It will reduce the time for processing reimbursement applications by a third and be about half a million zlotys cheaper for the responsible entity in the case of cardiovascular drugs with well-established efficacy. The Health Ministry has announced a list of substances covered by such a procedure. A similar one is being prepared for oncology indications.
The reimbursement procedure will be cheaper and shorter. The Ministry has published a list of substances for which this will be possible
Published Oct. 18, 2024 11:08
- Drugs with well-established clinical efficacy are those whose effectiveness and safety have been confirmed in numerous clinical trials and through long periods of use in clinical practice. They are effective and safe for treating diseases, and we know this based on empirical evidence and data. Responsible entities whose drug technologies are on the list can apply for reimbursement through the Refund List Service System," Deputy Health Minister Marek Kos explained at Friday's press conference.
As he added, it is now often the case that an effective and successfully used drug, which has even generic equivalents for several years, is not submitted by manufacturers for reimbursement. This is because the process is costly and lengthy. Lists of drugs with well-established efficacy are intended to allow for a shorter-than-standard procedure for including a drug in reimbursement.
- The difference is that in the shorter path we waive the HTA analysis, there is no charge for the verification analysis, the AOTMiT evaluation is no longer needed, and the application goes to negotiations after the formal, legal and substantive evaluation. The elimination of financial barriers is something that responsible parties will be most interested in," Marek Kos pointed out.
Savings for responsible entities can be significant, because the cost of developing HTA analyses ranges from 350 to 400 thousand zlotys, and the cost of performing a verification analysis by AOTMiT for a new technlogy is about 145 thousand zlotys. In total, for the company, the cost of introducing a new indication in Poland is about 500-550 thousand zlotys, and this is also the savings according to the pathway shortened from 180 to 60 days.
The list includes 21 items, selected based on analysis of nearly 3,000 records. Some of the active substances do not yet have registration in Poland. The cardiology list is the first to be published. A similar one in the field of oncology is in development. It is expected to be published in the first quarter of next year.
- Also in the first quarter of next year, we want to implement the amendment to the Reimbursement Law, or SNUR, which has been talked about for several months now. It will allow us to do something very important. We will be able to call on the responsible party to submit a reimbursement application. Now it's all up to the company that manufactures the drugs. If there is a health need, then after the law is amended, we will be the ones who can call on the company to submit the application and proceed with it in a short period of time," the deputy health minister explained.
