Availability and accessibility of monoclonal antibodies in Bosnia and Herzegovina: Findings and implications

Abstract

Background: Monoclonal antibodies (mAbs) represent the most numerous and significant group of biotherapeutics. While mAbs have undoubtedly improved treatment for many chronic diseases, including inflammatory diseases, they are typically expensive for health care systems and patients. Consequently, access to mAbs has been a problem for many patients especially among Central and Eastern European (CEE) countries. However, biosimilars can potentially help with costs, although there are concerns with their effectiveness and safety. This includes biosimilars for long-acting insulin analogues. Aim: Assess the availability and use of biological medicines, including biosimilars within Bosnia and Herzegovina (B&H). Methods: Assess the availability of mAbs via the current lists of approved and accessed mAbs versus those licenced in Europe and the United States and their utilisation, as well as specifically insulin glargine and its biosimilars, within B&H. Results: The availability of the mAbs in B&H appears satisfactory, which is encouraging. However, current usage is limited to a few mAbs which is a concern for subsequent patient care especially with limited use of biosimilars to address issues of affordability. We also see limited use of biosimilar insulin glargine. Conclusion The limited use of mAbs including biosimilars needs to be addressed in B&H to improve the future care of patients within finite resources. We will monitor these developments.

Biosimilars are essential for sustainable healthcare systems; however, key challenges remain as seen with long-acting insulin analogues

“…Defined daily doses (DDDs) were used where possible for utilization to enhance the comparisons between countries, with DDDs recognized as a robust measure for undertaking crosscountry utilization research (Godman et al, 2014Tubic et al, 2021).…”

“…High patient co-payments and reimbursement issues with biologic medicines have resulted in many Central and Eastern European (CEE) countries struggling to fund originator biologic medicines (Baumgart et al, 2019;Tubic et al, 2021). Rencz et al (2015) found only 0.25% of all patients diagnosed with psoriasis were treated with biologics among six researched CEE countries, with a 14.6-fold difference in utilization rates between them (Rencz et al, 2015).…”

“…The costs of long-acting insulin analogues can be reduced by the availability of biosimilars (Haque et al, 2021a). However, the originator company has been promoting the patented high concentration 300 IU/ml formulation of insulin glargine (Gla-300) to protect their overall insulin glargine sales as well as reduce the price of 100 IU/ml formulation to reduce the attractiveness of this market for biosimilar manufacturers Tubic et al, 2021).…”

Enhancing Choices Regarding the Administration of Insulin Among Patients With Diabetes Requiring Insulin Across Countries and Implications for Future Care

“…This recognises that such discussions are more difficult in some LMICs where patients are struggling to fund even standard insulins within public healthcare systems, with these discussions continuing exacerbated by the recent COVID-19 pandemic (Ogunleye et al, 2020). However, this is not universal as seen with growing use of long-acting insulin analogues, including biosimilars, in a number of Asian and CEE countries (Godman et al, 2021c;Godman et al, 2021d;Tubic et al, 2021).…”

“…This is welcomed as there have been concerns in CEE countries regarding the availability and funding of biological medicines to treat patients with rheumatoid arthritis, psoriasis, and inflammatory bowel disease (Putrik et al, 2014;Kostic et al, 2017;Baumgart et al, 2019). Among CEE countries, including Bosnia and Herzegovina, the Czech Republic, and Estonia, there has been high use of long-acting insulin analogues versus other forms of insulin, with high expenditure on long-acting insulin analogues also seen in Romania in recent years (Godman et al, 2021d;Tubic et al, 2021), with this trend continuing.…”