The Association for the Study of Obesity on the Island of Ireland and the Irish Coalition for People Living with Obesity welcome the HSE Medicines Management Programme approval for reimbursement for Liraglutide 3.0mg (Saxenda ®) for adults living with obesity and it’s cardiometabolic complications. It offers hope for the future for thousands of adults living with obesity in Ireland.
Obesity as a complex chronic disease where adiposity adversely effects many aspects of health, and we would welcome further expansion of the programme with longer term prescribing to those with respiratory, musculoskeletal, mental health and other complications of obesity. This would bring HSE prescribing policy in line with its own HSE Model of Care for Obesity in Adults, including the recommendation to use the Edmonton Obesity Staging System for categorisation of obesity complexity.
Approval under this Managed Access Protocol also raises a number of specific concerns:
- The current inclusion criteria (of body mass index > 35kg/m2, with pre-diabetes and high risk of cardiovascular disease) severely limit eligibility and may in fact penalise some individuals who have received treatment for obesity complications with the use of other medications.
- The requirement for HbA1c and fasting glucose levels is inconsistent with the diagnosis of pre-diabetes within the HSE chronic disease management programme.
- The definition of ‘success’ in relation to response is based purely on 5% weight loss after 12 weeks. The focus on body weight, rather than health-outcomes in not in line with evidence-based obesity care guidelines. It also raises issues in relation to what clinicians should offer to patients who do not meet this threshold – particularly if the 12 week period has been interrupted by intercurrent illness common in complex obesity.
- The burden of the PCRS application process for prescribers, initially and at 6 months, must also be recognised as a barrier to timely obesity treatment. There also considerable difficulty in accessing this system for GPs who do not hold a GMS list.
- There are resourcing implications for clinicians using this protocol including sourcing 24 hour blood pressure monitors with appropriate cuff sizes to accurately measure blood pressure.
In the longer term, we would call for consideration of extension of the 24 month prescribing period following initial review of the data on prescribing practices, use and both health and economic impacts. We would also call again for obesity to be included in the Chronic Disease Management Programme and for better access to a range of treatment for obesity across primary, secondary and tertiary care.
ASOI have led the development of Clinical Practice Guidelines for the Management of Adult Obesity in Adults in Ireland https://asoi.info/guidelines/ which will provide support for prescribers undertaking obesity assessments, and guidance on having helpful non-stigmatising conversations with patients about living with the disease of obesity.