ABSTRACT

Objective

The goal is to perform a comparative analysis of multiple sclerosis patients’ access to medicines in Bulgaria and Greece.

Materials and methods

A comparative analysis of pharmaceutical legislation of Bulgaria and Greece focusing on medicines for multiple sclerosis (MS) was performed. Patients’ access to therapy is assessed through the guideline compliance index (GCI) and availability index.

Results

The procedures for marketing authorization, pricing and reimbursement, and inclusion of medicines in the positive drug list (PDL) are identical in both European Union member states. Almost all MS medicines authorized for sale in the European Union are included in the Bulgarian and Greek PDL. In both PDLs are included medicines from different groups: immunostimulants, other immunostimulants, immunosuppressors, selective immunosuppressors, and other immunosuppressors. All medicines are fully paid by the health insurance funds in both countries. The average time for inclusion of medicines for MS in the PDL of Bulgaria after their marketing authorization is 3 years. The analysis of pharmacotherapeutic guidelines showed high GCI as it is higher for Bulgaria: 0.846 vs. 0.769 out of 1.

Conclusion

The existing legislative measures at the national level of Bulgaria and Greece ensure adequate and timely access of patients with MS to treatment.

中文翻译：

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保加利亚和希腊多发性硬化症患者获得报销生物技术药物的分析

摘要

客观的

目标是对保加利亚和希腊的多发性硬化症患者获得药物的情况进行比较分析。

材料和方法

对保加利亚和希腊以多发性硬化症 (MS) 药物为重点的药品立法进行了比较分析。通过指南依从性指数 (GCI) 和可用性指数评估患者获得治疗的机会。

结果

欧盟两个成员国的上市许可、定价和报销以及将药物纳入阳性药物清单 (PDL) 的程序是相同的。几乎所有获准在欧盟销售的 MS 药物都包含在保加利亚和希腊的 PDL 中。在这两个 PDL 中都包括来自不同组的药物：免疫刺激剂、其他免疫刺激剂、免疫抑制剂、选择性免疫抑制剂和其他免疫抑制剂。所有药品均由两国医疗保险基金全额支付。在获得上市许可后，将 MS 药物纳入保加利亚 PDL 的平均时间为 3 年。对药物治疗指南的分析显示 GCI 较高，因为保加利亚的 GCI 较高：0.846 对 0.769（满分为 1）。

结论

保加利亚和希腊国家层面的现有立法措施确保 MS 患者能够充分和及时地接受治疗。