Exploration of the Product of the 5-Point Investigator's Global Assessment and Body Surface Area (IGA × BSA) as a Practical Minimal Disease Activity Goal in Patients with Moderate-to-Severe Psoriasis.

BACKGROUND/AIMS: In the treat-to-target era, psoriasis disease activity measures that can be easily performed in routine clinical practice are needed. This retrospective pooled analysis explored cutoff values of the product of the 5-point Investigator's Global Assessment and percentage of affected body surface area (IGA × BSA) correlating with achievement of minimal disease activity (MDA). METHODS: Post hoc analysis of the phase 3 clinical trials ERASURE, FIXTURE, FEATURE, and JUNCTURE was conducted to determine associations between IGA × BSA and 2 MDA definitions (Psoriasis Area and Severity Index [PASI] 90 and Dermatology Life Quality Index [DLQI] 0/1, or PASI score ≤1 or BSA <3%) in patients with moderate-to-severe psoriasis receiving secukinumab 300 mg. For each definition of MDA, a range of possible cutoff values of IGA × BSA was examined at each time point. The optimal cutoff value was determined using Youden index (YI), calculated as (sensitivity + specificity - 1). RESULTS: For MDA defined as PASI 90 and DLQI 0/1, optimal IGA × BSA cutoffs were 2.10 at week 12 (YI, 0.60; sensitivity, 0.78; specificity, 0.82), 1.02 at week 24 (YI, 0.55; sensitivity, 0.73; specificity, 0.82), and 1.00 at week 52 (YI, 0.65; sensitivity, 0.79; specificity, 0.86). For MDA defined as PASI score ≤1 or BSA <3%, optimal IGA × BSA cutoffs were 2.98 at week 12 (YI, 0.91; sensitivity, 0.99; specificity, 0.92), 2.80 at week 24 (YI, 0.94; sensitivity, 0.99; specificity, 0.95), and 3.00 at week 52 (YI, 0.96; sensitivity, 1.00; specificity, 0.96). CONCLUSION: IGA × BSA could be a valid measure highly associated with achievement of MDA.

The Impact of Price Reductions After Loss of Exclusivity in a Cost-Effectiveness Analysis: Fingolimod Versus Interferon Beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis.

BACKGROUND: Cost-effectiveness analyses tend not to take into account the availability of lower-priced generics following loss of exclusivity (LOE) of branded products. By not considering these generics, which are typically adopted quickly, total costs are likely to be overestimated and may be unreflective of real-world payer conditions in the United States. OBJECTIVE: To assess the impact of including future price reductions following LOE on the cost-effectiveness of fingolimod versus intramuscularly administered interferon beta-1a (IM IFNß-1a) as treatments for multiple sclerosis. METHODS: This model was adopted from a previously published Markov model and was conducted from a U.S. payer perspective over a 10-year time horizon. Patients with relapsing-remitting multiple sclerosis entered the model and received either fingolimod (an oral therapy) or IM IFNß-1a (an injectable). These treatments reflect the interventions studied in the TRANSFORMS randomized clinical trial. Clinical, cost, and utility inputs were based on a recent cost-effectiveness review of therapies for multiple sclerosis. To model LOE, price reductions and the proportion of patients switching to generic versions following LOE were based on published estimates. Price reductions varied to reflect the difference in product types (oral vs. large molecule injectable). Assumptions were also made around the proportion of patients switching to generic versions over time following LOE and the projected date of LOE. Outcomes included per-patient total direct costs (medication, administration and monitoring, and disease-related costs including relapses), quality-adjusted life-years, and the incremental cost per quality-adjusted life-year. RESULTS: Assuming no price reductions following LOE, fingolimod was considered cost-effective versus IM IFNß-1a ($118,434 per quality-adjusted life-year), despite having higher total direct costs over 10 years ($475,740 vs. $446,792). When including future price reductions following LOE, total direct costs were reduced with fingolimod and were lower than those accrued with IM IFNß-1a over the model time horizon ($308,570 vs. $442,653). Cost-effectiveness results were sensitive to changes in both clinical parameters and medication costs. Scenario analyses demonstrated that an earlier date of LOE was associated with lower total costs. CONCLUSIONS: Health economic models may predict higher total costs when the price reductions following LOE are not considered. Here, oral fingolimod was seen to be cost-saving versus IM IFNß-1a over the model time horizon when such price reductions were included. The cost implications of not accounting for future price changes may determine whether an intervention is considered cost-effective and as such may influence reimbursement decisions based on cost-effectiveness thresholds. Multiple product types (e.g., oral, injectable, and infused agents) have been approved for use as treatments for multiple sclerosis in the United States, and LOE is likely to have a different effect on each of these therapies. DISCLOSURES: This study was funded by Novartis Pharmaceuticals Corporation. Hua and Hersh report consulting fees from Novartis for work on this study. Hua also reports speaking, advisory board, and consulting fees from Biogen, Genzyme, Teva, EMD Serono, Genentech, TG Therapeutics, and Novartis for activities outside of this study. Hersh also reports speaking and consulting fees from Novartis, Biogen, Genzyme, Genentech, and EMD Serono for activities outside of this study, and research grants from PCORI and Biogen. At the time of this research, Morten and Kusel were paid employees of Costello Medical, which was contracted by Novartis to undertake some of this study's work. Lin, Cave, Herrera, and Ko were paid employees of Novartis at the time of this research. Cave, Herrera, and Ko also report owning stock in Novartis Pharmaceuticals. Varga provided services to Novartis at the time of this research and has nothing further to disclose. This research was presented as a poster at the AMCP Managed Care & Specialty Pharmacy Annual Meeting 2017; March 27-30, 2017; Denver, CO.

