Use of Efficiency Frontiers to Align Prices and Clinical Benefits of Biologic Therapies for Plaque Psoriasis.

Importance: The US lacks a systematic approach for aligning drug prices with clinical benefit, and traditional cost-effectiveness analysis (CEA) faces political obstacles. The efficiency frontier (EF) method offers policymakers an alternative approach. Objective: To assess how the EF approach could align prices and clinical benefits of biologic medications for plaque psoriasis and estimate price reductions in the US vs 4 peer countries: Australia, Canada, France, and Germany. Design and Setting: This health economic evaluation used the EF approach to compare the prices and clinical benefits of 11 biologics and 2 biosimilars for plaque psoriasis in the US, Australia, Canada, France, and Germany. Data were collected from February to March 2023 and analyzed from March to June 2023. Main Outcome Measures: EFs were constructed based on each biologic's efficacy, measured using the Psoriasis Area and Severity Index (PASI) 90 response rate, and annual treatment cost as of January 2023; US costs were net of estimated manufacturer rebates. Prices based on the EF were compared with traditional CEA-based prices calculated by the Institute for Clinical and Economic Review at a threshold of $150 000 per quality-adjusted life-year gained. Results: Among 13 biologics, PASI 90 response rates ranged from 17.9% (etanercept) to 71.6% (risankizumab); US net annual treatment costs ranged from $1664 (infliximab-dyyb) to $79 277 (risankizumab). The median (IQR) net annual treatment cost was higher in the US ($34 965 [$20 493-$48 942]) than prerebate costs in Australia ($9179 [$6691-$12 688]), Canada ($15 556 [$13 017-$16 112]), France ($9478 [$6637-$11 678]), and Germany ($13 829 [$13 231-$15 837]). The US EF included infliximab-dyyb (PASI 90: 57.4%; annual cost: $1664), ixekizumab (PASI 90: 70.8%; annual cost: $33 004), and risankizumab (PASI 90: 71.6%; annual cost: $79 277). US prices for psoriasis biologics would need to be reduced by a median (IQR) of 71% (31%-95%) to align with those estimated using the EF; the same approach would yield smaller price reductions in Canada (41% [6%-57%]), Australia (36% [0%-65%]), France (19% [0%-67%]), and Germany (11% [8%-26%]). Except for risankizumab, the EF-based prices were lower than the prices based on traditional CEA. Conclusions and Relevance: This economic evaluation showed that for plaque psoriasis biologics, using an EF approach to negotiate prices could lead to substantial price reductions and better align prices with clinical benefits. US policymakers might consider using EFs to achieve prices commensurate with comparative clinical benefits, particularly for drug classes with multiple therapeutic alternatives for which differences can be adequately summarized by a single outcome measurement.

Clinical, patient and estimated cost benefits of proactive management versus reactive management with calcipotriol/betamethasone dipropionate foam for the treatment of plaque psoriasis in Finland.

BACKGROUND: Proactive management of plaque psoriasis with twice-weekly topical calcipotriol/betamethasone dipropionate (Cal/BD) foam has a demonstrated clinical benefit in preventing disease relapse compared to reactive management, where Cal/BD foam is only given as rescue therapy once-daily for four weeks after relapse. The impact of proactive management with Cal/BD foam on a wider range of clinical responses is not yet known, nor is its potential cost-effectiveness in the healthcare system of Finland. METHODS: This study involved a post-hoc analysis exploring the clinical and patient-reported benefits of proactive versus reactive management with Cal/BD foam observed in the PSO-LONG trial (NCT02899962). A range of response criteria based on modified psoriasis area and severity index (mPASI) and dermatology life quality index (DLQI) were analyzed, and the cost-effectiveness of proactive versus reactive management was estimated in a Finnish healthcare setting. RESULTS AND CONCLUSION: The analysis found a consistent clinical benefit of proactive management compared to reactive management on all response criteria, and a markedly lower cost-per-responder for the response criteria of mPASI 75, mPASI ≤ 2 and DLQ1 ≤ 1. The analysis was robust to sensitivity analyses on key inputs and demonstrates the cost and clinical benefits of proactive over reactive management of plaque psoriasis with Cal/BD foam in the Finnish healthcare setting.

