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 rules will have an effect on the work of the National Health Care Institute.
The EU HTAR: collaborating to evaluate care
Since 2025, all the countries of the European Union and Norway, Iceland and Liechtenstein collaborate to evaluate medicinal products and medical devices. This helps ensure that the right treatment reaches the right patient more quickly. These joint evaluations support national decision-making on insured care.
The European collaboration focusses only on reporting results on the clinical effectiveness and safety of a medicinal product or medical device compared to usual care. The European reports do not contain statements about the value of interventions. Economic, ethical and organisational factors are also not considered at European level. Each country assesses those aspects nationally. In the Netherlands, we remain responsible for deciding which interventions are covered by the basic health care package.
The European reports are used as input for national assessments, especially when evaluating the effectiveness of care. In the Netherlands, the national assessment process starts once the European report is final and the marketing authorisation holder applies for reimbursement. This national process includes the standard consultation steps with stakeholders. The National Health Care Institute also consults stakeholders at the start of the European process.
Phased introduction from 2025 onwards
The EU HTAR will start in 2025, but several types of care will be introduced step by step for the joint clinical assessments (JCAs). The schedule for medicinal products is as follows.
- From 2025 onwards, medicinal products for cancer and advanced therapy medicinal products (ATMPs) are eligible for a JCA. ATMPs are medicines which are used in advanced treatments, such as cell and gene therapy.
- From 2028 onwards, the products eligible for a JCA will be expanded to include also orphan medicinal products. These medicines are used for rare, often serious, diseases.
- From 2030 onwards, all other medicinal products will also be eligible for a JCA.
It is anticipated that the JCA for medical devices may start as early as the second half of 2026.
The National Health Care Institute and the EU HTAR
At a European level, the Coordination Group and 4 sub-groups are continuing to work on the EU HTAR. Together, they are working on joint clinical evaluation reports, scientific consultation and the mapping of emerging technologies and procedural guidelines. The National Health Care Institute is represented in the Coordination Group and in the subgroups. The 4 subgroups are:
- Joint Clinical Assessments (JCA)
- Joint Scientific Consultations (JSC)
- Identification of Emerging Health Technologies (EHT)
- Development of Methodological and Procedural Guidelines (MPG).
Further information
If you have any questions about EU HTAR, please send an e-mail to:
E-mail: warcg@zinl.nl