Real-world durability of relapse rate reduction in patients with multiple sclerosis receiving fingolimod for up to 3 years: a retrospective US claims database analysis.

OBJECTIVE: To assess real-world durability of reduction in relapse rates among patients with multiple sclerosis (MS) receiving fingolimod therapy over a longer-term period of follow-up. METHODS: Patients with MS who initiated fingolimod were identified from a US claims database (January 1, 2009 to September 30, 2016) and followed for 3 years post-initiation. Annualized relapse rates (ARRs) were calculated during the 1-year pre-initiation period, and during each year over the 3-year follow-up period. Time from fingolimod initiation to discontinuation (≥60-day treatment gap) was also summarized. RESULTS: Among 1599 fingolimod initiators, 1158 (72%) had continuous fingolimod use up to the start of year 2 and 937 (59%) had continuous fingolimod use up to the start of year 3. The mean baseline ARR during the 1-year pre-initiation period for all initiators was 0.51. After fingolimod initiation, mean ARRs were consistently lower in each year of follow-up: 0.25 (95% CI: 0.22, 0.28) in year 1 for all fingolimod initiators, 0.22 (0.18, 0.25) in year 2 for patients with continuous fingolimod use up to the start of year 2, and 0.23 (0.19, 0.27) in year 3 for patients with continuous fingolimod use up to the start of year 3. Median time on treatment was 33 months for all patients initiating fingolimod. CONCLUSIONS: Patients with MS who received continuous fingolimod therapy experienced a sustained reduction in relapse rates (>50% vs. baseline) during each year of a 3-year follow-up period.

Direct healthcare costs and comorbidity burden among patients with psoriatic arthritis in the USA.

This study assessed the comorbidity burden and direct healthcare costs associated with psoriatic arthritis (PsA). Adults (18-64 years) with ≥ 2 claims for a PsA diagnosis ≥ 30 days apart in the Truven Health MarketScan database (July 2009-June 2014) were selected as the case group. The index date was randomly selected after the first claim for PsA. Controls free of PsA and psoriasis (PsO) in their entire claims history were assigned the same index date and were matched with the cases on age, gender, and geographic region. All patients had ≥ 12 months of continuous eligibility before and after (study period) the index date. PsA-associated comorbidities, medication use, and medical service utilization were compared between matched groups using Wilcoxon signed rank and McNemar's tests. Costs were compared using multivariable generalized linear models. The 35,061 matched pairs had a mean age of 49.11 ± 10.20 years and 52.73% were female. During the study period, PsA patients had more PsA-associated comorbidities and significantly higher medication use than controls (all-cause medications 96.64 vs. 78.95%, p < 0.0001). PsA patients had significantly greater medical service use (inpatient admissions, hospitalization days, emergency room visits, outpatient services; all p < 0.0001) and higher annual direct healthcare costs per patient than controls (adjusted cost difference [ACD] = $18,482, including higher medical costs [ACD = $6440] and all-cause pharmacy costs [ACD = $11,737]; all p < 0.0001). Overall, PsA patients had a significantly higher PsA-related comorbidity burden, healthcare utilization, and direct healthcare costs than people free of PsA and PsO, underscoring the need for more effective treatments and improved care delivery systems.

Higher Psoriasis Skin Clearance Is Associated with Lower Annual Indirect Costs in the United States: A Post Hoc Analysis from the CLEAR Study.