Real-world biologic and apremilast treatment patterns and healthcare costs in moderate-to-severe plaque psoriasis.

Plaque psoriasis is a chronic disease requiring long-term therapy. However, long-term real-world treatment patterns and costs are not well characterized. This study examined treatment patterns and healthcare costs among patients newly initiating a biologic or apremilast for moderate-to-severe plaque psoriasis. Included patients had ?1 prescription for secukinumab, ixekizumab, adalimumab, ustekinumab, etanercept, or apremilast between 01/01/2015 and 08/31/2018, no prior use of the index medication, and continuous enrolment 12 months pre-index and 24 months post-index. Treatment adherence, non-persistence, discontinuation, switching, use of combination therapy, and re-initiation were assessed at 12, 18, and 24 -months post-index. In addition, total and psoriasis-related healthcare costs were evaluated at 24 months. A total of 7,773 patients with 24-month follow-up were included. Overall, adherence was low (21.3%-33.5%) and non-persistence was high (58.4%-86.5%) over 24 months. Discontinuation (38.4%-51.3%), switching (29.7%-52.6%), combination therapy (27.6%-42.9%), and re-initiation of the index medication (19.3%-44.5%) were common. Healthcare costs were high and mostly contributed by psoriasis treatment. Therefore, maintaining disease control on long-term therapy is still challenging for many patients.

Dermatologists' Perspectives on Defining Moderate Psoriasis: The Canadian Moderate Psoriasis Survey.

BACKGROUND: Psoriasis is commonly classified as either mild or moderate to severe, without specific parameters to differentiate moderate versus severe disease. This may lead to patients with moderate psoriasis being underrecognized and undertreated. OBJECTIVE: An online survey was conducted to assess Canadian dermatologists’ perspectives on the definition and treatment of psoriasis. METHOD: Dermatologists included in the survey were regional and national leaders with expertise in psoriasis. Questions were developed based on feedback from a steering committee of Canadian dermatologists. RESULTS: Of 88 dermatologists contacted, 69 responded; 42.0% were in practice for >20 years. Most dermatologists reported using the percentage of psoriasis-affected body surface area (BSA) to describe disease severity (90.8% for moderate and 87.5% for severe psoriasis). The lower and upper median cutoffs for moderate psoriasis were reported as 5.0% and 10.0% for BSA and 7.0 and 11.5 for the Dermatology Life Quality Index. Most dermatologists also consider psoriasis location (eg, palms, scalp, genital area, face) as an important indicator of disease severity. The majority of Canadian dermatologists (87.5%) identified access to treatment as one of the biggest challenges for patients with moderate psoriasis. Most dermatologists estimated that ≤40% of their patients with moderate plaque psoriasis were being treated with traditional oral systemics, targeted oral systemics, or biologics. CONCLUSIONS: This is the first survey of Canadian dermatologists on moderate psoriasis. Efforts are needed to implement a clinically useful definition of moderate plaque psoriasis to improve patient care and to raise awareness of the definition among regulatory agencies and reimbursement authorities. J Drugs Dermatol. 2021;20(2):126-132. doi:10.36849/JDD.5531.

Real-world treatment patterns and healthcare costs of biologics and apremilast among patients with moderate-to-severe plaque psoriasis by metabolic condition status.

