Self-monitoring with glucose test strips is used as a comparator of FreeStyle Libre. The health technology assessment includes an economic evaluation of FreeStyle Libre and is based on two clinical studies and a quality of life measurement in the form of a so called time-trade-off-study (TTO-study). The cost-effectiveness analysis include those with type 1 or type 2 diabetes who are treated with a combination of basal and mealtime insulin. The health technology assessment report presented by TLV provides a basis for decisions made by the county councils.
Diabetes is a condition that leads to high blood glucose levels (hyperglycemia) due to a malfunction in the body’s ability to produce or handle the hormone insulin. The most common forms of diabetes are type 1 and type 2 diabetes. A person with type 1 diabetes is normally treated with basal insulin in combination with fast-acting mealtime insulin. There are approximately 48,000 people with type 1 diabetes in Sweden, of which roughly 7,000 are children. Approximately 40,000 people with type 2 diabetes are like those with type 1 diabetes treated with a combination of basal and mealtime insulin. A person who often needs to monitor the glucose level can use a continuous glucose monitor instead of a blood glucose test strip. FreeStyle Libre is a sensor-powered system for continuous glucose monitoring which is CE certified for adults with diabetes and for children with diabetes aged 4 to 17 under adult supervision.
In the economic evaluation of FreeStyle Libre, the cost-effectiveness analysis of FreeStyle Libre is based on data that pertains to people with type 1 diabetes since there is a lack of relevant information on continuous glucose monitoring in those with type 2 diabetes. The time horizon in the analysis is 50 years. In the company’s base-case scenario the cost per quality-adjusted life years (QALYs) is SEK 291,000 for people with type 1 diabetes. In TLV’s base-case scenario the cost per QALY is SEK 389,000. TLV bases its estimates on a product cost of SEK 13,000 per year for FreeStyle Libre and a product cost of SEK 7,300 per year for blood glucose monitoring with test strips.