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The Burden of Illness Associated With Psoriasis: Cost of Treatment With Systemic Therapy and Phototherapy in the US

Posted on: Friday, 25 February 2005, 03:00 CST

Key words: Comorbidity - Cost of illness - Health care utilization - Psoriasis

SUMMARY

Objective: evaluate utilization and direct healthcare expenditures among psoriasis patients treated with systemic therapy and phototherapy in the United States.

Design: Cohort study using retrospective administrative medical claims.

Patients: Psoriasis patients treated with systemic therapy and phototherapy, as well as a matched cohort of non-psoriasis patients. All patients were covered by employer-sponsored insurance between 1 April 1996 and 31 December 2000.

Main outcome measures: Estimated risk of hospitalization and total annual healthcare expenditures overall and by comorbidity status were compared for persons with psoriasis using systemic therapy or phototherapy and persons without psoriasis. Annualized utilization rates for hospitalizations, and use of emergency department, outpatient physician, outpatient laboratory, and outpatient pharmaceutical services were also compared across the two cohorts.

Results: Seventeen percent of psoriasis patients were treated with systemic therapy or phototherapy. Patients with comorbid anemia, carcinoma, diabetes, depression, GI disorders, hepatotoxicity, hypertension, and nephrotoxicity had significantly higher expenditures than non-psoriasis patients with the same comorbidities (p ≤ 0.05). Elevated risk of hospitalization also contributed to higher expenditures in patients treated with systemic therapy or phototherapy. Limitations of this study include those inherent in using claims data such as dependence on diagnosis coding, the fact that psoriasis severity cannot be determined directly from claims data, confounding comorbidities, and the fact that only direct healthcare expenditures were considered in this analysis.

Conclusion: Psoriasis patients treated with systemic therapies/ phototherapies have significantly more comorbidities and higher mean total healthcare expenditures compared to non-psoriasis patients. Psoriasis patients with selected comorbidities have significantly higher mean total healthcare expenditures compared to non-psoriasis persons with the same comorbidities.

Introduction

Psoriasis, an autoimmune hyperproliferative skin disorder1, affects approximately two to three percent of people in the United States (US)2-4, or over 4.5 million Americans3,4, 1.5 million of whom seek physician care2,5. Studies estimate the annual economic burden of psoriasis between $1.6 billion and $4.3 billion1,6. Javitz et al. calculated the direct psoriasis-related costs for a cohort of 1.4 million people to be $649.6 million6. Hospitalizations accounted for $30.5 million of psoriasis expenditure while outpatient visits and psoriasis treatment accounted for $86.6 million and $532.5 million, respectively. Current research indicates that treatment costs are a notable portion of psoriasis-related expenditures7. Marchetti et al. estimated that average per patient outpatient treatment costs ranged from $1400 to $6600 depending on disease severity and treatment modality8. Feldman et al. have also demonstrated that total and out-of-pocket expenditures rise with increasing disease severity9.

Different medications are used to treat and manage psoriasis depending on disease severity. Patients with a milder form of psoriasis typically utilize topical treatments, such as topical steroids, anthralin, calcipotriene, clobetasol, and tazarotene. Patients with more severe forms of this disease (moderate to severe psoriasis) usually require treatment with systemic therapy (methotrexate, retinoids, cyclosporine) or phototherapy (photochemotherapy [PUVA] and ultraviolet B [UVB])10.

Traditional psoriasis therapies vary in their attributes, including safety concerns, time consuming regimens, and inconvenience11,12. The administration of phototherapy and systemic therapy require careful monitoring that entails additional costs for the health system2. Systemic medications can lead to serious side effects, including hypertension, bone marrow suppression, liver disease, kidney disease, and gastrointestinal symptoms1,13. Moreover, monitoring and treatment of these side effects leads to increased healthcare utilization. Studies have found that 71% of cyclosporine users with severe psoriasis develop renal impairment and 57% develop hypertension14. Other systemic treatments, such as retinoids and methotrexate, have been associated with an elevated risk of developing cirrhosis and other serious liver diseases. Methotrexate has also been associated with bone marrow toxicity1,15. Phototherapy requires expensive equipment and dedicated space in the office setting and has been associated with an increased incidence of photo-damage and skin cancers16.

