Authors: Václav Audes, Michal Blahovec, Martina Rievajová
A few days ago, the President of the Slovak Republic signed the long-awaited amendment to the Act on the Conditions of Reimbursement of Medicinal Products from Public Health Insurance[1]. In addition to the main objective of the amendment, facilitating the arrival of innovative medicinal products, the amendment also introduces a number of fundamental changes for pharmaceutical companies that produce and distribute categorised medicinal products or so-called medicinal products subject to exemption. These fundamental changes concern, in particular, the conditions for the reimbursement of medicinal products from public insurance. As this is a complex and wide-ranging issue, we have prepared a series of articles on the reforms entailed by the amendment. We are currently preparing articles on the changes in the process of concluding MEA contracts, the content of the contracts themselves, the demonstration of reimbursement efficiency and many others to make it as easy as possible for you to orientate in the changes in the legislation.
Earlier this year, the Ministry of Health of the Slovak Republic (the “MoH SR”) declared the need to address the current problem of (un)availability of innovative medicinal products for patients with rare diagnoses. Currently, innovative medicinal products are reimbursed to these patients in the so-called exemption regime, in which the health insurance company individually assesses the patient’s application for such a medicinal product and decides according to its capabilities and set priorities. As a result, the decisions of the insurance companies and, therefore, the patient’s access to innovative medicinal product vary, as the legislation does not lay down clear and, above all, uniform rules for the decision-making of health insurance companies.
The amendment introduces two main changes to address this situation.
The first change is a change in the method of concluding contracts on the inclusion of a medicinal product in the list of categorised medicinal products,i.e., medicinal products reimbursed from public health insurance.
The second change is to increase the transparency of the process of decision-making by health insurance companies on the reimbursement of medicinal products that have not been included in this list.
Despite the fact that this is a major amendment that requires preparation on the part of pharmaceutical companies, the legislators have stipulated that the amendment will become effective as early as from 1 August 2022.
As already mentioned, one of the main changes is the change in the method of concluding contracts on the terms and conditions of reimbursement of a medicinal product, the so-called MEA contracts. According to the current legislation, in order for a specific medicinal product to be reimbursed from public insurance, the marketing authorisation holder in respect of a medicinal product (pharmaceutical company) must conclude a contract on the conditions of reimbursement of the medicinal product with all health insurance companies. Such a contract may also include special arrangements for discounts or back payments.
After the amendment comes into effect, in order for a specific medicinal product to be reimbursed from public insurance, the marketing authorisation holder must conclude a contract on the conditions of reimbursement of the medicinal product directly with the MoH SR. It should be added that it remains possible for the marketing authorisation holder to negotiate special discounts or other conditions with individual health insurance companies.
In any case, however, the essential conditions, such as the maximum amount of reimbursement of all insurance companies for the medicinal product, indication and prescription limitations or the settlement difference, will be negotiated directly between the marketing authorisation holder and the MoH SR.
Particulars of reimbursement contracts
In practice, contracts with the MoH SR should not differ substantially from those that marketing authorisation holders are used to conclude with health insurance companies. However, the settlement difference, which is the difference between the amount of reimbursements incurred by health insurance companies for a specific medicinal product over a 12-month period and the agreed maximum amount of reimbursement for the medicinal product for that period, is regulated in more detail in the amendment.
The contract with the MoH SR must explicitly stipulate the obligation of the marketing authorisation holder to pay the health insurance companies for the difference between the sum of reimbursements actually incurred by the health insurance companies for the medicinal product and the agreed maximum sum of reimbursements by the health insurance companies. In cases where the marketing authorisation holder fails to pay such a difference, the contract must contain a provision on the amount of the contractual penalty.
Apart from the changes to the contracting regime, from a pharmaceutical company’s point of view, not so much has changed for the so-called contracts subject to exemption. These are contracts concluded pursuant to Section 88 of the Act on the Conditions of Reimbursement of Medicinal Products from Public Health Insurance, under which the conditions of reimbursement for medicinal products that do not meet the conditions for general reimbursement from public insurance are determined. After the amendment comes into effect, marketing authorisation holders will be entitled to conclude contracts on reimbursement of medicinal products in the so-called exemption regime directly with health insurance companies.
In this respect, the amendment sets out precise conditions and procedures for health insurance companies when dealing with requests from medical doctors for reimbursement of a medicinal product that is not generally reimbursed from public insurance. Another novelty is the change in the maximum amounts of reimbursement by health insurance companies for a medicinal product under this regime.
As we have already mentioned, despite the complexity of the amendment, the legislators have left pharmaceutical companies approximately one month to adapt to the changes. It should be noted, however, that the entry into effect of the amendment, i.e., on 1 August 2022, will not automatically terminate the validity of the contracts on the conditions of reimbursement of a medicinal product already concluded. The amendment stipulates that the MoH SR is obliged to conclude new contracts with the affected marketing authorisation holders who have concluded contracts on the conditions of reimbursement under the legislation in force until 31 July 2022 by 28 February 2023.
Only by concluding a new contract on the conditions of reimbursement of medicinal products with the MoH SR will the validity of the existing contracts concluded between the marketing authorisation holders and health insurance companies be automatically terminated. In the meantime, the original contracts between marketing authorisation holders and health insurance companies will remain in force without change. For completeness, however, we would like to add that the amendment does not address the situation if a new contract has not been concluded between the MoH SR and the marketing authorisation holder by 28 February 2023.
The above sections of the amendment are only a basic introduction to the amendment and the changes it entails. We will discuss the selected changes in more detail in further articles that we are preparing for you.
[1] Act No. 363/2011 Coll. on the Conditions of Reimbursement of Medicinal Products, Medical Devices and Dietetic Foods from Public Health Insurance, as amended
