Seventeen active substances used in oncology have been added to the list of drugs with established efficacy, Deputy Health Minister Marek Kos announced on Thursday. The inclusion of the drugs on the list gives their manufacturers the opportunity to take advantage of a shorter and less costly reimbursement path.
Oncology drugs on a simplified reimbursement pathway
Published May 8, 2025 15:05
fot. MZ
The list of oncology drugs with well-established efficacy includes four under pharmacy availability and thirteen under chemotherapy. Five active substances are used for breast cancer, three for lung cancer, three for leukemia, two for hepatocellular carcinoma or bladder cancer, one for ovarian, testicular and colorectal cancer, and two for treating complications of anticancer treatment.
Prior to the oncology list, in the fall of 2024, the health ministry presented an analogous solution - possible under the reimbursement law - for cardiovascular drugs. Of the fourteen active substances placed, nine (six on the January list, three on the April list) have already been reimbursed. As the deputy minister stressed, responsible entities can submit applications for this all the time. In the second half of the year, the MZ will present a list of gynecological, endocrinological and gastroenterological drugs that will be able to receive a reimbursement decision on a simplified pathway.
As Marek Kos stressed, these are drugs whose effectiveness has been confirmed by numerous clinical studies and medical practice, these are drugs for which the patent protection period is no longer valid, also generic drugs for which manufacturers have not applied for reimbursement.
Regarding innovative therapies, Marek Kos reminded that the long waiting time for patients to be approved for certain drugs (according to INFARMA's data, in Poland the average time from the registration of a drug to its reimbursement is 723 days, and although it has been shortened over the past year by 81 days, it is still one of the longest in the EU), is mainly due to the policy of pharmaceutical companies, which are not in a hurry to submit applications in Poland. The reason, of course, is money, Poland negotiates prices very hard (low health expenditures), drugs are among the cheapest in Europe, so we are not a priority market. Kos stressed that the amendment to the Reimbursement Act currently under way at the ministry (internal consultation stage) is expected to give the ministry a tool in the form of calling on the responsible entity to submit a reimbursement application. However, work on the amendment will still take time, with the deputy minister admitting that he expects the draft to reach the Parliament in the second half of the year, most likely not until autumn.
