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Supplements Management and Pharmacoeconomics of Dry Eye Disease: The Role of Cyclosporine
Prevalence, Burden, and Pharmacoeconomics of Dry Eye Disease
Stephen C. Pflugfelder, MD
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Utilization Characteristics of Topical Cycolsporine and Punctal Plugs in a Managed Care Database
Richard G. Fiscella, BS Pharm, MPH; Jeffrey T. Lee, PharmD, FCCP; John G. Walt, MBA; and Todd D. Killian, MBA, MS
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Dry Eye Disease: Pathophysiology, Classification, and Diagnosis
Henry D. Perry, MD

Utilization Characteristics of Topical Cycolsporine and Punctal Plugs in a Managed Care Database

Richard G. Fiscella, BS Pharm, MPH; Jeffrey T. Lee, PharmD, FCCP; John G. Walt, MBA; and Todd D. Killian, MBA, MS

A retrospective administrative claims analysis of treatment options for dry eye disease (DED) evaluated treatment patterns and utilization characteristics of patients receiving cyclosporine, punctal plugs, or a combination of cyclosporine and punctal plugs, and examined differences in health plan costs with the 2 treatments. A total of 23,821 commercial health plan enrollees that initiated treatment with cyclosporine or punctal plugs between January 1, 2004, and December 31, 2005, were reviewed. There were 9065 subjects in the cyclosporine group, with a mean of 3.93 (median of 3) prescription fills reported in the 365-day follow-up period per subject. The mean health plan cost per patient was $336 (median $228), with total health plan costs of $3.05 million. In the punctal plugs cohort of 8758 subjects, there was a mean of 2.85 punctal plugs procedures per patient in the follow-up period. Total health plan costs for punctal plugs procedures were $3.28 million (mean cost per patient $375). During the follow-up period, 21.1% of punctal plugs patients subsequently received cyclosporine, whereas only 11.4% of topical cyclosporine patients subsequently received punctal plugs. Our results suggest that use of topical cyclosporine before punctal plugs insertion may be of benefit to patients with DED and could result in a savings in overall treatment costs.

(Am J Manag Care. 2008;14:S107-S112)

Introduction
Various terms have been used to describe dry eye disease (DED) including keratoconjunctivitis sicca and, more recently, dysfunctional tear syndrome.1 DED is a condition characterized by the inability of the tear film to function properly in lubricating and nourishing the external eye. The typical symptoms include scratchiness, itchiness, burning, and foreign body sensation.1 Studies have demonstrated that DED appears to have an inflammatory component that is further exacerbated by various external factors.1 Increased T-cell infiltration and cytokine production of the lacrimal gland with resulting release of these inflammatory mediators onto the ocular surface have been linked to the pathophysiology of DED. These inflammatory mediators continue to assault the external ocular surface.1 By providing relief from the ocular inflammatory cascade, the underlying pathophysiology is addressed.

The prevalence of DED seems to increase with age. DED is estimated to affect more than 3.2 million women 50 years of age or older and 1.7 million men 50 years of age or older in the United States alone.2,3 Until the release of cyclosporine ophthalmic emulsion, approved by the US Food and Drug Administration (FDA) late in 2002,4 very few treatment options existed. In fact, generally the treatment consisted of artificial tears, gels, and nighttime ointments. The sheer number and variety of artificial tear solutions (the most common treatment for DED) available over the counter (OTC) illustrates that very few treatments provide the DED patient with more than palliative relief. In many cases the signs and symptoms continue to intensify with the patients administering more frequent eye drops, gels, or nighttime ointments to obtain relief. Topical cyclosporine is the first nonsteroidal prescription product for the treatment of DED that provides pharmacologic treatment for the inflammatory component of DED. Topical ocular steroids have been known to have some benefit in DED, but are limited to short-term use because of their ocular side-effect profile, which includes glaucoma, secondary infections, and cataract formation, as noted by Lemp in an accompanying article in this supplement.5

Another treatment option is to insert punctal plugs. Punctal plugs are small collagen or silicone devices that are inserted into the puncta of the lower eyelids to provide conservation of tears. However, based on what is known today about the pathophysiology of DED, punctal plugs may not provide full DED relief because the inflammatory component of the disease is not addressed.

A Delphi panel was conducted to determine treatment recommendations for DED.1 Because evidencebased treatment guidelines are not available to address all the considerations for DED, international experts convened to provide a simplified approach to treatment for the clinician incorporating the most updated evidence-based trials available. A full description of these recommendations is beyond the scope of this paper; however, treatment-specific guidelines by this International Task Force (ITF) included topical cyclosporine or steroid therapy at level 2 severity whereas punctal plugs insertion was included as an option at level 3 severity, after control of the inflammatory component of the disease (Table 1).



The purpose of this study was to investigate DED patients who are treated with topical cyclosporine and/or punctal plugs by evaluating treatment patterns of topical cyclosporine prescription fills, assessing utilization characteristics of punctal plugs patients, and examining the combination use of topical cyclosporine and punctal plugs. The study also investigated health plan costs for topical cyclosporine and punctal plugs among the topical cyclosporine and punctal plugs cohorts. An assessment of the overall clinical outcomes of topical cyclosporine relative to punctal plugs in DED patients was not conducted because the claims data analyses performed were retrospective in nature. Rather, our focus was on evaluating the utilization characteristics and costs associated with use of these treatments in patients with DED.