The current psoriasis literature does not address the economic implications of disease-related comorbidities. In addition to side effects associated with traditional psoriasis therapies, depression and other comorbidities associated with chronic disease may also influence expenditures for psoriasis patients. Psoriasis patients have reported elevated levels of stress and depression2, with up to 75% reporting that the disease has a moderate to large impact on their daily lives3 and that the psychological impact of psoriasis adversely affects work productivity and general health-related quality of life2,15.

This paper examines the direct costs in psoriasis patients treated with systemic therapy or phototherapy. Additionally, the rates and associated costs of potential psoriasis-related comorbidities and treatment side effects are assessed in this analysis. Unlike other studies that rely on a variety of data sources to make cost estimates, this paper reports results from a large-scale comprehensive medical claims database using patient- level longitudinal data across treatment settings. Findings from this analysis will help managed care organizations, employers, and physicians understand the costs associated with the treatment of moderate-severe psoriasis using systemic therapy or phototherapy when considering new therapeutic options.

Patients and methods

Data Source

Data were derived from the MarketScan Commercial Claims and Encounters Database and the Medicare Supplemental and Coordination of Benefits (COB) Database for the years 1996 through 2000. These databases contain the inpatient and outpatient services, and outpatient prescription drug utilization and expenditures, of several million employees and their dependents/children, early retirees, and Consolidated Omnibus Budget Reconciliation Act (COBRA) continuees, covered under a variety of fee-for-service and capitated health plans. MarketScan data collection and data use procedures conform to all current US health care privacy laws and regulation.

Study Sample

The study sample included persons with a medical claim for psoriasis (ICD-9-CM 696.1) between 1 April 1996 and 31 December 1999 treated with systemic therapy and/or phototherapy. Systemic therapy includes methotrexate, cyclosporine, acitretin, mycophenolate, hydroxyurea, thioguanine, leflunomide, or biologic therapy. Phototherapy includes PUVA, UVB, Goeckerman, and some laser procedures.

The study follow-up period began with the first observed medical claim with a 696.1 ICD-9 diagnosis; this event was defined as the index date. Qualifying patients were required to have at least 12 months of continuous enrollment after the index date and three months of continuous enrollment prior to the index date. As a consequence, data between 1 January 1996 and 31 December 2000 were utilized for the analysis. The three month pre-period was used to establish baseline demographic characteristics. The final sample of patients with a psoriasis diagnosis using one or more systemic or phototherapies, and meeting the enrollment criteria, was defined as the systemic/phototherapy cohort.

A comparison sample of patients without psoriasis was matched to the systemic/phototherapy cohort at a 3:1 ratio using the SAS Survey Select function. Survey Select applies sampling at the level of the selection strata, not by choosing pair-wise matches. The following strata were considered in the selection process: age, gender, geographic region, plan type, and length of follow-up. Thus, while the overall characteristics between the non-psoriasis and systemic/ phototherapy cohorts are similar across these characteristics, they are not exact. Comorbidities were not included in the selection algorithm because one of the objectives of this study was to compare comorbidity rates for selected illnesses in the systemic/ phototherapy cohort to rates among patients without psoriasis.

Outcomes Measures and Covariates

The primary objective of this study was to quantify the economic burden of illness among patients with psoriasis treated with systemic/phototherapy compared to a matched sample without psoriasis, as measured by differences in annualized direct medical expenditures. Expenditures for all service types included the total gross payment to a provider for specific services before application of deductibles, copayments, and coordination of benefits. The analyses included assessing the burden associated with potential disease-related and known treatment-related comorbidities. Annualized utilization rates were also compute\d for hospitalization, emergency department, outpatient physician services, outpatient laboratory, and outpatient pharmaceutical services.

