significant delay in launching Control-IQ globally as well as in the New Zealand market. Tandem International has since visited New Zealand and listened to the concerns of New Zealand clinicians.

We understand Tandem is committed to communicating openly with Pharmac regarding project timelines to help support clinical decision making in New Zealand. 

Type 1 diabetes is a highly personalised chronic condition. Two funded options of insulin pumps do not provide sufficient choice and flexibility for people with type 1 diabetes, as people have different preferences and requirements.

All diabetes technologies should be funded (either in full, or in part for the more expensive options) so that patients can select the product or technology best suits their needs.

We appreciate this feedback. While we would like to fund all options, Pharmac operates within a fixed budget which means we need to make difficult decisions to ensure that we can achieve the best health outcomes for all New Zealanders from within this fixed budget. As a result of this competitive process, we have been able to fully fund diabetes technologies for all people with type 1 diabetes (and other similar conditions).

We sought advice from our expert clinical advisors (the Diabetes Advisory Committee) who considered that in almost all cases it will be possible to successfully transition to a funded solution with the appropriate support.

We acknowledge that the two funded insulin pump options may not be suitable for a small number of people with exceptional circumstances. We have created a streamlined Exceptional Circumstances pathway for those individuals. Details on how to apply will be available on the Pharmac website here.(external link)

Instead of utilising a Dual Supply model, Pharmac should provide individuals with a grant through which they could access whatever product they consider best suits their needs.

Pharmac operates within a fixed budget which means we need to make difficult decisions to ensure that we can achieve the best health outcomes for all New Zealanders from within this fixed budget. As a result of this competitive process, we are able to propose multiple fully funded diabetes technologies for all people with type 1 diabetes (and other similar conditions).

We understand that there are several support schemes provided by other agencies for people with type 1 diabetes, and that these schemes can be used to support the funding of diabetes technologies and it is our understanding that they would remain in place.

Request for clarification about whether users will be able to switch between different funded CGMs during the Dual Supply Period.

People will be able to switch between different funded CGMs as long as they do not exceed the annual funded limit of sensors.

Concerns about the lack of transparency about the rationale for selecting the proposed systems.

We appreciate this feedback and acknowledge these concerns.

After the commercial bids from suppliers were received in response to the RFP, Pharmac engaged in a robust evaluation process which included independent, external clinician and patient representatives who provided insight and advice which was pivotal to the decision making.

A key theme that emerged from the evaluation process was the importance of flexibility and interoperability between systems which will provide consumers with a degree of choice. This was consistent with clinical advice we have previously received from our Diabetes Advisory Committee.

This proposal provides an environment where users of either funded insulin pump will have a choice from at least two compatible CGMs which could be used to create an AID system. The proposal also provides people who do not want to use an AID system, the choice between two funded standalone CGM options.

Some responders expressed frustration that the Medtronic MiniMed 780G with Guardian 4 CGM supplied by InterMed was not selected as a preferred option.

Pharmac should re-negotiate with InterMed/Medtronic if cost was a reason for not selecting InterMed/Medtronic as a preferred supplier.

As the RFP is an open competitive process, suppliers were expected to submit their best proposal. Pharmac operates within a fixed budget which means we need to make difficult decisions to ensure that we can achieve the best health outcomes from within this fixed budget.

There has been significant consumer and clinical involvement in the evaluation of the products. We used this information to inform the selection of preferred suppliers.

The evaluation process included independent, external clinician and patient representatives who provided valuable insights and advice pivotal to the decision making. This process considered various aspects of the proposed systems including the strength of the evidence supporting their use, the various technical specifications, and specific features of each system.

We understand the preferred suppliers may not have been the suppliers that everyone hoped for. However, as result of this competitive process, we are able to propose fully funded diabetes technologies for all people with type 1 diabetes (and other similar conditions).

Pharmac is unable to disclose any details about Medtronic’s participation in the process.

Concern that the preferred suppliers were selected solely based on cost.

The competitive process we ran for the supply of insulin pumps, consumables and CGMs allowed us to look at all products and how they’d be used side by side, comparing them to ensure we fund the best possible products. There has been significant consumer and clinical involvement in the evaluation of the products. We used this information along with our Factors for Consideration to inform the selection of preferred suppliers.

