INCREMENTAL COST-EFFECTIVENESS ANALYSIS OF BIOLOGICAL DRUG THERAPIES FOR THE TREATMENT OF ANKYLOSING SPONDYLITIS IN BULGARIA, 2016

• Published in: Value in health Vol. 20; no. 5; p. A221
• Main Authors: Djambazov, S, Vekov, T
• Format: Journal Article
• Language: English
• Published: Lawrenceville Elsevier Science Ltd 01-05-2017
• Subjects: Alternatives; Ankylosing spondylitis; Clinical research; Clinical trials; Cost analysis; Data processing; Drug abuse; Drug therapy; Efficacy; Etanercept; Health care expenditures; Immunotherapy; Infliximab; Monoclonal antibodies; Prices; Quality adjusted life years; Spondylitis; Tumor necrosis factor-α; Bulgaria
• ISSN: 1098-3015; 1524-4733
• DOI: 10.1016/j.jval.2017.05.005

OBJECTIVES: Biological therapies, alone or in combination with other medications, are used as second or subsequent therapy line in the treatment of ankylosing spondylitis (AS). The biologies authorized in Bulgaria in August 2016 are etanercept (ETA), infliximab (INF), adalimumab (ADA), golimumab (GOL), cetrolizumab (CER), and secukinumab (SEC). The objective of the study is to assess the incremental costs (Acosts), incremental health benefits (ΔQALY) and incremental ratio (ICER) of the biological therapies for AS in Bulgaria. METHODS: The data on SEC efficacy have been derived from two randomized multicenter clinical trials: MEASURE-1 and MEASURE-2. Long-term data on therapeutic efficacy have been modelled using a model of RTI Health Solutions. The data on therapeutic efficacy are directly transferred in the local environment from the clinical trials and the applied model. The data on costs of the alternatives are based on the reference prices of ETA, INF, ADA, GOL, CER and SEC published in the Positive Drug List. Other direct or indirect health costs, besides the drug therapy costs, are not included in the analysis as they are considered comparable in the various therapeutic alternatives in the Bulgarian healthcare setting. RESULTS: The analysis of adapted data on SEC cost-effectiveness of AS in Bulgaria shows that SEC dominates CER, ETA, ADA, GOL and if we consider a cost-effectiveness threshold three times GDP per capita in Bulgaria (WTPth 36 221 BGN, 2015), is a cost-effective therapy in comparison to INF (ICER 27 552 BGN/QALY). CONCLUSIONS: The pharmacotherapeutic guidelines based on both clinical data on therapeutic efficacy and safety and economic data on comparative cost-effectiveness of potential biological therapeutic alternatives for the treatment of AS, recommend SEC as first choice for second line in AS treatment in Bulgaria, after failure of conventional therapy, as well as for third line after failure of anti-TNFa therapy.