Cost Effectiveness Analysis of Clinically Driven versus Routine Laboratory Monitoring of Antiretroviral Therapy in Uganda and Zimbabwe
Abstract
Background
Despite funding constraints for treatment programmes in Africa, the
costs and economic consequences of routine laboratory monitoring for
efficacy and toxicity of antiretroviral therapy (ART) have rarely been
evaluated.
Methods
Cost-effectiveness analysis was conducted in the DART trial
(ISRCTN13968779). Adults in Uganda/Zimbabwe starting ART were randomised
to clinically-driven monitoring (CDM) or laboratory and clinical
monitoring (LCM); individual patient data on healthcare resource
utilisation and outcomes were valued with primary economic costs and
utilities. Total costs of first/second-line ART, routine 12-weekly CD4
and biochemistry/haematology tests, additional diagnostic
investigations, clinic visits, concomitant medications and
hospitalisations were considered from the public healthcare sector
perspective. A Markov model was used to extrapolate costs and benefits
20 years beyond the trial.
Results
3316 (1660LCM;1656CDM) symptomatic, immunosuppressed ART-naive adults
(median (IQR) age 37 (32,42); CD4 86 (31,139) cells/mm3) were followed
for median 4.9 years. LCM had a mean 0.112 year (41 days) survival
benefit at an additional mean cost of $765 [95%CI:685,845],
translating into an adjusted incremental cost of $7386
[3277,dominated] per life-year gained and $7793 [4442,39179] per
quality-adjusted life year gained. Routine toxicity tests were prominent
cost-drivers and had no benefit. With 12-weekly CD4 monitoring from year
2 on ART, low-cost second-line ART, but without toxicity monitoring, CD4
test costs need to fall below $3.78 to become cost-effective (
Conclusions
There is no rationale for routine toxicity monitoring, which did not
affect outcomes and was costly. Even though beneficial, there is little
justification for routine 12-weekly CD4 monitoring of ART at current
test costs in low-income African countries. CD4 monitoring, restricted
to the second year on ART onwards, could be cost-effective with lower
cost second-line therapy and development of a cheaper, ideally
point-of-care, CD4 test.
Citation
Medina Lara, A.; Kigozi, J.; Amurwon, J.; Muchabaiwa, L.; Nyanzi Wakaholi, B.; Mujica Mota, R.E.; Walker, A.S.; Kasirye, R.; Ssali, F.; Reid, A.; Grosskurth, H.; Babiker, A.G.; Kityo, C.; Katabira, E.; Munderi, P.; Mugyenyi, P.; Hakim, J.; Darbyshire, J.; Gibb, D.M.; Gilks, C.F. Cost Effectiveness Analysis of Clinically Driven versus Routine Laboratory Monitoring of Antiretroviral Therapy in Uganda and Zimbabwe. PLoS ONE (2012) 7 (4) e33672. [DOI: 10.1371/journal.pone.0033672]