Request for the transition period to be extended from 12 months to 2 years or until the warranty of current pumps expires.

Concern that the health sector will have insufficient resource and capacity to transition all current Minimed pump users to a new system within 12 months. Additional concern that because diabetes clinic resource will be taken up by transitioning current Medtronic users to an alternative system that there will be limited capacity to onboard new patients to insulin pumps. 

We appreciate this feedback and acknowledge the current resourcing and capacity constraints within the health sector.

We have extended the transition period for insulin pump consumables from 12 months to 2 years in line with advice received from our Diabetes Advisory Committee and other stakeholders. This will enable those who currently use a Minimed pump to continue to access funded consumables for 2 years.

Diabetes clinics are currently not familiar with the YpsoPump with CamAPS FX system. It will be potentially unsafe to onboard or initiate people on to this system before the diabetes clinics have upskilled and are familiar with the system.

We are working with the supplier (Pharmaco) to ensure it provides adequate education and training to upskill diabetes clinicians so they feel confident onboarding patients on to the YpsoPump with CamAPS FX system.

Suggestion that Pharmac not allow any new patients to be initiated on the MiniMed 770G during the transition period, but that current users of the MiniMed 770G/780G be allowed to transition to a new system only after their warranty has expired.

Transitioning current MiniMed 770G/780G users before their current warranty expires is costly and wasteful.

Transitioning current users of the MiniMed 770G/780G to another system within the transition period will take health system resource away from onboarding AID system naïve patients who will gain the most benefit from an AID system.

When designing this procurement process, in order to ensure commercial viability of the market for new pump suppliers, a defined transition period was considered necessary if a change was proposed.

A key intended outcome of the RFP was to enable access to automated insulin delivery systems for people with type 1 diabetes, as this technology is not currently funded by Pharmac. The cost associated with individuals transitioning to a new pump prior to warranty expiry was considered during the evaluation. While we have not been able to extend the transition period to the end of the warranty period, we have extended the transition period to two years.

Concern that current MiniMed 770G/780G insulin pump users will be disadvantaged compared to non-MiniMed users who will be able to access funded AID systems immediately at the implementation date, while MiniMed users will not.

Responders considered this to be a major equity issue and requested that the Medtronic Guardian 4 CGM be funded for current users of the MiniMed 770G/780G insulin pump during the transition period.

We appreciate the desire for all people to have access to an AID system from the implementation date.

However, this is not possible, as it will take time for the New Zealand health system to onboard individuals onto their chosen diabetes technology. It will be up to the individual’s diabetes team, to determine who will be prioritised for a funded CGM or insulin pump.

Pharmac has considered whether it will be possible to fund the compatible Guardian 4 CGM during the transition period. However, this option has not been progressed due to the substantial potential cost, both for the CGM and the likely impact on transition times for the insulin pumps. Pharmac operates within a fixed budget which means we need to make difficult decisions to ensure that we can achieve the best health outcomes from within this fixed budget.

MiniMed pump users should be allowed a trial period of each of the alternative AID systems to help inform their decision on which system to transition to.

We understand that there is a desire for choice at any time during a patient’s journey.

While it will be possible for people to transition between CGMs as required, it will not be possible for people to freely transition to a different pump technology due to the significant financial and clinical resource implications of such changes.

There will be substantial training and support provided to the health care professionals who initiate people on these devices. This will include information to help individuals with the use and selection of which CGM and insulin pump is right for each person. We expect individuals to discuss their clinical needs with their diabetes health care team, prior to selection of a device.

Changing between AID systems is very complex and will be a challenge for many people, even those who are comfortable using diabetes technology. Responders shared their experience that it is straightforward for some people and challenging for others.

It is unfair for people who, for various reasons, have changed from the Tandem system to the MiniMed system to be required to change systems again.

We appreciate this feedback. Automated insulin delivery systems are not currently funded by Pharmac, although we do understand that some people are using AIDs currently, often by individuals self-funding CGMs.

