Paradoxical effects of cost reduction measures in managed care systems for treatment of severe psoriasis.

BACKGROUND: Insurance companies vary widely in their coverage policies for severe psoriasis therapies. Unfortunately, coverage policies for psoriasis therapies do not necessarily follow current treatment paradigms, such that more expensive second or third line treatments may be more easily obtained than first line treatments. METHODS: We reviewed insurance policy bulletins, statements of coverage/medical necessity, and prior authorization forms for three large insurance carriers regarding psoriasis treatment with biologic agents and phototherapy. A cost comparison was performed to estimate total costs to patients and insurer under the current system as well as a hypothetical system in which co-pays and deductibles are eliminated. Additionally, we reviewed the total cost to an insurer for placing a patient on a trial of home phototherapy before approving use of expensive biologics. RESULTS: Requirements for coverage for phototherapy treatments are often the same, if not more stringent, than those for biologics. On an annual per patient basis, insurance companies pay an estimated $5, $76, and $23,408 for home phototherapy, office phototherapy, and biologics, respectively. The first year cost to patients, however, is estimated to be $2,590, $3,040, and $920 for home phototherapy, office phototherapy, and biologics, respectively. An initial 3-month trial of home phototherapy yields a graded annual cost savings to insurers of $21,610 to $2,110 per patient. DISCUSSION: The evolution of psoriasis treatment has resulted in a paradoxical situation in which the use of lower-cost psoriasis treatments, with longer safety track records, is discouraged relative to newer options. If co-pays, deductibles, and prior authorization requirements that discourage phototherapy were reduced or eliminated, more patients and physicians would likely choose phototherapy over biologics. This has the potential to reduce overall healthcare costs for psoriasis management.

Adherence to acitretin and home narrowband ultraviolet B phototherapy in patients with psoriasis.

BACKGROUND: In the treatment of psoriasis, patient adherence to oral medications is poor and even worse for topical therapy. However, few data exist about adherence rates to home phototherapy, adding to concerns about the appropriateness of home phototherapy as a psoriasis treatment option. OBJECTIVE: We sought to assess adherence to both oral acitretin and home ultraviolet B phototherapy for the treatment of psoriasis. METHODS: In all, 27 patients with moderate to severe psoriasis were treated with 10 to 25 mg of acitretin daily, combined with narrowband ultraviolet B, 3 times weekly at home, for 12 weeks. Adherence to acitretin was monitored by an electronic monitoring medication bottle cap, and to phototherapy by a light-sensing data logger. RESULTS: Adherence data were collected on 22 patients for acitretin and 16 patients for adherence to ultraviolet B. Mean adherence to acitretin decreased steadily during the 12-week trial (slope -0.24), whereas mean adherence to home phototherapy remained steady at 2 to 3 d/wk. Adherence was similar between patients who reported side effects and those who did not. LIMITATIONS: Small sample size and lack of follow-up on some patients were limitations of this study. CONCLUSIONS: Adherence rates to home phototherapy were very good and higher than adherence rates for the oral medication. Side effects of treatment were well tolerated in this small group and did not affect use of the treatment. Home phototherapy with acitretin may be an appropriate option for some patients with extensive psoriasis.

Use of a silklike bedding fabric in patients with atopic dermatitis.

Symptoms of atopic dermatitis are often affected by environmental irritants. Modulation of potential irritants may benefit such symptoms. The purpose of this study was to evaluate the impact of a novel silklike bedding fabric for persons with mild to moderate atopic dermatitis. Participants with mild to moderate atopic dermatitis were provided a bedsheet set. Eczema Area and Severity Index and Investigator Global Assessment were the primary outcome measures. Visual Analog Scale for itch and a quality of life were also evaluated. The Wilcoxon signed rank test indicated a significant decrease in severity, with the Investigator Global Assessment score decreasing from 2.05 to 1.74 at week 8 (p = 0.03), the Eczema Area and Severity Index decreasing from 2.63 at baseline to 2.19 (p = 0.014), and the itching score decreasing from 3.97 to 3.00 (p = 0.010). An increase in the study-specific quality of life index was also observed, changing from -0.08 (no change in quality of life) to 1.23 (some improvement) (p < 0.0001). Atopic dermatitis is commonly recalcitrant to therapy and synthetic silklike bed linens may have value as another option for the treatment of this disease. This pilot study demonstrated promising results that warrant confirmation in controlled clinical studies.

Managing rosacea: a review of the use of metronidazole alone and in combination with oral antibiotics.

