The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to expand the List 2 conditions for vutrisiran (Amvuttra®). This medicine can be used in certain patients with several forms of amyloidosis with cardiomyopathy. This medicine is already in the Medicine Reimbursement System (GVS) for the treatment of patients with a hereditary form of amyloidosis with neuropathy. If the Minister adopts our advice, vutrisiran will also be reimbursed for patients with other forms of amyloidosis.
Current state of affairs: advisory report sent to the Minister
The National Health Care Institute has sent this advice to the Minister of Health, Welfare and Sport (VWS). The Minister makes the final decision whether or not to extend the conditions of reimbursement.
Vutrisiran is intended for certain people with different forms of amyloidosis with cardiomyopathy
Vutrisiran is the active substance; The brand name is Amvuttra®. The medicine is given as an injection under the skin every 3 months.
It can be used in adults with various forms of amyloidosis with cardiomyopathy (ATTR-CM). Cardiomyopathy is a disease of the heart muscle that causes damage to the heart. Amyloidosis is a collective name for diseases in which the body does not handle a certain type of protein well. In healthy people, the body’s own proteins are folded so they can do their job. In people with amyloidosis, the folding of these proteins goes wrong. These proteins clot in places in the body where they do not belong. They also lose their function, causing damage to tissues and organs. In people with ATTR-CM, these proteins accumulate mainly in the heart. This interferes with the tissue structure and function of the heart. This leads to thickening and stiffness of the heart muscle, and at some point also to cardiomyopathy and heart failure.
The National Health Care Institute advice on the reimbursement of vutrisiran (Amvuttra®)
The National Health Care Institute advises the Minister of VWS to extend the reimbursement conditions for vutrisiran (Amvuttra®) for certain patients with various forms of amyloidosis with cardiomyopathy. These are the so-called List 2 conditions.
For more information on the GVS and lists 1A, 1B and 2, see the page on ‘Reimbursement of outpatient medicines’.
Expansion of conditions for the reimbursement of vutrisiran (Amvuttra®)
Vutrisiran (Amvuttra®) is already reimbursed for patients with hereditary amyloidosis with neuropathy. We advise the Minister to extend the List 2 conditions as follows:
Only for an insured person aged 18 years or older with
- genetically confirmed hereditary transthyretin amyloidosis and stage 1 or 2 polyneuropathy, who is being treated at or under the supervision of a centre of expertise; or
- wild-type or hereditary transthyretin amyloidosis and cardiomyopathy and NYHA class I-II, who is being treated at or under the supervision of a centre of expertise.
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
Vutrisiran is an extramural medicinal product. ‘Extramural’ means medicines for home use that can be obtained at the pharmacy with a prescription from a physician. They are only reimbursed from the basic healthcare package if they are listed in the GVS.