Patients who are insured by the largest health insurance company, the General Health Insurance Institution (General Health Insurance Institution) will continue to have access to "exceptional medicines' as long as their health conditions so require and meet the conditions set. These patients are not affected by the established rationalisation measures to be implemented by the GPA.
A year ago the amendment of Law No 363/2011 was approved, thanks to which many medicinal products have entered the categorization so far covered in the exceptional regime. Medicinal products in the categorisation are automatically fully covered by health insurance companies without the need for reimbursement. In 2022, for example, a total of 12 innovative oncology medicines were included in the list of categorised medicinal products in 17 different indications. Since 1.1.2023 to date, a total of 36 medicinal products have been added to the categorisation, including the extension of indication restrictions in a total of 47 indications. There are currently 15 other innovative oncology medicines that could reach patients this year if the legal conditions are met. Due to these changes under the amendment of the Act and depending on the implementation of the rationalisation steps, the PZP alone envisages an increase in drug spending of between EUR 59 million and 69 million (increase of between 6,5% and 8%).
By facilitating the entry of new medicines into the categorization, Members also approved the threshold for exceptional medicines last year. To put it simply: they have stipulated that health insurance companies can pay for medicines at a level of 3,9% of the allocated funds under the exceptional scheme. This limit has been informed for more than a year. Therefore, the Board of Supervisors also requested the GTC to implement the law. It should also be pointed out that patients would not suffer any harm as, as mentioned above, exceptional medicinal products are already entering the categorisation in a much larger volume than in the past. However, at the end of June, the law was amended again and the effectiveness of the 3.9-percent limit on so-called "exceptional medicines" was postponed to 2024. Therefore, the Ministry of Health sent a turnover update of the decision of the sole shareholder requiring the implementation of the austerity measures only to the extent determined by the management of the VZP itself.
This year's total expenditure on medicinal products for exceptions is expected at around €40 million. However, it has to be said that other exceptional medicines for approximately EUR 14 million have entered or entered the categorisation, which represents additional costs for insurance companies.
Summary of the operation of the derogation scheme in the VZP
- all patients treated with special medicines will continue to be treated with these medicines;
- all medicines in the so-called "exception" regimen remain in this regimen and new patients will be treated with them;
- in 2023, the expenditure of the GPA on so-called "exceptional medicines" is estimated at EUR 40 million;
-drugs in volume approx. EUR 14 million previously in derogation have already entered or entered the categorisation;
- a single restriction is that new medicinal products or new diagnoses will not be included in the exclusion regime and experimental medicinal products for which there is no indication in the Summary of Product Characteristics (SmPC) will not be approved;
- from next year, there will be a 3.9-percent limit on medicinal products for exemptions, while by the end of 2023 additional medicinal products will be introduced into the standard classification from the exceptional regime.