Article type
Abstract
Background: Health-technology assessment of short-acting insulin analogues for Type-1 Diabetes Mellitus (DM1), including systematic reviews, economic evaluation and budgetary impact, revealed, not surprisingly, their non-superiority over regular human insulin. Incremental budget impact could reach USD 260 million after 5 years, covering around 600 000 people. Before decision making, online public consultation is mandatory for every decision regarding new technologies in the Brazilian Public Health System (SUS). The preliminary recommendation of the Committee for Health Technology Incorporation (CONITEC) was for non-incorporation.
Objectives: To describe the participation of society in the decision to cover short-acting insulin analogues for DM1 in SUS.
Method: Descriptive case study.
Results: Online public consultation was held in September and October 2016. 1092 contributions were received regarding the experience of patients, relatives, friends or caregivers of patients, health professionals or people interested in the subject. Participation was predominantly by patients (79%), women (75%), self-declared whites (76%) and people aged between 25 and 59 years (83%). The most-frequent narrative was the lower frequency of hypoglycaemia, better glycaemic control and better quality of life. In addition, it was argued that short-acting insulin analogues allow carbohydrate counting and safe practice of physical exercise. Other positive effects mentioned were: increased food flexibility, treatment malleability, predictability of results, ease of use, better dose adjustment and greater compliance. The participants also indicated that the rapid effect of these insulins favours the control of hyperglycaemia due to other factors besides feeding only.
Conclusions: CONITEC Plenary considered all the contributions sent in public consultation, considering them as sufficient evidence to alter the initial recommendation, supplanting the methodological limitations of the available studies. CONITEC issued as final recommendation the incorporation of short-acting insulin analogues for DM1 in SUS.
Objectives: To describe the participation of society in the decision to cover short-acting insulin analogues for DM1 in SUS.
Method: Descriptive case study.
Results: Online public consultation was held in September and October 2016. 1092 contributions were received regarding the experience of patients, relatives, friends or caregivers of patients, health professionals or people interested in the subject. Participation was predominantly by patients (79%), women (75%), self-declared whites (76%) and people aged between 25 and 59 years (83%). The most-frequent narrative was the lower frequency of hypoglycaemia, better glycaemic control and better quality of life. In addition, it was argued that short-acting insulin analogues allow carbohydrate counting and safe practice of physical exercise. Other positive effects mentioned were: increased food flexibility, treatment malleability, predictability of results, ease of use, better dose adjustment and greater compliance. The participants also indicated that the rapid effect of these insulins favours the control of hyperglycaemia due to other factors besides feeding only.
Conclusions: CONITEC Plenary considered all the contributions sent in public consultation, considering them as sufficient evidence to alter the initial recommendation, supplanting the methodological limitations of the available studies. CONITEC issued as final recommendation the incorporation of short-acting insulin analogues for DM1 in SUS.