GVS advice bupropion in combination with naltrexone (Mysimba®)
The National Health Care Institute has completed its assessment whether the product bupropion in combination with naltrexone (Mysimba®) can be included in the Medicine Reimbursement System (GVS). This product is indicated for the treatment of adult patients with obesity (BMI ≥30 kg/m2) or overweight patients (BMI 27 kg/m2 to 30 kg/m2 combined with one or more weight-related comorbidities) in addition to a combined lifestyle intervention (CLI). The National Health Care Institute advises the Minister to include Mysimba® on List 1A of the GVS in a new combination cluster.
Indication for which reimbursement is requested
Mysimba® is indicated as an addition to a calorie-restricted diet and increased physical activity, for weight control in adult patients (≥ 18 years) with an initial Body Mass Index (BMI) of:
• 30 kg/m2 or more (obesity), or
• 27 kg/m2 to 30 kg/m2 (overweight) in the presence of one or more weight-related comorbidities (e.g., type 2 diabetes, dyslipidaemia or controlled hypertension).
National Health Care Institute's advice
The National Health Care Institute recommends that naltrexone/bupropion (Mysimba®) be included in the GVS with the following reimbursement condition:
In combination with a combined lifestyle intervention (CLI) recognized by the RIVM, 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%.