Availability and reimbursement of biological products for severe asthma in Bulgaria

Abstract

Objectives: This study aims to analyze the reimbursement and cost of biological therapy for severe asthma in Bulgaria during 2014–2019 from the perspective of the National Health Insurance Fund. Methods: It is a retrospective, Marco-costing, top-down study of the expenditures for biological products for severe asthma. The changes in the cost paid by the National Health Insurance Fund per year, per product, and per patient during 2015–2020 were systematized and calculated. The utilization of biologicals was analyzed by calculating the defined daily dose/1000inh/day. Three databases were searched—the European Medicines Agency for the date of marketing authorization of biological products, National Council of Prices and Reimbursement for the date of their respective inclusion in the positive drug list, and National Health Insurance Fund about the number of patients with asthma, reimbursed sum for all asthma patients, and number of packages sold of biological products. Results: At the end of 2019, five international non-proprietary names of biologicals with indication for severe asthma had received European marketing authorization, and three of them were included in the Bulgarian positive drug list—omalizumab, mepolizumab, and benralizumab with a 75% reimbursement. Upon their introduction into the positive drug list, the reimbursed expenditures for asthma therapy started to increase from 27 million in 2014 to 33 million BGN in 2019 (€13.5–€16.5 million). The cost of therapy with biologicals rose from 16% to 24% of all anti-asthmatic medicines budget. The National Health Insurance Fund database reported that between 47,000 and 52,000 of patients with asthma, 466 are on biological therapy. The yearly cost of one asthma patient ranges between 512 and 615 BGN (€258–€307), and the yearly per-patient cost of severe asthma is 16,666 BGN (appr. €8333). Total utilization in defined daily dose/1000inh/day increases from 0.0199 to 0.0383 from 2015 to 2019. Conclusion: The access to biological therapy through the reimbursement system has improved during the last 3 years. The cost of therapy is posing a high burden on the National Health Insurance Fund and on the patients and is expected to increase due to the small number of patients on biological therapy currently in comparison to all reimbursed asthmatics.

Global Variability in Administrative Approval Prescription Criteria for Biologic Therapy in Severe Asthma

“…15,16 Others looked only at reimbursement and costs of severe asthma biologics over time in Bulgaria. 17 All of these single country studies are relevant to inform within-country policy, but they limit direct cross-country comparisons regarding access or comparisons with our study. The Identification and Description of sEvere Asthma patients in a cross-sectionaL study assessed eligibility for three biologics (omalizumab, reslizumab, and mepolizumab) across six countries (Australia, Canada, France, Germany, the United Kingdom, and the United States).…”

Attitudes of Croatian pulmonologists concerning obstacles to earlier, more appropriate use of biologics in severe asthma: Survey results

“…Other health-care systems with significantly varying health resources share the same challenges. Biologics were prescribed in only 1% of patients with asthma in Bulgaria and fewer than 3 of 1,000 patients with asthma in the United States [16,17]. In our survey, three primary causes for the disproportionate number of patients receiving biologics for SA were identified: a) an inadequate diagnosis of SA by GPs and pulmonologists and/or referral of patients with uncontrolled asthma to specialist centers; 2) restrictive criteria for the prescription and reimbursement of biologics approved by the CHIF; and c) institutional financial limitations.…”