The National Health Care Institute has completed its assessment whether the List 2 conditions for liraglutide (Saxenda®) and naltrexone/ bupropion (Mysimba®) can be adjusted. Liraglutide (Saxenda®) and naltrexone/bupropion (Mysimba®) can be used for the treatment of adults with an extremely increased weight-related health risk. The National Health Care Institute advises the Minister of Health, Welfare and Sport (VWS) to add to the List 2 conditions that the treatment may only be prescribed if combined lifestyle intervention (CLI) is unsuccessful after one year.
Reason for request to adjust List 2 conditions
The request is based on the communications between the Ministry and the National Health Care Institute, to adjust the existing List 2 conditions for liraglutide (Saxenda®) and naltrexone/bupropion (Mysimba®). These communications have indicated a possible lack of clarity, in the practical field, about the List 2 conditions for these medicinal products, with regards to the appropriateness agreements already made by the occupational group. Adaptation of the List 2 conditions could possibly eliminate this ambiguity.
The National Health Care Institute's advice
We advise the Minister to adjust the List 2 condition for liraglutide and naltrexone/bupropion as follows in order to promote appropriate care (bold print):
In combination with a combined lifestyle intervention (CLI) recognized by the RIVM, if the CLI is unsuccessful after one year, for the treatment of adults with an extremely increased weight-related health risk, without type 2 diabetes and who are not (yet) eligible for metabolic surgery:
- BMI ≥35 kg/m2 in combination with a co-morbidity (cardiovascular disease, sleep apnoea and/or osteoarthritis) or;
- A BMI ≥40 kg/m2.
Treatment should be discontinued if after 3 months of using the maintenance dosage the initial weight has not decreased by at least 5%.
In combination with a combined lifestyle intervention (CLI) recognized by the RIVM, if the CLI is unsuccessful after one year, for the treatment of adults with:
- BMI ≥30 kg/m2 or;
- BMI 27 kg/m2 to 30 kg/m2 in combination with a comorbidity ((risk factors) for cardiovascular disease, type 2 diabetes, sleep apnoea and/or osteoarthritis).
Treatment should be discontinued if, after 4 months of use, the initial weight has not decreased by at least 5%.