Abstract
Background
The development of tyrosine kinase inhibitors (TKIs) has improved chronic myeloid leukemia (CML) management and increased CML prevalence due to low mortality rates. CML management is potentially lifelong and expensive and requires pharmacoeconomic approaches and regular review of therapy to ensure that patients obtain cost-effective therapeutic outcomes. Although the introduction of TKIs generics has improved the availability of TKIs, the high-cost implications continue to hinder TKIs accessibility and translate into poor quality of life. To improve the availability and accessibility of TKIs in South Africa, interventional programs have been instrumental. A notable intervention is the collaborative effort of Novartis pharmaceuticals and The Max Foundation which has provided free access to Imatinib to patients in need. In recognition of the needs of CML patients, this study aimed to provide an overview of TKIs regulatory approval, availability, and cost profile in the South African (SA) context for the 2019 period.
Methods
The researchers searched the South African Health Products Regulatory Authority (SAHPRA) website on 20 August 2019 to identify TKIs, generic and innovator brands, that was duly registered. The costs of the registered TKIs were extracted from the Medicines Price Registry (2019) and the Department of Health awarded tenders for oncology medications (2019). The results were analysed quantitatively using Microsoft Excel and presented as tables.
Results
Three TKIs were registered in SA: Imatinib, Dasatinib, and Nilotinib. Generics were only available for Imatinib. Despite the numerous Imatinib generics available in the private sector, treatment for CML chronic phase (CP) patients in the private sector was more expensive than in the public sector. Apparent cost inequality was noted where the same TKI (Nilotinib 200 mg) costs substantially less (by 92.4%) in the public sector than in the private sector.
Conclusion
The study concluded that the accessibility to CML management in the private sector is hindered by the high cost of therapy compared to the public sector. The availability of generic forms of Imatinib eliminated monopoly and improved medicated access compared to Dasatinib and Nilotinib. To improve CML medication access, stakeholders' engagement is required to control cost.
A Detailed Decomposition Analysis of the Public-Private Sector Wage Gap in South Africa