Analysis of patients’ access to reimbursed biotechnological medicines for multiple sclerosis in Bulgaria and Greece

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.

KEYWORDS:

• Multiple sclerosis
• medicines
• access
• Bulgaria
• Greece

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contribution

The authors provided equally valuable contribution to the manuscript. YS and IT carried out the research. YS, MD, MK, and GP drafted the manuscript. YS and IT entered the data in a database. MD, MK, and GP performed the statistical analysis. All authors participated in the study design and reviewed the paper. All co-authors read and approved the final manuscript.

Additional information

Funding

This manuscript was not funded.