AOTMiT: There is the first list of cardiovascular drugs without reimbursement claims

The June 10, 2024 list included 21 active substances.

The creation of the list, is the first stage of the reimbursement process. The prepared list will become the basis for further work on the reimbursement of drug technologies included in the list.

The next step is for the Minister of Health to create a list of drugs on the basis of the list, after consulting with the Transparency Council, national consultants in the relevant medical field and the Patient Ombudsman.

Subsequently, the Minister of Health informs the responsible entities whose drugs are on this list of the possibility of submitting an application for reimbursement coverage, as referred to in Article 24(1)(1) of the Reimbursement Act (hereinafter UoR), but the provisions of Article 35 of the UoR do not apply to these applications. Drug technology is covered by reimbursement only if the application passes the entire procedure specified in the provisions of the Reimbursement Law.

As part of its work on the list, the agency conducts an assessment of expected health effects guided by, among other things:

• health priorities,
• an unmet health need,
• strength of intervention,
• quality of scientific data,
• The size of the target population,
• The impact on the payer's budget.
• Identification of drug technologies

The basis for the assessment was a compilation of information from clinical management guidelines, which included recommendations from the Polish Society of Cardiology (PTK), the European Society of Cardiology (ESC), the European Society for Vascular Surgery (ESVS), and the European Stroke Organization (ESO), among others.

Based on clinical guidelines, 15 therapeutic areas in the field of cardiology were distinguished, within which 406 precise clinical conditions were selected. As a result of the analysis based on the above principles, 177 active substances were included for detailed evaluation. 155 active substances for which market exclusivity had expired were included for further analysis.

Drug technologies were selected in the following stages:

• A detailed assessment of the identified drug technologies, including an evaluation of the proposals presented in the order of the Minister of Health;
• Substantive discussion of individual drug technologies;
• Final verification, creation of the first list.

In compiling the first list, consideration was given to:

• in the first instance, indications, clinical conditions, including the existence of special groups of patients for whom there are currently no reimbursable therapeutic options in the pregnant population, among others;
• The second consideration was whether current reimbursement actually covers the needs of patients with a given indication, e.g., the pharmacological distinctiveness between torasemide and reimbursable furosemide;
• Thirdly, economic aspects related to the amount of expenses incurred by patients in the target population and the potential financial impact on the public payer were weighed.

List: TU

Source: AOTMiT