BACKGROUND: Rosacea is an extremely common chronic dermatosis affecting an estimated 14 million Americans. Rosacea is most commonly managed with topical metronidazole, sometimes in combination with oral antibiotics. PURPOSE: To review published studies about topical metronidazole therapy for rosacea, both as a monotherapy and in conjunction with oral antibiotics. METHODS: Medline searches were conducted for clinical trials using metronidazole, tetracycline, and doxycycline for rosacea. RESULTS: Topical metronidazole has been well studied as a rosacea therapy. Twice-daily dosing of metronidazole 1.0% cream is as effective as 250 mg tetracycline twice daily. Metronidazole 1.0% gel used once daily is as effective as azelaic acid 15% gel dosed twice daily. When dosed at subantimicrobial levels, doxycycline 20 mg taken twice daily is effective in decreasing inflammatory lesions and erythema associated with rosacea. Metronidazole 0.75% lotion is more effective when used in combination with doxycycline 20 mg dosed twice daily. DISCUSSION: Metronidazole in 0.75% strength lotion, cream, and gel and 1.0% metronidazole cream and gel are all efficacious in treating rosacea. Combination treatment with oral antibiotics at both antimicrobial and subantimicrobial doses is an efficacious means of treating rosacea. Maintenance treatment with topical metronidazole decreases relapses and allows for longer intervals between flares.

Do utilization management controls for phototherapy increase the prescription of biologics?

The use of phototherapy for psoriasis has declined because of inconvenience, managed care disincentives, and poor reimbursements. However, phototherapy is safer than other options, and the efficacy rates for different methods of phototherapy are among the highest of all available treatment options. Phototherapy is also one of the least costly treatments for moderate-to-severe psoriasis. We hypothesize that utilization management controls on phototherapy shift patients to more expensive and risky systemic treatments. Reducing disincentives on phototherapy will benefit both patients and payors, while increasing physicians' ability to manage this debilitating disease.

Gel vehicles are not inherently more irritating than creams.

BACKGROUND: It has been thought that topical gels are inherently more irritating than topical creams. Nevertheless, the irritancies of topical products are potentially quite variable, and a priori assumptions about relative irritancy of gels versus creams may not be accurate. PURPOSE: To determine whether a metronidazole gel formulation is more or less irritating to the skin compared to metronidazole creams. METHODS: A total of 32 normal, healthy volunteers were tested using irritancy patches with 0.75% metronidazole gel and cream, 1% metronidazole cream, and petrolatum (used as the "negative control"). Blinded observers evaluated the application sites for signs of irritancy. A numerical score was assigned to these irritancy patch sites each day for 21 days, or until significant irritation developed, and cumulative irritancy scores were calculated for the study period. A mixed model of variance analysis was performed. RESULTS: After 21 days of evaluation, analysis of the mean cumulative irritancy scores for each of the agents used showed there to be no statistical difference in irritancy potential between the metronidazole gel and the metronidazole creams. However, the 1% metronidazole cream was significantly more irritating than petrolatum. CONCLUSION: There was no significant difference in the cumulative irritancy potential of cream and gel preparations of metronidazole. The irritancy of topical formulations for treating rosacea should be considered on a case by case basis.

Fatal sporotrichosis.

Disseminated sporotrichosis is a serious fungal infection caused by the soil inhabitant Sporothrix schenckii. It is seen in immunocompromised patients, with a substantial number of recent cases involving patients with acquired immunodeficiency syndrome (AIDS). However, individuals with other conditions that affect the immune system also are at increased risk. We report a case of fatal disseminated sporotrichosis in a patient with liver disease and a diagnosis of a granulomatous condition presumed to be sarcoidosis; the patient was receiving systemic corticosteroid therapy. The various presentations of S schenckii infection, the risk of disseminated disease in immunocompromised hosts, and the importance of making accurate histologic diagnoses are reviewed.

Home ultraviolet B phototherapy: a cost-effective option for severe psoriasis.

The cost of treating severe psoriasis has risen dramatically, and treatment options vary widely in terms of cost and efficacy. However, little information is available on the relative costs of home phototherapy and other long-term management options, specifically in the context of managed care. A payer-perspective cost model was developed to estimate and compare the direct expenditures associated with a 30-year course of various treatments for severe psoriasis. Within two years of treatment initiation, home-administered ultraviolet B phototherapy was less costly than any of the other treatments examined, including methotrexate, psoralen plus ultraviolet A, the retinoid acitretin, and new biologic agents. In addition, the efficacy and safety profile of home ultraviolet B phototherapy make it an excellent choice for extended management.

Would elimination of copayments for phototherapy decrease the cost of treating psoriasis with systemic biologics? A cost analysis.

