Patients suffering serious diseases, where actual therapy has been proved insufficient, are usually willing to undergo and pay for any treatment. So called innovative medicines were presented during the latest years of medicine advancement, which can represent a solution for the patients suffering for example from rare or oncological diseases. Innovative medicines are used in the treatment of serious and rare diseases and they significantly reduce mortality or have much fewer undesirable effects compared to the existing available treatment, which allows the patients to continue in uninterrupted therapy.
Thus, innovative medicines represent the last possibility for saving life or improve lifestyle quality of many patients; nevertheless the access to these innovative medicines has been restricted to majority of patients in Slovakia and also in other countries. In efforts to ensure better accessibility of innovative medicines, amendment of Act No. 363/2011 Coll. on the Extent and the Terms of Repayment of Medicines, Medical Aids and Dietary Food on the Basis of Public Health Insurance as amended (hereinafter the „Amendment“) was adopted on June 23, 2022. The institute of special price regulation (hereinafter „SPR") represents one of main tools aimed at reaching the declared goal of the Amendment.
The institute of SPR should replace the existing, so called „exception regime“, referring to full or partial repayment of a medicine in reasonable cases for a person insured by the health insurance company upon consent conferred in advance, which is not included in the List of Categorized Medicines (especially if, taking in account the person´s insured health condition, the medicine provision represents the only suitable option), provided that the health insurance company approves the medicine repayment upon written request. However, decisions of the health insurance companies were mostly different and they often refused to approve a medicine repayment to patients. Among other reasons, this situation had made the lawmakers to establish a new special price regulation system.
The fact that a medicine is subject to the SPR means that it is no more subject to repayment revision, officially determined price of the medicine can exceed the European reference medicine price, it is not subject to referencing, nor is it subject to restricted compensation of patient´s surcharge for the medicine.
The Amendment has introduced a special procedural method regulating the decision on determination/ cancelled determination of a medicine being subject to special price regulation.
The Ministry shall decide whether a medicine will or will not be subject to special price regulation upon request or upon own consideration. Registration holder or a health insurance company shall file request at the Ministry for determination that a medicine is subject to special price regulation. The request subject could refer to the proposal that a medicine will be subject to special price regulation in combination with one of the following proposals:
- proposal for determination of officially determined medicine price that exceeds the European reference price,
- proposal for not changing the officially determined medicine price and maximum amount of repayment by the health insurance company for a standard medicine dosage at determination that the medicine is subject to special price regulation,
- proposal for increase of officially determined medicine price and increase of maximum amount of repayment by the health insurance company for a standard medicine dosage, or
- proposal for increase of officially determined medicine price without increase of maximum amount of repayment by the health insurance company for a standard medicine dosage.
Request for determination that a medicine is subject to special price regulation can be filed concurrently for a few medicines. The Ministry shall decide on the request and publish its decision on the Ministry website within 90 days from the request delivery date at the latest.
The terms, at which, if met, the Ministry will decide on a medicine being subject to SPR and on officially determined medicine price that exceeds the European reference price is determined, the amount of officially determined medicine price and maximum amount of repayment by the health insurance company for a standard medicine dosage shall remain unchanged or officially determined medicine price will increase without the increase of maximum amount of repayment by the health insurance company for a standard medicine dosage, are as follows:
- the applicant has proved that there are circumstances that special attention should be paid to and it should be determined that the medicine is subject to special price regulation,
- maximum amount of repayment for a medicine by the health insurance company, stated in the List of Categorized Medicines, or maximum amount of repayment for a medicine by every health insurance company as agreed in the Contract of Medicine Repayment Terms concluded pursuant to §7a or in the contract concluded pursuant to Act No. 581/2004 Coll. doesn´t exceed the maximum amount of repayment by the health insurance company for the medicine, calculated from the European reference price of the medicine valid as of the request filing date,
- officially determined medicine price or proposed officially determined medicine price doesn´t exceed the arithmetical mean of ten lowest prices amongst the officially determined medicine prices in other EU member countries, or the arithmetical mean of the lowest prices amongst the officially determined medicine prices in other EU member countries, provided that there wasn´t officially determined price of the medicine in other ten EU member countries,
- the applicant attached the request with pharmacological – economic analysis of the medicine, provided that:
an original medicine is a subject of the request that was for the first time included in the List of Categorized Medicines after January 01, 2012, provided that any other medicine containing the same active ingredient or the same combination of active ingredient as the medicine subject to the request had not been included for the first time in the List of Categorized Medicines before January 01, 2012, and
pharmacological – economic analysis of the medicine wasn´t attached to the request for inclusion of the medicine in the List of Categorized Medicines.
The vague criterion of medicine inclusion in SPR – circumstances that special attention should be paid to – should be specified in detail in the generally mandatory legal regulation to be issued by the Ministry. According to information available, the regulation is currently being prepared.
Applicant for determination that the medicine is subject to special price regulation is obliged to prove the continuation of meeting the terms for determination that the medicine is subject to special price regulation within 120 – 90 days before lapsed every 12 months following the effective date of the decision enforceability on the determination that the medicine is subject to special price regulation. For purpose of proving the continuation of meeting the terms for determination that the medicine is subject to special price regulation by the applicant, the applicant shall deliver notification to the Ministry on the continuation of meeting the terms for determination that the medicine is subject to special price regulation, otherwise the determination that the medicine is subject to SPR shall be cancelled.
As one of rather few attorney offices on the Slovak market, the attorney office Hronček & Partners, s. r. o. exclusively deals with the area of medicine and pharmaceutical law. The team of our specialists in the area of medicine and pharmaceutical law represents a guarantee of effective legal services provision. If you need an advice or consultations about any issue in the stated area (SPR including the preparation and filing requests for determination that the medicine is subject to SPR) or in other law areas focused on healthcare institutions and pharmaceutical companies (tax law and deduction tax, registration of public sector partners, personal data protection, etc.), the attorney office Hronček & Partners, s. r. o. is ready to help you.