OBJECTIVES: To compare treatment patterns and costs among psoriasis patients with and without metabolic conditions newly initiating a biologic or apremilast. METHODS: Adult patients included had ≥1 prescription for secukinumab, adalimumab, ustekinumab, etanercept, or apremilast between 01/01/2015 and 08/31/2018 (date of first prescription was index date) and no index drug use in the 12-months pre-index, and continuous enrollment in the 12-month pre-index and 24-month post-index periods. Patients were divided into mutually exclusive treatment cohorts and stratified by their pre-index metabolic condition status. Treatment patterns (adherence, non-persistence, switching, discontinuation, use of combination therapy, and re-initiation) and healthcare costs were compared. RESULTS: Overall, 7773 patients were included; 47.5-56.7% had a metabolic condition. Except for the apremilast group, patients with metabolic conditions had higher discontinuation (secukinumab: 50.6% vs. 43.7%; adalimumab*: 53.9% vs. 48.7%; ustekinumab*: 41.9% vs. 35.1%; etanercept: 42.8% vs. 41.2%; apremilast: 43.1% vs. 46.1%) and switching (secukinumab: 48.1% vs. 41.2%; adalimumab*: 47.8% vs. 41.9%; ustekinumab*: 34.5% vs. 25.3%; etanercept*: 53.6% vs. 51.5%; apremilast: 45.8% vs. 44.6%) than patients without (*p < .05). Patients with metabolic conditions incurred significantly higher costs. CONCLUSION: Many psoriasis patients initiating biologics or apremilast had metabolic conditions. These patients had higher discontinuation and switching, and significantly higher healthcare costs.

Model to Determine the Cost-Effectiveness of Screening Psoriasis Patients for Psoriatic Arthritis.

OBJECTIVE: Screening psoriasis patients for psoriatic arthritis (PsA) is intended to identify patients at earlier stages of the disease. Early treatment is expected to slow disease progression and delay the need for biologic therapy. Our objective was to determine the cost-effectiveness of screening for PsA in patients with psoriasis in Canada. METHODS: A Markov model was built to estimate the costs and quality-adjusted life years (QALYs) of screening tools for PsA in psoriasis patients. The screening tools included the Toronto Psoriatic Arthritis Screen, Psoriasis Epidemiology Screening Tool, Psoriatic Arthritis Screening and Evaluation, and Early Psoriatic Arthritis Screening Questionnaire (EARP) questionnaires. States of health were defined by disability levels as measured by the Health Assessment Questionnaire. State transitions were modeled based on annual disease progression. Incremental cost-effectiveness ratios and incremental net monetary benefits were estimated. Sensitivity analyses were undertaken to account for parameter uncertainty and to test model assumptions. RESULTS: Screening was cost-effective compared to no screening. The EARP tool had the lowest total cost ($2,000 per patient per year saved compared to no screening) and the highest total QALYs (additional 0.18 per patient compared to no screening). The results were most sensitive to test accuracy and the efficacy of disease-modifying antirheumatic drugs (DMARDs). No screening was cost-effective (at $50,000 per QALY) relative to screening when DMARDs failed to slow disease progression. CONCLUSION: If early therapy with DMARDs delays biologic treatment, implementing screening in patients with psoriasis in Canada is expected to represent a cost savings of $220 million per year and improve the quality of life.

Therapies for Psoriasis: Clinical and Economic Comparisons.

BACKGROUND: Clinical and economic comparisons of therapies for plaque psoriasis are regularly updated following each new devel- opment in the field. With the recent availability of a novel accessory (Multi Micro DoseTM [MMD®] tip) for the 308nm excimer laser (XTRAC®, Strata Skin Sciences, Horsham, PA), which can determine and deliver an optimal therapeutic dose (OTDTM) of ultraviolet-B light in an improved protocol, the need for comparative health-economic assessment recurs. To this end, a comprehensive evaluation of treatment-related costs was undertaken from the payer perspective. Results show that outcomes are influenced by many factors; most importantly, the severity and extent of disease, treatment selection, and patient preference, as well as compliance, adherence, and persistence with care. Among study comparators, the 308nm excimer laser – XTRAC – with its latest MMD enhancement, is safe and delivers incremental clinical benefits with the potential for significant cost savings. These benefits are particularly relevant today in the context of SARS-CoV-2 virus and the COVid-19 pandemic. J Drugs Dermatol. 2020;19(11):1101-1108. doi:10.36849/JDD.2020.5510.

