SNUR: Deregulation in reimbursement

The new version of the Reimbursement Act is the result of months of intensive analysis and consultation, Deputy Health Minister Marek Kos said at Thursday's press conference. - The amendment to the Reimbursement Law is a topic we have been dealing with for several months," he said. In November 2023, the so-called "large amendment to the Reimbursement Law" (DNUR) came into force, which generated a number of problems. Work on the next amendment, which was supposed to be carried out quickly (that's why it was called "fast"), began in April 2024, and the first major meeting with stakeholders was held in July. However, it quickly became apparent that there was no way to have a quick amendment if it was to be prepared well, contain solutions to the problems caused by DNUR and meet the challenges. The Ministry of Health conducted pre-consultations (with some 270 comments), and finally - on Thursday - published a draft.

The amendment provides for more than a hundred changes, including about 30 deregulatory ones. The most important assumptions are to simplify the reimbursement process, eliminate administrative barriers, increase the availability of therapies and rationalize public spending. - Above all, we want to remove flawed or such unworkable provisions from the previous law," Kos stressed.

One of the most important goals, however, is to increase the health minister's real ability to create reimbursement policy. This is to be achieved, first and foremost, by giving the minister the ability to call on responsible parties to submit reimbursement applications. The Health Ministry assumes that this could shorten the period between the registration of drugs at the EMA and their availability to Polish patients.

The ministry also plans to introduce financing for technology losses, which is particularly important for oncology drugs and therapies for rare diseases. - This is a huge problem for hospitals when these drug losses are very high," Kos explained, referring to the situation when some of the drugs in vials have to be disposed of.

Another fundamental change concerns the availability of drugs from the first day of reimbursement coverage. At the moment, it takes weeks, even months, from the announcement of a drug's placement on the reimbursement list to the possibility of administering it to patients. - We want it to be available immediately," the deputy minister pointed out. During the bridging period, the responsible party will supply the drug to the reference center, while the NHF will have three months to conclude contracts with providers.

The amendment will also introduce multi-criteria analysis for rare and ultra-rare diseases. The Ministry also wants to simplify the responsibilities of responsible parties - for example, it will not be necessary to submit proof of drug availability already at the application stage. The role of patient organizations in the reimbursement process is also to be increased.