Slovakia is one of the countries of the European Union where cardiovascular deaths are one of the main causes of mortality. Although hospital mortality in acute coronary syndromes has been reduced to developed countries and health systems in recent years, mortality in subsequent care remains high. However, this should soon be changed, also thanks to the decision of the Health Department's CEC.
In order to prevent major cardiovascular events that translate into real health care costs and cardiovascular mortality indicators, lipid-lowering treatment is crucial. We consider the shortcomings in both secondary and primary prevention to be one of the causes of the high rate of avoidable deaths in us, by Professor Eva Goncalvesová, President of the Slovak Cardiology Society. As part of the lipid-lowering treatment, there are medications that can significantly improve patients' survival. Until now, physicians have had the opportunity to prescribe statins, ezetimibe and their fixed combinations for this type of treatment, but full use of the potential of these medicines in Slovakia has limited their indication limits in the list of categorised medicines. At the last meeting of the CEC, it was decided that these restrictions would be lifted.
In line with current scientific opinions, we have agreed to abolish the indication and prescription restrictions in order to make this treatment widely available, especially for patients with high and highest risk of cardiovascular mortality, added Róbert Babeľa, State Secretary for Health. The main risk factors for cardiovascular disease include high blood pressure, smoking, diabetes or obesity, but the main problem is high cholesterol levels. The Slovak Association of Atherosclerosis initiated the initiative to regulate the indication and prescription restrictions. She has prepared a request for a change in the indication restrictions limited to patients after experiencing acute coronary syndrome, but the very high cardiovascular risk category also covers many other clinical circumstances. This request was not only supported by the resort, but also proposed further changes in cooperation with the Slovak cardiology company, which aim to ensure that the group of patients after the atherosclerotic cardiovascular diseases are prevented from relapse as effectively as possible and in particular to ensure its availability in time after discharge from hospital care.
At the same time, a limitation of prescription has been extended to all statins, ezetimibe strengths and combinations thereof with general physicians for adults. Today, due to the widely applied preventive examinations, they are starting to play a principal role in preventing cardiovascular diseases.
On the other hand, previous rules for the prescription of medicinal products have often made it difficult for the most at risk patients, i.e. patients hospitalised for acute cardiovascular events, to have high-dose lipidemic treatment, as they often waited for a term to a specialist for six months. Following this decision of the health department, the general practitioner will be able to prescribe treatment started at the hospital without delay in these cases.
The risk of relapse is greatest in the first three months after the event, and it is during them that efforts to reach the target cholesterol levels need to be maximised, i.e. to intensify lipid-lowering treatment as quickly as possible, added Goncalves. Within modern evidence-based medicine, any consideration of the indicative restriction of statins, ezetimibe and their fixed combinations is counterproductive and will worsen the lipid-lowering treatment in Slovakia, with all its consequences for avoidable causes of death. The working group of the Slovak Ministry of Health focused on cardiology also agreed on this.
Accelerating the availability of innovative medicines as a result of a major drug reform
In addition to a significant step to reduce avoidable cardiovascular deaths, four additional medicinal products with the active substances neratinib, gilteritinib, daratumumab and the combination of venetoclix and obinutuzumab were included in the categorisation list at the Committee meeting. These medicinal products, as well as other medicinal products included in the categorisation list since the effectiveness of the major drug amendment, are predominantly intended for oncology and haematonic patients. Since August of this year, since the entry into force of the amendment to Act 363/2011 on conditions for reimbursement of medicinal products, medical devices and dietetic foods, the Ministry of Health of the Slovak Republic, following the recommendation of the Categorisation Commission, approved 10 innovative medicines intended for treatment of 15 different indications. This will particularly benefit patients with multiple myeloma, breast cancer, lung cancer or malignant melanoma.
Overall, since the beginning of 2022, 57 most innovative medicines have been included in the categorisation list, which can be applied to 69 different indications. This number of medicines (57 medicines and 69 indications) represents a significant acceleration in the inclusion of innovative medicines, which are needed to catch up on their availability 🙂 Slovak patients have been waiting for them for years.