Home Narrowband Ultraviolet B Phototherapy for Photoresponsive Skin Conditions: A Health Technology Assessment.

BACKGROUND: Skin conditions are photoresponsive if they respond to ultraviolet (UV) radiation with partial or complete clearing. Ultraviolet phototherapy is performed by exposing the skin to UV radiation on a regular basis under medical supervision. Three types of UV radiation are used to treat photoresponsive skin conditions: broadband ultraviolet B (BB-UVB), psoralen plus ultraviolet A (PUVA), and narrowband ultraviolet B (NB-UVB). Narrowband UVB phototherapy is generally more effective than BB-UVB and safer than PUVA in the management of several photoresponsive skin conditions. While typically performed in an outpatient clinic setting, home NB-UVB phototherapy may be a viable option for people with limited access to outpatient treatment. We conducted a health technology assessment of home NB-UVB phototherapy for people with photoresponsive skin conditions that included an evaluation of the effectiveness, safety, cost-effectiveness, and budget impact of publicly funding home NB-UVB phototherapy, and patient preferences and values. METHODS: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using version 2 of the Cochrane risk-of-bias tool for randomized studies, and we assessed the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted a cost-utility analysis with a 10-year horizon from a public payer perspective. The cost-utility analysis was conducted for psoriasis based on the available clinical evidence. We also analyzed the budget impact of publicly funding home NB-UVB phototherapy in people with photoresponsive skin conditions in Ontario. To contextualize the potential value of NB-UVB phototherapy, we spoke with people with photoresponsive skin conditions. RESULTS: We included one randomized controlled trial in the clinical evidence review. We found that home NB-UVB phototherapy is at least as effective as outpatient clinic NB-UVB phototherapy for the treatment of mild to severe psoriasis (the only photoresponsive skin condition investigated in the included study). In the included study, 82% of participants were treated at home, compared with 79% treated in an outpatient clinic setting (many participants had experience with both treatment settings). They demonstrated an improvement in baseline Psoriasis Area and Severity Index 50 (mean difference 2.8%, 95% confidence interval -8.6% to 14.2%), with the mean difference exceeding the preset noninferiority margin of -15%. Similar results were observed for other psoriasis area and severity indices (GRADE: Moderate). Episodes of mild erythema, burning sensation, severe erythema, and blistering were reported in both treatment groups, but were too few to allow a comparative safety assessment (GRADE: Low).The primary economic evaluation showed that home NB-UVB phototherapy is more costly (incremental cost $4,509) and has higher quality-adjusted life-years (QALYs; incremental QALY 0.29) than outpatient clinic NB-UVB. Our best estimate of the incremental cost-effectiveness ratio of home NB-UVB compared with outpatient clinic NB-UVB is $15,675 per QALY gained. The probability of home NB-UVB being cost-effective versus outpatient clinic NB-UVB is 77% at a willingness-to-pay of $50,000 per QALY gained. Publicly funding home NB-UVB phototherapy in the psoriasis population would lead to about $0.7 million each year and a total 5-year net budget impact of about $3.3 million. Publicly funding home treatment for people with photoresponsive skin conditions would lead to about $1.3 million each year and a total 5-year net budget impact of $6.3 million; however, this scenario accounted for the cost of phototherapy only (it did not include treatment-specific medical costs for conditions other than psoriasis).People with photoresponsive skin conditions with whom we spoke viewed home NB-UVB phototherapy as beneficial for those with health conditions that make it difficult to travel, for those with busy schedules, and for those who may not have the means to pay for travel to clinics. CONCLUSIONS: Home NB-UVB phototherapy is at least as effective as outpatient clinic NB-UVB phototherapy for the treatment of mild to severe psoriasis (GRADE: Moderate). We are uncertain if adverse events happen more often or less often with home NB-UVB phototherapy than outpatient clinic NB-UVB phototherapy (GRADE: Low).Home NB-UVB phototherapy has an ICER of $15,675 per QALY gained, and the probability of home NB-UVB phototherapy being cost-effective is 77% at a willingness-to-pay of $50,000 per QALY gained. When accounting for the cost of phototherapy and other psoriasis-specific treatment costs (e.g., physician visits and adjuvant treatments), publicly funding home NB-UVB phototherapy in the psoriasis population would lead to a total 5-year net budget impact of about $3.3 million. Funding home NB-UVB phototherapy to people with photoresponsive skin conditions would lead to a total 5-year net budget impact of $6.3 million.People with photoresponsive skin conditions with whom we spoke viewed both outpatient clinic and home NB-UVB phototherapy to be effective treatment options.

