Conditional inclusion of orphan drugs, conditionals and exceptionals (progress report for 2022)
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 procedures. This report contains the progress report of the ongoing processes in 2022.
CI process for orphan drugs, conditionals and exceptions
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 process allows patients with a serious, often rare disease to be eligible for temporary and conditional reimbursement of promising medicinal products whose effectiveness is still uncertain. The CI process 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 medicinal products or treatments that meet this criterion, can be permanently eligible for reimbursement from the basic health care package.
CI process initial progress report
The first conditional admission procedures started in September 2021. This report contains the progress reports of the 3 conditional admission that were in progress in 2022. The Minister admitted 4 medicinal products to the basic health care package on a conditional basis until at least 31 December 2022. The National Health Care Institute advises to continue all 3 CI Processes.
Continuation
This year, the National Health Care Institute is expected to begin the assessment of 3 medicinal products that have been included conditionally. The National Health Care Institute also expects to present several potential candidates to the Minister this year. The National Health Care Institute will issue a 2023 progress report in early 2024.