Cost-effectiveness of Confirmatory Testing Before Treatment of Onychomycosis

Abstract

IMPORTANCE Onychomycosis is the most common disease of the nail in adults. International guidelines urge health care professionals to perform confirmatory diagnostic testing before initiating systemic therapy. This approach was determined to be cost-effective in studies from the late 1990s but has not been evaluated more recently. The effect of testing on the costs of efinaconazole, 10%, topical solution treatment is unknown.OBJECTIVE To evaluate the cost and potential harm associated with 3 approaches to onychomycosis evaluation before treatment with oral terbinafine or efinaconazole, 10%. DESIGN, SETTING, AND PARTICIPANTSA decision analysis that compared the costs of 3 onychomycosis management algorithms based on recently published data of test statistics, disease prevalence, and relevant costs: (1) empirical therapy without confirmatory testing, (2) pretreatment confirmatory testing with potassium hydroxide (KOH) stain followed by periodic acid-Schiff (PAS) evaluation if KOH testing is negative, and (3) pretreatment testing with PAS. There was no direct patient evaluation. Selection of included studies was based on outcome variables and the quality of study design. The study was conducted from April 1, 2014, to September 1, 2015. MAIN OUTCOMES AND MEASURESPrimary outcomes included direct cost of onychomycosis testing and therapy and cost to avoid harm when treating patients with oral terbinafine.RESULTS At a disease prevalence of 75%, per-patient cost savings of empirical terbinafine therapy without confirmatory testing was $47 compared with the KOH screening model and $135 compared with PAS testing. The cost of testing necessary to prevent a single case of clinically relevant liver toxic effects related to

A practical application of onychomycosis cure – combining patient, physician and regulatory body perspectives

“…Despite the cost savings of performing confirmatory testing prior to treatment, family practitioners almost never perform mycological tests (46.6%) while dermatologists almost always conduct a mycological test (63.5%) . This result is compounded by the fact that clinicians (excluding dermatologists and podiatrists) have a lower positive predictive value (66%) in diagnosing onychomycosis as compared to dermatologists (75%) . Thus, incorporating mycological testing into the definition of cure is cost effective and an aid to those not well versed in onychomycosis …”

Fungal Infections From Human and Animal Contact

“…6,8 Confirmatory diagnosis is made by fungal stain (or KOH preparation) and culture of scrapings of debris following alcohol swabbing and nail clipping as described by Gupta et al 33 However, a recent analysis indicated that empiric treatment of onychomycosis with terbinafine is more cost-effective than confirmatory testing with fungal periodic acidSchiff stain or KOH prep. 34 The opposite was true for treatment with 10% topical efinaconazole. 34 Majocchi's Granuloma: Majocchi's granuloma occurs when dermatophytes like T. rubrum --or, rarely, nondermatophytes such as Aspergillus sp.…”

“…34 The opposite was true for treatment with 10% topical efinaconazole. 34 Majocchi's Granuloma: Majocchi's granuloma occurs when dermatophytes like T. rubrum --or, rarely, nondermatophytes such as Aspergillus sp. --invade the dermis and subcutaneous tissue, usually via disrupted hair follicles ( Figure 11).…”

A critical review of improvement rates for laser therapy used to treat toenail onychomycosis

“…Laser therapy is currently not covered by health insurance plans and can cost from $400 to $1 #bib200 US per session . Comparatively the cost of terbinafine, an approved onychomycosis treatment, is $10 US for a 12 week course . Another major difference between oral, topical and laser treatments is treatment duration.…”