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Pharmacoeconomic Guidelines Around The World

Country/Region: South Africa

Published PE Recommendations
Guidelines for Pharmacoeconomic Evaluations of Medicines and Scheduled Substances (February 2013)
PDF in English

Published PE Recommendations Source:

Additional Information:

Last Webpage Update: Wednesday, January 17, 2018

Published PE Recommendations Key Features:

Key Features:  
Title and year of the documentGuidelines for Pharmacoeconomic Submissions (December 2012)  
Affiliation of authorsNational Department of Health 
Purpose of the documentTo describe the process to be followed for PE applications and the criteria for medicines which require submissions; To create a forum which provides independent and objective review of the value of medicines 
Standard reporting format includedYes 
DisclosureNothing required 
Target audience of funding/ author's interestsPharmaceutical companies, researchers, decision makers 
PerspectiveDefault perspective: third-party payer. Option to use a broader perspective where justified according to specific considerations. 
IndicationApproved Indication 
Target populationIf submission pertains to a specific sub-group, within the registered indication, this must be clearly defined 
Subgroup analysisYes (only if the group has been defined a priori in the clinical trial protocol and the study was sufficiently powered to analyse specified strata. 
Choice of comparatorThe main comparator is deemed to be the standard of care for local practice. All possible comparators need to be listed and justified. 
Time horizonTime Horizon is based on the natural course of the condition and the likely impact of the treatment. Depending on the type of intervention, it may be necessary to present a short term analysis based on the primary clinical data. 
Assumptions requiredYes 
Preferred analytical techniqueAny of CMA, CEA, CUA and CBA considered but choice of analysis must be clearly justified. The modelled evaluation should be based on the outcomes measures which most closely validly estimate the final outcome. 
Costs to be includedDirect costs. Indirect costs should generally be excluded. 
Source of costsNo prefered source specified, although table needs to be provided clearly identifying the source of the reference for unit costs. 
ModelingYes - where randomised trials available do not provide sufficient information. Modelling options include spreadsheet analysis, decision analysis, Markov models and Monte Carlo simulations. 
Systematic review of evidencesYes, including crtieria for inclusion and exclusion of sources of evidence, evaluation of clinical trials for inclusion, assessment of measures taken to minimize bias, meta-analysis and indirect comparison. Searhc strategy to be clearly defined and be reproducible. 
Preference for effectiveness over efficacyYes 
Preferred outcome measureLife Years Gained, deaths prevented or QALYs gained 
Preferred method to derive utilityNo preference stated for measurement of utilities 
Equity issues statedNo differentiation between QALYs accruing to different groups 
Discounting costsFuture costs should be discounted at an annual rate of 5% (range 0% to 10% for sensitivity analysis) 
Discounting outcomesFuture benefits should be discounted at an annual rate of 5% (range 0% to 10% for sensitivity analysis) 
Sensitivity analysis-parameters and rangeSensitivity analysis must be conducted on all variables using an appropriate range, as justified and referenced. Results to be presented in tabular form and tornado diagrams. 
Sensitivity analysis-methodsOne way sensitivity analysis must be conducted on all variables using an appropriate range, as justified and referenced. Two-way sensitivity analysis should be conducted on variables shown to be sensitive in the one-way analysis. 
Presenting resultsResults to be presented in a disaggregated form, and then increasingly aggregated. Present appropriately aggregated and discounted costs results separately for outcomes and resources and separtely for proposed medicine and its comparator. The final outcome should be presented as an ICER. 
Incremental analysisYes 
Total costs vs effectiveness (cost/effectiveness ratio)Yes 
Portability of results (Generalizability)The patient population to which the pharmaco-economic evaluation applies should be consistent with the patient population defined in the clinical part of the reimbursement request submission. 
Financial impact analysisNot specified 
Mandatory or recommended or voluntaryCurrently, the submission for pharmacoeconomic assessment is essentially voluntary, however, key figures in the Department of Health have to power to "call a product up" for economic assessment. 

Acknowledgement: ISPOR South Africa Chapter highly contributed to the Published PE Recommendations in South Africa and the key feature form.

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