Study on the Impact of Psoriasis on Quality of Life: Psychological, Social and Financial Implications.

BACKGROUND: Psoriasis is a chronic and stigmatising disease with significant and hard to meet clinical needs in patient management. Psoriasis is a relatively common disease, affecting up to 2% of the population. The impact of psoriasis on quality of life is significant given its chronicity and visibility. Psychological stress is a well-established systemic triggering factor in psoriasis. It has been associated with initial presentation of the disease as well as exacerbations of pre-existing psoriasis. The purpose of this study is to assess the psychological, social and financial implications of psoriasis. SUBJECTS AND METHODS: 51 patients participated in this study. After dermatological examination and determination of Psoriasis Area and Severity Index score, patients were referred to a psychological consult. Assessment was done through questionnaires concerning quality of life, depression, anxiety, illness perception, financial domain and personal data. RESULTS: Results of our study indicate that psoriasis has a strong impact on patients' life. It influences working habits, poses a significant financial burden, but most of all, significantly impairs their quality of life and psychological status. CONCLUSION: Psoriasis poses a substantial threat to several dimensions in patient's quality of life. Patients feel that the current treatment, although often effective, does not provide a satisfactory long-term solution. Thus, long-term psychologic support for patients with psoriasis is desirable.

Comparing Medical Utilization and Cost Outcomes in Oral Versus Injectable Immunotherapy Users with Chronic Inflammatory Joint and Skin Diseases.

BACKGROUND: Rheumatoid arthritis (RA), psoriatic arthritis (PsA), and psoriasis (PSO) are immune-mediated systemic, chronic inflammatory conditions. Moderate to severe disease is treated with conventional disease-modifying antirheumatic drugs (DMARDs) such as methotrexate, sulfasalazine, or leflunomide. If a patient does not respond to these firstline treatments, then tumor necrosis factor inhibitor (TNFi) or non-TNFi immunotherapy agents are administered via infusion, injection, or taken orally. Although the effectiveness of established infusion, injection, and newer oral therapies are known, the relative effectiveness among the routes of administration is not well understood. OBJECTIVE: To compare drug use, health care resource utilization, and costs among patients who are treatment-naive to oral immunotherapy and injectable biologic immunotherapy. METHODS: This retrospective observational study used claims data from a large U.S. health plan to identify new users of oral and injectable immunotherapy, diagnosed with a joint (RA or PsA), skin (PSO), or joint and skin condition from July 1, 2014, to June 30, 2017. The index date was the first claim for an oral or injectable medication. Medicaid, Medicare Advantage, and commercial plan patients aged 19-89 years with continuous enrollment 6 months before and 12 months after the index date were included in the study. Outcomes were adjusted using propensity score by inverse probability of treatment weighting. Treatment discontinuation, switching, health care resource utilization, and costs were measured during the post-index period. RESULTS: Oral versus injectable users with joint (n = 458 vs. 3,875), skin (n = 265 vs. 951), or joint and skin (n = 171 vs. 805) conditions were identified. For drug utilization outcomes, no differences in discontinuation rates were observed between oral and injectable groups for any of the cohorts. However, those in skin and joint and skin cohorts had higher rates of switching to other immunotherapies in patients initiated on orals compared with injectables. Health care resource utilization outcomes were mixed. While mean outpatient and physician office visits were significantly higher in oral compared with injectable groups across all 3 cohorts, no differences were observed for inpatient stays. Total costs (medical plus pharmacy) were lower for oral groups across all 3 cohorts. Pharmacy costs were lower for oral groups, but medical costs were higher for oral groups across all 3 cohorts. CONCLUSIONS: This is the first population-level study at a route-of-administration level, which compared switching, health care resource utilization, and costs across several conditions. Switching drugs was more likely in the oral group, which may indicate lower effectiveness or tolerability of oral immunotherapies relative to injectables. Health care resource utilization was higher in the oral group, but total costs were lower, which was likely driven by the lower costs of oral drugs. DISCLOSURES: This study was a Humana internal study, and all authors were at the time employees of Humana and used Humana resources. The authors have no conflicts of interest or financial interests to disclose that relate to the research described in this study. This study was presented as a podium and poster presentation at the AMCP Managed Care & Specialty Pharmacy Annual Meeting; April 23-26, 2018; Boston, MA.