BACKGROUND: Psoriasis is associated with a high economic burden to society. New psoriasis systemic treatments offer the potential for improved skin clearance. Whether a higher degree of clearing translates into economic benefit through decreased work impairment has not been fully determined. OBJECTIVE: To assess whether more complete clearing of psoriasis is associated with a reduction in disease-related indirect costs. METHODS: Pooled data from employed patients included in the CLEAR study, a phase 3b study comparing the efficacy and safety of secukinumab (337 subjects) versus ustekinumab (339 subjects), were classified into 4 levels of skin clearance improvement at weeks 16 and 52: Psoriasis Area and Severity Index (PASI) improvement from baseline of < 50% (PASI < 50), 50%-74% (PASI 50-74), 75%-89% (PASI 75-89), and ≥ 90% (PASI ≥ 90). Patients completed the Work Productivity and Activity Impairment questionnaire for psoriasis (WPAI-PSO), which assessed absenteeism, presenteeism, and a composite overall work impairment over the previous 7 days at weeks 16 and 52. U.S. Department of Labor data were used to calculate annual indirect costs due to work productivity loss. RESULTS: In the CLEAR study, 452 (67%) were employed at baseline and included in this analysis. At week 16, mean overall work impairment significantly decreased with higher PASI improvements: 22.8% for PASI < 50, compared with 13.3% for PASI 50-74 (P = 0.001); 6.4% for PASI 75-89 (P < 0.001); and 4.9% for PASI ≥ 90 (P < 0.001), with the majority of work impairment related to presenteeism. Calculated mean work hours lost by overall work impairment decreased with higher PASI improvements: 8.2 hours lost/week (429 hours/year) for patients with PASI 50; 4.6 hours lost/week (251 hours/year) for PASI 50-74; 2.3 hours lost/week (121 hours/year) for PASI 75-89; and 1.8 hours lost/week (93 hours/year) for PASI ≥ 90. Associated mean annual indirect costs due to work productivity loss per worker decreased with higher PASI improvements: $10,318 for PASI < 50, $6,042 for PASI 50-74, $2,901 for PASI 75-89, and $2,233 for PASI ≥ 90. Similar results were observed at week 52. Mean overall work impairment decreased with higher PASI improvements, ranging from 26.3% for PASI < 50 to 6.9% for PASI ≥ 90. A decrease in overall work hours lost (ranging from 9.5 hours lost/week [495 hours/year] for PASI < 50 to 2.5 hours/week [130 hours/year] for PASI ≥ 90), as well as associated annual indirect costs due to work productivity loss (ranging from $11,906 for PASI < 50 to $3,125 for PASI ≥ 90), were also shown with higher PASI improvements at week 52. CONCLUSIONS: Among working patients with moderate to severe psoriasis, higher PASI improvements were associated with lower work productivity loss and reduced annual indirect costs. By improving and sustaining skin clearance, psoriasis treatments may contribute to increased work productivity and decreased societal economic burden. DISCLOSURES: Funding for this study was provided by Novartis Pharmaceuticals. Zhao and Herrera are employed by Novartis. Gilloteau is employed by Novartis Pharma AG. McBride, Graham, and Miles are employed by RTI Health Solutions, which provides consulting and other research services to pharmaceutical, device, governmental, and nongovernmental organizations and received funding from Novartis for manuscript development, analysis development, and general consultation. Feldman reports grants and personal fees from Novartis, Abbvie, Janssen, Lilly, and Celgene, along with personal fees from Amgen and Valeant.

Treatment Changes in Patients With Moderate to Severe Psoriasis: A Retrospective Chart Review.

BACKGROUND: Psoriasis treatment involves topical medications, oral medications, phototherapy, and/or biologics. The treatments used depend on a myriad of factors that change over time. OBJECTIVE: To characterise the frequency of and reasons for treatment changes in patients with moderate to severe psoriasis. METHODS: A chart review examined treatment changes at 902 visits by 116 patients seen between January 1, 2010, and June 30, 2015, for moderate to severe psoriasis and the physicians' justifications for those changes. 'Treatment change' was defined as switching between, adding, or removing medication classes or switching within the oral or biologic class. RESULTS: There were 221 visits with treatment changes identified, and a change occurred every 4.1 visits. On average, there were 1.2 treatment changes per year. Patients treated for at least 1 year averaged 1 treatment change every 16 months. The most common type of change was from one biologic to another biologic (24.9%), followed by adding a nonbiologic to a biologic (18.6%). The most common reason for switching was poor control or flare of psoriasis. Affordability was a more common problem for biologics than for nonbiologic treatments. CONCLUSIONS: Biologic treatment options provide a major improvement over older systemic treatments, but patients still undergo frequent treatment changes to help control their disease.

Real-World Adherence and Persistence to Oral Disease-Modifying Therapies in Multiple Sclerosis Patients Over 1 Year.

