The Association of Innovative Pharmaceutical Industry (AIFP) asks the Minister of Health Kamil Šaška (Voice-SD) to withdraw a decree that tightens the conditions for the entry of new medicines to Slovakia. It warns that it can block access to existing medicines. She pointed out this AIFP at Wednesday’s press briefing, saying that the decree ignored the expert consensus. According to the Association, the Ministry’s declared intention may not be real.
“The greatest change that actually occurs is that While the willingness to pay for a year is currently EUR 44,000, the Decree says that the state will be willing to pay 22 000 euros for a year,“Explained by AIFP Executive Director Iveta Pálešová.
According to the Decree of the Ministry of Health, cost effectiveness remains the only criterion for the inclusion of the drug in the payment system. As Pálešová pointed out, other countries also take into account the medical need, social benefits or the rareness of the disease. She added that the Ministry also wants to review the new regulations also existing therapies and medicines that can be removed from the categorization list. She also explained that, according to recent analyzes, 173 drugs were approved by the European Medicines Agency in 2020-2023, while 47 of them were categorized in Slovakia, which represents 27 % availability of treatment in Slovakia.
Pálešová pointed out that the use of cost -effectiveness in deciding on medicines may contribute to more efficient use of public finances, but does not automatically mean saving the state funds. She pointed out that the medicine could be effective, but if it is intended for a large group of patients, it will significantly burden the budget. “Moreover, the impact analysis lacks any source data, so we do not know what the ministry has calculated,” Pálešová informed.
She recalled that the decree states that it favors drugs for patients with a worse prognosis, but it may actually mean that they will get to treatment later. “It can disadvantage the entry of drugs that are intended for earlier therapies. Many times they lead to the cure of the patient and it is no longer forced to be further treated at later stages,“She explained.
According to AIFP, one of the problems of the Decree is that it introduces an unrealistic requirement for the benefit of the drug. If the medicine is to be “really good” and the state is to pay it in exceptional cases, it must extend a quality life by 20 years according to the new rules. Pálešová pointed out that such a drug almost does not exist in practice – either because such a long prolongation of life in serious diagnoses is not realistic, or because the so -called. The discount rate – a technical coefficient that “discounts” future years of life, thus reducing their value over time.
“Medicines for rare diseases cannot meet such a requirement at all. Based on the criteria that are mentioned in the Decree, there is neither a disease nor the drug that would meet them,“She explained.
She added that the set priority of medicines in the area of medicines, together with dietary food, represents only 19 percent of the public health insurance budget. “We believe that, with sufficient efforts to identify savings in all other budget items, the ministry will not have to risk the lives of patients,” she concluded.
The Ministry of Health (MZ) SR proposes a change in the conditions for the entry of new medicines into the system of reimbursement from public health insurance. The Ministry pointed out that, in the current rules of calculating their cost efficiency, the funds earmarked for medicines this year would not be sufficient. Since June, it is therefore to be adjusted by a decree, which is in a shortened interdepartmental comment procedure. The Ministry has guessed that this could save at least EUR 583 million over five years.
The Patient Rights Association pointed out that the most affected delayed approaches to innovative treatment are oncological, neurological and patients with rare diagnoses.