Methods
Claims data were gathered from a proprietary research database containing health plan enrollment, medical claims, and pharmacy claims data from 1993 until the current date. The claims submitted by providers and pharmacies to obtain payment for healthcare services rendered were collected. Enrollment data to track plan membership were procured in addition to health plan provider data to track physicians providing services. For 2004, data for approximately 13 million individuals with pharmacy and medical coverage were mined. Data are updated regularly with about 95% of medical claims complete within 6 months. The full study period was July 4, 2003, through December 31, 2006. The period for identification of study subjects was January 1, 2004, through December 31, 2005. The proprietary research database used enrollment data, pharmacy claims, and medical claims to capture a longitudinal record of medical services, irrespective of treatment site.

The study population consisted of 23,821 commercial health plan members with both medical and pharmacy benefits initiating treatment with topical cyclosporine or punctal plugs during the identification period.

Inclusion criteria:
1. More than 1 prescription filled for topical cyclosporine or 1 physician or facility claim for a punctal plugs procedure between January 1, 2004, and December 31, 2005. The service date on the first claim for either topical cyclosporine or punctal plugs was assigned as the index date.
2. Continuously enrolled in health plan for 180 days prior to the index date with no prescription for topical cyclosporine or claim for punctal plugs insertion and at least 365 days of follow-up.
3. Aged 18 years or older as of the year of the index date.
4. Patients were assigned to either the topical cyclosporine cohort or the punctal plugs cohort based on the treatment used on the index date. Patients initially treated with topical cyclosporine and punctal plugs on the same date were identified, but were not analyzed further (n = 133). Cohorts were analyzed separately according to their treatment regimen in the follow-up period (includes the index date).

The first objective was to evaluate treatment patterns for topical cyclosporine. A descriptive analysis of the topical cyclosporine cohort was conducted to assess basic utilization characteristics, including the number of unique prescription fills in the 365- day follow-up period, days supplied per prescription, quantity supplied per prescription, average days between filled prescriptions, and plan cost per filled prescription. Cyclosporine ophthalmic emulsion 0.05% is commercially available as a unit-dose vial with 32 vials per tray.

The utilization characteristics of patients with punctal plugs were also assessed. This consisted of a descriptive analysis of the punctal plugs cohort, identified as treated with a punctal plugs procedure on the index date. The outcomes measured included the number of unique procedures in the follow-up period and associated plan costs. The type of procedure was also analyzed based on appearance of Healthcare Commom Procedure Coding System (HCPCS) code A4262 (collagen) and/or A4263 (silicone) with the procedure code. In cases where an HCPCS was not reported, the procedure type was classified as “unknown.” In cases where both HCPCS designations were reported, the procedure type was classified as “both.” Collagen plugs are often inserted as initial therapy to determine if punctal plugs provide any therapeutic value for a particular DED patient. These plugs are not permanent, are absorbed over a period of days to months,6 and may be replaced with nonabsorbable silicone plugs. The average number of days between procedures, the total plan cost for the first punctal plugs procedure, and the total plan cost for subsequent punctal plugs procedures in the 365-day follow-up period were also reviewed.

The examination of the combination use of topical cyclosporine and punctal plugs included descriptive analysis of combination treatment by the topical cyclosporine and punctal plugs cohorts. These analyses focused on describing the supplemental use of topical cyclosporine or punctal plugs in patients during the follow-up period of the study. Outcomes measured for the topical cyclosporine cohort included treatment with punctal plugs in the follow-up period and time from index date to treatment with punctal plugs. The outcomes measured for the punctal plugs cohort included treatment with topical cyclosporine in the follow-up period and time from the index date to treatment with topical cyclosporine.

Patient characteristics assessed were age, sex, and length of time following the index date during which a patient was continuously enrolled. The descriptive analysis included the numbers and percents for dichotomous and polychotomous variables, and the means, medians, and standard deviations for continuous variables.

Results
Among the commercial health plan enrollees who met all inclusion criteria, there were 9065 subjects in the topical cyclosporine group, while the punctal plugs cohort had 8758 members. The overall topical cyclosporine and punctal plugs cohorts are similarly distributed across age, sex, and length of study follow-up. The majority of the study population was aged 45 years or older including 76.6% of the topical cyclosporine cohort and 65.8% of the punctal plugs cohort. The patients were predominantly female (80% in the topical cyclosporine group and 76% in the punctal plugs group).

Topical cyclosporine cohort analyses
Topical cyclosporine utilization varied during the follow-up period, with 58.4% (5294) having 2 to 4 prescriptions filled during the follow-up period, while 41.6% (3771) of topical cyclosporine patients had 5 or more prescription fills for topical cyclosporine during the follow-up period. There were 35,591 unique topical cyclosporine prescription fills reported in the 365-day follow-up period (includes the index date), with a mean of 3.93 (median of 3) per subject (Table 2). The mean days supply per topical cyclosporine prescription was 31.51. The mean quantity per prescription was 55.02 vials for the topical cyclosporine cohort. There was a mean of 128.29 (median of 92.44) days between prescription fills for the topical cyclosporine cohort.



The mean health plan cost per patient (prescription cost paid by the plan) in the 365-day followup period was $336 (median $228) for the topical cyclosporine cohort. The health plan cost per topical cyclosporine prescription for the average patient was $98. Total health plan costs for the topical cyclosporine cohort in the follow-up period were $3.05 million.

 
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