The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to reimburse fezolinetant (Veoza®) from the basic health insurance package. This medicine can be used for women with frequent and severe hot flushes and night sweats during the menopause, and for whom hormone therapy is not suitable. If the Minister adopts our advice, fezolinetant will be entered into the Medicine Reimbursement System (GVS). Only then will this medicinal product be reimbursed from the healthcare insurer's basic health insurance 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 health insurance package.
Fezolinetant is intended for women with frequent and severe hot flushes and night sweats during menopause and for whom hormone therapy is not suitable
Fezolinetant is the active substance. The brand name is Veoza®. The medicinal product is a tablet that has to be taken once a day.
The medicine can be used in women with moderate to severe vasomotor symptoms during menopause. Vasomotor symptoms include symptoms such as hot flushes and night sweats. These symptoms are caused by the reduction of female hormones, such as oestrogen. Usually, women with menopausal symptoms are first advised to change their lifestyle. If that does not help sufficiently, hormone replacement therapy (HRT) is the next step. This treatment complements the decline in female hormones, thereby reducing symptoms. Hormone therapy works best for menopausal symptoms. But for 5 to 10% of women with menopausal symptoms who want treatment, hormone therapy is not suitable for medical reasons. They are therefore eligible for the use of fezolinetant. Treatment with fezolinetant should be prescribed by a gynaecologist. The gynaecologist should also regularly check with each woman whether the benefits outweigh the disadvantages.
The National Health Care Institute advice on the reimbursement of fezolinetant (Veoza®)
The National Health Care Institute advises the Minister of Health, Welfare and Sport to reimburse fezolinetant (Veoza®) from the basic health insurance package. We conclude that fezolinetant has added value compared to no medical treatment. In most women, fezolinetant reduces hot flushes and night sweats, and it improves the quality of life. But the medicinal product does not work well in all women and there is also a risk of severe adverse effects. We do not know much about the long-term safety and effectiveness of fezolinetant. Therefore, the National Health Care Institute recommends that the reimbursement of fezolinetant should only apply to women who are not eligible for hormone therapy for medical reasons.
The advice is to include the medicinal product on List 1B of the GVS. For more information on the GVS and the Lists 1A, 1B and 2, see page ‘Reimbursement of outpatient medicines’.
Only for an insured person with moderate to severe vasomotor symptoms associated with menopause and a contraindication for hormone replacement therapy.
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 health insurance package.
Explanation about the reimbursement of medicinal products
Fezolinetant is an outpatient medicinal product. ‘Outpatient’ 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 insurance package if they are listed in the GVS.