Pharmac is working with both proposed suppliers and independent organisations such as, NZSSD, Diabetes NZ, Health Pathways and Healthify to ensure there are appropriate education materials in a variety of formats to support both users and clinicians in the transition process.

We appreciate that some people have moved to a different insulin pump during their time on insulin pump therapy. We are proposing an alternative option, the YpsoPump with CamAPS FX, for people who have previously used the Tandem pump without success.

We understand from our clinical advisors and other clinical stakeholders that the two funded insulin pump options and the 5 different models of CGMs may not be suitable for a small number of people with exceptional circumstances. We have created a streamlined Exceptional Circumstances pathway for those individuals. Details on how to apply will be available on the Pharmac website(external link).

There was a significant amount of feedback about the proposal causing significant worry and anxiety for Medtronic Minimed pump users.

We understand that change is complicated and can cause anxiety for individuals and their whānau. We appreciate that there is preference for various technologies and that this is understandable, given the value of insulin pump therapy in the lives of people with type 1 diabetes.

We understand from the advice that we have received from various clinical stakeholders that while the requirement for change may be difficult for some people, in almost all cases it will be possible to successfully transition to an alternative funded pump with the appropriate support.

We understand from our clinical advisors and other clinical stakeholders that there will be a very small number of people who cannot use or be transitioned onto one of the proposed options. We have created a streamlined Exceptional Circumstances pathway for those individuals. Details on how to apply will be available on the Pharmac website.

Pharmac should also fund insulin pump and CGM accessories including screen protectors, protector cases, insulin pump carry bags and/or clips, overpatches, alcohol wipes and skin preparation materials, and carry bags for general diabetes supplies.

We appreciate these requests. Insulin pump, CGM and other diabetes-related accessories were not considered within the scope of this procurement process. Overpatches will however be provided for the Dexcom CGMs, however in discussion with Abbott we understand that the FreeStyle Libre CGM’s does not necessitate the use of overpatches.

Pharmac should fund smart insulin pens and additional forms of insulin such as Fiasp and Lyumjev.

We appreciate these requests. Funding additional forms of insulin or smart insulin pens is outside the scope of this procurement process.

We have not received funding applications for either Fiasp (insulin aspart), or Lyumjev (insulin lispro-aabc). You can review the status of all funding applications Pharmac has received on Pharmac’s Application Tracker(external link).

We have not received funding applications for any smart insulin pens. You can review the status of all funding applications Pharmac has received at Pharmac’s Application Tracker(external link).

We welcome funding applications for these products. You can find more information on how to submit a funding application here.(external link)

People are currently accessing funded CGMs via alternative funding streams including:

• Health NZ Carer Support
• Work and Income Disability Allowance
• Ministry of Disabled People | Whaikaha Carer Support

We have engaged with these agencies regarding their respective support schemes, which are being used to enable access to diabetes technology. These agencies have indicated their intention to continue providing these alternative funding streams.

Community pharmacies currently dispense insulin pump consumables at a loss as the Pharmac subsidy does not cover the markup charged by wholesalers.

The Pharmac subsidy is the price at which suppliers are contracted to supply the products to wholesalers at. The service fee paid to community pharmacies via the Integrated Community Pharmacy Services Agreement is managed and paid by Health NZ | Te Whatu Ora and is intended to cover mark-up charges. We have shared this feedback with Health NZ.

The requirement for “objective evidence of maintained improvement in glycaemic control” should be removed from the Special Authority renewal criteria.

· Some responders noted that it will be difficult for people who already have good glycaemic control (e.g. those who are currently self-funding CGMs) to continue demonstrating an improvement

· Some responders noted that some user groups (e.g. adolescents going through puberty) will struggle to demonstrate an improvement in glycaemic markers but that CGMs will still benefit these groups.

· Some responders expressed concern that a user will not meet the renewal criteria if their glycaemic control worsens or did not improve

We acknowledge that individuals will derive clinically meaningful benefit from CGM use outside of strict glycaemic parameters. These benefits include reduction in diabetes fatigue, improvements in time in range, a reduction in the burden of finger-prick testing and a reduction in psychological distress due to potential hypoglycaemic events.