BACKGROUND: Disease-modifying therapies (DMTs) are indicated to reduce relapse rates and slow disease progression for relapsing-remitting multiple sclerosis (MS) patients when taken as prescribed. Nonadherence or non-persistence in the real-world setting can lead to greater risk for negative clinical outcomes. Although previous research has demonstrated greater adherence and persistence to oral DMTs compared with injectable DMTs, comparisons among oral DMTs are lacking. OBJECTIVE: To compare adherence, persistence, and time to discontinuation among MS patients newly prescribed the oral DMTs fingolimod, dimethyl fumarate, or teriflunomide. METHODS: This retrospective study used MarketScan Commercial and Medicare Supplemental claims databases. MS patients with ≥ 1 claim for specified DMTs from April 1, 2013, to June 30, 2013, were identified. The index drug was defined as the first oral DMT within this period. To capture patients newly initiating index DMTs, patients could not have a claim for their index drugs in the previous 12 months. Baseline characteristics were described for patients in each treatment cohort. Adherence, as measured by medication possession ratio (MPR) and proportion of days covered (PDC); persistence (30-day gap allowed); and time to discontinuation over a 12-month follow-up period were compared across treatment cohorts. Adjusted logistic regression models were used to examine adherence, and Cox regression models estimated risk of discontinuation. RESULTS: 1,498 patients newly initiated oral DMTs and met study inclusion criteria: fingolimod (n = 185), dimethyl fumarate (n = 1,160), and teriflunomide (n = 143). Patients were similar across most baseline characteristics, including region, relapse history, and health care resource utilization. Statistically significant differences were observed across the treatment cohorts for age, gender, previous injectable/infused DMT use, and comorbidities. Adherence and time to discontinuation were adjusted for age, gender, region, previous oral and injectable/infused DMT use, relapse history, and Charlson Comorbidity Index score. Relative to fingolimod patients, dimethyl fumarate and teriflunomide patients were significantly less likely to have an MPR ≥ 80% (OR = 0.18; 95% CI = 0.09-0.36; P < 0.001 and OR = 0.19; 95% CI = 0.08-0.42; P < 0.001, respectively). Similarly, relative to fingolimod patients, dimethyl fumarate and teriflunomide patients were significantly less likely to have PDC ≥ 80% (OR = 0.47; 95% CI = 0.33-0.67; P < 0.001 and OR = 0.37; 95% CI = 0.23-0.59; P < 0.001, respectively). Additionally, the HR for discontinuation was about 2 times greater for dimethyl fumarate (HR = 1.93; 95% CI = 1.44-2.59; P < 0.001) and teriflunomide patients (HR = 2.27; 95% CI = 1.57-3.28; P < 0.001) compared with fingolimod. CONCLUSIONS: In a real-world setting, patients taking fingolimod had better adherence and persistence compared with patients taking other oral DMTs over 12 months. Coupled with clinical factors, medication adherence and persistence should be important considerations when determining coverage decisions for MS patients. DISCLOSURES: This research was funded by Novartis Pharmaceuticals. Johnson, Lin, Ko, and Herrera are employed by Novartis Pharmaceuticals and own Novartis stock. Huanxue Zhou is employed by KMK Consulting, which provides consulting services to Novartis. Study concept and design were contributed by Johnson, Lin, Ko, and Herrera. Zhou collected the data, and data interpretation was performed by Johnson, Lin, Ko, and Herrera. All authors were involved in manuscript revision. The abstract for this study was presented at the AMCP Nexus 2015; October 26-29, 2015; Orlando, Florida.

Drivers of Healthcare Costs Among the Costliest Patients With Psoriasis Over Three Years in a United States Health Plan.

OBJECTIVE: To compare patients with psoriasis by cost level over 3 years.

METHODS: Psoriasis patients in a large US health plan in 2011-2013 were identified. Four groups were created by healthcare costs excluding biologics: patients having top 10% of costs in all 3 years (Top), top 10% in 2 of 3 years (High), bottom 90% in 2 of 3 years (Medium), and bottom 90% in all 3 years (Bottom). Comorbidities, utilization, and costs between groups were compared.

RESULTS: The study included 18,653 patients: 514 (3%), 805 (4%), 2,443 (13%), and 14,891 (80%) patients in the Top, High, Medium, and Bottom groups, respectively. Significantly more patients in the Top vs Bottom group had diabetes (31.1% vs 9.4%), cardiovascular disease (26.5% vs 4.3%), psoriatic arthritis (25.7% vs 10.7%), depression (27.8% vs 6.9%), and anxiety (22.0% vs 7.9%) in 2011 (all P less than 0.05). Patients in the Top group had more unique 2011 prescriptions (17.7 vs 6.6; P less than 0.001) than the Bottom group, but similar biologic use (22.4% vs 21.6%). Patients in the Top, High, Medium, and Bottom groups had mean 2011 total costs of $68,913, $40,575, $24,292, and $8,815, and contributed to 14%, 13%, 23%, and 51% of the overall costs, respectively. Mean total costs increased 14-18% over time for all groups. Although mean 2011 total costs for patients in the Top group were 7.8 times of those in the Bottom group, psoriasis-related costs were less disparate ($8,716 vs $4,541). Compared with patients in the Bottom group, those in the Top group were more likely to have any 2011 hospitalization (36.8% vs 2.6%; psoriasis-related: 11.1% vs 0.7%) or emergency visit (50.8% vs 20.8%; psoriasis-related: 3.9% vs 1.0%).

CONCLUSION: The costliest patients with psoriasis had significantly higher prevalence of comorbidities, prescription fills, inpatient and emergency utilization, but not biologic medication use or biologic costs.

J Drugs Dermatol. 2017;16(7):651-658.

Clinical and Patient-reported Outcomes in Patients with Psoriatic Arthritis (PsA) by Body Surface Area Affected by Psoriasis: Results from the Corrona PsA/Spondyloarthritis Registry.

