These oncology drugs may be reimbursed. The decision is up to the pharmaceutical company. LIST

• There is a list of oncological drugs with established efficacy
• There are 17 items on the list: 4 within the pharmacy availability and 13 within the chemotherapy
• The Ministry of Health invites companies to submit applications via the fast track

On May 8, the Ministry of Health presented a list of drugs with established efficacy in the field of oncology . This is a list of products used chronically in oncology, which have been present on the market for years, but until now their manufacturer has not been interested in making them available for reimbursement.

Now the move is up to companies, which can submit applications for entry into reimbursement based on provision 30a of the Reimbursement Act. The mechanism assumes a fast track. The application does not have to contain full HTA analyses (an analysis of the impact on the budget is sufficient). In this mode, the company is also exempt from the fee for the verification analysis. The application does not require an AOTMiT assessment either. Immediately after the formal, legal and substantive assessment, it goes directly to the Economic Commission for negotiations.

- We are conducting horizon scanning talks with various pharmaceutical departments and we see interest. It may therefore happen that some of the technologies we presented today will be included in the July reimbursement announcement. We believe that Article 30a is a significant game-changer for our Polish reimbursement market and a huge success in the form of incentives to introduce new technologies, especially those that are not interested in going through the entire reimbursement path - commented Mateusz Oczkowski, deputy director of the Department of Drug Policy and Pharmacy of the Ministry of Health.

There are 17 items on the list (15 active substances): 4 within the framework of pharmacy availability and 13 within the framework of chemotherapy. - In terms of indications, 5 substances are dedicated to breast cancer, 3 in lung cancer, 3 in leukemia, 2 in hepatocellular carcinoma and bladder cancer, and one each in ovarian cancer, testicular cancer and colon cancer, as well as two in the treatment of complications of anticancer treatment - listed Deputy Minister of Health Marek Kos.

It is estimated that a population of 7,760 patients could benefit from access to these therapies. In terms of the estimated impact on the budget, it is approximately PLN 135 million.

In the case of 4 substances from the pharmacy list, they are not currently included in the lists of free medicines. - Of course, it is possible, but their possible inclusion in these lists will require an assessment by the Agency for Medical Technology Assessment and Tariff System - said Minister Kos.

List of drugs with established efficacy in oncology

• anastrozole in the treatment of advanced breast cancer in postmenopausal women who are estrogen receptor positive (pharmacy reimbursement) • dasatinib in the treatment of children and adolescents up to 18 years of age with newly diagnosed chronic myeloid leukemia with the Philadelphia chromosome in the chronic phase. This is a treatment in case of resistance or intolerance to previous treatment regimens (as part of chemotherapy) • deferasirox in the treatment of chronic iron overload caused by blood transfusions (pharmacy reimbursement) • defibrotide in the treatment of veno-occlusive disease in adults, adolescents, children and infants over 1 month of age, also with hepatic sinusoidal obstruction syndrome (as part of the chemotherapy catalogue) • exemestane in the treatment of advanced breast cancer in women in a natural or treatment-induced postmenopausal state, whose disease has progressed after the use of anti-estrogen therapy (as part of the pharmacy reimbursement) • eribulin in the treatment of adult patients with locally advanced or metastatic breast cancer, with disease progression after at least one cycle of chemotherapy, in the treatment of advanced disease (in the chemotherapy catalogue) • etoposide (oral form) in the treatment of non-epithelial ovarian cancer in adults and the treatment of platinum-resistant epithelial ovarian cancer in adults. Other indications include the treatment of testicular cancer and lung cancer (as part of chemotherapy)• letrozole for the treatment of advanced breast cancer in women after a physiological or artificially induced menopause, whose tumour has relapsed or progressed (pharmacy catalogue)• nab-paclitaxel for the single-agent treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and who are not candidates for standard anthracycline-based therapy (chemotherapy catalogue)• nab-paclitaxel for the first-line treatment of non-small cell lung cancer in combination with carboplatin in adult patients who are not candidates for radical surgery or radiotherapy (as part of chemotherapy)• ramucirumab for the single-agent treatment of adult patients with advanced or unresectable hepatocellular carcinoma in second-line therapy after previous treatment with sorafenib, whose serum alpha-fetoprotein level is greater than or equal to 400 nanograms per milliliter (as part of chemotherapy)• regorafenib in monotherapy for adult patients with hepatocellular carcinoma in the second line of treatment after previous use of sorafenib (as part of chemotherapy)• regorafenib in monotherapy for adult patients with metastatic colorectal cancer who have exhausted the treatment options with available drugs such as chemotherapy (chemotherapy catalog)• topotecan (oral) in monotherapy for adult patients with relapsed small cell lung cancer, for whom chemotherapy in the first line of therapy is considered inappropriate (as part of chemotherapy)• tretinoin in combination with arsenic trioxide or chemotherapy in patients with newly diagnosed relapsed or chemotherapy-resistant acute promyelocytic leukemia (as part of chemotherapy)• vinblastine in the treatment of patients with Hodgkin's lymphoma, non-Hodgkin's lymphoma, as well as chemotherapy neoadjuvant in urothelial tumors and in the treatment of bladder cancer (as part of chemotherapy)

• vinflunine in monotherapy treatment of adult patients with advanced or metastatic transitional cell carcinoma of the bladder after failure of prior therapy with platinum derivatives, immunotherapy, or enfotumab vedotin (chemotherapy catalogue).