The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to reimburse iptacopan (Fabhalta®) from the basic healthcare package. This medicine can be used for certain patients with paroxysmal nocturnal haemoglobinuria (PNH). This is a rare bone marrow disease. If the Minister adopts our advice, iptacopan will be included in the Medicine Reimbursement System (GVS). Only then will this medicinal product be reimbursed from the healthcare insurer's basic healthcare package.
Current state of affairs: advisory report sent to the Minister
The National Health Care Institute has sent this advice to the Minister of VWS. The Minister makes the final decision whether or not to reimburse the medicinal product from the basic healthcare package.
Iptacopan is intended for certain people with paroxysmal nocturnal haemoglobinuria
Iptacopan is the active substance. The brand name is Fabhalta®. The medicine is a capsule that is taken orally.
The medicine can be used in adult patients with paroxysmal nocturnal haemoglobinuria (PNH). PNH is a non-hereditary, rare bone marrow disease. Patients with PNH suffer from severe anaemia. Anaemia is caused by the increased breakdown of red blood cells, infections that cause the breakdown of white blood cells, and thrombosis.
Advice of the National Health Care Institute on the reimbursement of iptacopan
The National Health Care Institute advises the Minister of VWS to reimburse iptacopan (Fabhalta®) from the basic healthcare package.. The advice is to include the medicinal product in List 1B of the GVS. Fabhalta® is subject to certain additional conditions, the so-called List 2 conditions.
For more information on the GVS and the Lists 1A, 1B and 2, see page ‘Reimbursement of outpatient medicines’.
Conditions for reimbursement of iptacopan
Only for an insured person with paroxysmal nocturnal haemoglobinuria who, after treatment with a C5 inhibitor for at least 3 months, is anaemic with a haemoglobin level of <6.5 mmol/L, or if there is C5 inhibitor intolerance.
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 Scientific Advisory Board (WAR) advises the National Health Care Institute about the 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
Iptacopan is an extramural medicinal product. Extramural means: medicines for home use that can be obtained at the pharmacy with the prescription from a physician. They are only reimbursed from the basic healthcare package if they are listed in the GVS.