The Ministry of Health of the Slovak Republic extended the payment of innovative treatment of cystic fibrosis from public health insurance. Treatment will be available for children from the age of 2 years and for a wider range of genetic mutations causing the disease. This is possible on the basis of clinical studies and the extension of the authorisation of medicinal products by the European Medicines Agency (EMA).
Until now, these medicines have only been reimbursed for patients from the age of 12 years with selected CFTR gene mutations. With the extension of the indication restrictions, the Slovak Republic has been included among the countries that allow for the early introduction of effective therapy in young children. This increases the chances of slowing disease progression and improving the quality of life of patients.
This is an important step to improve life and care for patients with cystic fibrosis. The decision to extend the reimbursement is based on scientific knowledge and clinical data that have demonstrated the safety and efficacy of treatment in younger children as well. said Minister of Health Kamil Šaško.
Cystic fibrosis is a serious inherited disease affecting the respiratory, digestive and reproductive systems. Early diagnosis and availability of modern treatment can significantly affect the length and quality of life of patients. Over 300 patients with cystic fibrosis live in Slovakia, of which more than a third are children.
The extension of access to treatment will allow the youngest patients to reach effective therapy. This is a significant shift in the quality of childcare with this serious genetic disease, added chief expert of MZ SR for pediatrics Elena Prokopová.
The Slovak Republic was the only country in the European Union where it has not yet been possible to set patients up for this new treatment since 2 years of age. This medicine is a breakthrough and highly effective therapy that provides a clear improvement in the health and quality of life of cystic fibrosis patients, as confirmed by both domestic and international experience. The extension of the indication criteria and the reduction in the age limit will also enable the youngest patients to benefit significantly from the treatment. said the head of the centre of cystic fibrosis for children at Clinic children's pneumology and phtizeology, NÚDCH Bratislava Nina Bližnáková. Doctors also appreciate that the Ministry of Health of the Slovak Republic shares the expert opinion of doctors for cystic fibrosis and supports its application in the interest of patients in Slovakia.