Productivity Loss in Patients With Chronic Diseases: A Pooled Economic Analysis of Hungarian Cost-of-Illness Studies.

OBJECTIVES: To assess productivity loss (PL) variations across a set of chronic diseases and analyze significant PL drivers (demographics, health status, healthcare resource use) in Hungary. METHODS: Data from 11 cost-of-illness studies (psoriasis, dementia, systemic sclerosis, multiple sclerosis, benign prostatic hyperplasia, Parkinson's disease, psoriatic arthritis, rheumatoid arthritis, schizophrenia, epilepsy, and diabetes) were pooled, and patient-level data were analyzed. A weighted multiple linear regression analysis was run to identify significant PL indicators. All costs were adjusted to 2018 euro rates and PL was further presented as a proportion of gross domestic product/capita, facilitating results comparability and transferability. RESULTS: The dataset comprised 1888 patients from 11 chronic diseases. The average indirect cost/(gross domestic product/capita) ratio was highest in schizophrenia (72.4%) and rheumatoid arthritis (71.3%) and lowest in benign prostatic hyperplasia (1.6%). Correlation results infer that a higher EuroQol 5-dimension 3-level index score was significantly associated with lower PL. The number of hospital admissions was the main contributor toward increasing PL among resource use indicators. Age and sex showed inconsistent and insignificant correlations with PL. In regression analysis, a better EuroQol 5-dimension 3-level index score and higher education were consistently associated with decreasing PL in all models. CONCLUSIONS: This article will enable health decision makers to understand the importance of adopting a societal perspective for chronic disease reimbursement decisions. The correlation between PL and health status supports that timely started effective treatments may prevent patients from losing their workability.

Fixed Combination Calcipotriene and Betamethasone Dipropionate (Cal/BD) Foam for Beyond-Mild Psoriasis: A Possible Alternative to Systemic Medication.

Calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) aerosol foam is a topical agent indicated for the treatment of plaque psoriasis. While topical treatments are typically reserved for milder disease, in clinical trials with Cal/BD foam, the vast majority of patients had beyond-mild psoriasis at baseline, and multiple studies (including subgroup analyses from randomized controlled trials and other small-scale studies) have demonstrated favorable outcomes with the use of Cal/BD foam in this population. The objective of this article is to review existing data on the efficacy, safety, and cost-effectiveness of Cal/BD foam used in patients with beyond-mild psoriasis, either alone as topical monotherapy or as adjunctive therapy. Practical recommendations for managing beyond-mild psoriasis with Cal/BD foam are also provided. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5300.

