The South African Guidelines for Pharmacoeconomic Submissions’ Evidence Requirements Compared with Other African Countries and The National Institute for Health and Care Excellence in England

ABSTRACT

Objectives: The South African Guidelines for Pharmacoeconomic Submissions (SAGPS) were compared with other African pharmacoeconomic guidelines and the National Institute of Health and Care Excellence Methods Guide (NICE MG) to make recommendations for evidence generation and further development thereof.

Methods: The European Network for HTA Core Model (version 3.0) (the Model) provided the comparative framework, using three criteria: completely, partly, or not completely requiring the same/similar information.

Results: Of 45 African countries reviewed, only Egypt had a publicly accessible pharmacoeconomic guideline (EPG). The guidelines were different in respect to their intended audience, size, and content but for all the main focus are the economic evaluation, and health problem and current treatment domains. The SAGPS and EPG had few requirements for a medicine’s safety, organizational, ethical, and legal aspects. The SAGPS completely or partly required the same/similar information as the Model for 41.2% of total issues, the EPG 33.3%, and the NICE MG 63.2%.

Conclusions: The SAGPS was similar to the EPG, but not as comprehensive as the NICE MG and could be strengthened for decision-making and priority setting. Evidence generation should focus on describing the medicine’s targeted disease and current treatment options, and associated cost and outcomes data.

KEYWORDS:

• health technology assessment
• South Africa

Declaration of interest

S Marsh owns a company that provides health economic, health technology assessment, outcomes research, and other market access services to the pharmaceutical, biotechnology, and medical device industries across Europe. However, no funding or other financial payments were received from any of my clients for this research. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Author contribution statement

The main author was responsible for the conception and design of the study, the analysis and interpretation of the data; the drafting of the article; and the final approval of the published version; the second author was involved in the design of the study; revising it critically for intellectual content and final approval of the published versions. Both authors agree to be accountable for all aspects of the work.

Reviewer Disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

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Funding

This article was not funded.