OBJECTIVE: Psoriatic arthritis (PsA) is commonly comorbid with psoriasis; the extent of skin lesions is a major contributor to psoriatic disease severity/burden. We evaluated whether extent of skin involvement with psoriasis [body surface area (BSA) > 3% vs ≤ 3%] affects overall clinical and patient-reported outcomes (PRO) in patients with PsA. METHODS: Using the Corrona PsA/Spondyloarthritis Registry, patient characteristics, disease activity, and PRO at registry enrollment were assessed for patients with PsA aged ≥ 18 years with BSA > 3% versus ≤ 3%. Regression models were used to evaluate associations of BSA level with outcome [modified minimal disease activity (MDA), Health Assessment Questionnaire (HAQ) score, patient-reported pain and fatigue, and the Work Productivity and Activity Impairment questionnaire score]. Adjustments were made for age, sex, race, body mass index, disease duration, and history of biologics, disease-modifying antirheumatic drug, and prednisone use. RESULTS: This analysis included 1240 patients with PsA with known BSA level (n = 451, BSA > 3%; n = 789, BSA ≤ 3%). After adjusting for potential confounding variables, patients with BSA > 3% versus ≤ 3% had greater patient-reported pain and fatigue and higher HAQ scores (p = 2.33 × 10-8, p = 0.002, and p = 1.21 × 10-7, respectively), were 1.7× more likely not to be in modified MDA (95% CI 1.21-2.41, p = 0.002), and were 2.1× more likely to have overall work impairment (1.37-3.21, p = 0.0001). CONCLUSION: These Corrona Registry data show that substantial skin involvement (BSA > 3%) is associated with greater PsA disease burden, underscoring the importance of assessing and effectively managing psoriasis in patients with PsA because this may be a contributing factor in PsA severity.

Economic Impact of Above-Label Dosing with Etanercept, Adalimumab, or Ustekinumab in Patients with Psoriasis.

BACKGROUND: Patients with moderate-to-severe psoriasis may be treated with above-label doses of biologics in an attempt to optimize outcomes. Dose escalation will have an effect on the cost of treatment. OBJECTIVE: To examine costs related to above-label use of etanercept, adalimumab, and ustekinumab among patients with moderate-to-severe psoriasis. METHODS: A retrospective study was performed using a large U.S. claims database. Patients were included in the study if they were aged ≥ 18 years with a diagnosis of psoriasis (excluding psoriatic arthritis) and had at least 1 medication fill for etanercept, adalimumab, or ustekinumab between January 1, 2011, and June 30, 2012. In addition, patients were required to have continuous enrollment for 12 months before, and 18 months after, the first biologic use (index biologic) during the maintenance period (defined as the period following the induction period in which each agent was titrated to its recommended maintenance dose per label) and at least 1 prescription filled for the index biologic during the 18 months after the maintenance period. Extensive above-label use was defined as taking an above-label dose (at least 10% higher than indicated in the label) for ≥ 180 days over a 12-month period following the maintenance period. Percentages of patients with extensive above-label use, mean number of days of above-label use, and additional costs associated with extensive above-label use (abovelabel cost minus on-label cost) were examined. RESULTS: The study included 3,310 patients who started treatment with etanercept (n = 1,443), adalimumab (n = 1,447), or ustekinumab (n = 420). Extensive above-label use occurred in 20.0% of etanercept patients, 2.6% of adalimumab patients, and 14.8% of ustekinumab patients. The mean duration of extensive above-label use was roughly similar for the 3 biologics (mean days [±SD]: 282 [±55] for etanercept, 279 [±57] for adalimumab, and 305 [±43] for ustekinumab). Additional annual costs per patient because of extensive above-label use were $19,458 for etanercept, $18,972 for adalimumab, and $21,045 for ustekinumab. Total additional annual costs were $5,623,362 for etanercept, $701,964 for adalimumab, and $1,304,790 for ustekinumab. CONCLUSIONS: Psoriasis patients treated with etanercept, adalimumab, or ustekinumab had extensive above-label use over the 12-month follow-up period, which subsequently led to higher costs. DISCLOSURES: Novartis Pharmaceuticals Corporation sponsored this study and the resultant publication. BioScience Communications provided medical writing and editorial support, which was also funded by Novartis Pharmaceuticals Corporation. Feldman was engaged by Novartis Pharmaceuticals as a paid clinical expert and scientific advisor for this study. He has received research support and speaking and/or consulting fees from AbbVie, Advance Medical, Amgen, Anacor, Astellas, Baxter, Boehringer Ingelheim, Caremark, Celgene, Eli Lilly, Galderma, GSK/Stiefel, Informa, Janssen, LEO Pharma, Merck, Merz, Mylan, National Biological, National Psoriasis Foundation, Pfizer, Qurient, Suncare Research, UpToDate, and Valeant; is the founder and majority owner of www.DrScore.com ; and is founder and part owner of Causa Research. Zhao, Herrera, Tian, and Li are employees of Novartis Pharmaceuticals. Zhou is a paid consultant for Novartis Pharmaceuticals and is an employee of KMK Consulting. Study concept and design were contributed by Feldman, Zhao, Herrera, and Li. Zhou and Li were responsible for data collection. Data were interpreted by Feldman and Zhao, with assistance from Zhou, Herrera, Tian, and Li. The manuscript was written primarily by Feldman and Zhao, with assistance from Zhou and Li. The manuscript was revised by Feldman and Zhao, assisted by Zhou, Herrera, Tian, and Li. Portions of this work were presented at the 34th Anniversary Fall Clinical Dermatology Conference in Las Vegas, Nevada, October 1-4, 2015.

