Announcement – TLI effectiveness assessment report

Pursuant to Article 40a(7) of the Act of May 12, 2011, on the reimbursement of drugs, foodstuffs for special nutritional purposes, and medical devices (Journal of Laws of 2024, item 930, as amended), 90 days before the end of the reimbursement period for highly innovative drug technologies, the Agency shall publish a report on the effectiveness of reimbursed highly innovative drug technologies and the quality of treatment, based on data from medical registers or the electronic drug program monitoring system, referred to in Article 188c(1) of the Act of August 27, 2004, on healthcare services financed from public funds, provided that the clinical data necessary to prepare this report are sufficient.

Publication of a report on the effectiveness and quality of treatment with a highly innovative drug technology covered by reimbursement under the Medical Fund:

• Givlaari (giwosyran) in the indication: in accordance with the provisions of drug program B.128.FM. Treatment of patients with acute hepatic porphyria (AHP) in adults and adolescents aged 12 years and older (ICD-10: E80.2)