Georgian Gov’t to provide innovative Trikafta treatment to cystic fibrosis patients

Georgian Health Minister Mikheil Sarjveladze announced on Tuesday that the country will purchase the innovative medicine Trikafta for patients with cystic fibrosis under the expanded Rare Disease Management Programme, describing its introduction as a turning point toward a healthier life for many children and their families.

At a briefing, Sarjveladze said an agreement had already been signed with US-based manufacturer Vertex Pharmaceuticals, with the process of providing the medicine to patients set to begin in September.

Trikafta has been approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for patients aged two and older whose genetic mutations fall within the approved indications.

The innovative therapy directly targets the genetic defect underlying the disease and can significantly improve lung function in patients.

The treatment also significantly reduces the frequency of pulmonary exacerbations and the need for hospitalisation. Real-world data from studies show an overall reduction of 76%, with these findings supported by both clinical research and real-world experience.

“Today, I would like to inform the public about another important expansion of the Rare Disease Management Programme, this time concerning the treatment of cystic fibrosis, also known as mucoviscidosis - a rare and severe genetic disorder. The condition is caused by a gene mutation that leads to the production of thick, sticky mucus in the body. It primarily affects the respiratory system, causing chronic inflammation of the airways and progressive deterioration of lung function, which can ultimately lead to respiratory failure. The disease also affects the digestive system, pancreas and other organs. Cystic fibrosis can significantly reduce life expectancy and quality of life, with particularly severe consequences for children”, Sarjveladze said.

“Therefore, largely as a result of successful cooperation with parents, a decision has been made for the state to purchase the most effective medicine currently available for the treatment of cystic fibrosis”, he continued.

He expressed his gratitude to the government, the Prime Minister, the patients’ parents and medical professionals for their cooperation in expanding the programme.

In close cooperation with the medical community, patients with cystic fibrosis and their parents, the Ministry of Health has been working consistently to expand access to modern treatment.

To this end, the ministry has been gradually expanding state-funded programmes. Last year, the programme was expanded to include essential inhaled medicines, antibiotics, vitamins and other medications, while funding for inpatient care was also increased.