Burden and treatment patterns of advanced basal cell carcinoma among commercially insured patients in a United States database from 2010 to 2014.

BACKGROUND: The burden of advanced basal cell carcinoma (aBCC) is not fully understood. OBJECTIVE: To compare BCC disease burden and treatment patterns for aBCC with those for non-aBCC. METHODS: A retrospective, insurance claims-based study design was used. Adults with ≥2 claims associated with a BCC diagnosis (ICD-9-CM 173.x1) separated by ≥30 days on or after October 1, 2011, were classified as aBCC or non-aBCC by using an algorithm based on metastasis diagnosis, radiation therapy use, and medical oncologist/other specialist use. Non-aBCC and aBCC patients were matched 1:1 on the basis of age, sex, and region, and assigned the same index date (date of first qualifying diagnosis or event). Comparisons were made using Wilcoxon signed-rank (continuous variables) and McNemar's (categorical variables) tests. RESULTS: In total, 847 matched aBCC/non-aBCC patient pairs were selected (mean age 75 years; 57% men; locally advanced BCC, n = 826; metastatic BCC, n = 21). During the 12-month study period following the index date, aBCC patients had a significantly higher mean Charlson Comorbidity Index (P = .0023), significantly higher mean numbers of outpatient/dermatologist/medical oncologist visits (all P < .0001), and significantly higher mean total/medical/inpatient/outpatient/BCC treatment costs (all P < .05). LIMITATIONS: This study only included information from a database on commercial insurance and Medicare claims. The algorithm criteria might have restricted patient numbers; data were not fully reflective of targeted therapy era. CONCLUSIONS: aBCC patients had a higher disease burden than non-aBCC patients. Cost differences were largely driven by higher BCC treatment costs, specifically radiation therapy.

Rethinking costs of psoriasis: 10% of patients account for nearly 40% of healthcare expenditures among enrollees with psoriasis in a U.S. health plan.

OBJECTIVE: To examine characteristics, healthcare utilization and costs among patients with psoriasis who have high medical costs. METHODS: This is a retrospective study of patients with psoriasis with continuous enrollment from 1 January 2011 to 31 December 2013 in a large US health plan. Total paid 2012 healthcare costs excluding biologics (to identify costliest not due to biologic costs) were used to create cohorts representing the top 10% (T10) and bottom 90% (B90) of expenditures. Demographics, comorbidities, prescriptions, all-cause and psoriasis-related healthcare utilization and costs were compared between cohorts. Logistic regression identified demographic and clinical characteristics associated with the 2012 T10 cohort status. RESULTS: 18,653 patients (mean age 48 years; 49% female) were included. Patients in the T10 group accounted for 26% (2011), 39% (2012) and 26% (2013) of all-cause costs including biologics and 13% (2011), 18% (2012) and 11% (2013) of psoriasis-related costs. Mean 2012 total costs were $58,030 for T10 vs. $10,295 for B90 (all-cause) and $10,475 vs. $5301 (psoriasis-related). T10 patients in 2012 filled more prescriptions and were more likely to use corticosteroids (57% vs. 31%); however, biologic use and costs were similar (any use: 23% vs. 24%; prescriptions: 1.5 vs. 1.7, biologic costs: $4959 vs. $5095). Compared with B90 patients, T10 patients were more likely to have hospitalizations (all-cause: 45% vs. 3%; psoriasis-related: 14% vs. 1%) and ER visits (all-cause: 53% vs. 21%; psoriasis-related: 3% vs. 1%), and more likely to have renal disease (odds ratio (OR) = 2.05), depression (OR =1.96), cardiovascular disease (OR =1.88), psoriatic arthritis (OR =1.57) and diabetes (OR =1.50) (all p < .05). CONCLUSIONS: The T10 patient cohort in 2012 accounted for nearly 40% of overall healthcare expenditures. However, cost differences between the T10 and B90 patients were not attributable to psoriasis-related biologic treatment utilization and costs. The T10 patients had significantly more inpatient and emergency utilization, and comorbid medical conditions.

Assessing the overall benefit of a medication: cumulative benefit of secukinumab over time in patients with moderate-to-severe plaque psoriasis.

