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Early 2024 - where are we in terms of implementing the Rare Disease Plan?

MedExpress Team

Published Feb. 2, 2024 12:42

Early 2024 - where are we in terms of implementing the Rare Disease Plan? - Header image
Fot. Getty Images/iStockphoto
We entered 2024 with only partially implemented Plan for Rare Diseases[1]. The Plan itself was adopted back in 2021,[2] and the implementation of the tasks enshrined in it was scheduled for 2021-2023. In the last days of December 2023, however, a draft amendment to the Plan appeared in the list of legislative work of the Council of Ministers.[3] It assumes the extension of work on the Plan until the end of 2024, which involves changing the deadlines for the implementation of individual tasks, as well as several changes described as "organizational." Among the latter, it is worth noting, for example, the proposal for strictlyreimbursement, including, among other things, the abandonment of the concept of introducing QALYs for rare disease drugs into the Reimbursement Act[4], or modifications to the Compassionate Use procedure (which the Plan only calls for). However, it is unclear when the changes proposed in the draft will come into effect and what their final form will be.

Instead, in January 2024, we asked the Ministry of Health about the progress of the Plan relative to the beginning of last year (we wrote about how the implementation of the Plan looked at the beginning of 2023 here: link). We received a response from the Ministry of Health in mid-January, and it shows that:

  1. The Council for Rare Diseases and the Scientific Council of the Rare Disease Information Platform and the Scientific Council for Rare Disease Registries were established.
  2. The Centers of Expertise for Rare Diseases (OECR) was established in March 2023, and the Minister of Health is working to identify more OECRs and plans to introduce new billing products billed in OECRs in the near future.
  3. The Plan provides for the provision of modern methods of laboratory analysis (both large-scale genetic and non-genetic highly specialized) in the diagnosis of rare diseases. As we were informed in the answer given, to this end, the Minister of Health is working closely with experts to create a list of necessary diagnostic tests, and then their implementation in the health care system, this work, depending on the field of rare diseases, is at the stage of development of the Health Care Delivery Charter by experts, to the stage of conducting the legislative process.
  4. In addition, as reported to us by the Ministry of Health, the following tasks have been carried out in the area of access to drugs and special dietary measures for rare diseases:

(a) Supporting the development and use of advanced risk-sharing instruments - by introducing a provision in the DNUR[5] that if an administrative decision on reimbursement coverage includes a risk-sharing instrument, it may be billed in the manner specified in the instrument, even if the decision has either expired or been revoked. As explained by the Ministry of He...

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