GVS assessment of extension of further conditions for GLP-1ra
The minister for Medical Care asked Zorginstituut Nederland to extend the further conditions for the glucagon-like peptide 1 receptor agonists (GLP-1ra). The application for further extension was submitted by the Rondetafel Diabeteszorg (Diabetes Care Round Table), concerning a reduction in the BMI cut-off value from 35 kg/m2 to 30 kg/m2. The application was prompted by recent changes made to the treatment guidelines for type 2 diabetes mellitus in primary and secondary care by the Dutch College of General Practitioners and the Dutch Internists Association respectively. The Zorginstituut recommends extending the List 2 conditions for GLP-1ra by reducing the BMI cut-off value in the 1st condition from 35 kg/m2 to 30 kg/m2.
Current situation
GLP-1ra are registered for the regulation of blood glucose levels in adults with type 2 diabetes mellitus, in combination with oral hypoglycaemic medicinal products and/or basal insulin, if these do not provide adequate glycaemic control in conjunction with diet and exercise. Six GLP-1ra are currently registered in the Netherlands, namely:
- dulaglutide (Trulicity®)
- exenatide (Byetta® and Bydureon®)
- liraglutide (Victoza®)
- lixisenatide (Lyxumia®)
- semaglutide (Ozempic®)
Based on previous assessments by the Zorginstituut , these GLP-1ra have been placed on List 1A (cluster 0A10BXAP V) of the Medicines Reimbursement System (GVS), including List 2 conditions.
Zorginstituut's advice
GLP-1ra are already included in List 1A of the Medicine Reimbursement System (cluster 0A10BXAP V). We recommend extending the List 2 conditions for GLP-1ra by reducing the BMI cut-off value in the 1st condition from 35 kg/m2 to 30 kg/m2.
New conditions for GLP-1ra
- only for insured persons with type 2 diabetes mellitus and a BMI ≥30 kg/m² whose blood glucose values cannot be adequately regulated with the combination of metformin and a sulphonylurea derivative at the maximum tolerable dosages, and who do not use insulin;
- as an addition to metformin and basal insulin (NPH insulin/long-acting insulin analogue) in an insured person with type 2 diabetes mellitus and a BMI ≥ 30kg/m2 whose blood glucose values are insufficiently regulated after ≥3 months of treatment with optimally titrated basal insulin in combination with metformin (whether or not with a sulphonylurea derivative) at a maximum tolerable dosage.