Table 2.

Eligibility criteria developed and implemented in the managed access protocol for liraglutide (Saxenda^®) [27]

Control	HTA assumption	Approval criteria
Prescriber	Weight management specialists	General practitioners
Clinical diagnostic criteria	BMI ≥ 35 mg/m2	BMI ≥ 35 mg/m2
Clinical severity criteria	Pre-diabetes and high-risk for cardiovascular disease, based on population enrolled in a subgroup analysis of the SCALE 1839 trial	Pre-diabetes, defined as fasting plasma glucose level of 5.5–6.9 mmol/L, haemoglobin A1c (HbA1c) level of 42–47 mmol/mol, measured within 30 days of the date of the application AND High risk for cardiovascular disease, defined as having either fasting total cholesterol > 5 mmol/L, or mean systolic blood pressure > 140 mmHg confirmed on a 24-h blood pressure monitor
Concomitant interventions	Non-pharmacological interventions for weight management, i.e., reduced calorie diet and increased physical activity	Non-pharmacological interventions for weight management, i.e., reduced calorie diet and increased physical activity
Conditional reimbursementa	Non-responders discontinue treatment	Two-phase application system, with phase 1 providing reimbursement support for six months, and continued phase 2 reimbursement contingent on attaining pre-specified weight loss
Treatment duration	24 months in budget impact model	24 months

BMI body mass index, HbA1c haemoglobin A1c, HTA health technology assessment

^aIncluded in line with the HSE Drugs Group recommendation and the summary of product characteristics