Progress report on the conditional inclusion of orphan drugs, conditionals and exceptionals (progress report year 2023)

CI process 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 process allows patients with a serious, often rare disease to be eligible for temporary 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 when a medicinal product or treatment meets this criterion can it become eligible for reimbursement from the basic health care package.

CI procedure second progress report

The first conditional inclusion procedures started in September 2021. This report contains the progress reports of the 3 conditional inclusion procedures that were in progress in 2023. The Minister admitted 4 medicinal products to the basic health care package on a conditional basis until at least 31 December 2022. The current status for these procedures is as follows:

• In July 2023, the National Health Care Institute recommended that larotrectinib (Vitrakvi®) and entrectinib (Rozlytrek®) be reimbursed from the basic health insurance package. Both medicinal products have been reimbursed since 1 September 2023.
• In February 2024, the National Health Care Institute recommended that the other two CI procedures, for rhPTH 1-84 (Natpar®) and ataluren (Translarna®), should be terminated early. 

Continuation

The National Health Care Institute expects to be able to present several potential candidates to the Minister and to start new CI procedures in 2024. In addition, the National Health Care Institute is conducting the second evaluation of the procedure. It will be offered to the Minister in mid-2024. The National Health Care Institute will issue a 2024 progress report in early 2025.

This report is a summary of recommendations by the National Health Care Institute. The original text is in Dutch.