The Slovak framework for the reimbursement of medicines from public health insurance funds rests on a combination of a general rule and a flexible exception. Under the general rule, medicines are assessed under cost-effectiveness criteria and, if they do not exceed the relevant threshold value for a Quality-Adjusted Life Year, placed on a list of reimbursed medicines. However, even if they choose not to apply for general reimbursement or do not meet the criteria, they can still be reimbursed on the basis of individual exceptions granted by health insurers for the treatment of specific patients.
This exceptional reimbursement regime has long been one of the most sensitive and controversial areas of the Slovak public health insurance system. The mechanism, originally conceived as an exceptional instrument for patients with specific medical conditions, has become a widely used supplement to the standard reimbursement regime. In recent years, it has therefore become highly exposed to public debate, pitting payers against patients. On one hand, patients wish for medicines to be reimbursed. On the other hand, the public health insurance system needs a predictable and sustainable financial framework.
Although this question has long resonated with professionals, it is only recently that it has become a mainstream debate. Several authorities that are not tasked with regulating health expenditures have weighed in.
The Administrative Court in Bratislava and the Ombudsman challenged the exception regime in the Constitutional Court, mainly on the grounds that the criteria for invoking it are not set out in law but drawn up by the health insurers. In a similar vein, the Public Prosecutor challenged 13 individual decisions of insurers not to grant reimbursement on the grounds that they were insufficiently reasoned. After the private insurers dismissed these challenges, the Public Prosecutor brought the cases before Administrative Courts, which went on to quash the insurers’ rulings. In a widely publicized case, a civil court issued an injunction ordering an insurer to reimburse critical treatment of a child that cost more than EUR 1 million. The ruling was overturned on appeal. In the meantime, the Ministry of Justice has tabled legislation ordering courts to rule on applications against insurers’ decisions within 30 days.
To bring clarity, two legislative initiatives – one by individual Members of Parliament and one by the Ministry of Justice – have been put forward to set clear statutory criteria for exceptional reimbursement. These proposals are currently making their way through the legislative process.
Both legislative proposals remove the most serious objections to the current regime by replacing its discretionary nature with clear criteria. If these conditions are met, reimbursement would be mandatory. This would remove the differences between the insurers and provide a higher degree of legal certainty and predictability to patients. Thereby, both proposals alleviate the main concerns raised by the Ombudsman, the Public Prosecutor, and Administrative Courts.
However, the criteria themselves are problematic.
Most importantly, one of the criteria is the medicine extending overall survival or progression-free survival. This criterion is easily applicable to oncological products, but less so to medicines for chronic debilitating diseases. Secondly, the exceptional regime would generally only be available during the first two years after the product’s marketing authorization. In practice, this means that unless the medicine obtains standard reimbursement in the meantime, it would not be reimbursed under any regime (save for some pediatric medicines and products for rare diseases). It seems that the drafters intend to incentivize marketing authorization holders to apply for standard reimbursement, but it is far from guaranteed that they would do so. Considering the strict cost-effectiveness thresholds and low prices in Slovakia, entering the Slovak reimbursement list drives down prices in other jurisdictions that reference their prices.
Therefore, some marketing authorization holders already choose to stay out of the Slovak reimbursement list. While the current regime still leaves some room for exceptional reimbursement of such medicines, the new regime may close it altogether.
At the end of the day, the need to align limited financial resources available for medicines with the needs of patients poses complex questions in all jurisdictions.
It remains to be seen how the Slovak legislator will attempt to square this circle in the present iteration.
By Juraj Gyarfas, Partner, and Patricia Dutkova, Associate, Dentons
This article was originally published in Issue 12.11 of the CEE Legal Matters Magazine. If you would like to receive a hard copy of the magazine, you can subscribe here.
