GVS advice on volanesorsen (Waylivra)
The National Health Care Institute has completed its assessment whether the product volanesorsen (Waylivra®) can be included in the Medicine Reimbursement System (GVS). Volanesorsen is indicated as an adjunct to diet in adult patients with genetically confirmed familial chylomicronaemia syndrome (FCS) and at high risk for pancreatitis, in whom response to diet and triglyceride-lowering treatment has been inadequate. Based on the criteria for interchangeability, it can be concluded that volanesorsen (Waylivra®) is not interchangeable with any products in the GVS. The National Health Care Institute advises the Minister to include volanesorsen on List 1B of the GVS.
Indication for which reimbursement is requested
Volanesorsen is available as a pre-filled syringe containing 300 mg volanesorsen sodium corresponding to 285 mg volanesorsen in 1.5 ml of solution. The recommended starting dose of volanesorsen is 285 mg injected subcutaneously once a week for 3 months. After those 3 months, the dose frequency should be reduced to 285 mg every 2 weeks. Volanesorsen (Waylivra®) is indicated as an adjunct to diet in adult patients with genetically confirmed familial chylomicronaemia syndrome (FCS) and at high risk for pancreatitis, in whom response to diet and triglyceride-lowering treatment has been inadequate.
National Health Care Institute's advice
The National Health Care Institute recommends the Minister to include volanesorsen (Waylivra®) on List 1B. If the application of volanesorsen (Waylivra®) is included in the package, the National Health Care Institute recommends the following reimbursement conditions:
Only for insured persons aged 18 or older, as an adjunct to the diet for treating genetically confirmed familial chylomicronaemia syndrome (FCS) at high risk of pancreatitis in whom response to diet and triglyceride-lowering treatment has been inadequate.