The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to reimburse benralizumab (Fasenra®) from the basic healthcare package. This medicine can be used for certain patients with Eosinophilic granulomatosis with polyangiitis (EGPA). EGPA is a form of vasculitis, an inflammation of blood vessels. This medicine is already in the Medicine Reimbursement System (GVS) for the treatment of severe asthma. If the Minister adopts our advice, this medicine will also be reimbursed for those patients with EGPA mentioned. However, we do recommend additional conditions for reimbursement.
Benralizumab is intended for certain people with EGPA
Benralizumab is the active substance. The brand name is Fasenra®. The medicinal product is an injection given subcutaneously every 4 weeks. Subcutaneous means under the skin.
The medicinal product can be used for people with EGPA. EGPA is a rare condition in which the body's own immune system attacks the cells of the blood vessel wall. This causes inflammation, especially of the small blood vessels. This is also known as vasculitis or vascular inflammation. The inflammation of the blood vessels disrupts the blood supply to other organs and tissues. As a result, their function deteriorates or they may even die off completely. In EGPA, the inflammation is caused by an excess of a certain type of white blood cells, the eosinophils. This disease was previously known as Churg-Strauss syndrome.
People with EGPA may experience symptoms such as pulmonary attacks, coughing up blood and nasal inflammation. They may also experience skin blotches, chest pain or pressure, arrhythmia, severe abdominal pain, and loss of strength and sensation. The symptoms often come in attacks, with periods of inflammatory attacks alternating with symptom-free periods. The disease cannot be cured but the attacks can be stopped or prevented with medication.
The marketing authorisation holder has requested reimbursement for the treatment of adult patients with recurrent or refractory EGPA. Recurrent or refractory means that the attacks of the disease keep coming back.
Advice from the National Health Care Institute on the reimbursement of benralizumab
The National Health Care Institute advises the Minister of VWS to reimburse benralizumab (Fasenra®) from the basic healthcare package. The medicinal product is already included in List 1A in the GVS cluster 0R03DXAP as add-on treatment for adults with severe eosinophilic asthma. This inclusion is subject to certain additional conditions, the so-called List 2 conditions.
The National Health Care Institute recommends that the additional conditions in List 2 for benralizumab (Fasenra®) be adjusted.
For more information on the GVS and the Annexes 1A, 1B and 2, see page ‘Reimbursement of outpatient medicines‘.
New additional conditions for reimbursement of benralizumab (Fasenra®)
Only for an insured person:
- as an add-on maintenance treatment in patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists. The treatment must be performed in the hospital for at least the first 6 months; or
- As an add-on treatment in patients with recurrent or refractory eosinophilic granulomatosis with polyangiitis (EGPA). The treatment should be prescribed by an approved vasculitis expertise centre and performed in the hospital for at least the first 6 months.
More information or questions?
If you have any questions about this advice, please send your question to the National Health Care Institute via warcg@zinl.nl. If you have questions about the reimbursement of a medicinal product, the personal expenses or whether you should pay a contribution, please ask your health insurance provider.
How did the advice come about?
The Minister of VWS asks the National Health Care Institute to make an assessment. The Minister makes the final decision whether or not to reimburse the medicinal product from the basic healthcare package.
Explanation about the reimbursement of medicinal products
Benralizumab is an extramural medicinal product. ‘Extramural’ means medicines for home use that can be obtained at a pharmacy with a prescription from a physician. They are only reimbursed from the basic healthcare package if they are listed in the GVS.