Onychomycosis is a fungal infection of fingernails and toenails, most
cases of which are caused by dermatophytes. The disease accounts for 1
5% of all nail disease, and affects approximately 2 to 3% of people of
all ages and both sexes. Topical treatment with tioconazole, amorolfi
ne or ciclopirox has limited effectiveness. Oral griseofulvin 500 to 1
000mg daily has been the mainstay of treatment, but prolonged therapy
is required and success rates are low. Therapy with itraconazole 200mg
daily for 3 to 6 months is more effective (70 to 85% success), althou
gh so-called 'pulse' therapy has shown similar success with potentiall
y fewer adverse effects. Terbinafine 250mg daily produces clinical and
mycological cure in approximately 80% of patients treated for 6 and 1
2 weeks for fingernail and toenail infections, respectively. The overa
ll costs of treating onychomycosis are substantial, and it has been es
timated that direct costs for Medicare patients with the disease were
$US43 million in 1 year. In addition, the disease has a negative impac
t on quality of life, in the domains of mental functioning, health con
cern, social functioning and physical appearance. Few pharmacoeconomic
analyses have been published, but all have indicated an advantage of
oral terbinafine over griseofulvin and other oral agents. To date, no
economic studies have been performed on topical agents, pulse therapy
or combination treatments.