Biological therapies use proteins that have been produced with biological technology to generate targeted effects within the body, impact the body's immune system, and reduce inflammation at various stages. Biologics are used in the treatment of conditions such as rheumatoid arthritis, systemic lupus, ankylosing spondylitis, arthropathic psoriasis, and psoriatic arthritis. The aim of the study is to conduct a comprehensive review and analyze the market dynamics related to the use of these treatments in Albania. Methods: This is a retrospective and observational study based on FDSKSH’s data for 2023. Results: The total annual reimbursement cost for 2023 was ALL 188,208,780 (1 ALL = 0.01 USD). The average reimbursement cost per patient was ALL 209820.2679. The use of biologics and biosimilars represents 0.028% of all prescriptions and accounts for 1.56% of the total reimbursement costs for drugs. In 2023, the reimbursement cost covered by FDSKSH was 7.14% lower than in 2022. 87.17% of the patients were treated with Tumor Necrosis Factor (TNF) Inhibitors. Etanercept 25 mg (biosimilar) had the highest price reduction of 32.83% in 2024. The most expensive drug in 2023 was Secukinumab 150 mg. Biologics account for 61% of the total annual reimbursement cost, while biosimilars account for 39%. Conclusions: The prescription of biologics is lower compared to biosimilars, but they are associated with significant costs that impact the overall reimbursement costs. The prices of biologics and biosimilars were lower than those in Kosovo, Italy, Greece and will decrease in 2024. Cost- economic evaluations of the most expensive biologics and biosimilars are important for the management of financial resources.
Biological therapies, the total annual reimbursement cost, the average reimbursement cost per patient, prices, biosimilars