GVS advice setmelanotide (Imcivree®)
The National Health Care Institute has completed its assessment whether the product setmelanotide (Imcivree®) can be included in the Medicine Reimbursement System (GVS). Setmelanotide is indicated for the treatment of an extremely rare form of obesity. The National Health Care Institute advises the Minister to include setmelanotide in the GVS with reimbursement conditions as described below.
Indication for which reimbursement is requested
Setmelanotide (Imcivree®) is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic pro-opiomelanocortin deficiency (POMC deficiency), including PCSK1 deficiency, or biallelic leptin receptor deficiency (LEPR deficiency) in adults and in children 6 years of age and above.
National Health Care Institute's advice
The National Health Care Institute advises the Minister to include setmelanotide (Imcivree®) in List 1B of the GVS, with the following reimbursement condition.
Only for an insured person aged 6 years or above:
- With genetically confirmed (according to international genetic classification standards) pro-opiomelanocortin (POMC) deficiency, including proprotein convertase subtilisin/kexin type 1 (PCSK1) deficiency, or biallelic leptin receptor (LEPR) deficiency.
- Who have undergone a combined lifestyle intervention.
- Treatment should be discontinued if, after 6 months at the maintenance dosage, the initial weight in growing children has not stabilized or if it has not decreased by at least 5% in mature adolescents and adults.
- The treatment should be carried out by a centre of expertise.