Health Technology Assessment in Support of National Health Insurance in South Africa.

South Africa has embarked on major health policy reform to deliver universal health coverage through the establishment of National Health Insurance (NHI). The aim is to improve access, remove financial barriers to care, and enhance care quality. Health technology assessment (HTA) is explicitly identified in the proposed NHI legislation and will have a prominent role in informing decisions about adoption and access to health interventions and technologies. The specific arrangements and approach to HTA in support of this legislation are yet to be determined. Although there is currently no formal national HTA institution in South Africa, there are several processes in both the public and private healthcare sectors that use elements of HTA to varying extents to inform access and resource allocation decisions. Institutions performing HTAs or related activities in South Africa include the National and Provincial Departments of Health, National Treasury, National Health Laboratory Service, Council for Medical Schemes, medical scheme administrators, managed care organizations, academic or research institutions, clinical societies and associations, pharmaceutical and devices companies, private consultancies, and private sector hospital groups. Existing fragmented HTA processes should coordinate and conform to a standardized, fit-for-purpose process and structure that can usefully inform priority setting under NHI and for other decision makers. This transformation will require comprehensive and inclusive planning with dedicated funding and regulation, and provision of strong oversight mechanisms and leadership.

Cost-Effectiveness Modelling of Sofosbuvir-Containing Regimens for Chronic Genotype 5 Hepatitis C Virus Infection in South Africa.

BACKGROUND: The recently launched nucleotide polymerase inhibitor sofosbuvir represents a significant turn in the treatment paradigm of chronic hepatitis C. While effective, sofosbuvir is also associated with a considerable cost. OBJECTIVE: The objective of this study was to evaluate the cost effectiveness of sofosbuvir-containing regimens in treatment-naive patients with chronic hepatitis C virus (HCV) genotype 5 (HCV-G5) mono-infection in South Africa (SA). DESIGN: We constructed a lifetime horizon decision-analytic Markov model of the natural history of HCV infection to evaluate the cost effectiveness of sofosbuvir-ledipasvir (SOF/LDV) monotherapy against sofosbuvir triple therapy (SOF-TT) (sofosbuvir + pegylated interferon and ribavirin [peg-INF/RBV]) and the current standard of care (SOC) (peg-INF/RBV) for patients with chronic HCV-G5 in the South African context. The model was populated with data from published literature, expert opinion and South African private sector cost data. The price modelled for sofosbuvir was the predicted South African private sector price of 82,129.32 South African rand (R) (US$7000) for 12 weeks. The analysis was conducted from a third-party payer perspective. OUTCOME MEASURES: The outcome measures were discounted and undiscounted costs (in 2015 South African rand and US dollars) and quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). RESULTS: Outcomes from the cost-effectiveness model show that SOF/LDV yields the most favourable future health economic outcomes compared with SOF-TT and the current SOC in SA. Findings relating to the lifetime incremental cost per QALY gained for patients infected with HCV-G5 indicate that SOF/LDV dominated both SOF-TT and SOC, i.e. SOF/LDV is less costly and more effective. CONCLUSION: Outcomes from this analysis suggest that at a price of R123,190 ($US10,500) for 12 weeks of SOF/LDV might be cost effective for South African patients infected with HCV-G5.