March 2023 – Zolgensma1 is an orphan medicinal product designated by the European Medicines Agency for the treatment of spinal muscular atrophy ("SMA"), a long-term debilitating and life-threatening disease that causes breathing difficulties and paralysis that worsens over time. Zolgensma, which has been authorised in the EU since 18 May 2020, was developed by AveXis EU, Ltd. and later acquired by Novartis. On 13 March 2023, the Bratislava V District Court issued an injunction against public health insurance provider Vaeobecná zdravotná poisťovňa (General Health Insurance, "VsZP"), ordering it to pay for Zolgensma, which is not reimbursed by the Slovak public health insurance system.
This is the first court decision ordering a health insurance company in Slovakia to pay for a medicinal product that is not reimbursed. The cost of Zolgensma is approximately EUR 2 million. Under Slovak law, the injunction can be appealed but is effective immediately. We believe that the injunction, if confirmed by the Bratislava Regional Court, may have a negative impact on patients' ability to obtain reimbursement for medicines not covered by public health insurance or not authorised in Slovakia, as well as on the operations of Slovak health insurance companies.
Special cases of reimbursement, such as the reimbursement of medicines not included in the list of categorised medicinal products or medicinal products not included in the list of products with an officially fixed price, are regulated by Section 88 of Act No. 363/2011 Coll. on the Scope and Conditions of the Reimbursement of Medicines, Medical Devices and Dietetic Foods on the Basis of Public Health Insurance, as amended ("Reimbursement Act").
Zolgensma has been tested and repeatedly used for the treatment of spinal muscular atrophy in children under two years of age. In the past, Zolgensma has been reimbursed several times by the VsZP for SMA type I patients.
A minor girl, "Editka", was diagnosed with SMA type II on 28 November 2022 at the Slovak National Institute for Children's Diseases in Bratislava.2 Her attending physician submitted a petition for the reimbursement of Zolgensma on 30 November 2022.3 VsZP rejected the petition on 5 December 2022, arguing that Editka's diagnosis does not correspond to the registration studies for Zolgensma or to the reimbursement contracting terms for patients insured by VsZP. The attending physician appealed the decision, arguing that Zolgensma is the optimal therapy and that the issue is urgent. VsZP denied the appeal on 11 January 2023, with reference, inter alia, to its approval for the reimbursement of the categorised medicinal product Spinraza.
Section 29(1) of Act No. 580/2004 Coll. on Health Insurance, as amended, applies the principle of equal treatment pursuant to Act No 365/2004 Coll. on Equal Treatment and Protection against Discrimination, as amended. This principle applies to the rights of the insured arising from the establishment of health insurance and to the rights of the insured in health insurance. VsZP, as a provider of public health insurance, is obliged to observe the principle of equal treatment in relation to all persons insured by VsZP. Zolgensma had already been administered to children with this disease in Slovakia, and VsZP had financed the use of this medicine.1
On 13 March 2023, the Bratislava V District Court issued an injunction against VsZP and ordered VsZP to pay for Zolgensma. VsZP said it respected the court's decision and would take all necessary steps to implement it. However, it is not clear whether VsZP will exercise its right to appeal the decision.
The court argued in its decision that the uncertainty of the law with regard to Section 88 of the Reimbursement Act, the absence of clear and unified terms for such reimbursement, as well as the lack of unification in the decision-making process by the (three) public health insurance providers conflicts sharply with the right to one's health and for the life of the petitioner. The court, inter alia, stated it considers the lack of unification and the rigidity of the Reimbursement Act's Section 88 (9) too harsh. Therefore, the court deemed it necessary, given the extraordinary and special nature of the case, to provide an ad hoc remedy while acting strictly in accordance with the law.
The court noted that it is well aware of the conflict between the limited resources of public health insurance and the individual's right for health and life. Prioritising fiscal criteria over one's life violates, according to the court opinion, the proportionality principle, and in this exceptional case the right for one's life shall prevail. The court also adopted the position of the attending physician, stating that VsZP's refusal to reimburse Zolgensma interferes with the physician's obligation to provide healthcare consistent with the lege artis principle.
VsZP's argumentation that SMA type I and SMA type II patients are groups in dissimilar situations was addressed the court by citing the summary of Zolgensma's product characteristics, arguing that the medicinal product may also be used for SMA type II with results not guaranteed but with a possible benefit. The court also noted that the attending physician is fully competent to assess the state of the patient's health and recommend the appropriate treatment. Due to the above reason, the court deems the situation of Editka suffering from SMA type II similar to patients suffering from SMA type I, whose treatment was reimbursed by VsZP.
The court noted that the petitioner's attending physician acted in violation of Act No. 363/2011 Coll. on Medicinal Products ("Medicinal Product Act") by submitting petitions for the reimbursement of both non-reimbursed Zolgensma and reimbursed Spinraza for the same patient. Under Section 119 (12) (a) of the Medicinal Product Act, a physician, when prescribing a medicinal product, shall act expediently and economically, according to the current knowledge of pharmacotherapy and in accordance with the approved summary of product characteristics.
Furthermore, the court notified VsZP of its right to file a lawsuit against the plaintiff for compensation for damage caused by the execution of the injunction.
While the provision of the medicine to Editka is positive news, the reasoning behind the decision itself is cause for concern. The Bratislava V District Court's injunction, if not appealed or upheld at the appellate court, will have a profound effect on public health insurance in Slovakia.
The logical consequence of the discrimination argument is the risk-avoiding strategy – the refusal of any and all extraordinary reimbursement pursuant to Section 88 of the Reimbursement Act, as even one reimbursement means the availability of the medicinal product to everyone similarly affected.
Furthermore, in light of the injunction, all past reimbursement refusals may become a high-risk liability for health insurance providers. The affected patients could ask for an injunction or sue for damages. Therefore, Slovak health insurance providers will need to create appropriate provisions in their accounting that will reflect this potential risk.
Footnotes
1 https://ec.europa.eu/health/documents/community-register/2020/20200518147982/anx_147982_en.pdf; https://www.medicalnewstoday.com/articles/drugs-zolgensma#_noHeaderPrefixedContent
2 https://domov.sme.sk/c/23147817/editka-zolgensma-vseobecna-zdravotna-poistovna-vszp.html?ref=tab
3 According to Section 88 (9) and (10) of the Reimbursement Act, active legitimation for submitting petition is with the health care provider, not the attending physician"
4 https://www.vszp.sk/transparentne/pre-verejnost/informacie-media/tlacove-spravy/vszp-preplati-malej-eliske-najdrahsi-liek-svete.html; https://tvnoviny.sk/domace/clanok/116032-aj-alexej-so-spinalnou-svalovou-atrofiou-dostane-najdrahsi-liek-na-svete
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