OBJECTIVES: to build a cost-effectiveness model for assessing continuous glucose monitoring with Freestyle Libre system (FSL) against standard self-monitoring of blood glucose using glucose meter (SMBG) in adults with diabetes type 1 (T1DM) in Russia.

METHODS: A cohort level Markov model predicted long-term disease progression. The model consists of 18 different health states (1-year cycle length, 50-year horizon). Patients start complication-free and may develop long-term microvascular complications (retinopathy, neuropathy and nephropathy, macrovascular complications and acute diabetes complications (severe hypoglycaemia and ketoacidosis). The model allows for combined health states (maximum two complications simultaneously). Patient characteristics were drawn from the National Diabetes Registry. The HbA1c benefit of using FSL was derived from a meta-analysis of 75 real-world observational studies. Long-term clinical outcomes in relation to HbA1c level were based on DCCT trials. Transition probabilities were drawn from several published models. A direct medical public cost perspective was used. Based on the cost-effectiveness model, budget impact analysis was developed to capture the effect of gradual SMBG replacement with FSL. Budget impact horizon of 5 years was chosen to model change in costs in adults with T1DM. Population coverage with FSL start at 10% in year 1 and hits 30% in year 5.

RESULTS: FSL compared to SMBG resulted in an expected improvement of 0.68 QALYs and additional costs of 967,000 rubles ($13,130) per person, resulting in an ICER of 1,428,720 rubles/QALY ($19,399/QALY) which is lower than approximated willingness-to-pay threshold by 36%. Budget impact analysis showed partial cost offset due to lower incidence of complications. Additional 8 billion rubles ($108.6 million) in a cohort of 223,532 adults with T1DM or 37,000 ruble/person ($502/person) are required to partially introduce FSL within the horizon of 5 years.

CONCLUSIONS: FSL is a cost-effective option for HbA1c control in Russia. Moderate additional budget allocations are necessary to introduce FSL gradually.