Cost-effectiveness of disease-modifying treatments for multiple sclerosis in bulgaria based on evidence from real world settings

This study aims to provide insight into the early application of high efficacy 2nd line DMDs (disease-modifying drugs) from a Bulgarian public payer perspective, referring to RWD (real-world data). An Excel-based model was developed to compare the effectiveness of 1st versus 2nd line DMDs in terms of ARRs (annualized relapse rate) and the direct medical costs over the 4 year follow-up period. MS (multiple sclerosis) therapies were categorized into two groups (1st and 2nd line) according to public payer guidelines. The results of the cost-effectiveness analysis are presented as an incremental cost-effectiveness ratio (ICER). The annualized relapse rate per line of therapy (ARR of 0.385 for 1st line DMDs was significantly higher than the one for 2nd line DMDs, which was 0.153. The direct medical costs were 18,548 BGN (9,485 euros) and 33,857 BGN (17,315 euros) for 1st and 2nd line DMDs respectively. Thus, the ICER was 63 950 BGN (32.700 euros) per relapse avoided, which is slightly above the informal threshold of 3 x gross domestic product (GDP) per capita. The results of this study showed that escalation to 2nd line DMDs is a cost-effective approach in relapsing-remitting multiple sclerosis (RRMS) patients who do not respond adequately to conventional 1st line DMDs. Although 2nd line DMDs direct medical costs were substantially higher, early escalation might produce long-term savings.