Prostate cancer and access to medicines: disturbing information for patients

According to data from the National Health Fund, in 2022 alone, over 5,000 patients were treated under this drug program, of which approximately 3,800 patients were treated with enzalutamide. In 2023, over 4,000 people have already benefited from treatment with this drug.

The Ministry of Health also ignored the latest recommendation of the President of the Agency for Health Technology Assessment and Tarification: (AOTMiT) of February 21, 2024 and the Transparency Council of February 17, 2024 operating under the President of AOTMiT, which consider it justified to expand patients' access to this therapy by a group of people with metastatic castration-sensitive prostate cancer (mHSPC). On the same day, the Transparency Council issued a similar recommendation for therapy using darolutamide. This means that instead of extending treatment with these drugs to new patients with other indications, the Minister of Health may take them away from them completely.

Patient problems

– Where is the logic here? – asks Zbigniew Augustynek, chairman of the Prostate Section of the “UroConti” Association and adds – this whole situation raises serious doubts as to whether anyone in the Ministry of Health still controls the drug reimbursement process. After all, our life and health directly depend on the availability of them. We are dealing with a drug that is widely reimbursed in Europe, with the largest application profile, with documented effectiveness and therapeutic safety. Why do we want to take it away now, when at the same time AOTMiT and the Transparency Council recommend its wider use in the drug program? – informs Zbigniew Augustynek.

For over 4,000 patients who are currently using this therapy, this decision means losing access to enzalutamide treatment in just 12 months. What's worse, however, is that new patients whose doctors will qualify them for treatment with this drug will no longer be able to take advantage of this option after April 1.

– The letter we received from the manufacturer clearly shows that the Ministry of Health rejected the proposals for new, lower prices and wants to remove the drug from reimbursement, thus exposing the health and life of patients and the state budget to higher expenses. Instead of paying a lower price for the drug from April 1, the National Health Fund will have to continue paying the current higher price for the treatment of existing patients. For me, this is an incomprehensible situation, because the saved amounts could be used to pay for the treatment of additional patients, including people with a new indication, resulting from the recommendation of the President of AOTMiT. – adds Zbigniew Augustynek.

Enzalutamide is another modern molecule to be removed from the “B.56” drug program. Treatment of patients with prostate cancer. As of November 1, 2023, as a result of updating the list of reimbursed drugs, another modern drug for patients with advanced, castration-resistant prostate cancer – radium-223 dichloride – used in the last line of treatment, was unexpectedly removed from the list. This is surprising because both molecules are characterized by high effectiveness and a well-recognized safety profile, documented in many high-quality clinical studies and clinical practice, and are also recommended by the most important international scientific societies.

– This whole situation is shocking and incomprehensible to me. In the name of whose interests the Minister of Health first deprives men of the possibility of last-line treatment (radium-223 dichloride) and now wants to take away from them another drug (enzalutamide), which is most often chosen by doctors and patients from this drug program – asks Anna Sarbak, president of the Management Board of the Association “UroConti” and adds – such a reimbursement policy affects the lives and health of thousands of Poles, but also the finances of the state budget. After all, the National Health Fund will have to pay the current, higher price for continuing the therapy. In my opinion, this is a basic lack of economy that should not happen.

The sick person should come first

Zbigniew Augustynek, in turn, draws attention to the human element and the need to care for the well-being of each patient.

– This is another modern drug that treats far fewer patients, but every human life should be important to the Minister of Health. This is not a number in the table. – sums up Zbigniew Augustynek.

Prostate cancer is the most common male malignancy. If diagnosed at an early stage, the patient's chances of recovery are very high. However, nearly 25 percent patients have metastases at the time of diagnosis, which means they are no longer eligible for surgical removal of the tumor or the so-called radical radiotherapy. They need modern drugs that will help them live with cancer longer and in good shape. Modern medicines give them such a chance. Thanks to modern therapies, prostate cancer has begun to be recognized as a chronic disease worldwide.

Among all male cancers, prostate cancer has the highest incidence rate with a simultaneous increase in mortality. In Poland, the five-year survival rate of patients is much lower than in Western European countries – 67%. vs. 83 percent in EU countries. Moreover, this cancer remains in the 4th place in terms of mortality in the world.

The lack of reimbursement for drugs such as enzalutamide or radium-223 dichloride is not only a serious threat to patients' lives, but also a violation of the fundamental rights to use the therapeutic possibilities offered by modern medicine. The “UroConti” Association therefore expects that the Ministry of Health will make responsible and thoughtful decisions that will serve the good of patients and society as a whole.