Table 3.

Reimbursement criteria for SAP in Central and Eastern Europe

Country	Reimbursement status	Healthcare funding type	Population indications	Economic details
Bulgaria [55]	Limited	National insurance for pump, out-of-pocket for CGM	Confirmed diagnosis of T1D Unsuccessful intensified therapy with insulin analogues with at least four applications per day Frequent and unpredictable severe daytime and/or nocturnal hypoglycemia High blood sugar in the morning (dawn phenomenon) Inadequate glycemic control—HbA1c > 8.5% (69 mmol/mol) (< 18 years of age HbA1c over > 7.5% [58 mmol/mol]) Children < 6 years of age Pregnancy or planned pregnancy and a persistently high level of HbA1c > 7.0% (53 mmol/mol)	NHIF pays fixed amount per product for intensified insulin treatment, but no price set for sensors/CGM and they are therefore fully funded out-of-pocket
Croatia [56]	Reimbursed	National insurance	CGM/SAP reimbursed for all individuals that are insulin pump users with HbA1c levels > 7.5% (58 mmol/mol)	Product-based reimbursement prices (for pump, consumables, and CGM sensors) are set by the payer body, the HZZO Up to 40 sensors per year (plus one transmitter) are covered
Czech Republik [57]	Reimbursed with possible co-payment	National insurance	CGM/SAP is covered for T1D for any age on CSII (or MDI) if individual with T1D meets CGM/SAP/CSII reimbursement criteria Recurrent and unrecognized hypoglycemia that cannot be controlled by other therapeutic methods (including analogue-Lantus administration) Significant dawn phenomenon Preconception stage and pregnancy, if successful treatment of diabetes by another intensified regimen is not achieved Prevention of or beneficial influence on diabetes-related microvascular complications with long-term inadequate glycemic control on other insulin regimens, plus evidence of improvements during pump therapy Protection of a transplanted kidney in individuals who have had their graft rejected or who have not had a pancreatic transplant Must be prescribed by a physician specialized in diabetology (Centralized Diabetology Clinics) and approved by health insurance Reimbursement is limited to one pump per treating physician every 4 years	Reimbursement limit applies for the CGM per person per year; co-payment in cases where person exceeds the reimbursement limit
Hungary [58]	Reimbursed with possible co-payment	National insurance	Aged < 18 years, with T1D and cystic fibrosis Aged > 18 years, with T1D and cystic fibrosis with:  Hypoglycemia unawareness  Frequent hypoglycemia (five events per month)  Severe hypoglycemia (BG < 3.0 mmol/L)  HbA1c > 8.0% (64 mmol/mol)  Pregnancy or planned pregnancy (within next 6 months) CGM-naïve individuals start with a 4-week “probation time”, after which individuals/physicians decide whether to start official CGM therapy with prescription Evaluation every 6 months (physician can prescribe 24 sensors for 6 months)—criteria to continue the CGM are sensor usage at least 70% of time plus one of:  Fewer hypoglycemic events than before CGM  Increased time in range  Hb1Ac in individual target range	Co-payment system:  Aged < 18 years: 98% reimbursed + 2% co-payment  For individuals with T1D with cystic fibrosis   Aged > 18 years: 80% reimbursed + 20% co-payment  For individuals with T1D with cystic fibrosis and any complication (as shown in the “Population indications” column):   4 weeks’ probation time (products provided free of charge by distributor)   Sensor quantity: 12 units per 3 months per prescription (48 units per year)   2-year warranty for transmitters
Poland [59, 60]	Limited	National insurance	T1D insulin pump users with hypoglycemia unawareness, for individuals aged ≤ 26 years	Reimbursement limits set by the Polish payer body applies:  Four sensors per month with reimbursement limit and 30% co-payment  One transmitter per 8 months with reimbursement limit and 30% co-payment
Romania [61]	Reimbursed	Tender	T1D children on a CGM with a coefficient of variability > 36% T1D adults on a CGM with at least two hypoglycemic comas in the last 6 months (proven through hospitalization) Individuals that are already on a pump without sensors are eligible for SAP only if their current pump is out of warranty	100% reimbursement, no co-pay Tender market for all diabetes-related devices Therapy bundles (CSII/CGM/SAP) are available, set by the payer and MoH with input from the DIB Health Committee
Serbia [62–64]	Reimbursed	National insurance	Individuals on MDI with three consecutive HbA1c measurements > 8.5% (69 mmol/mol) in routine appointments Individuals on MDI with diabetic kidney disease with two consecutive HbA1c measurements > 7.5% (58 mmol/mol) Pregnant individuals with two consecutive HbA1c measurements > 7.0% (53 mmol/mol) Individuals with T1D receiving CSII	Product-specific reimbursement amounts and quantities apply Individuals receiving CSII are limited to 52 sensors and one transmitter per year
Slovakia [65]	Reimbursed with possible co-payment	National insurance	Pregnant women with T1D Children with T1D (aged < 19 years) Adults with T1D receiving insulin pump therapy with LGS or PLGM, with hypoglycemia unawareness and high cardiovascular risk Continuation criteria:  Minimum 6 months of monitoring in a diabetology center  Confirmed improvement in glycemic control (compared to initial indication)	Substantial reimbursement of sensors with little co-pay  Pregnant women with T1D: 40 sensors  Children with T1D aged < 19 years: 70–80% time on sensors per year (up to 42 sensors per year)  Adults with T1D aged ≥ 19 years on SAP therapy with LGS or PLGM, with hypoglycemia unawareness and high cardiovascular risk: 26 sensors per year Transmitter 100% covered for individuals fulfilling the following indications:  Pregnant women with T1D  Children with T1D aged < 18 years on SAP therapy with LGS or PLGM
Slovenia [66]	Reimbursed	National insurance	Personal CGM reimbursement covers:  Pediatric individuals with T1D aged ≤ 7 years  Pregnant women with T1D on intensive insulin treatment Intermittently scanned CGM is reimbursed for all people with T1D with significant glycemic variability despite treatment with MDI CGM reimbursement is also covered in individuals with T1D receiving CSII, MDI plus SMBG or intermittently scanned CGM with one of the following:  HbA1c values > 7.0% (53 mmol/mol)  TIR (3.9–10.0%) < 70% across 3 months  Recurring severe hypoglycemia with TBR > 4.0% HCL reimbursement is covered in individuals with T1D receiving CSII, CSII plus CGM, or MDI plus CGM with one of the following:  HbA1c values > 7.0% (53 mmol/mol)  TIR (3.9–10.0%) < 70% across 3 months [31]  Recurring severe hypoglycemia with TBR > 4.0% Reimbursement of all devices is contingent on individuals actively participating in their diabetes management and if the use of devices is expected to improve their diabetes management	Generic reimbursement of 52 sensors plus one transmitter per year
Ukraine	Not reimbursed	–	–	–

CGM continuous glucose monitoring, CSII continuous subcutaneous insulin infusion, CVD cardiovascular disease, HbA1c glycated hemoglobin, HZZO Hrvatski zavod za zdravstveno osiguranje [Croatian Health Insurance Fund], LGS low glucose suspend, MoH Ministry of Health, NHIF National Health Insurance Fund, PLGM predictive low glucose management, SAP sensor-augmented pump, SMBG self-monitoring of blood glucose, T1D type 1 diabetes, T2D type 2 diabetes, TBR time below range, TIR time in range