BACKGROUND: Conventional measurements for assessing psoriasis treatment effects capture improvements at fixed, pre-specified timepoints, failing to account for cumulative clinical benefit over time. OBJECTIVE: Explore the innovative concept of "cumulative clinical benefit" by examining the effect of secukinumab over 52 weeks in moderate-to-severe psoriasis patients. METHODS: Cumulative clinical benefit was determined as the area-under-the-curve of the percentage of responders over 52 weeks (AUC0-52 wks), using pooled data from two phase III trials for patients receiving secukinumab (300 or 150 mg) or etanercept. RESULTS: Normalized cumulative benefit with secukinumab 300 mg, secukinumab 150 mg, and etanercept was 74.2%, 63.2%, and 50.5%, respectively, for PASI 75; 58.0%, 42.5%, and 29.5%, respectively, for PASI 90; 32.3%, 18.8%, and 8.7%, respectively, for PASI 100; and 58.3%, 47.9%, and 38.3%, respectively, for DLQI 0/1. 52-week PASI 75 clinical benefit ratios for secukinumab 300 and 150 mg versus etanercept were 1.47 and 1.25, respectively; the ratio of the two secukinumab doses was 1.17, favoring 300 mg. LIMITATIONS: Post hoc analysis. CONCLUSION: Cumulative clinical benefit estimated by AUC0-52 wks is a novel measure for comparing psoriasis treatments. Secukinumab 300 mg provides greater cumulative clinical benefit than secukinumab 150 mg; both provide greater cumulative benefit than etanercept.

Incidence and prevalence of basal cell carcinoma (BCC) and locally advanced BCC (LABCC) in a large commercially insured population in the United States: A retrospective cohort study.

BACKGROUND: Accurate evaluation of basal cell carcinoma (BCC) in the United States was not possible before the 2011 release of BCC-specific International Classification of Diseases, Ninth Revision, Clinical Modification codes. OBJECTIVE: We sought to describe BCC (including locally advanced BCC [LABCC]) incidence/prevalence and the characteristics of patients in a commercially insured US population. METHODS: This retrospective cohort study used Truven Health MarketScan database insurance claims. Patients, aged 18 years or older with 2 or more BCC claims at least 30 days apart from October 1, 2011, to September 30, 2012, were continuously enrolled in medical and pharmacy benefits for 12 months before and after the index claim. A specific algorithm was used to classify patients with LABCC. RESULTS: A total of 56,987 patients with BCC were identified (39,035 incident cases; 17,952 prevalent cases). Age-adjusted BCC incidence and prevalence were 226.09 and 342.64 per 100,000 persons, respectively. These values project to 542,782 patients (incidence) and 822,593 patients (prevalence) in the 2012 US population. LABCC was uncommon (471 cases identified; projected US incidence and prevalence: 4399 and 7940 patients, respectively). LIMITATIONS: Use of medical claims data and retrospective analysis are limitations. CONCLUSION: In a study designed to distinguish patients with LABCC from the general BCC population based on BCC-specific International Classification of Diseases, Ninth Revision, Clinical Modification codes, 0.8% were found to have LABCC, the majority having pre-existing disease.

Treatment patterns and costs for anti-TNFα biologic therapy in patients with psoriatic arthritis.

BACKGROUND: Real-world data regarding anti-tumor necrosis factor alpha (anti-TNFα) biologic therapy use in psoriatic arthritis (PsA) are limited; therefore, we described treatment patterns and costs of anti-TNFα therapy in PsA patients in the United States. METHODS: PsA patients (N = 990) aged ≥18 years who initiated anti-TNFα therapy were selected from MarketScan claims databases (10/1/2009 to 9/30/2010). Number of patients on first- (n = 881), second- (n = 72), or third- or greater (n = 37) line of anti-TNFα therapy, persistence, time-to-switch or modification, pharmacy and medical costs (measured per patient per month [PPPM]) for each line of therapy were observed during the 3-year follow-up. RESULTS: PsA patients receiving only one line of anti-TNFα therapy remained on first-line for ~17 months while those who switched to second- or third- or greater persisted on first-line for ~11 to 12 months, respectively. Time to first-line modification was longer for patients who switched to third- or greater line therapy (7 months) than those who did not switch or switched to second-line (range, ~2 to 4 months). Time-to-switch and time to first-line modification was progressively shorter with each line of therapy for patients who received third- or greater line. PPPM medical costs were higher for patients who did not switch ($322) than those who switched to second- ($167) or third- or greater ($217) line. PPPM pharmacy costs were greater for patients with third- or greater line therapy ($2539) than those who did not switch ($1985) or switched to second-line ($2045). CONCLUSION: While the majority of patients received only one line of anti-TNFα therapy, a subset of patients switched to multiple lines of therapy during the 3-year follow-up period. Persistence and therapy modifications differed between these patients and those receiving only one line. Overall medical costs were highest for patients who did not switch, and pharmacy costs increased as patients switched to each new line of therapy.

Healthcare Resource Use and Direct Costs in Patients with Ankylosing Spondylitis and Psoriatic Arthritis in a Large US Cohort.

