Advice - reimburse vutrisiran (Amvuttra®) for the treatment of one particular form of amyloidosis
The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to reimburse vutrisiran (Amvuttra®) from the basic healthcare package. This medicinal product can be used for certain people with a hereditary form of amyloidosis with nerve damage. This is a specific condition in which the body is unable to handle a certain type of protein. If the Minister adopts our advice, vutrisiran will be included in the Medicine Reimbursement System (GVS). Only then will this medicinal product be reimbursed from the health care insurer’s basic health care package. We do however recommend additional conditions for reimbursement.
Download "GVS advice vutrisiran (Amvuttra®) for the treatment of one particular form of amyloidosis"
Vutrisiran is intended for certain people with a hereditary form of amyloidosis
Vutrisiran is the active substance; the brand name is Amvuttra®. The medicinal product is an injection that is administered once every 3 months under the skin (subcutaneously).
The medicinal product can be used for people with a hereditary form of amyloidosis with nerve damage (ATTRv-PN) in stage 1 or stage 2. Amyloidosis is a collective term for conditions in which the body is unable to handle a certain type of protein. In healthy people, endogenous protein molecules are folded up in a specific way that allows them to do their work. This does not happen in people with amyloidosis: in them, the folding of the protein molecules goes wrong. Those proteins then clump together in the body at places where they do not belong. They also lose their functional capability and can damage tissues and organs. In people with ATTRv-PN, these proteins accumulate above all in the nerves. As a result, the nerves often no longer work properly. This is known as polyneuropathy (PN). People with this condition suffer in particular from tingling sensations, increased or reduced sensation, pain and muscular weakness in the arms and legs.
Advice from the National Health Care Institute on the reimbursement of vutrisiran
The National Health Care Institute advises the Minister of VWS to reimburse vutrisiran (Amvuttra®) through the basic healthcare package. The recommendation is to include the medicinal product on List 1B of the GVS. Specific additional conditions apply for Amvuttra®, known as the List 2 conditions.
For more information on the GVS and the Lists 1A, 1B and 2, see page ‘Reimbursement of extramural drugs (GVS)’.
Conditions for reimbursement of vutrisiran
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 National Health Care Institute advise the minister about the assessment. The Minister makes the final decision whether or not to reimburse the medication from the basic health care 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 health care package if they are listed in the GVS.