Patients suffering from serious illnesses whose current treatment is failing are generally willing to undergo and pay for any treatment. In recent years, marked by advances in medicine, so-called innovative medicines have come to the forefront; these may offer a solution for patients suffering from rare diseases or cancer, for example. Innovative medicines are used to treat serious, rare diseases and, compared to existing available treatments, significantly reduce mortality or have significantly fewer side effects for patients, allowing patients to continue treatment without interruption.
For many patients, innovative medicines thus represent the last chance to save their lives or improve their quality of life; yet, despite this, access to innovative medicines remains significantly limited for most patients, not only in the Slovak Republic but also in other countries. In an effort to ensure greater availability of innovative medicines, an amendment to Act No. 363/2011 Coll. on the scope and conditions of reimbursement for medicines, medical devices, and dietary foods under public health insurance and on amendments to certain laws (hereinafter also referred to as the “amendment”). One of the main tools through which the stated objective of the amendment is to be achieved is the institution of special price regulation (OCR).
The institution of special price regulation is intended to replace the current so-called exception regime, under which a health insurance company may, upon prior approval, fully or partially reimburse an insured person for a medicine not included in the list of categorized medicines in justified cases (especially when, given the insured person’s health condition, providing the drug is the only appropriate option), with the health insurance company approving reimbursement based on a written request. However, the decisions of health insurance companies were not uniform, and reimbursement for the medication was often not approved for patients. Among other things, this fact prompted the legislature to introduce the new OCR system.
The fact that a drug is subject to special price regulation means that it is not subject to reimbursement reviews, the officially set price of the drug may exceed the European reference price of the drug, it is not subject to benchmarking, and it is not subject to a ban on compensating the patient’s copayment for the drug.
The amendment introduces a special procedural process governing decisions on determining or revoking the determination that a drug is subject to special price regulation.
The Ministry decides whether a drug is subject to special price regulation based on a request or on its own initiative. A request to determine that a medicine is subject to OCR is submitted to the Ministry by the marketing authorization holder or a health insurance company. The subject of the request may be a proposal to determine that a medicine is subject to special price regulation in combination with one of the following proposals:
- a proposal to set an officially determined price for the medicinal product that exceeds the European reference price,
- a proposal that the officially determined price of the medicinal product and the maximum amount of reimbursement by the health insurance company for a standard dose of the medicinal product remain unchanged when determining that the medicinal product is subject to special price regulation,
- a proposal to increase the officially set price of a medicinal product and to increase the maximum amount of reimbursement by the health insurance company for a standard dose of the medicinal product, or
- a proposal to increase the officially set price of a medicinal product without increasing the maximum amount of reimbursement by the health insurance company for a standard dose of the medicinal product.
An application to determine that a drug is subject to special price regulation may be submitted simultaneously for multiple drugs. The Ministry shall decide on the application and publish its decision on its website no later than 90 days from the date of receipt of the application.
The conditions under which the Ministry may decide that a drug is subject to special price regulation and set an officially determined price for the drug that exceeds the European reference price, the amount of the officially determined price of the medicinal product and the maximum amount of reimbursement by the health insurance company for a standard dose of the medicinal product remain unchanged, or the officially determined price of the medicinal product is increased without an increase in the maximum amount of reimbursement by the health insurance company for a standard dose of the medicinal product, are:
- the applicant has demonstrated that there are circumstances worthy of special consideration for determining that the medicine is subject to special price regulation
- the maximum reimbursement amount paid by the health insurance company for the drug as listed in the list of categorized drugs or the maximum reimbursement amount of each health insurance company agreed upon in the contract on the conditions for drug reimbursement concluded pursuant to Section 7a or in a contract concluded pursuant to Act No. 581/2004 Coll. does not exceed the maximum amount of reimbursement by the health insurance company for the drug calculated on the basis of the European reference price of the drug valid as of the date of submission of the application
- the officially determined price of the medicinal product or the proposed officially determined price of the medicinal product does not exceed the arithmetic mean of the ten lowest prices among the officially determined prices of the medicinal product in other Member States or the arithmetic mean of the lowest prices among the officially determined prices of the medicinal product in other Member States, if the medicinal product does not have an officially determined price in ten other Member States
- the applicant has attached a pharmacoeconomic analysis of the medicinal product to the application, provided that:
- the subject of the application is an original medicinal product that was first included in the list of categorized medicinal products after January 1, 2012, and no other medicinal product containing the same active ingredient or the same combination of active ingredients as the medicinal product that is the subject of the application was first included in the list of categorized medicinal products before January 1, 2012, and
- a pharmacoeconomic analysis of the medicinal product was not attached to the application for inclusion of the medicinal product in the list of categorized medicinal products.
The vague criterion for including medicines in the OCR—circumstances worthy of special consideration—is to be further specified by a generally binding legal regulation to be issued by the Ministry, which, according to the information available to us, is currently in preparation.
An applicant seeking a determination that a drug is subject to special price regulation is required to demonstrate continued compliance with the conditions for such a determination, no earlier than 120 days and no later than 90 days before the expiration of each 12-month period following the date on which the decision determining that the medicinal product is subject to special price regulation becomes enforceable. In order to demonstrate the continued fulfillment of the conditions for determining that a medicinal product is subject to special price regulation, the applicant is required to submit a notification to the Ministry regarding the continued fulfillment of the conditions for determining that the medicinal product is subject to special price regulation. Failure to submit such a notification to the Ministry results in the revocation of the determination that the medicinal product is subject to special price regulation.
The law firm Hronček & Partners, s. r. o. is one of the relatively few law firms on the Slovak market that explicitly specializes in the field of medical law and pharmaceutical law. Our team of experts in medical and pharmaceutical law thus guarantees the provision of effective legal services. If you need advice or assistance with any issue in this area (special price regulation, including the preparation and submission of applications to determine that a drug is subject to special price regulation), or in other areas of law relevant to healthcare institutions and pharmaceutical companies
(tax law and withholding tax, registration of public sector partners, personal data protection, and others), the law firm Hronček & Partners, s. r. o. is at your full disposal.
