On Friday, 19 January 2024, the Ministry of Health held a meeting of the Stakeholder Platform on the issue of medical device regulation. This time, the only topic was to discuss the comments of representatives of suppliers on the methodology for inclusion of separately reported material in the VZP-ZP reimbursement catalogue. VZP itself announced at the launch of the new system in March 2023 that after about half a year of real operation of the new rules, it would carry out a certain revision of the methodology, which would reflect the previous experience.
The CzechMed Association made a request for a new separate scenario for the inclusion of a new "generation" of ZUM already in the codebook, with the comment that this should be a quick way to enter into reimbursement if the supplier is willing to offer the same price and reimbursement as the previous generation of the same ZUM in the codebook. From the suppliers' point of view, it is often acceptable to offer a minor innovation on the same terms as the run-out model. On the other hand, an automatic scenario with a reference reimbursement that is constructed as an average influenced by the price/reimbursement of other manufacturers' products is completely unacceptable to them. VZP confirmed that the CzechMed proposal is mutually beneficial and accepted the possibility of scenario 2a (a slight innovation to the previous generation ZUM from the same manufacturer). However, the VZP supplemented its preliminary agreement with a requirement to reduce the price/reimbursement of the run-out model by about 5%. This additional requirement was not agreed to by the suppliers at the first moment, and so the issue of creating a new scenario will be resolved at the next meeting at the Ministry on 23 February 2024.
On the other hand, consensus was reached on the separation of scenarios 2 (moderate innovation) and 3 (major innovation). The main criterion should be the value of the expected budgetary impact. VZP should discuss internally by the next meeting what limit it will propose. The aim should be to have units of proposals per year going through scenario 3 to make the agenda manageable in terms of capacity.
The VZP further informed that on the basis of the ongoing inclusion of ZUM in the codebook, it intends to gradually extract comparative criteria that will allow the VZP-ZP Reimbursement Catalogue to be divided into quasi-categories that will simplify the submission of further proposals for inclusion by presenting the expected range of comparators in a certain way. A single ZUM could then have more than one such category assigned in index form if it has multiple applications.
Author: Jakub Král