Table 2.

Reimbursement criteria for CSII in Central and Eastern Europe

Country	Reimbursement status	Healthcare funding type	Population indications	Economic details
Bulgaria [55]	Limited	National insurance	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)	Insulin pumps provided by manufacturers, and NHIF pays fixed amount per product for intensified insulin treatment:  Up to 10 pieces per month of infusion sets and reservoirs according to medical criteria and instructions  Co-pay covers remaining amount
Croatia [56]	Limited	National insurance	People with T1D with uncontrolled HbA1c, glycemic variability, frequent hypoglycemia, dawn phenomenon, unregulated glycemia, preconception	Insulin pumps funded through national tender in about 95% of cases Consumables are 100% reimbursed for all people with a pump No co-pay for any devices, but PwD can cover the full cost of the device out-of-pocket if not covered through national tender
Czech Republik [57]	Reimbursed	National insurance	Both children and adults 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 PwD 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	100% reimbursed, with a price cap (regulation of State Institute on Drug Control) There are three reimbursement categories  Basic pump (CSII)  CGM only  SAP
Hungary [58]	Reimbursed	National insurance	People with uncontrolled T1D in one of the following areas:  Repeated HbA1c > 7.0% (53 mmol/mol), pre-conceptual care > 6.5% (48 mmol/mol)  Significant daily blood glucose fluctuations (≥ 10.0 mmol/L)  Early morning fast (morning fasting blood glucose) repeatedly > 8.0 mmol/L  Hypoglycemia with clinical symptoms at least 3 times per month  Documented reduction or loss of hypoglycemia  Severe hypoglycemia (blood glucose < 3.0 mmol/L) at least once every 6 months People with T1D with recurrent (> 3 times per year) or severe (requiring hospital admission) ketoacidosis One of the following must be satisfied for treatment continuation:  Mean HbA1c value < 8.0% (64 mmol/mol) during previous 6 months, plus HbA1c value (before daily blood glucose fluctuations) less than before pump therapy  Reduced number of symptomatic or asymptomatic hypoglycemic events compared with period before pump therapy	Prior authorization required, involving substantial paperwork Co-payment system:  Aged < 18 years: 98% reimbursed plus 2% co-payment  Aged > 18 years with cystic fibrosis: 80% reimbursed plus 20% co-payment 3 months’ probation time (products provided free of charge by distributor)—upgrade on pumps only under strict conditions NHIF has a yearly budget for pumps, managed through price–volume agreements
Poland [59, 60]	Limited	National insurance	People with T1D aged < 26 years diagnosed with one or more of the following:  Repetitive severe hypoglycemia  Repetitive hypoglycemia at dawn  Glucose instability requiring ≥ 7 measurements per day Presence of diabetes-related complications/ketoacidosis	Insulin pumps reimbursed through the DRG system; tariffs set by AOTMIT (HTA body) with no co-pay allowed Public funding limits apply for pump consumables (i.e., fixed amounts for reservoirs [up to 5 units per month]; infusion sets [up to 10 units per month])
Romania [61]	Reimbursed	Tender	People with T1D or T2D, prioritized as follows:  Children aged < 18 years  Between 18 and26 years of age with no income  Pregnant individuals  Adults	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	People with T1D administering MDI with inadequate glycemic control  Adults with an HbA1c ≥ 8.5% (69 mmol/mol) or HbA1c ≥ 7.5% (58 mmol/mol) plus microalbuminuria  Children with an HbA1c ≥ 7.5% (58 mmol/mol) or brittle diabetes  Pregnant individuals with an HbA1c ≥ 7.0% (53 mmol/mol)	Pump, infusion sets, and reservoirs (120 per year) are fully reimbursed according to defined clinical indications
Slovakia [65]	Reimbursed	National insurance	All people with diabetes:  Individuals on intensified insulin treatment with HbA1c > 8.0% (64 mmol/mol) and/or significant hypoglycemia and/or significant glucose variability despite the use of a long-acting insulin analogue (minimum 6 months)  Inadequate glycemic control before a planned pregnancy/during pregnancy  Individuals at increased mortality risk (i.e., with CVD complications), with premature occurrence/rapid progression of complications, or post organ transplantation Continuation criteria:  Minimum 6 months of monitoring in diabetology center  Confirmed improvement in glycemic control (compared to the initial indication)	Pump (one per 4 years), infusion sets (120 per year) and reservoirs (100 per year) are fully reimbursed with no co-pay
Slovenia [66]	Reimbursed	National insurance	People with T1D with:  Unmet glycemic targets despite treatment with MDI  Hypoglycemia unawareness  High glycemic variability when receiving MDI (in ages < 18 years)  Diagnosis when aged < 7 years  Pregnancy or planned pregnancy and unmet glycemic targets despite treatment with MDI	CSII components (pump and consumables) are reimbursed through the generic reimbursement amounts defined by the payer body, the ZZZS
Ukraine	Not reimbursed	Occasional tender	Case-by-case basis in pediatric individuals	Occasional, limited, regional funding for consumables for pediatric individuals through tenders

CGM continuous glucose monitoring, CSII continuous subcutaneous insulin infusion, CVD cardiovascular disease, HbA1c glycated hemoglobin, MDI multiple daily insulin, MoH Ministry of Health, NHIF National Health Insurance Fund, PwD people with diabetes, SAP sensor-augmented pump, T1D type 1 diabetes, T2D type 2 diabetes, ZZZS Zavod za zdravstveno zavarovanje Slovenije [Health Insurance Institute of Slovenia]