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



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.



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.



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.
Department of Pharmacy, University of Washington, 1959 NE Pacific Ave, H-375, Box 357630, Seattle, WA, 98195-7630, USA. mm97@uw.edu.
Marita
M
Mann
Therapeutics Information and Pharmacovigilance Centre, Namibia Medicines Regulatory Council, Windhoek, Namibia.
Assegid
A
Mengistu
Namibia Medicines Regulatory Council, Ministry of Health and Social Services, Windhoek, Namibia.
Johannes
J
Gaeseb
Systems for Improved Access to Pharmaceutical and Services (SIAPS/Namibia), Management Sciences for Health, Windhoek, Namibia.
Evans
E
Sagwa
Systems for Improved Access to Pharmaceutical and Services (SIAPS/Namibia), Management Sciences for Health, Windhoek, Namibia.
Greatjoy
G
Mazibuko
Department of Global Health, University of Washington, Seattle, WA, USA.
Joseph B
JB
Babigumira
Department of Pharmacy, University of Washington, 1959 NE Pacific Ave, H-375, Box 357630, Seattle, WA, 98195-7630, USA.
Louis P
LP
Garrison
Department of Pharmacy, University of Washington, 1959 NE Pacific Ave, H-375, Box 357630, Seattle, WA, 98195-7630, USA.|Department of Global Health, University of Washington, Seattle, WA, USA.
Andy
A
Stergachis
D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000191:economics*; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects*; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects / Q000379:methods; D015331:Cohort Studies; D003362:Cost-Benefit Analysis; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D017048:Health Care Costs / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D008875:Middle Aged; D009276:Namibia; D060735:Pharmacovigilance; D019057:Quality-Adjusted Life Years; D018571:Sentinel Surveillance
D019380:Anti-HIV Agents