Background: The statins are а developing group of cardiovascular medicines, widely used for dyslipidemia. As a whole statins consumption leads to reduction in cardiovascular events and death, and improves the disease control. The main study issue considers the differences in an affordability to lipid lowering medicines in the countries with the highest morbidity and mortally rate within and outside EU. The affordability has been researched by exploring the price differences and average wages. Methods: On total 7 international nonproprietary names and 19 dosage forms available on both markets are observed during 2013–2016. An average, minimum, and maximum retail prices per DDD, standard deviation (SD) has been calculated for all marketed dosage forms. A price ratio between the minimal and maximal price per DDD is estimated in order to evaluate their difference. Affordability of the treatment is determined as the number of working hours per month needed for patient to purchase medicines for a monthly therapy. Results: Large variations of price per DDD, SD and the average price exist between different dosage forms in both countries. The highest value of a price ratio is observed for 5 mg rosuvastatin in Bulgaria and 10 mg rosuvastatin in Ukraine. The number of working hours needed to cover monthly therapy has increased during 2013–2016 in Ukraine. The most affordable is treatment with a generic atorvastatin in Bulgaria and generic rosuvastatin in Ukraine. The most expensive rosuvastatin in Bulgaria and atorvastatin in Ukraine are found as the least affordable for a monthly therapy. Conclusions: The decrease of prices for statins is not the only reason influencing patients’ affordability to therapy for statin therapy in Ukraine and Bulgaria. The difference in affordability in Ukraine and Bulgaria is affected mainly by the economic development in the country as well as wages variation.

The analysis included 466 patients with myelofibrosis on treatment with ruxolitinib. The PFS at 12 ^th , 20 ^th , 30 ^th , 40 ^th , and 50 ^th month was 88%, 83%, 75%, 65%, and 61% respectively. Median for PFS was reached at 73.5 months. OS median was reached at 48.2 months. OS at month 12 ^th , 20 ^th , 30 ^th , and 40 ^th month was 87%, 78%, 70%, and 56% respectively. Eligible patients for comparison with COMFORT-II trial after application of inclusion and exclusion criteria were 68, while the clinical trial included 146 patients. The estimated value for PFS at 12 ^th month was 84% and the median PFS was reached at 35.3 months. The values for OS was estimated to be 74% at 12 ^th month and the median of OS was reached at 30 ^th month. The clinical benefit rate from real-world population was estimated at 98%, and objective response rate was estimated at 79.2%, based on 53 patients.

Background/Objectives: Small cell lung cancer (SCLC) is a highly metastatic and lethal malignancy. Doublet chemotherapy consisting of a platinum compound and etoposide had remained the standard first-line regimen for decades, particularly for the majority of patients, who are diagnosed with extensive-stage disease. Over the past 5 years, results from the IMpower133 trial led to the approval of anti-PD-L1 agent atezolizumab as part of the first-line regimen for extensive-stage SCLC. The accumulation of real-world evidence on atezolizumab efficacy in this context is essential for corroborating trial results and further improving patient outcomes. Herein, we present real-world evidence from a Bulgarian cohort receiving atezolizumab as part of first-line extensive-stage SCLC treatment, comparing these data to the results of IMpower133. Methods: Data were extracted from the electronic health records of patients receiving atezolizumab plus chemotherapy as first-line treatment for extensive-stage SCLC in the period between 1 January 2022 and 31 December 2024. Analysis was conducted via the Danny Platform, an analytic platform for the integration of real-world evidence using embedded machine learning and LLM algorithms. Patients matching IMpower133 inclusion criteria were included in a group for comparison with trial results. Results: A total of 302 patients were included in the analysis. The real-world progression-free survival (PFS) in our study surpassed that in IMpower133 (7.6 versus 5.2 months), in addition to higher PFS rates beyond six months. A lower Objective Response Rate (ORR) (38.7% versus 65.4%) was noted in our real-world cohort, which we attribute to real-world documentation practices. Conclusions: Real-world evidence regarding PFS and treatment response generally align with the efficacy of adding atezolizumab to first-line extensive-stage SCLC treatment reported in the IMpower133 trial, while reflecting differences that may arise in routine clinical practice.

Malignant melanoma is among the leading forms of cancer on a global scale, accounting for 1 in 5 skin cancers. Over the past decades, the treatment of melanoma has significantly improved following the development of therapies such as MAPK molecular therapy targeted at BRAF and MEK signaling pathways. We present real-world evidence from clinical practice in Bulgaria on the treatment of malignant melanoma with dabrafenib and trametinib from 2018 to 2022. Treatment outcomes from the real-world data are compared against the pivotal clinical trials, namely COMBI-d and COMBI-v. Outcomes are compared on the basis of metrics, including overall survival, progression-free survival, and clinical benefit. Further, iterational proportional fitting is performed to control for differences in characteristics across the patient cohorts. Results show that real-world overall survival and progression-free survival outperform results from the clinical trials, particularly with respect to COMBI-d.

Third-generation EGFR tyrosine kinase inhibitor (EGFR-TKI) osimertinib is approved as first-line treatment against non-small-cell lung cancer (NSCLC) harboring sensitizing EGFR mutations. Herein, we perform retrospective analysis of real-world data on first-line osimertinib treatment among Bulgarian patients with NSCLC, comparing treatment outcomes to FLAURA results. Patient data were obtained from electronic health records over a 4-year period. Baseline characteristics and endpoints (progression-free survival [PFS], objective response rate [ORR], and clinical benefit rate [CBR]) were compared. Iterative proportional fitting was performed to balance patient characteristics prior to survival analysis. A total of 365 patients on first-line osimertinib were included. Partial responses were more frequent in the RWE cohort (24% vs 13%), while the opposite was noted for stable disease (63% vs 80%). Complete response frequency was comparable (2% vs 1%). The ORR was higher in the real world compared to in FLAURA (26% vs 14%), whereas CBR was slightly higher in the trial (89% vs 94%). The real-world PFS was higher than reported in FLAURA (19.1 vs 18.9 months), with more favorable outcomes in the RWE cohort beyond 18 months. RWE closely aligns with FLAURA results, suggesting even greater benefit of first-line osimertinib in the real-world setting.