GVS advice fenfluramine (Fintepla®) for the treatment of epileptic seizures in Dravet Syndrome or Lennox-Gastaut Syndrome
The National Health Care Institute has assessed whether fenfluramine (Fintepla®) can be included in the Medicine Reimbursement System (GVS). This medicinal product can be used in the treatment of patients aged 2 years and older with Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS). The National Health Care Institute advises the Minister of Health, Welfare and Sport (VWS) to include fenfluramine (Fintepla®) on List 1A of the reimbursement conditions, in a new cluster with cannabidiol (Epidyolex®).
Indication for which reimbursement is requested
Fenfluramine is registered for the treatment of seizures associated with Dravet Syndrome and Lennox-Gastaut Syndrome as an add-on therapy to other anti-epileptic medicinal products for patients 2 years of age and older.
The marketing authorisation holder has requested reimbursement of this product for patients aged 2 years and older with DS or LGS who have at least 2 other anti-epileptic medicinal products and treated insufficiently . These are treatment-resistant patients who have not achieved enough seizure control with the currently available treatments. The applicant claims that the addition of fenfluramine to standard treatment has a therapeutic value comparable with the addition of cannabidiol in combination with clobazam to the standard treatment.
DS and LGS are severe epileptic conditions in which the symptoms occur at a young age. In both syndromes, the patient may experience different types of seizures. In addition, patients often experience other conditions, such as developmental delay and behavioural and cognitive problems.
Recommendations from the National Health Care Institute
The National Health Care Institute advises the Minister of VWS to include fenfluramine (Fintepla®) on List 1A of the GVS, in a new cluster with cannabidiol. The List 2 condition for cannabidiol also applies to fenfluramine. We therefore recommend that the wording of part 153 of List 2 be amended as follows.
Medicine Reimbursement System (GVS)
Fenfluramine is an extramural drug. Extramural drugs are medicinal products for home use, available at the pharmacy on prescription from a physician. They will only be reimbursed from the basic health care package if they are listed in the GVS. The amount of the reimbursement depends on the list the product is on. Interchangeable medicinal products are clustered in List 1A. These may be subject to a reimbursement limit. Unique medicinal products are listed in List 1B. There is no reimbursement limit for these products. Additional conditions may apply for reimbursement. In that case, a medicinal product is also listed on List 2.
The Scientific Advisory Board (WAR) advises the National Health Care Institute about the assessment. Based on the assessment, the National Health Care Institute sends an advisory report to the Minister of Health, Welfare and Sport. The Minister makes the final decision whether or not to reimburse the medication from the basic health care package.