Monday, July 15, 2024

Glucose Monitors, Insulin Pumps, and Consumables: Procurement Status

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Glucose monitors were the focus of a Request for Proposals (RFP) for the supply of continuous glucose monitors (CGMs), insulin pumps, and insulin pump consumables, to which Pharmac received bids from multiple suppliers. The evaluation of these bids was conducted through three committee meetings, which included clinical experts, consumer representatives, and Pharmac staff. The information gathered during these meetings, along with the Factors for Consideration, helped in selecting the preferred suppliers.

Potential Benefits and Usage: The Committee advised that CGMs could benefit anyone with type 1 diabetes. They highlighted that CGMs can be used independently or in conjunction with insulin pumps, creating a “hybrid closed-loop” or automated insulin delivery system. Both standalone and integrated systems should be funded since the automated system might not be suitable for everyone. The Committee discussed two types of glucose monitoring: real-time monitoring, which continuously sends data to the monitor, and intermittently scanning, which requires manual scanning of the sensor. Each method has its advantages and disadvantages, which Pharmac should consider.

Glucose Monitors: Evaluating Technical Specifications in the RFP Process

Technical Specifications: Pharmac was advised to evaluate several technical aspects of CGMs during the RFP process, including accuracy, especially in a hybrid-closed loop setting, sensor life balancing ease of use and accuracy, on-set and off-set times of sensors, transmitter warranty periods, presence of a reader device, calibration needs, size and ease of use of the applicator, data storage and sharing capabilities, hypoglycemic and hyperglycemic alerts, closed-loop functionality, and a variety of algorithms to meet different user needs.

Additionally, considerations for accessibility, future development plans, and software licenses were emphasized. The Committee also recommended funding a CGM option that does not require a smartphone.

Evaluation Considerations: The Committee proposed including device users in the evaluation process, recognizing that assessment requires more than clinical expertise. They noted the availability of various CGM devices offering similar health benefits and the need for education among healthcare professionals if multiple products are funded. The successful supplier should provide support and educational tools for healthcare professionals.

The Committee suggested consulting with other countries that fund CGMs and insulin pumps to understand minimum requirements. Key aspects for consideration included variable dosing needs, especially for children and lightweight adults, the necessity of funding both tubeless and tubed insulin pumps, and suppliers’ research and development capabilities.

Glucose Monitors

Glucose Monitors: Revised Funding Criteria for Insulin Pump Infusion Sets

Funding Criteria: The Committee recommended reviewing the current 13-pack limit for insulin pump infusion sets, which is deemed unfair for people needing higher doses of insulin or more frequent insertion site changes. They advised that insulin pump initiation should occur in secondary care, whereas CGMs could be prescribed by any qualified healthcare provider, albeit with additional resources. New access criteria for insulin pumps were suggested, removing the current HbA1c criteria to simplify and ensure that those who would benefit the most could access the treatment.

Transition Considerations: If the brand of funded insulin pumps were to change, both patients and the health sector would require a substantial lead time, potentially up to two years. The Committee stressed the importance of face-to-face and online support, as well as targeted support for Māori and Pacific peoples, beyond just written materials in Te Reo Māori or Pacific languages.

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Pharmac has not yet received funding applications for CGM use in type 2 diabetes, gestational diabetes, or other conditions. The Committee noted that CGMs might be used differently by people with type 2 diabetes, potentially offering more benefit in short-term applications. CGMs could also be beneficial in hospitals for patients undergoing intensive insulin therapy, such as after organ transplants or in oncology and intensive care settings. Approximately 10% of people with type 2 diabetes manage their condition similarly to type 1 diabetes, and this group could benefit from access to CGMs and/or insulin pumps.

The procurement process for CGMs, insulin pumps, and consumables involves careful consideration of technical specifications, user needs, and broader access criteria to ensure that effective and high-quality treatment options are available for individuals with diabetes and other conditions. By including diverse perspectives and focusing on user-centric evaluation, Pharmac aims to enhance the accessibility and effectiveness of these critical medical devices.

Resource: Pharmac, June 12, 2024

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