Cost of managing severe cutaneous adverse drug reactions to first‐line tuberculosis therapy in South Africa

Abstract

objective To compare the cost of managing treatment-limiting cutaneous adverse drug reactions (CADRs) to first-line anti-tuberculosis drugs to an alternative strategy of immediate treatment initiation using second-line drugs in a South African setting.methods Clinical and cost data were retrospectively collected from patients presenting with a firstline anti-tuberculosis therapy-associated CADR. Costs (2016 US$) were estimated using an ingredient's approach from a healthcare provider perspective. The per-patient and total cost of drug rechallenge, the current management strategy for severe CADR, was calculated. Alternative strategies involving second-line treatment were derived from literature and expert clinical advice.results Drug rechallenge costs US $5831 (95% CI: 5134-6527) per patient. Hospitalisation accounted for 62% of this cost. Alternative CADR management strategies using regimens containing rifabutin, bedaquiline and/or delamanid cost 44%-55% less than drug rechallenge (US $2651-US $3276/patient). In univariate sensitivity analyses, drug rechallenge and alternative strategies were most sensitive to hospitalisation and tuberculosis drug costs, respectively.conclusion Cutaneous adverse drug reactions to anti-tuberculosis treatment represent a significant economic burden. An alternate strategy of outpatient-initiated second-line therapy is economically feasible but requires clinical validation to assess effectiveness.keywords economic analysis, drug rechallenge, drug reaction with eosinophilia and systemic symptom, Steven Johnson syndrome, toxic epidermal necrolysis 994

Evaluating the costs of adverse drug events in hospitalized patients: a systematic review

“…Twelve studies (60%) were not focused on a specific therapeutic group. Among the studies which analyzed a specific therapeutic group, the cost of ADEs caused by anti-infective drugs ( n = 3, 15%) [ 11 – 13 ] or painkiller drugs ( n = 2, 10%) [ 14 , 15 ] were the most evaluated. Most of the studies did not assess a specific ADE ( n = 18, 90%).…”

“…Most of the studies did not assess a specific ADE ( n = 18, 90%). Only one focused on cutaneous ADEs [ 11 ] and another on gastrointestinal ADEs [ 14 ]. Two studies (10%) evaluated the costs of ADEs in geriatric population [ 16 , 17 ] and two (10%) in pediatric population [ 12 , 18 ].…”

“…Only 2 studies considered non-medical costs. Knight et al [ 11 ] included the cost of food served to the patients in their calculation and Kurle et al [ 22 ] included the cost of patients’ transport to hospital.…”

Economic evaluation of microbiological and host biomarker-based tests for the diagnosis of pleural tuberculosis in a high burden setting

“…No discount rate was applied to the model as the timeframe of the model was less than 1 year. Test costs for SM, MGIT, Xpert and ADA were obtained directly from the National Health Laboratory Service (NHLS), the designated reference lab providing services for the South African public healthcare system, and thus represented the actual costs incurred by the National TB program (NTP) (13)(14)(15). As IRISA-TB is not yet readily available through the NHLS, the unit test cost was calculated from supplier quotations for equipment and laboratory consumables as well as staff time using an ingredient's approach (Table S1).…”

Cutaneous adverse drug reactions to fixed-dose combination treatments for TB

“…Adverse drug reactions are a concern for patients on ATT, and have clinical and economic consequences, in addition to a negative patient experience [4]. Cutaneous adverse drug reactions (CADR) with ATT range from mild flushing, rash, and itch, through to less frequent severe reactions including Stevens-Johnson syndrome (SJS), generalised hypersensitivity reactions, and drug reaction with eosinophilia and systemic symptoms (DRESS) [5][6][7].…”