A Charlson Comorbidity Index (CCI) score was calculated in the pre-period and follow-up periods. The CCI score is a validated method of classifying comorbidity to predict short and long term mortality. It assigns weights to certain major diseases and the index score is a sum of those weights, representing a measure of the burden of comorbid disease17.

Rates of potential disease or treatment-related comorbidities were also assessed during the post-index period. These comorbidities were selected based on potential side effects of systemic therapies and phototherapies identified from Product Information Sheets. Side, effects for which at least 100 patients had a coded diagnosis in the study period, as well as hepatotoxicity and nephrotoxicity (well established side effects of methotrexate and cyclosporine) were further investigated for this analysis. The final set of conditions meeting these criteria included anemia (ICD-9 283.0-283.9, 285.29- 285.9), malignant neoplasm of skin (172.xx, 173.xx), diabetes (250.xx), gastrointestinal disorders (555.0-555.9, 558.9, 564.1, 556.x, 531-535, 536, 537, 558, 564, 571.6), noninfectious hepatitis and hepatosis (573.3, 573.8), hypertension (ICD-9 401.0x-404.93), and acute renal failure with tubular necrosis (584.5). In addition, the impact of depression (296.2x, 296.3x, 298.0x, 300.4x, 309.0, 309.1, 311) as a comorbidity was also investigated.

Statistical Analyses

The statistical analyses for this study focused on the comparison of a cohort of psoriasis patients using systemic/phototherapy to a matched group of patients without psoriasis. The descriptive analysis includes summary statistics on key demographic and clinical characteristics for the two cohorts. Means and standard deviations were calculated for annualized healthcare expenditures by type of service (e.g. hospitalizations, emergency department, outpatient services, and outpatient pharmaceutical prescriptions) for each group. Chi-square and t-tests were performed for key covariates of interest.

To account for the non-normal distribution of healthcare costs, exponential conditional mean (ECM) models18 were estimated to analyze mean annual overall health expenditures in the systemic/ phototherapy and non-psoriasis groups. Covariates in the two ECM models included age (< 18 vs. 18 and older), gender, region, health plan type, length of follow-up, and individual indicators for the presence of the following comorbidities: anemia, carcinoma, depression, diabetes, GI disorders, hepatotoxicity, hypertension, and nephrotoxicity. To address differences in comorbidity status across the two cohorts, estimated overall costs were generated based on the subset of the population in the systemic/phototherapy and non- psoriasis cohorts with each particular comorbidity. Coefficients, standard errors and 95% confidence intervals were obtained using statistical bootstrapping19 with 500 iterations, the point at which the standard errors stabilized to an asymptotic value. Logistic regression was used to examine the variables associated with the odds of hospitalization for psoriasis patients20,21. Covariates in the logistic regression model included an indicator if the patient was in the systemic/phototherapy cohort or control cohort, age (< 18 vs. 18 and older), gender, region, health plan type, pre-period CCI score, Medicare eligibility, and individual indicators for presence of the following comorbidities: anemia, carcinoma, depression, diabetes, GI disorders, hepatotoxicity, hypertension, and nephrotoxicity.

Results

The final sample consisted of 2489 psoriasis patients who fulfilled the systemic/phototherapy cohort criteria and a matched sample of 7467 non-psoriasis patients. Table 1 presents the demographic and clinical characteristics of the two patient cohorts. In both cohorts, approximately half of the sample was female, the mean age was 50 years, approximately 26 percent of patients in the study participated in non-capitated health insurance plans, and 17% had Medicare coverage. Systemic/phototherapy patients had significantly higher Charlson Comorbidity Index (CCI) scores and were more likely to have been diagnosed with allergic rhinitis/ acute sinusitis, anemia, carcinoma, depression, diabetes, gastrointestinal (GI) disorders, hepatotoxicity, hyperlipidemia, hypertension and nephrotoxicity compared to patients without psoriasis.

