Active Surveillance versus Spontaneous Reporting for First-Line Antiretroviral Medicines in Namibia: A Cost–Utility Analysis

Marita Mann (), Assegid Mengistu, Johannes Gaeseb, Evans Sagwa, Greatjoy Mazibuko, Joseph B. Babigumira, Louis P. Garrison and Andy Stergachis
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Marita Mann: University of Washington
Assegid Mengistu: Therapeutics Information and Pharmacovigilance Centre, Namibia Medicines Regulatory Council
Johannes Gaeseb: Namibia Medicines Regulatory Council, Ministry of Health and Social Services
Evans Sagwa: Systems for Improved Access to Pharmaceutical and Services (SIAPS/Namibia), Management Sciences for Health
Greatjoy Mazibuko: Systems for Improved Access to Pharmaceutical and Services (SIAPS/Namibia), Management Sciences for Health
Joseph B. Babigumira: University of Washington
Louis P. Garrison: University of Washington
Andy Stergachis: University of Washington

Drug Safety, 2016, vol. 39, issue 9, No 7, 859-872

Abstract: Abstract Introduction Active surveillance pharmacovigilance is a systematic approach to medicine safety assessment and health systems strengthening, but has not been widely implemented in low- and middle-income countries. This study aimed to assess the cost effectiveness of a national active surveillance pharmacovigilance system for highly active antiretroviral therapy (HAART) compared with the existing spontaneous reporting system in Namibia. Methods A cost–utility analysis from a governmental perspective compared active surveillance pharmacovigilance to spontaneous reporting. Data from a sentinel site active surveillance program in Namibia from August 2012 to April 2013 was projected to all HIV-infected adults initiating HAART in Namibia. Costs (pharmacovigilance program, HAART, adverse event [AE] treatment), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs, dollars/QALY) were evaluated. Analysis was completed for (i) cohort analysis: a single cohort beginning HAART in 1 year in Namibia followed over their remaining lifetime, and (ii) population analysis: patients continued to enter and leave care and treatment over 10 years. Results For the cohort analysis, totals were US$21,267,902 (2015 US dollars) and 116,224 QALYs for care and treatment under active surveillance pharmacovigilance versus US$15,257,381 and 116,122 QALYs for care and treatment under spontaneous reporting pharmacovigilance, resulting in an ICER of US$58,867/QALY for active surveillance compared with spontaneous reporting pharmacovigilance. The population analysis ICER was US$4989/QALY. Results were sensitive to quality of life associated with AEs. Conclusion Active surveillance pharmacovigilance was projected to be highly cost effective to improve treatment for HIV in Namibia. Active surveillance pharmacovigilance may be valuable to improve lives of HIV patients and more efficiently allocate health resources in Namibia.

Date: 2016
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DOI: 10.1007/s40264-016-0432-y

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