Institutionalizing Health Technology Assessment in South Africa-An Opportunity in National Health Insurance.

While South Africa has some experience in various forms of health technology assessment (HTA), it is currently fragmented across numerous players. Additionally, there is a lack of systematic and consistently applied HTA processes that inform priority-setting and budget allocations. To address this, the country is journeying toward more institutionalized use of HTA. This will begin with the establishment of a Ministerial Advisory Committee on HTA for National Health Insurance (NHI) and will gradually embed HTA processes in decision-making. The goal is to create an independent HTA agency. Although these reforms will be intrinsically linked to the wider health financing reforms envisaged under NHI, such as formulating the benefits package, they will also assist in strengthening South Africa's health system. As a country facing a highly constrained fiscal environment, with limited space for additional funding for the health sector, evidence-based priority-setting will be critical to ensure that value for money is achieved in the government's investments in health care services in NHI.

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.

COVID-19: lessons and experiences from South Africa's first surge.

On 5 March 2020, South Africa recorded its first case of imported COVID-19. Since then, cases in South Africa have increased exponentially with significant community transmission. A multisectoral approach to containing and mitigating the spread of SARS-CoV-2 was instituted, led by the South African National Department of Health. A National COVID-19 Command Council was established to take government-wide decisions. An adapted World Health Organiszion (WHO) COVID-19 strategy for containing and mitigating the spread of the virus was implemented by the National Department of Health. The strategy included the creation of national and provincial incident management teams (IMTs), which comprised of a variety of work streams, namely, governance and leadership; medical supplies; port and environmental health; epidemiology and response; facility readiness and case management; emergency medical services; information systems; risk communication and community engagement; occupational health and safety and human resources. The following were the most salient lessons learnt between March and September 2020: strengthened command and control were achieved through both centralised and decentralised IMTs; swift evidenced-based decision-making from the highest political levels for instituting lockdowns to buy time to prepare the health system; the stringent lockdown enabled the health sector to increase its healthcare capacity. Despite these successes, the stringent lockdown measures resulted in economic hardship particularly for the most vulnerable sections of the population.

Third-Line Antiretroviral Therapy Program in the South African Public Sector: Cohort Description and Virological Outcomes.

BACKGROUND: The World Health Organization recommends that antiretroviral therapy (ART) programs in resource-limited settings develop third-line ART policies. South Africa developed a national third-line ART program for patients who have failed both first-line non-nucleoside reverse transcriptase inhibitor-based ART and second-line protease inhibitor (PI)-based ART. We report on this program. METHODS: Third-line ART in South Africa is accessed through a national committee that assesses eligibility and makes individual regimen recommendations. Criteria for third-line include the following: ≥1 year on PI-based ART with virologic failure, despite adherence optimization, and genotypic antiretroviral resistance test showing PI resistance. We describe baseline characteristics and resistance patterns of this cohort and present longitudinal data on virological suppression rates. RESULTS: Between August 2013 and July 2014, 144 patients were approved for third-line ART. Median age was 41 years [interquartile range (IQR): 19-47]; 60% were women (N = 85). Median CD4 count and viral load were 172 (IQR: 128-351) and 14,759 (IQR: 314-90,378), respectively. About 2.8% started PI-based ART before 2004; 11.1% from 2004 to 2007; 31.3% from 2008 to 2011; and 6.3% from 2012 to 2014 (48.6% unknown start date). Of the 144 patients, 97% and 98% had resistance to lopinavir and atazanavir, respectively; 57% had resistance to darunavir. All were initiated on a regimen containing darunavir, with raltegravir in 101, and etravirine in 33. Among those with at least 1 viral load at least 6 months after third-line approval (n = 118), a large proportion (83%, n = 98) suppressed to <1000 copies per milliliter, and 79% (n = 93) to <400 copies per milliliter. CONCLUSION: A high proportion of third-line patients with follow-up viral loads are virologically suppressed.

AGREE to disagree: critical appraisal and the publication of practice guidelines.

Treatment guidelines are important in influencing public policy, promoting distributive justice and advocating better healthcare delivery for those in need. With an increased frequency in publication of clinical guidelines in South Africa, there is a heightened responsibility to ensure the application of due process throughout their development and publication. The need for consensus opinion is critical in the application of evidence-based medicine principles, and clinical guidelines contribute fundamentally towards the process of decision making and prioritisation. The SAMJ has recognised these imperatives as well as the important role that guidelines play in setting standards for clinical practice. In fulfilling this obligation, this editorial introduces the journal's readership to the AGREE II instrument as an objective appraisal mechanism against which prospective clinical guidelines will be assessed prior to their publication.