Now that the EC has agreed the marketing authorization for nitisinone, each member state of the EU will then need to decide how much they will pay for nitisinone and how this will be covered by socialised health care or insurance. This process is typically undertaken by each country’s HTA (health technology assessment) agency. These are often non-governmental organisations that help the health department of each member state’s government decide on what drugs they should give to people with diseases and how much they should cost. An example of an HTA is the National Institute for Health and Care Excellence (NICE) in the UK.
For a full list of HTA agencies in Europe, please head to here.
This process may take some time. However, the AKU Society, along with our sister societies, will assist, where possible, for AKU patients in each country to get access to the drug. We hope this process will be as quick and painless as possible.