To the Editor: Oral terbinafine and itraconazole as well as topical ciclopirox, efinaconazole, and tavaborole solutions have been approved by the US Food and Drug Administration for onychomycosis treatment.1Lipner S.R. Pharmacotherapy for onychomycosis: new and emerging treatments.Expert Opin Pharmacother. 2019; 20: 725-735Crossref PubMed Scopus (21) Google Scholar,2Lipner S.R. Scher R.K. Onychomycosis: treatment and prevention of recurrence.J Am Acad Dermatol. 2019; 80: 853-867Abstract Full Text Full Text PDF PubMed Scopus (90) Google Scholar Our objectives were to analyze onychomycosis antifungal prescription cost and trends in utilization by dermatologists. Medicare provider utilization and payment data, part D, 2013-2018,3Medicare provider utilization and payment data: part D [database].https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/Part-D-PrescriberDate accessed: December 15, 2020Google Scholar were searched for oral terbinafine and itraconazole as well as topical ciclopirox, efinaconazole, and tavaborole prescribed by US dermatologists. Other provider types were excluded. Microsoft Excel was used to perform data analysis. Supply day was calculated by dividing the dispensed amount by the maximum medication used in 1 day. Total cost was calculated as cost per supply day multiplied by the number of supply days. Among oral antifungals, terbinafine claims experienced an annual average growth rate of 6.7%, with total spending increased by 15.1%, during 2013-2018 (Table I). This increase in claim outpaced the corresponding increase in total spending because of decreased cost per supply day ($0.36 to $0.24) (Table II). Comparatively, on average, itraconazole use was 150-fold lower than terbinafine use, with claims peaking in 2014, then decreasing by 0.9% annually, with total spending decreased by 35.6% overall (Table I). Itraconazole cost per supply day decreased by 7.4% during the study period (Table I).Table ITotal number of claims, drug supply days, and cost of oral terbinafine, oral itraconazole, topical ciclopirox, topical efinaconazole, and topical tavaboroleTotal number of claimsYearTerbinafineItraconazoleCiclopiroxEfinaconazoleTavaborole201328,86324978,77300201430,34029685,885940201531,89224288,1692343312201635,30213695,6181688401201737,554225108,8841518253201839,990209119,3821839199Total drug supply daysYearTerbinafineItraconazoleCiclopiroxEfinaconazoleTavaborole2013905,84555071,929,303002014964,00062442,149,1572641020151,023,05247492,246,03370,63010,00820161,156,63525852,490,64055,09512,47620171,233,47245612,888,04749,433738220181,338,74938323,220,61156,5806155Total Cost, $YearTerbinafineItraconazoleCiclopiroxEfinaconazoleTavaborole2013307,332.646,793.24,798,218.70.00.02014283,302.657,236.05,024,159.753,858.40.02015258,128.548,492.34,518,402.01,507,515.8339,722.62016311,248.124,785.74,752,927.41,361,291.7475,897.22017315,195.635,921.45,379,693.41,333,304.5311,679.72018353,805.630,145.55,625,524.21,665,178.7297,213.5 Open table in a new tab Table IICost per supply day of oral terbinafine, oral itraconazole, topical ciclopirox, topical efinaconazole, and topical tavaboroleYearCost per supply day terbinafine, $20130.3420140.2920150.2520160.2720170.2620180.26YearCost per supply day itraconazole, $20138.5020149.17201510.2120169.5920177.8820187.87YearCost per supply day ciclopirox, $20132.5020142.3020152.0020161.9020171.9020181.70YearCost per supply day efinaconazole, $2013None201420.40201521.30201624.70201727.00201829.40YearCost per supply day tavaborole, $2013None2014None201533.90201638.10201742.20201848.30 Open table in a new tab Among topical antifungals, ciclopirox claims experienced an annual average growth rate of 8.7%, with total spending increased by 66.9% overall (Table I). This increase in claim outpaced the increase in spending because of decreased cost per supply day ($2.50 to $1.70) (Table II). Efinaconazole claims peaked in 2015 and then decreased by 5.6% annually (Table I). However, both the total cost and cost per supply day increased yearly by 3091% and 144%, respectively, during 2014-2018 (Table II). Tavaborole claims decreased by 0.9% annually during 2015-2018, and the total cost decreased by 12.5% (Table I). Tavaborole cost per supply day increased by 42.4% annually during 2014-2018 (Table II). During 2013-2018, dermatologists had increased overall prescriptions of terbinafine and ciclopirox in the Medicare population, outpacing Medicare enrollment growth (14.3% increase during 2013-2018).4Centers for Medicare and Medicaid ServicesTwelve-year ever-enrolled trends report (2006-2018 data).https://www.cms.gov/Medicare-Medicaid-Coordination/Medicare-and- Medicaid-Coordination/Medicare-Medicaid-Coordination-Office/DataStatisticalResources/Downloads/MedicareMedicaidDualEnrollmentEverEnrolledTren dsDataBrief2006-2018.pdfDate: 2020Date accessed: December 15, 2020Google Scholar The reasons are likely multifactorial, including easy accessibility, availability of generics, low costs, and excellent safety profiles and efficacies.5Lin K. Lipner S.R. Modeling of usage and estimation of cost for efinaconazole 10% topical solution in the treatment of onychomycosis.J Am Acad Dermatol. 2020; 83: 227-228Abstract Full Text Full Text PDF PubMed Scopus (5) Google Scholar Itraconazole claims did not increase, likely because of higher cost, frequent drug-drug interactions, and unfavorable safety profile compared with that of terbinafine. Although efinaconazole and tavaborole have no reported systemic adverse events, their claims remained relatively flat, likely because of higher cost and lower accessibility and efficacy compared with those of alternatives. Future prescribing patterns will likely change because of patent expirations, availability of lower-priced generics, new antifungal approvals, and the development of devices for onychomycosis treatment. Our study included only Medicare patients, with the exclusion of Medicare Advantage, Medicaid, private insurance plans, and self-pay patients. The database includes only dermatologists who prescribe a medication ≥10 times, limiting our analysis. Because onychomycosis is the most common nail disease seen in clinical practice and Medicare enrollment continues to increase,4Centers for Medicare and Medicaid ServicesTwelve-year ever-enrolled trends report (2006-2018 data).https://www.cms.gov/Medicare-Medicaid-Coordination/Medicare-and- Medicaid-Coordination/Medicare-Medicaid-Coordination-Office/DataStatisticalResources/Downloads/MedicareMedicaidDualEnrollmentEverEnrolledTren dsDataBrief2006-2018.pdfDate: 2020Date accessed: December 15, 2020Google Scholar treatment choices will have a greater impact on health care costs. Dermatologists should consider clinical presentations, comorbidities, efficacy, safety profile, and cost while prescribing therapy for onychomycosis. Further research should focus on utilization, cost, and prescriptions trends in addition to onychomycosis patients with other insurances. Dr Lipner has served as a consultant for Verrica, Hoth Therapeutics, and Ortho-dermatologics. Dr Wang has no conflicts of interest to declare.
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