The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) not to reimburse omaveloxolone (Skyclarys®) from the basic healthcare package, unless the asking price is lowered significantly. This medicine can be used in certain patients with Friedreich ataxia. This is a rare disorder in which people lack proper control over their body movements. If the Minister adopts our advice, omaveloxolone will only be entered into the Medicine Reimbursement System (GVS) if the price drops. 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 advisory report to the Minister of VWS. The Minister makes the final decision whether or not to reimburse the medicinal product from the basic healthcare package.
Omaveloxolone is intended for people with Friedreich ataxia
Omaveloxolone is the active substance. The brand name is Skyclarys®. The medicine is a capsule that is swallowed.
The medicine can be used in people with Friedreich ataxia. Friedreich ataxia is a rare congenital disease in the spinal cord, nerves and small brain. Because the protein frataxin is not made in sufficient amounts, nerve cells eventually die. These are mainly the nerve cells in the spinal cord, the optic nerve, the auditory nerve and the cardiac nerve. The first symptoms of the disease are often balance issues, being shaky and stumbling. People may also become more clumsy than they used to be, their writing can become less neat, and they may often drop things from their hands. People with ataxia can also start talking unclearly. In Friedreich ataxia, people often also suffer from cardiomyopathy and diabetes. The symptoms gradually progress, and people with this disease eventually need a wheelchair. Many patients die between 40 and 60 years of age. The manufacturer has requested reimbursement for the treatment of Friedreich ataxia in patients aged 16 years and older.
Advice from the National Health Care Institute on the reimbursement
The National Health Care Institute concludes that omaveloxolone (Skyclarys®) has added value for people with Friedreich ataxia. However, the marketing authorisation holder's asking price is too high in relation to the benefits achieved for patients. That is why the National Health Care Institute advises the Minister to reimburse omaveloxolone only if the price is lowered significantly.
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) and the Insured Package Advisory Committee (ACP) advise the National Health Care Institute about this 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
Omaveloxolone 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.