GVS advice metreleptin (Myalepta®)
The National Health Care Institute has completed its assessment whether the product metreleptin (Myalepta®) can be included in the Medicine Reimbursement System (GVS). Metreleptin is indicated in addition to a diet as replacement therapy to treat the complications of leptin deficiency in patients with lipodystrophy. The National Health Care Institute advises the Minister to include metreleptin in the GVS with reimbursement conditions as described on this page.
Indication for which reimbursement is requested
Metreleptin (Myalepta®) is indicated in addition to a diet as replacement therapy to treat the complications of leptin deficiency in patients with lipodystrophy:
- With confirmed congenital generalized lipodystrophy (Berardinelli-Seip syndrome) or acquired generalized lipodystrophy (Lawrence syndrome), in adults and children aged 2 and older;
- With confirmed familial partial lipodystrophy or acquired partial lipodystrophy (Barraquer-Simons syndrome), in adults and children aged 12 years and older for whom standard treatments did not achieve adequate metabolic control.
National Health Care Institute's advice
The National Health Care Institute advises the Minister to include metreleptin (Myalepta®) in List 1B of the GVS, with the following reimbursement condition:
Only for insured persons aged 2 years or older
- With congenital generalized lipodystrophy (Berardinelli-Seip syndrome) or acquired generalized lipodystrophy (Lawrence syndrome);
- If patients with the current treatments for diabetes mellitus or dyslipidaemia and a strict diet cannot meet the target values for HbA1c, triglycerides and LDL cholesterol, or in case of hepatic steatosis with steatohepatitis (increased transaminases) and/or decreased elasticity on the fibroscan.
The treatment should be evaluated every 6 months and terminated in the event of insufficient efficacy. The treatment must be carried out by an expertise centre.