Observed treatment rates for the systemic/phototherapy cohort are presented in Table 2. Approximately 11% had claims that specified use of UVB treatment (mean annualized days of treatment = 48.0), 14% had evidence of PUVA (mean annualized days 25.2), and 39% had claims for other phototherapy (mean annualized days 36.6); 30% used methotrexate treatment (mean annualized days of treatment = 147.1), roughly 14% had acitretin treatment (mean annualized days = 98.6) and 5% received cyclosporine treatment (mean annualized days = 115.7).

Table 1. Study sample characteristics*

The systemic/phototherapy cohort had significantly higher medical utilization across all service areas compared to patients without psoriasis. Rates of hospitalization, emergency department visits, outpatient visits, laboratory services, and outpatient pharmaceutical use for the systemic/phototherapy cohort were approximately twice that of the non-psoriasis cohort (Table 3).

Comorbidity was an important determinant of the risk of hospitalization among all patients in the study population (Table 4). The presence of anemia, depression, diabetes, GI disorders, hepatotoxicity, hypertension, and nephrotoxicity were all associated with a higher risk of hospitalization (all p < 0.0001), as compared to patients without these comorbidities. Nephrotoxicity was associated with 4.7 times greater risk, and hepatotoxicity was associated with 2.2 times greater risk of hospitalization, compared to patients without these comorbidities. After controlling for demographic and comorbidity characteristics, the odds of hospitalization among systemic/phototherapy patients with psoriasis was 44% higher than that of non-psoriasis patients (p < 0.0001).

Table 2. Percent and number of days of psoriasis therapy usage*

Table 3. Annualized healthcare utilization*

Table 4. Significant predictors of annual hospitalization risk*

Table 5. Estimated total annual healthcare expenditures

Due to the importance of comorbidities impacting the risk of hospitalization and higher rates of other types of medical utilization, the expected expenditures for patients with selected comorbidities were estimated separately for the systemic/ phototherapy and non-psoriasis groups. After controlling for age, gender, region, type of health plan, and comorbidities (of which are known to be associated with psoriasis and its treatment), annual total health care expenditures were significantly higher for patients in the systemic/phototherapy group compared to the non- psoriasis group (mean difference $4121, p < 0.05) (Table 5). Differences in total healthcare expenditures between the systemic/ phototherapy group and the non-psoriasis group also were significantly higher for psoriasis patients with anemia ($4911), carcinoma ($2600), depression ($10482), diabetes ($2727), hepatotoxicity ($15784), GI disorders ($5867), hypertension ($2936) and nephrotoxicity ($14 478) compared to non-psoriasis patients with these same conditions (p < 0.01).

Discussion

Costs associated with psoriasis treatments have been previously documented6. However, no studies have specifically examined the total medical costs of patients receiving treatments generally used for moderate to severe psoriasis or the impact of comorbidities on costs. Overall, mean direct costs for psoriasis patients requiring systemic or phototherapy were estimated at $7778 annually. As expected, this estimate is higher than the overall average cost of psoriasis without respect to disease severity ($464 per patient) reported by Javitz et al., but close to the range of $1400-$6600 for varying severity levels reported by Marchetti et al6,7. Mean annual total healthcare expenditures among psoriasis patients receiving systemic or phototherapy were $4000 higher than among matched non- psoriasis patients.

To better understand the clinical factors that might influence the total treatment costs incurred by patients with psoriasis, common comorbidities and possible treatment side effects were examined. Traditional treatment options for psoriasis can have serious safety concerns that require close monitoring of patients on these therapies (e.g. elevated rates of malignancies are associated with systemic treatment and PUVA therapy21,22). In addition, other illness-related comorbidities can be costly and worrisome to the patient. Patients with moderate to severe psoriasis are more likely to suffer from both treatment-related conditions (nephrotoxicity, hepatotoxicity, carcinoma, hypertension, and hyperlipidemia) and other comorbidities, some of which may be disease-related23,24. In this study, patients with psoriasis were found to have a significantly higher prevalence of depression, diabetes, anemia, skin cancer, gastrointestinal disorders, hyper-tension, hepatotoxicity, and nephrotoxicity compared to controls, and nearly twice the overall level of comorbidity measured by the Charlson Comorbidity Index score.

