The health department has long and clearly declared its efforts to make innovative medicines available on our market - from today on, this is becoming a reality. The Government of the Slovak Republic approved draft law No. 363/2011 on the scope and conditions of reimbursement of medicines, medical devices and dietetic foods based on public health insurance in the current version, which improves conditions for the entry of demonstrably effective innovative medicines into our market, eliminates differences in access to treatment for patients with these medicines and also ensures that spending money for them is effective and efficient.
Currently, most of the new innovative medicines are covered by the so-called "exception" regime, i.e. it is up to the health insurance authority to assess and consider whether or not the medicine is covered by public health insurance. The choices made by health insurance companies vary on a case-by-case basis and therefore the availability of medicines for patients also varies.
Minister for Health Vladimir Lengvarsky: It was also necessary to promote the entry of innovative medicinal products into the list of categorised medicinal products, i.e. to encourage their transfer from the so-called "exceptional' regime to the categorisation regime, because the medicinal product is covered by public health insurance, without any differences, by all health insurance undertakings, only if it is included in the list of categorised medicinal products. I'm glad you did it.
The draft Law provides for changes in procedures designed to support the provision of standard reimbursement of medicinal products (changes in the procedure for entering into contracts on the terms of reimbursement of medicinal products or in the setting of a threshold for assessing the cost-effectiveness of medicinal products), the introduction of new tools to ensure the efficient and efficient use of resources (introducing a new process for determining, amending and abolishing reimbursement groups), as well as changes in procedures ensuring cost-savings for medicinal products (changes in the revision of reimbursement, referencing or entry of generic and biologically similar medicinal products), thereby ensuring that public health insurance means are covered by medicinal products corresponding to the duly proven clinical benefit that the medicinal product brings to the patient.
This material also includes legislation on medical devices, special medical materials and dietetic foods and other related changes.
The date of entry into force of the amendment of the Act to make available innovative medicines with clinical benefit to patients as soon as possible was proposed for 1 August 2022 except for § 8 (1) (a). b) Point 22, point 24, Paragraph 20 (6), point 61 and points 120 and 121, in Art. I, which shall enter into force on 1 March 2023 and Art. I point 119, which shall enter into force on 1 January 2024.