At the request of the Minister of Health, Welfare and Sport (VWS), the National Health Care Institute publishes an annual report on the progress of the current conditional inclusion processes. This report contains the progress report for the ongoing processes in 2025.
CI procedure for orphan drugs, conditionals and exceptionals
With the conditional inclusion procedure (CI) for orphan drugs, conditionals and exceptionals, the National Health Care Institute is committed to proactive package management to promote appropriate care. The CI procedure makes patients with a serious, often rare disease eligible for temporary reimbursement of promising medicinal products whose effectiveness is still uncertain. The CI procedure allows time to gather evidence on the effectiveness while patients have access to the medicinal product. At the end of a CI process, the National Health Care Institute tests the effectiveness on the basis of the criterion ‘established medical science and medical practice’. Only when a medicinal product or treatment meets this criterion can it become eligible for reimbursement from the basic health insurance package.
CI procedure fourth progress report
In 2025, two medicinal products, ataluren (Translarna®) and teduglutide (Revestive®), were conditionally included in the basic health insurance package. The current status for these processes is as follows:
- On 17 April 2025, the National Health Care Institute advised the Minister to stop the CI process of ataluren immediately. This followed the European Commission's decision to remove the medicine from the European market. As of 1 June 2025, ataluren was removed from List 1B of the Health Insurance Regulation. Thus, ataluren’s conditional inclusion to the basic health insurance package for the treatment of certain patients with Duchenne's disease has ended. All patients have since finished treatment with ataluren.
- Teduglutide was conditionally included from 1 April 2025 to 1 April 2030 in the basic health insurance package for the treatment of certain patients with short bowel syndrome.
Continuation
In 2026, the National Health Care Institute expects to be able to present several potential candidates to the Minister and to start new CI procedures. The National Health Care Institute will issue a 2026 progress report in early 2027.