Comorbid conditions were associated with significantly higher expenditures among systemic/phototherapy patients with psoriasis relative to non-psoriasis patients having these same comorbidities. This finding was driven by the increased risk of hospitalization and use of other healthcare services associated with these comorbidities, particularly nephrotoxicity, anemia, hepatotoxicity, depression, and GI disorders. The presence of nephrotoxicity and hepatotoxicity increased the annual costs \of psoriasis substantially compared to the mean cost of all psoriasis patients ($14 478 and $15 784, respectively). Other comorbidities resulted in annual costs for psoriasis patients ranging from $2600 to $10 482 more than the annual costs of non-psoriasis patients with the same comorbidities. The impact of comorbidities on healthcare costs was consistently higher for patients in the systemic/phototherapy group compared to the non-psoriasis group. There are several possible explanations for these higher costs: (1) comorbidities may be more serious when associated with psoriasis, (2) psoriasis patients who experience these comorbidities include those with the most severe disease, or (3) a combination of these and other factors.

The elevated prevalence and cost of comorbidities that may represent adverse effects of psoriasis therapy suggest that psoriasis patients experience an unmet medical need for safe and effective therapy. Systemic therapy and phototherapy treatments require cycling patients on and off therapy and monitoring lifetime exposure due to their side effects. Methotrexate and cyclosporine are often used in tandem with a patient being rotated from one treatment to the other, specifically due to dangerous side effects25. Yet, despite such precautions, 10% of patients were found to have experienced serious renal or hepatic injury or skin malignancy.

The findings from this study should be evaluated in light of several considerations. The use of a retrospective claims database for this study enabled the analysis of a large sample of psoriasis patients from across the United States. However, all patients included in the analysis had private health coverage or private Medicare supplemental coverage. In addition, the distribution of patients across regions was not reflective of the overall US population; specifically, patients from the west coast were underrepresented. The identification of psoriasis patients in the study relied on the accurate reporting of the appropriate ICD-9-CM code for psoriasis (696.1) by physician offices. Although there is a potential for miscoding, because of our additional requirement that patients also be using systemic/phototherapy, it is likely that the vast majority of patients in the cohort actually had psoriasis.

Clinical data on severity of psoriasis is not available in claims data. Nevertheless, the intensity of treatment should serve as a proxy for clinical severity because systemic and phototherapies are generally reserved for patients with moderate to severe disease22,26. Many patients and physicians have concerns about the safety profile of systemic/phototherapy. Consequently, some more severe psoriasis patients may not be treated with these therapies and thus not captured in these analyses. Other patients with severe psoriasis may only be treated with topical agents because their psoriasis was under control during the time period in which they were observed or they were no longer eligible for systemic treatments due to reaching lifetime exposure limits. For these reasons, the current paper focused on psoriasis treatments rather than the severity of disease.

Some published studies have found a relationship between psoriasis and obesity27-24. This relationship could have a confounding effect on the expenditure and hospitalization results for individual comorbid conditions. The clinical pathways associated with psoriasis and comorbid conditions would be a productive area for further investigation, but was beyond the scope of the current study.

Standard t-tests were used to assess statistical differences between the psoriasis and control groups. While the control group was matched to the study group to more evenly balance the demographic and clinical characteristics of the two groups, it is possible that the matching process may have introduced covariance among the residuals of the patients in the two groups. To the extent that this was true, it would undermine the assumption of independence inherent in standard f-tests.

Finally, by looking only at direct costs, we have not accounted for indirect costs and health-related quality of life factors. As a result, the cost estimates are likely understated. Many psoriasis patients with severe disease are under-treated or functionally disengaged from the healthcare system that is unable or unwilling to provide care5. To the extent that individuals miss work because of their psoriasis, or because of their treatments, productivity losses will be incurred. The same general principle also would apply to decrements in functioning or overall well-being among those not in the labor force. Although the current study was confined to the examination of the direct medical costs of psoriasis patients, the indirect economic and health-related quality of life burden of illness is likely to be substantial.