We have removed this requirement from the Special Authority criteria in line with advice from the Diabetes Advisory Committee. Under the new renewal criteria, people will meet the renewal criteria as long as the treating clinician can confirm that the individual is still deriving a health benefit.

Special Authorities for insulin pumps and CGMs should be valid for life without the need for renewal because type 1 diabetes is a lifelong condition.

We appreciate this feedback and acknowledge the lifelong nature of type 1 diabetes. However, we have retained the requirement for Special Authorities to be renewed to ensure that these devices are only funded for people who continue to receive benefit from their use.

The Special Authority criteria should be expanded to include people with type 2 diabetes, either for short-term use to facilitate education or for longer-term use.

We appreciate this feedback. Funding of CGMs for people with type 2 diabetes was not considered within the scope of this procurement process. We have not received or assessed any funding applications for CGMs for people with type 2 diabetes.

However, access could be widened in the future if Pharmac was in a position to potentially progress funding of CGMs for type 2 diabetes following receipt and assessment of a funding application, and available budget.

We welcome funding applications for the use of CGMs in people with type 2 diabetes. You can find more information on how to submit a funding application here.(external link)

Request for clarification about whether people with Latent Autoimmune Diabetes in Adults (LADA) will be eligible under the proposed Special Authority criteria.

People with LADA are included in the eligibility criteria as LADA is a form of type 1 diabetes and will therefore meet the intent of the current criteria, without the need to amend the criteria explicitly.

Request for the Special Authority criteria to be expanded to include gestational diabetes.

We understand that people with gestational diabetes will be expected to benefit from CGM technology.

The advice we have received from our expert clinical advisors is that gestational diabetes is not the same or very similar to type 1 diabetes and is outside the scope of this proposal to fund CGMs for people with type 1 diabetes.

We note however the risks to individuals and their babies if gestational diabetes results in high blood glucose levels during pregnancy. We welcome an application for the use of CGMs in people with gestational diabetes, particularly when blood sugars are difficult to manage and babies therefore at risk. You can find more information on how to submit a funding application here.(external link)

Request to expand the Special Authority criteria to include forms of monogenic diabetes including Maturity Onset Diabetes of the Young (MODY), and diabetes due to Wolfram Syndrome.

We appreciate this feedback and request. In line with advice from the Diabetes Advisory Committee, we have amended the eligibility criteria to include people with forms of monogenic diabetes with insulin deficiency where the treating endocrinologist considers the individual will benefit from a funded CGM. MODY and diabetes due to Wolfram Syndrome will be included under these revised criteria.

We have also amended the eligibility criteria to include people with atypical inherited forms of diabetes.

We acknowledge that not all forms of monogenic diabetes will require treatment, hence we have included the requirement for the individual to be assessed by an endocrinologist, in line with advice from our clinical advisors.

Request to expand the Special Authority criteria to include people with post-transplant diabetes.

We appreciate this feedback and request. In line with advice from the Diabetes Advisory Committee, we have not amended the Special Authority criteria to include post-transplant diabetes.

The Committee considered that post-transplant diabetes is not the same or very similar to type 1 diabetes, and is not within the scope of this proposal to fund CGMs for people with type 1 diabetes.

The Committee noted that the health needs of people with post-transplant diabetes should be considered alongside any proposal to access funded CGMs for people with type 2 diabetes. We welcome a funding application for the use of CGMs in people with post-transplant diabetes, otherwise it will be considered as part of any application for access to CGMs for people with type 2 diabetes. You can find more information on how to submit a funding application here(external link).

Request to expand the Special Authority criteria to include people with diabetes due to pancreatic insufficiency.

We appreciate this feedback and request. In line with advice from the Diabetes Advisory Committee, we have changed the Special Authority criteria to include people with type 3c (or pancreatogenic) diabetes where the treating endocrinologist considers the individual will benefit from access to a funded CGM.

The eligibility criteria as originally proposed were intended to include people with pancreatogenic diabetes. However, as stated, we acknowledge that this was unclear and could contribute to regional inequities of access.

All people with type 1 diabetes should be able to access a CGM with the ability for others to follow CGM readings.

