Infographic - Assessing care with the EU HTAR
From 12 January 2025, the National Health Care Institute will use European legislation for the evaluation of medicines and medical devices. This Act is called EU HTAR and should lead to a more efficient process, ensuring the right care can be delivered to the right patient more quickly.
The EU HTAR: collaborating to evaluate care
- Assessing care with the EU HTAR
- What is changing and what will stay the same?
- New care on the Dutch market
- When a new medicinal product or medical device enters the market, the National Health Care Institute or health insurers will assess whether it should be reimbursed from the basic health care package.
- The manufacturer must first register the new care for admission to the European market. When it comes to medicinal products, the European Medicine Agency (EMA) or the Medicines Evaluation Board (CBG) assesses, inter alia, the efficacy and safety of this care.
- If all requirements are met, the medicinal product will be admitted to the European market. The National Health Care Institute or the health insurer can then start the assessment. This assessment will determine whether or not the medicinal product will be reimbursed from the basic health care package, and for whom.
- What is the EU HTAR?
- International collaboration
- The EU HTAR is a law that ensures that all European member states will cooperate in the evaluation of medicinal products and medical devices. This should lead to a more efficient process, ensuring the right care can be delivered to the right patient more quickly.
- The EU HTAR entered into force on 12 January 2025. Countries work together to evaluate care, but continue to decide for themselves what care can be insured.
- Sharing tasks, working more efficiently, sharing knowledge
- What will change?
- In the Netherlands, we continue to decide for ourselves what care we insure from the basic health care package. What is changing is cooperation with other countries. First, all countries performed the evaluations themselves, leading to double the amount of work. With this law, we can share tasks, work more efficiently and share knowledge easily.
- Start of the assessment
- What will change?
- Situation before EU HTAR. A medicinal product or medical device must be registered for admission to the European and Dutch markets. Countries can only start their assessments after a positive opinion on a medicinal product by the EMA or an approval body for medical devices.
- Situation after EU HTAR. The EMA continues to conduct the same assessment of medicinal products. But at the same time, European member states are working together on their clinical evaluation of the same care. So these processes run simultaneously.
- The assessment
- What will change?
- Situation before EU HTAR. European countries work individually to assess new care. In the Netherlands, the National Health Care Institute and health insurers then assess whether the care can be reimbursed from the basic health care package.
- Situation after EU HTAR. 2 European countries jointly conduct the assessment of the efficacy and safety of the medicinal product or medical device. Before those start the assessment, all countries indicate what information is necessary for them. They then share the results of the assessment with all other European countries.
- This information is about:
- which patient group the treatment is for;
- what the existing treatment is;
- and which outcomes should be measured.
- Following the European assessment
- All European countries then decide for themselves whether the medicinal product or medical device will be reimbursed. That process does not change.
- In addition, the countries themselves also look at economic, ethical and organisational issues involved in assessing whether care can be reimbursed. Other parties from the healthcare field are also consulted in this process.
- In the Netherlands, the National Health Care Institute or health insurers are the ones who do this assessment.
- About the National Health Care Institute
- The National Health Care Institute is a government organisation whose main task it is to compile the basic health care package. In our work, we have to make complex but essential choices to ensure that everyone in the Netherlands can get good care. The Dutch healthcare system is influenced by international developments. That is why the National Health Care Institute operates at an international level. The National Health Care Institute collaborates with several countries in an increasing number of international activities. Collaboration strengthens us as a country, and allows us to learn from each other.