In conclusion, psoriasis patients treated with systemic or phototherapy incurred annual health care costs that are more than double those of a matched sample of patients without the disease. A major contributor to these excess costs was the presence of comorbid conditions that are known to be associated with toxic effects of psoriasis therapy such as, carcinoma, hepatotoxicity, and nephrotoxicity. Depression also appears to increase costs disproportionately for psoriasis patients. Patients having psoriasis and a diagnosis for other general comorbidities that might be treatment- or disease-related, such as, anemia, diabetes, gastrointestinal disorders, and hypertension, incurred significantly greater annual costs than non-psoriasis controls with the same comorbidities. Evaluating the comorbidity-related economic impact of psoriasis and its treatment provides further evidence of the complex nature of moderate to severe psoriasis and the need for safer therapeutic modalities.

Acknowledgements

Funding for this study was provided to Medstat by Genentech Inc, San Francisco, CA.

References

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9. Feldman SR, Fleischer AB Jr, Reboussin DM, et al. The economic impact of psoriasis increases with psoriasis severity. J Am Acad Dermatol 1997;37:564-9

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15. Griffiths CEM, Richards HL. Psychological influences in psoriasis. Clin Exp Dermatol 2001;26:338-42

16. Marcil I, Stern R. Squamous-cell cancer of the skin in patients given PUVA and ciclosporin: nested cohort crossover study. Lancet 2001;358:1042-45

17. D'Hoore W, Bouckaert A, Tilquin C. Practical Considerations on the Use of the Charlson Comorbidity Index with Administrative Data Bases. J Clin Epidemol 1996;49:1429-33

18. Manning WG, Mullahy J. Estimating log models: to transform or not to transform? J Health Econ 2001;20:461-94

19. Manly BFJ. Randomization, Bootstrap and Monte Carlo Methods in Biology, 2nd ed. London: Chapman & Hall, 1997

20. Hosmer D, Lemeshow S. Applied Logistic Regression. New York: John Wiley & Sons, 1989

21. Paul CF, Ho VC, McGeown C, et al. Risk of malignancies in psoriasis patients treated with cyclosporine: a 5 y cohort study. J Invest Dermatol 2003;120:211-16

22. McClure SL, Valentine J, Gordon KB. Comparative tolerability of systemic treatments for plaque-type psoriasis. Drug Safety 2002;25:915-27

23. Henseler T, Christophers E. Disease concomitance in psoriasis. J Am Acad Dermatol 1995;32:982-6

24. Lindegard B. Diseases associated with psoriasis in a general population of 159 200 middle-aged, urban, native Swedes. Dermatologica 1986; 172:298-304

25. Koo JYM. Current consensus and update on psoriasis therapy: a perspective from the U.S. J Dermatol 1999;26:723-33

26. Rapp SR, Feldman SR, Exum ML, et al. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol 1999;41(3 Pt 1):401-7

27. Henseler T, Christophers E. Disease concomitance in psoriasis. J Am Acad Dermatol. 1995;32:982-6

CrossRef links are available in the online published version of this paper: http://www.cmrojournal.com

Paper CMRO-2680_3, Accepted for publication: 25 October 2004

Published Online: 15 November 2004

doi: 10.1185/030079904X15192

William H. Crown1, Brian W. Bresnahan2, Lucinda S. Orsini3, Sean Kennedy4 and Craig Leonardi5

1 Medstat, Cambridge, MA, USA

2 Genentech, South San Francisco, CA, USA

3 Medstat, Cambridge, MA, USA

4 Medstat, Santa Barbara, CA, USA

5 St. Louis University\, St. Louis, MO, USA

Address for correspondence: Lucinda S. Orsini, Medstat, 125 Cambridge Park Drive, Cambridge, MA 02140, USA. Tel.: +1-617-492- 9343; Fax: +1-617-492-9365; email: Lucinda.Orsini@thomson.com

Copyright Librapharm Dec 2004

Source: Current Medical Research and Opinion

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