The FreeStyle Libre 2, FreeStyle Libre 3 Plus, Dexcom ONE+, Dexcom G6, and Dexcom G7 all permit users to share their CGM readings with authorised followers.

The requirement for CGMs to be funded via Special Authority applications creates a heavy administrative burden for clinicians. Consider replacing subsidy by Special Authority with subsidy by endorsement.

We appreciate this feedback. However, we consider that the requirement for a Special Authority is an appropriate means to target funding to the intended target population who will likely benefit from CGMs. This is considered even more necessary with the proposed changes to the eligibility criteria, as we need to be explicit about who is eligible for the technology to ensure that there is a consistent understanding of eligibility across the country.

Consider including CGMs, insulin pumps and insulin pump consumables within a single Special Authority.

Having to apply for multiple Special Authorities creates a significant administrative burden for clinicians.

We appreciate this feedback and acknowledge the administrative burden associated with Special Authority applications.

However, it is not functionally possible within the current IT systems to include CGMs, insulin pumps, and consumables within a single Special Authority. There are different eligibility criteria for standalone CGMs and AID systems (insulin pumps with interoperable CGMs).

The proposed 10% buffer allowance in the annual funded limit of CGM sensors should be increased as this is not sufficient to cover the number of faulty sensors or sensors which do not last their entire advertised life.

In addition to the 10% buffer allowance enabling access to more sensors in case there are issues with these, the suppliers (NZMS and Abbott (via Mediray) will continue to provide free replacements for any faulty sensors. These replacements will be provided free of charge by the suppliers.

Nurse prescribers and nurse practitioners should be able to submit applications for CGM Special Authorities.

Any relevant practitioner will be able to submit an application for a Special Authority for CGMs.

This means that any prescriber operating within their scope of practice including nurse prescribers and nurse practitioners will be able to complete Special Authority applications.

A range of feedback was provided regarding training and education needs to support implementation.

We appreciate this feedback. Appropriate education and training is required for clinicians and diabetes technology users to gain the most benefit from diabetes technology. We are working with the proposed suppliers and a range of independent organisations including Diabetes NZ, NZSSD, Health Pathways and Healthify to develop a range of New Zealand-specific education materials for both users and clinicians.

A range of feedback was provided specifically regarding implementation support for Māori and Pacific people.

We appreciate the wide range of suggestions that were provided. Pharmac is working with various stakeholders including Diabetes NZ, NZSSD, Health NZ | Te Whatu Ora, and the proposed suppliers to support the successful roll-out of this proposal.

Current practice is for specialist diabetes teams to evaluate whether a patient should be considered suitable for an insulin pump or AID system. However, the health system is currently stretched and there will be insufficient capacity for specialist diabetes teams to meet the anticipated increased demand.

Insulin pump suppliers should be able to evaluate patients and sign them off as being suitable AID system candidates to take some of the pressure away from the clinicians. 

We appreciate and acknowledge the current resourcing constraints within diabetes clinics.

We understand from our expert clinical advisors that evaluating whether an individual is suitable or not for insulin pump and AID system therapy is a clinical decision that should be made by relevant clinicians.

While we recognise that insulin pump suppliers play a significant role in the insulin pump onboarding process, we understand this is limited to education regarding the technical aspects of an insulin pump or AID system.

People should be able to trial a standalone CGM before deciding whether to commit to an AID system.

We appreciate this feedback. While it is not a formal requirement to access an AID system, we anticipate that most people will use a standalone CGM before being onboarded onto an AID system.

Responders wanted assurance that users of CGMs and/or insulin pumps will retain control and ownership of any personal health information/data generated by the devices. Wanted assurance that any data will not be shared with any third parties except those explicitly authorised by the user (e.g. healthcare professionals). 

In the agreements with suppliers, we have included provisions to ensure that the user’s data remains their property, complies with NZ Privacy Laws and HISO standards.

We have included provisions that prohibit any third party to access or use any user data unless the user provides consents to this.

The process and criteria for accessing an alternative system via the ABA should not be overly onerous.

The criteria and process for accessing products via the ABA should be publicised as soon as possible to provide the community with greater certainty.