Phototherapy is a proven treatment method for the treatment of psoriasis, yet is typically underutilized because of the frequency of physician visits and copayments required for each session (typically 2-5 treatments/wk). Injectable biologic therapies are effective but costly. The objective of this study was to explore how changes in copayment strategies for phototherapy may affect biologic usage. Published estimates of the cost of phototherapy and biologic treatment were used to determine the costs of these treatments to patients and insurers. With an estimated patient copayment of $30 per office visit and a pharmacy copayment of $50 per month, the $1,800 annual patient expense for phototherapy far exceeds the estimated out-of-pocket expenses for etanercept, alefacept, and efalizumab ($840, $405, and $780, respectively). The estimated annual costs to MCOs ranged from $3,008 for phototherapy, to $20,300 for etanercept. Copayments for phototherapy may be shifting patients toward biologic treatment, which is more convenient but more costly to managed care plans.

The rise of the generic drug market and its implications for dermatology.

BACKGROUND: Recent data from the pharmaceutical industry suggest that generic medications are occupying an increasing percentage of the prescription drug market. OBJECTIVE: The objective of this paper was to review the trends in branded and generic dermatological and overall medications in the United States. METHODS: A thorough literature search of research papers for the period 1990-2003 was performed. In addition, we utilized data from a number of medical databases to obtain and compare information on the manufacturing, production, patents and prescription of branded and generic drugs. RESULTS: Two of the top 10 drugs used exclusively for dermatological conditions prescribed in 2003 were generics. For all drugs, the number of generic equivalents increased from 2 (in 1990) to 6 (in 2003) of the top 10 prescription drugs. CONCLUSIONS: The economic, social and scientific implications of the rising prominence of generic drugs are incredibly complex. Dermatologists, pharmacists, pharmacy benefit managers, and health policy makers should consider medication decisions carefully.

Cumulative irritation potential of metronidazole gel compared to azelaic acid gel after repeated applications to healthy skin.

BACKGROUND: Metronidazole 0.75% gel and azelaic acid 15% gel are commonly used to treat rosacea. Irritation is a common side effect. OBJECTIVE: To assess the cumulative irritation potential of metronidazole 0.75% gel and azelaic acid 15% gel. METHODS: Metronidazole 0.75% gel, azelaic acid 15% gel, and a white petrolatum negative control were applied under occlusive conditions to the upper back of a total of 33 healthy subjects. There were twelve 24-hour applications (4 times a week) and three 72-hour applications on weekends during a 3-week period. Skin reactions (erythema score +/- other local reaction) were assessed within 15 to 30 minutes of removal of the products. RESULTS: The mean cumulative irritancy index of metronidazole 0.75% gel was significantly lower than that of azelaic acid 15% gel and not significantly higher than the negative control product. There was increasing cumulative irritancy with azelaic acid; no cumulative irritancy was seen for either metronidazole or white petrolatum. CONCLUSION: Metronidazole 0.75% gel is less irritating in sustained use than azelaic acid 15% gel.

A Medicare cost comparison of minor cutaneous procedures by surgical setting.

BACKGROUND: Regulations that cause minor cutaneous procedures to be moved from the physician's office to an ambulatory surgery center (ASC) or hospital may have the potential to unnecessarily increase the costs of these procedures from the Medicare perspective. OBJECTIVE: To investigate whether minor cutaneous procedures that could reasonably be performed in the office are being done in more intense settings (ASCs or hospitals), who is performing these procedures in alternative settings, and the cost of higher intensity settings. METHODS: Medicare claims data on a number of minor cutaneous surgery procedures performed by various medical disciplines, the location in which the procedures were performed, and the ratio of minor procedures done in each surgical setting by specialty were obtained using the 1992-2000 Medicare Current Beneficiary Survey (MCBS). We used Medicare reimbursements as a measure of the cost of the procedure. RESULTS: When compared by surgical setting, the mean charges for each minor cutaneous procedure were greatest when the procedure was performed in the hospital setting and least when performed in the office setting. Owing to surgical setting, dermatologists were the most cost-effective specialists for the performance of minor cutaneous procedures. CONCLUSIONS: Regulations that discourage office-based surgery could significantly increase medical care costs.

The cost-effectiveness of rosacea treatments.

BACKGROUND: Topical and oral antibiotic/anti-inflammatory agents are mainstays of therapy for rosacea. However, costs and efficacies of these therapies vary widely. OBJECTIVE: To determine relative cost-effectiveness of common therapeutic regimens using published data. METHODS: Average daily costs (ADC) were determined based on treatment frequency and estimated gram usage for facial application of topical regimens of metronidazole (0.75%, 1%), azelaic acid (15%, 20%), sodium sulfacetamide and sulfur 10%/5%, and oral regimens of tetracycline, doxycycline, and isotretinoin. The ADC was compared with published efficacy rates from clinical trials, with efforts to standardize outcome measures. Based on these efficacy rates, costs per success were calculated and combined with office visit costs to estimate the total cost for each treatment for a 15-week period. RESULTS: The medication cost per treatment success of topical regimens ranged from $60.90 ($205.40, total, including office visits) for metronidazole 1% gel once daily, to $152.25 ($296.75, total) for azelaic acid 20% cream twice daily. Tetracycline 250 mg/day was the least costly oral agent at $6.30 per treatment success, or $150.80 total. CONCLUSION: Based on our best assessments of retrospective data from the literature, metronidazole 1% gel, once daily, was considerably less costly than several other branded and generic alternatives.

