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 admission procedures. This report contains the progress report for the ongoing processes in 2024.

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 healthcare package.

Third CI Procedure Progress Report

In 2024, 2 medicinal products, rhPTH 1-84 (Natpar®) and ataluren (Translarna®), were conditionally included in the basic healthcare package. The current status for these procedures is as follows: 

  • The CI procedure for rhPTH 1-84 ended early on 1 May 2024. 
  • The Committee for Medicinal Products for Human Use (CHMP) has issued a negative advice about the renewal of the marketing authorisation for ataluren. In February 2024, the National Health Care Institute advised the Minister to terminate the CI procedure for ataluren early if the European Commission (EC) adopts the CHMP advice. Pending the decision of the EC, the National Health Care Institute advised the Minister in August 2024 to change the end date of the CI procedure for ataluren from 1 October 2024 to 1 October 2025. This is an extension of one year. The Minister has now adopted this advice. 

Continuation

In 2025, 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 2025 progress report in early 2026.

This report is a summary of recommendations by the National Health Care Institute

The original text of this report is in Dutch.