We have created a streamlined Exceptional Circumstances pathway for those individuals. Details on how to apply will be available on the Pharmac website

Request for clarification about whether people will be able to access an alternative CGM if they experience allergies to either of the proposed CGMs.

We have received advice on this from the Diabetes Advisory Committee. The Committee considered that for many people the issue of adhesive intolerance for newer CGMs is not a significant problem, particularly in adults where skin is generally more resilient. The Committee considered that for most people, including children, many skin issues could be managed by using one of the alternative CGM products (if suitable) or with appropriate skin preparation.

In the rare instances where a skin tolerance issue is unable to be resolved we will consider applications for CGMs via the exceptions process in situations where the listed CGMs could not be used due to allergies or intolerance.

Responders provided feedback and some published studies regarding the effectiveness of the proposed AID systems. Concerns were raised that the proposed AID systems would not provide the same health benefit as the Medtronic system and will cost the health system more in the long run due to increased diabetic complications from poorer control.

We have received clinical advice from the Diabetes Advisory Committee and NZSSD that the body of published evidence does not support the superiority of any one AID system over another.

They have also advised that clinical trials and real world experience demonstrate that Control-IQ, MiniMed 780G, and CamAPS FX likely have similar clinical effectiveness, safety, suitability and failure rates and that any of these systems will likely provide significant benefit to all people with type 1 diabetes.

We consider that the availability of a choice of fully funded CGMs, insulin pumps and interoperable AID systems will provide substantial short and long term benefits for people with type 1 diabetes.

Respondents provided feedback related to the variations between the functionality of the proposed algorithms

We acknowledge that all three algorithms (Control-IQ, CamAPS FX, SmartGuard) work differently with respect to both correction boluses and glucose targets, however we have received advice from NZSSD and the Diabetes Advisory Committee that they likely provide similar health benefit.

We understand that no one system will be perfect for all individuals. This is a key reason that we sought to ensure that individuals will be able to choose a system that best suits their needs.

Concerns that the proposed AID systems would not be effective for people with a high baseline HbA1c of 80mmol/L or greater.

The advice we have received from the Diabetes Advisory Committee is that very high HbA1c levels (>80 mmol/mol) can and are treated successfully in New Zealand using the Tandem pump. The Committee considered that the proposed products would be expected to provide the anticipated health benefits for this group of people.

Concerns about the proposed AID systems functionalities during exercise.

We understand the need for comprehensive educational resources so that individuals can optimise their device functionality. This will be included in the materials to support implementation.

Concerns that the preferred AIDs require more ‘hands’ on management.

The clinical advice we have received is that while individual systems employ various control techniques the outcome of glycaemic control is still comparable.

Concerns that the preferred AIDs are not useful for children and adolescents.

Our clinical advisors have also told us that both the Control-IQ and CamAPS-FX systems are suitable for children and adolescents. We understand that the Tandem pump with Control-IQ is currently used to treat children as young as 8 months old in the New Zealand clinical environment.

We understand from clinical experts that algorithms and AID systems do not remove the need for some degree of active management, and that this can be beneficial for many people as they remain in control of their therapy.

YpsoPump with CamAPS FX requires a compatible Android smartphone to run as an AID system.

This presents equity issues for people who currently use an iOS smartphone or who cannot afford to purchase a compatible smartphone.

The requirement for a phone also presents practical issues for example children, some of the work people do and those who don’t have access to a reliable power source.

Pharmaco, the distributor of YpsoPump with CamAPS FX in New Zealand, has committed to providing a limited number of compatible Android smartphones for people who are unable to access one.

Pharmaco has indicated that an iOS compatible version of CamAPS FX will be available in early 2025.

We note that there is an exemption that permits children to operate a phone that is required for a medical device during school hours.

We understand there are very few instances where a phone is not permitted in the work environment.

We encourage those with an intermittent power supply should take appropriate measures to ensure that there is a backup available. The National Emergency Management Authority also recommends that users always carry at least a week’s supply of medication and consumables (e.g. insulin, pens, and testing strips) for use in emergency situations.

Wi-fi, internet connectivity and/or cell-phone reception is required for the CamAPS FX algorithm to operate.

The YpsoPump with CamAPS FX system relies on Bluetooth connectivity to operate. Cell-phone reception is not required for the system to operate.