Exogenous factors in itch response.

Itch is a common sensation and a component of numerous disease states. Itch can be classified according to its origin and may be modulated by both endogenous and exogenous factors. The purpose of this chapter is to classify the common causes of exogenous itch in humans. These factors were classified into mechanical, chemical, and environmental components. A better understanding of the various mechanisms of pruritus is critical to effective research into the treatment of itch.

The utility of a data-logging device for measuring adherence to home phototherapy.

BACKGROUND: Treatment adherence to home phototherapy is not well characterized. PURPOSE: To develop an accurate measure of home phototherapy unit usage. METHODS: We tested a commercially available data logger containing a photo-sensor on two home phototherapy units. RESULTS: The data logger accurately recorded actual usage and did not record stray light sources over the study period. CONCLUSION: A data logger can accurately capture usage patterns for a home phototherapy unit. These devices could potentially be used in clinical trials to measure adherence to home phototherapy treatment regimens.

Treatment patterns and cost of nonmelanoma skin cancer management.

INTRODUCTION: Nonmelanoma skin cancer (NMSC) is the most common form of cancer in the United States, more common than all other cancers combined. The factors that affect the cost of skin cancer management are not well defined. OBJECTIVE: The objective was to estimate cost of episodes of NMSC care and the factors that impact those costs. DESIGN: Medicare Current Beneficiary Survey (MCBS) data from 1999 to 2000 were used to assess costs of episodes of NMSC care. MCBS estimates of the number of episodes occurring in three service settings (physician's office, outpatient/ambulatory surgical center, or hospital) and demographics were obtained. RESULTS: There were 497 episodes of care in 372 patients. Half the episodes were treated by dermatologists, and two-thirds were managed in physicians' offices. The mean episode cost for management in the office setting was 500 dollars (SD, +/- 487 dollars), and costs were higher when the episodes were treated in either the ambulatory surgical center or the hospital settings, 935 dollars (SD, +/- 456 dollars) and 4,345 dollars (SD, +/- 4939 dollars), respectively. CONCLUSION: With the rising incidence and cost of NMSC to Medicare, it is increasingly important to preserve the low-cost management of this disease. Maintaining care of NMSC in the office-based setting is more cost-efficient than utilizing ambulatory surgical centers or hospital operating rooms.

Adverse event reporting: lessons learned from 4 years of Florida office data.

BACKGROUND: Patient safety regulations and medical error reporting systems have been at the forefront of current health care legislature. In 2000, Florida mandated that all physicians report, to a central collecting agency, all adverse events occurring in an office setting. PURPOSE: To analyze the scope and incidence of adverse events and deaths resulting from office surgical procedures in Florida from 2000 to 2004. METHODS: We reviewed all reported adverse incidents (the death of a patient, serious injury, and subsequent hospital transfer) occurring in an office setting from March 1, 2000, through March 1, 2004, from the Florida Agency for Health Care Administration. We determined physician board certification status, hospital privileges, and office accreditation via telephone follow-up and Internet searches. RESULTS: Of 286 reported office adverse events, 77 occurred in association with an office surgical procedure (19 deaths and 58 hospital transfers). There were seven complications and five deaths associated with the use of intravenous sedation or general anesthesia. There were no adverse events associated with the use of dilute local (tumescent) anesthesia. Liposuction and/or abdominoplasty under general anesthesia or intravenous sedation were the most common surgical procedures associated with a death or complication. Fifty-three percent of offices reporting an adverse incident were accredited by the Joint Commission on Accreditation of Healthcare Organizations, American Association for Accreditation of Ambulatory Surgical Facilities, or American Association for Ambulatory Health Care. Ninety-four percent of the involved physicians were board certified, and 97% had hospital privileges. Forty-two percent of the reported deaths were delayed by several hours to weeks after uneventful discharge or after hospital transfer. CONCLUSIONS: Requiring physician board certification, physician hospital privileges, or office accreditation is not likely to reduce office adverse events. Restrictions on dilute local (tumescent) anesthesia for liposuction would not reduce adverse events and could increase adverse events if patients are shifted to riskier approaches. State and/or national legislation establishing adverse event reporting systems should be supported and should require the reporting of delayed deaths.