Slovak Court Orders Public Health Insurance Provider To Pay EUR 2 Million For The Medicinal Product Zolgensma, Citing Discrimination

• Jurisdiction: European Union
• Law Firm: Kinstellar
• Subject Matter: Insurance, Food, Drugs, Healthcare, Life Sciences, Insurance Laws and Products
• Author: Mr Peter Kov'č and Katarína Sowada
• Published date: 18 April 2023

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 Vaeobecn' zdravotn' 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...