The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to reimburse faricimab (Vabysmo®) from the basic healthcare package. This medicinal product can be used in certain patients with visual impairment due to fluid accumulation as a result of a blocked vein in the eye. The reason for this advice was the placing of the medicinal product in the so-called ‘lock procedure’ for expensive medicinal products.
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.
Faricimab is intended for certain people with loss of vision due to fluid accumulation as a result of a blocked vein in the eye
Faricimab is the active substance. The brand name is Vabysmo®. The medicinal product is an injection into the eye.
It can be used in adult people with vision loss due to macular oedema secondary to retinal venous occlusion. Macular oedema means that fluid accumulates behind the eye. ‘Secondary to’ means it is caused by. Retinal venous occlusion means that a vein in the eye is blocked. A blocked vein is caused by arteriosclerosis. Arteriosclerosis, or calcification of the arteries, causes the arteries to thicken and harden, blocking off the veins that cross them. This limits the flow of blood and oxygen to the eye and causes the cells in the retina of the eye to make new branches of the arteries. Those branches are of poor quality, causing fluid and blood to leak into the eye. This causes the patient to experience vision loss. Faricimab can reduce the production of these inferior branches, stopping the leakage of blood and fluid into the eye and reducing or eliminating the vision loss.
The marketing authorisation holder (MAH) has requested reimbursement for the treatment of adult patients with visual impairment due to macular oedema secondary to retinal venous occlusions (RVO): venous branch occlusion (branch RVO) or retinal venous stem occlusion (central RVO).
Advice of the National Health Care Institute on the reimbursement of faricimab
The National Health Care Institute advises the Minister of Health, Welfare and Sport to reimburse faricimab (Vabysmo®) from the basic healthcare package. The National Health Care Institute also recommends that the inclusion of faricimab in the basic healthcare package should not lead to additional costs compared to the costs of current treatment with aflibercept or ranibizumab.
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 when issuing a package advice. The final decision as to whether or not reimbursement from the basic health care package will take place lies with the Minister.
Explanation of lock procedure for expensive medicinal products
The Minister has placed faricimab for this indication in the lock procedure for expensive medicinal products. A medication in this lock procedure will not be eligible for reimbursement from the basic healthcare package until:
- there is a positive package advice from the National Health Care Institute;
- there are arrangements and safeguards for appropriateness in place;
- price reductions have been successfully negotiated with the marketing authorisation holder.
For more information, see the page ‘Lock procedure for expensive medicinal products’.