Continuous glucose monitors (CGMs), insulin pumps and insulin pump consumables: Procurement status

Continuous glucose monitors (CGMs)

The Committee advised that CGMs could benefit anyone with type 1 diabetes.

About CGMs

The Committee explained that CGMs can be used by themselves or in combination with insulin pumps. Used together, the CGM and insulin pump create a “hybrid closed-loop”, or automated insulin delivery system.

The Committee noted that both options should be funded because an automated insulin delivery system may not work for some people.

The Committee noted the different kinds of glucose monitoring: real time and intermittently scanning. One sends data continuously to the monitor and the other needs someone to scan the sensor. There are pros and cons to both methods, which they advised Pharmac to consider.

Requirements for CGMs

Pharmac was advised to consider the following technical specifications when evaluating bids received through the RFP process:

• accuracy (especially when used in a ‘hybrid-closed loop’ setting)
• sensor life (balancing ease of use and accuracy)
• on-set and off-set of sensors (‘wake up’ times)
• transmitter warranty periods
• whether it has a reader device
• calibration needs
• size and ease of use of applicator
• how data is stored and shared
• hypoglycaemic and hyperglycaemic alerts
• closed loop function
• variety of algorithms for people with different needs

In addition, Pharmac should also consider:

• how people with a visual impairment or other disabilities can use the device
• each supplier’s plans for future development and upgrades
• details of any software licenses.

Some CGMs need a smartphone as a display. The Committee advised that there should be a funded option that did not rely on a smartphone.

Evaluation considerations

The Committee proposed that Pharmac include users of the devices in any evaluation. Assessing the options would need more than just clinical expertise.

The Committee observed that there are a range of CGM devices available and that many of these products offer similar overall health benefits.

The Committee noted that funding multiple products would require more education for healthcare professionals. They advised that any successful supplier should provide support and education tools to healthcare professionals.

Insulin pumps and consumables

Technical specifications

The Committee suggested Pharmac check with other countries that fund CGMs and insulin pumps to understand minimum requirements.

Aspects that the committee advised Pharmac to consider:

• variable dosing, because children and lightweight adults have different dosing needs
• if a ‘tubeless’ style insulin pump were to be funded, there would still be a need to fund ‘tubed’ pumps
• suppliers’ research and development capacity and plans

Funding criteria

The Committee suggested that Pharmac review the current 13-pack limit for insulin pump infusion sets. The limit is unfair for people who:

• require higher doses of insulin or
• need to change the insertion site more often.

The Committee advised that people need to be started on insulin pumps in secondary care. However, any prescriber with the right expertise could start someone on a CGM. It would need extra resource though.

The Committee suggested new access criteria for insulin pumps, removing the current HbA1c criteria. The target group for funding remains the same, the aim was to simplify the criteria and ensure that those who would benefit most could access treatment.

Transition

The Committee considered what would be needed if the brand of funded insulin pumps was to change. They highlighted that both people using pumps and the health sector would need a long lead time for any change. While some people would adapt quickly, the Committee indicated, that others may need up to 2 years.

Face-to-face support and online support should be part of any programme. 

The Committee noted that Pharmac should also consider targeted support for Māori and Pacific peoples. This needs to be more than just written materials in Te Reo Māori or Pacific languages.

Other conditions that could benefit from CGMs

Pharmac has not received CGM funding applications for:

• type 2 diabetes
• gestational diabetes or
• other conditions that may benefit from CGMs.

The Committee advised that people with type 2 diabetes would likely use CGMs differently. In type 2 diabetes, short-term use of CGMs could be more beneficial. They noted that CGMs could be useful in hospitals, where patients are on intensive insulin therapy. (For example, after an organ transplant, in oncology or in the intensive care setting). 

About 10% of people with type 2 diabetes manage their condition the same way as type 1 is managed. The Committee felt that this group of people could benefit from access to CGM and/or insulin pumps.  

About Pharmac’s advice network

The Diabetes Specialist Advisory Committee and the Pharmacology and Therapeutics Advisory Committee (PTAC) both offer advice to Pharmac. Each committee offers different expert advice. We consider all the advice we receive from these committees. 

What is an RFP?

A Request for Proposals (RFP) is a formal request asking suppliers to propose how their goods or services or works can achieve a specific outcome and meet budgets.

Source: procurement.govt.nz(external link)

Why an RFP?

As a government entity, Pharmac is required to openly advertise procurement opportunities where there are several suppliers who may be able to participate. 

Pharmac must make decisions that are fair, evidence-based, and that achieve the best health outcomes for New Zealanders within the budget available. It is not as simple as picking a product that currently works for some people.

We must secure the most appropriate products from within our budget and ensure there will be continuity of supply and support for people who use them.

Using an RFP for this procurement process:

• Gives suppliers the opportunity to respond with various proposals (depending on their product range). For example, suppliers might want to submit more than one proposal for CGM devices and insulin pumps and consumables.
• Allows Pharmac to consider funding more than one product to make sure there is a suitable product for the user.
• Encourages competitive bidding between suppliers for different funding scenarios because, like a tender, they are not aware of other suppliers’ bids and must prepare their best offer.
• Ensures that suppliers consider how they would make it easier for New Zealanders to use these products. For example, allowing sufficient time and support for people if they need to change brand of insulin pumps and/or insulin pump consumables.
• Ensures that suppliers give thought to how they can support the development and implementation of their proposal that would contribute to equitable access and outcomes, for Māori, Pacific, disabled, and other populations living with type 1 diabetes who are experiencing inequitable health outcomes.

There is no certainty about the outcome of this process. The result of this procurement activity will depend on the bids received and the amount of available funding from within our fixed budget.

How we manage our fixed budget

RFP preparation

Planning the RFP is an essential part of the process to ensure we get the best outcome for the community.  Getting the right information from clinical experts, advocates and consumers is vital to our planning.

Throughout March and April this year Pharmac has discussed the RFP with:

• our Diabetes Advisory Committee
• our Consumer Advisory Committee
• New Zealand Society for the Study of Diabetes(external link)
• Diabetes New Zealand(external link)
• Other health sector partners 

Diabetes New Zealand Chief Executive Heather Verry says:

We are pleased that Pharmac has engaged with Diabetes NZ and other essential stakeholder groups about this procurement activity early in the process. We are supportive of the work to develop this RFP as it will be important for ensuring that we achieve the best outcomes for people living with diabetes who are insulin dependent. We look forward to working with them throughout this process.