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.

Impact of the introduction of mandatory generic substitution in South Africa: private sector sales of generic and originator medicines for chronic diseases.

OBJECTIVE: To assess the impact of mandatory offer of generic substitution, introduced in South Africa in May 2003, on private sector sales of generic and originator medicines for chronic diseases. METHODS: Private sector sales data (June 2001 to May 2005) were obtained from IMS Health for proton pump inhibitors (PPIs; ATC code A02BC), HMG-CoA reductase inhibitors (statins; C10AA), dihydropyridine calcium antagonists (C08CA), angiotensin-converting enzyme inhibitors (ACE-I; C09AA) and selective serotonin reuptake inhibitors (SSRIs; N06AB). Monthly sales were expressed as defined daily doses per 1000 insured population per month (DDD/TIM). Interrupted time-series models were used to estimate the changes in slope and level of medicines use after the policy change. ARIMA models were used to correct for autocorrelation and stationarity. RESULTS: Only the SSRIs saw a significant rise in level of generic utilisation (0.2 DDD/TIM; P < 0.001) and a fall in originator usage (-0.1 DDD/TIM; P < 0.001) after the policy change. Utilisation of generic PPIs fell (level 0.06 DDD/TIM, P = 0.048; slope 0.01 DDD/TIM, P = 0.043), but utilisation of originator products also grew (level 0.05 DDD/TIM, P < 0.001; slope 0.003, P = 0.001). Generic calcium antagonists and ACE-I showed an increase in slope (0.01 DDD/TIM, P = 0.016; 0.02 DDD/TIM, P < 0.001), while the originators showed a decrease in slope (-0.003 DDD/TIM, P = 0.046; -0.01 DDD/TIM, P < 0.001). There were insufficient data on generic statin use before the policy change to allow for analysis. CONCLUSION: The mandatory offer of generic substitution appeared to have had a quantifiable effect on utilisation patterns in the 2 years after May 2003. Managed care interventions that were already in place before the intervention may have blunted the extent of the changes seen in this period. Generic policies are an important enabling provision for cost-containment efforts. However, decisions taken outside of official policy may anticipate or differ from that policy, with important consequences.

The relevance of systematic reviews on pharmaceutical policy to low- and middle-income countries.

BACKGROUND: Low- and middle-income countries (LMICs) rely on available evidence when devising and implementing pharmaceutical policies. Aim of the review To provide a critical overview of systematic reviews of pharmaceutical policies, with particular focus on the relevance of such reviews in low- and middle-income countries. METHODS: A search for systematic reviews (SRs) of studies of the interventions of interest was conducted until May 2009 in MEDLINE, EconLit, CINAHL, the Cochrane site, ProQuest, EMBASE, JOLIS, ISI Web of Science, International Pharmaceutical Abstracts, International Network for Rational Use of Drugs, National Technical Information Service, Public Affairs Information Service, SourceOECD, the System for Information on Grey Literature in Europe, and the WHO library database. The search was updated to July 2013, based on the yields of the initial search strategy. RESULTS: 20 SRs that met all inclusion criteria were retrieved in full text. Four SRs were subsequently rejected on the basis of quality considerations and the findings of 16 SRs were extracted and their applicability in LMICs considered. Of these, 5 were Cochrane Reviews. All included SRs were published in English. SRs related to registration and classification policies, marketing policies, prescribing policies, reimbursement policies, policies on price and payments, co-payments and caps and multi-component policies were retrieved. No SRs related to patent and profit policies, sales and dispensing policies, policies that regulate the provision of health insurance, or policies on patient information were retrieved. CONCLUSION: Only one of the systematic reviews retrieved utilised a study conducted in a developing country. The direct applicability of the evidence from these SRs in LMICs is limited. However, as middle-income countries move towards universal health coverage, the multi-component policies that govern reimbursement for medicines, and which impose caps on payments and co-payments by patients, may become more applicable. As such they will have direct implications for the practice of clinical pharmacy in such settings. Considerable effort will be needed to systemically review the available primary evidence from studies conducted in developing country settings, where such data exist.