OBJECTIVE: Direct costs of ankylosing spondylitis (AS) and psoriatic arthritis (PsA) have not been well characterized in the United States. This study assessed healthcare resource use and direct cost of AS and PsA, and identified predictors of all-cause medical and pharmacy costs. METHODS: Adults aged ≥ 18 with a diagnosis of AS and PsA were identified in the MarketScan databases between October 1, 2011, and September 30, 2012. Patients were continuously enrolled with medical and pharmacy benefits for 12 months before and after the index date (first diagnosis). Baseline demographics and comorbidities were identified. Direct costs included hospitalizations, emergency room and office visits, and pharmacy costs. Multivariable regression was used to determine whether baseline covariates were associated with direct costs. RESULTS: Patients with AS were younger and mostly men compared with patients with PsA. Hypertension and hyperlipidemia were the most common comorbidities in both cohorts. A higher percentage of patients with PsA used biologics and nonbiologic disease-modifying drugs (61.1% and 52.4%, respectively) compared with patients with AS (52.5% and 21.8%, respectively). Office visits were the most commonly used resource by patients with AS and PsA (∼11 visits). Annual direct medical costs [all US dollars, mean (SD)] for patients with AS and PsA were $6514 ($32,982) and $5108 ($22,258), respectively. Prescription drug costs were higher for patients with PsA [$14,174 ($15,821)] compared with patients with AS [$11,214 ($14,249)]. Multivariable regression analysis showed higher all-cause direct costs were associated with biologic use, age, and increased comorbidities in patients with AS or PsA (all p < 0.05). CONCLUSION: Biologic use, age, and comorbidities were major determinants of all-cause direct costs in patients with AS and PsA.

Underuse of guideline-recommended long-term asthma management in children hospitalized to the intensive care unit: a multicenter observational study.

BACKGROUND: Despite the significant burden of childhood asthma, little is known about prevention-oriented management before and after hospitalizations for asthma exacerbation. OBJECTIVE: To investigate the proportion and characteristics of children admitted to the intensive care unit (ICU) for asthma exacerbation and the frequency of guideline-recommended outpatient management before and after the hospitalization. METHODS: A 14-center medical record review study of children aged 2 to 17 years hospitalized for asthma exacerbation during 2012-2013. Primary outcome was admission to the ICU; secondary outcomes were 2 preventive factors: inhaled corticosteroid (ICS) use and evaluation by asthma specialists in the pre- and posthospitalization periods. RESULTS: Among 385 children hospitalized for asthma, 130 (34%) were admitted to the ICU. Risk factors for ICU admission were female sex, having public insurance, a marker of chronic asthma severity (ICS use), and no prior evaluation by an asthma specialist. Among children with ICU admission, guideline-recommended outpatient management was suboptimal (eg, 65% were taking ICSs at the time of index hospitalization, and 19% had evidence of a prior evaluation by specialist). At hospital discharge, among children with ICU admission who had not previously used controller medications, 85% were prescribed ICSs. Furthermore, 62% of all children with ICU admission were referred to an asthma specialist during the 3-month posthospitalization period. CONCLUSION: In this multicenter study of US children hospitalized with asthma exacerbation, one-third of children were admitted to the ICU. In this high-risk group, we observed suboptimal pre- and posthospitalization asthma care. These findings underscore the importance of continued efforts to improve prevention-oriented asthma care at all clinical encounters.

Out-of-pocket drug costs and drug utilization patterns of postmenopausal Medicare beneficiaries with osteoporosis.

BACKGROUND: The Medicare Part D coverage gap has been associated with lower adherence and drug utilization and higher discontinuation. Because osteoporosis has a relatively high prevalence among Medicare-eligible postmenopausal women, we examined changes in utilization of osteoporosis medications during this coverage gap. OBJECTIVES: The purpose of this study was to investigate changes in out-of-pocket (OOP) drug costs and utilization associated with the Medicare Part D coverage gap among postmenopausal beneficiaries with osteoporosis. METHODS: This retrospective analysis of 2007 pharmacy claims focuses on postmenopausal female Medicare beneficiaries enrolled in full-, partial-, or no-gap exposure standard or Medicare Advantage prescription drug plans (PDPs), retiree drug subsidy (RDS) plans, or the low-income subsidy program. We compared beneficiaries with osteoporosis who were taking teriparatide (Eli Lilly and Company, Indianapolis, Indiana) (n = 5657) with matched samples of beneficiaries who were taking nonteriparatide osteoporosis medications (NTO; n = 16,971) or who had other chronic conditions (OCC; n = 16,971). We measured average monthly prescription drug fills and OOP costs, medication discontinuation, and skipping. RESULTS: More than half the sample reached the coverage gap; OOP costs then rose for teriparatide users enrolled in partial- or full-gap exposure plans (increase of 121% and 186%; $300 and $349) but fell for those in no-gap exposure PDPs or RDS plans (decrease of 49% and 30%; $131 and $40). OOP costs for beneficiaries in partial- or full-gap exposure PDPs increased >120% (increase of $144 and $176) in the NTO group and nearly doubled for the OCC group (increase of $124 and $151); these OOP costs were substantially lower than those for teriparatide users. Both teriparatide users and NTO group members discontinued or skipped medications more often than persons in the OCC group, regardless of plan or benefit design. CONCLUSION: Medication discontinuation and OOP costs among beneficiaries with osteoporosis were highest for those enrolled in Part D plans with a coverage gap. Providers should be aware of potential cost-related nonadherence among Medicare beneficiaries taking osteoporosis medications.