Data/wi-fi connectivity is only required in specific circumstances:

• initial setup: when activating the AID system for the first time to receive the activation code
• monthly security key exchange: once a month, data/wi-fi is required to exchange a security key for the safety and security of patient data
• information exchange: when sharing or exchanging information with authorised followers or clinicians.

Concerns about compatibility issues between different components of the preferred suppliers products.

We consider interoperability, that is the ability to pair with different CGMs from different suppliers, to be a key consideration in the benefit of this proposal. This interoperability enables people to select the components that will work best for them. We understand that the appropriate agreements are in place between proposed suppliers to enable this functionality.

The Dexcom G6 and Dexcom G7 will be the only AID-system compatible CGMs available at launch therefore NZMS will have a monopoly over the entire AID-system market.

We appreciate this feedback, which was relevant prior to the 3 month delay.

The FreeStyle Libre 3 Plus will be available from 1 October 2024 and is compatible with the YpsoPump with CamAPS-FX system.

We understand from Tandem that the FreeStyle Libre 3 Plus would be compatible with the Tandem t:slim with Control-IQ system no later than 1 July 2025.

The Dexcom G6 will also be compatible with the YpsoPump with CamAPS-FX system from 1 October 2024.

The Dexcom G7 and G6 will be compatible with the Tandem t:slim from 1 October 2024.

A range of concerns were raised about suitability of different aspects of the preferred insulin pumps, for example battery life, waterproofing and ease of use etc.

We have sought additional clinical advice on the suitability aspects of the selected devices that were raised through the consultation. Our clinical advisors have told us that the devices we have chosen to fund would provide appropriate clinical benefit for most people with type 1 diabetes and other specific forms of diabetes.

This feedback highlights the importance of flexibility and choice, which we have sought to provide as part of this proposal.

The YpsoPump insulin reservoir only has a capacity of 160 units. This makes it less suitable for people with high daily doses of insulin who may need to replace the cartridge more frequently.

We understand that there may be some people who require greater quantities of consumables as the reservoir for the Ypsopump is smaller than that of other insulin pumps. To address this issue, we have increased the maximum quantities of reservoirs and infusion sets to ensure that this remains a suitable option for those individuals who require greater quantities of insulin.

The Tandem pump is not compatible with insulin glulisine (Apidra), and it is difficult to spot air bubbles with the black cartridge.

We acknowledge that the Tandem t:slim pump is not compatible with insulin glulisine (Apidra) and we have communicated the issue of difficulty in spotting air bubbles to the supplier.

The YpsoPump is compatible with insulin glulisine (Apidra) and may be an appropriate option for people who require insulin glulisine (Apidra). We are pleased to be proposing more than one option for people.

Some people reported experiencing allergic reactions and other dermatological reactions when using the current range of CGM’s in the market.

Pharmac understands that some individuals may experience adverse skin reactions to some CGMs. It will be possible to switch to the other listed brands in this situation if it is not possible to resolve the issue. We sought advice on this from the Diabetes Advisory Committee, who considered that the issue of adhesive intolerance for CGM’s is not a significant problem, particularly in adults where skin is generally more resilient. The Committee considered that in most people, including children, most skin issues can be well managed using appropriate skin preparation.

A range of feedback was provided regarding the accuracy of different CGMs.

This feedback received highlights the importance of flexibility and choice, which we have sought to provide as part of this proposal.

All communications to date have been heavily focused on type 1 diabetes despite pancreatogenic diabetes also being considered within scope of this proposal. Any future communications and implementation plans should be more inclusive regarding pancreatogenic diabetes and other groups covered within scope of the proposal.

We acknowledge that there are some individuals who have similar health needs to people with type 1 diabetes and are included in the intended population for access. We have amended criteria to explicitly include this group and in future we will try to use more inclusive terms.

More supporting information about the YpsoPump with CamAPS FX system should have been released at the time of consultation. Many people are not have been familiar with this system so it would have been useful to have had some materials from a reputable source through which they could have learned about the system.

We appreciate this feedback and will take this into consideration for future funding proposals.

More information regarding the YpsoPump(external link)