Real-World Experience With Apremilast in the Treatment of Adults With Moderate to Severe Plaque Psoriasis in Québec: A Claims-Based Analysis of Drug Utilization and Healthcare Resource Utilization.

BACKGROUND: In Québec, targeted biologic therapies for moderate to severe plaque psoriasis are restricted to patients who have not responded to phototherapy or conventional systemic treatment, primarily due to high drug costs. Apremilast, an oral treatment for plaque psoriasis, was added to the Québec provincial health insurance plan (Régie de l'assurance maladie du Québec; RAMQ) formulary in 2015, making this the only province in Canada with public drug plan reimbursement for apremilast. OBJECTIVES: The aim of this study is to describe patients' characteristics, treatment patterns, healthcare resource utilization (HCRU), and associated costs and to measure real-world budget impact of using apremilast before biologics in plaque psoriasis. METHODS: This study was performed using RAMQ drug claims and medical services data. Patients diagnosed with psoriasis between January 2015 and December 2017 were identified. Medical services and prescription claims were categorized as all-cause and psoriasis-related. Using RAMQ database estimates, a 3-year budget impact analysis was developed comparing treatment cost with and without the addition of apremilast to the formulary. RESULTS: In all, 540 patients were identified (apremilast: n = 92; biologics: n = 448). Comorbidity burden and treatment persistence and adherence were comparable between apremilast and biologic users. The year following the index date, all-cause HCRU was lower for apremilast versus biologic users (CAN$19 763 vs CAN$28 025; P < .01), mainly driven by drug cost. Using apremilast before biologics resulted in an estimated RAMQ net savings of CAN$49 290 (2015), CAN$746 856 (2016), and CAN$1 216 512 (2017), and a total savings of CAN$2 012 658 since apremilast's addition to the formulary. CONCLUSION: Adding apremilast to the drug formulary of other Canadian provinces could result in significant healthcare savings.

TNF-α inhibitors biosimilars as first line systemic treatment for moderate-to-severe chronic plaque psoriasis.

INTRODUCTION: Biologics have revolutionized the therapy of moderate-to-severe plaque psoriasis. Despite their greater efficacy over conventional systemic therapies their high cost has represented a burden for health-care systems, which limited their use. The availability of biosimilars at low cost is changing the place in therapy of biologics for psoriasis. AREAS COVERED: The role of TNF- α inhibitors in the management of plaque psoriasis, their efficacy and safety profile are presented. Phase 3 clinical trials and real-life data from the use of TNF- α inhibitor biosimilars in the treatment of plaque psoriasis are also reviewed in detail. Furthermore, arguments in favor of the use of TNF- α inhibitor biosimilars as a first-line therapy in moderate-to-severe plaque psoriasis are discussed. EXPERT OPINION: An increasing amount of data show that biosimilars represent a safe and effective alternative to the originator biologics. In the face of ever-increasing health-care costs, switching to biosimilars and starting naïve patients on the best-value biologic can reduce expenditure for patients and payers while maintaining a high-quality care. Moreover, as the cost of biosimilars is approaching the cost of conventional systemic treatments, TNF-α inhibitors biosimilars may represent a first-line systemic treatment for psoriasis patients because they are effective and safe.

Treatment patterns and healthcare resource utilization in palmoplantar pustulosis patients in Japan: A claims database study.

BACKGROUND: Palmoplantar pustulosis (PPP) is a chronic, relapsing, inflammatory autoimmune condition, characterized by sterile pustules on the palms and soles. The treatment patterns of PPP and total health care resource utilization in Japan are not well described. Investigating these areas is needed to understand current PPP management in Japan. OBJECTIVE: To describe the characteristics, medication treatment and health care resource utilization patterns, and associated costs of PPP patients in Japan. METHODS: A retrospective analysis of insurance claims data was conducted using the Japan Medical Data Center database. Adult Patients with at least two claims with a PPP diagnosis from January 1, 2011 to March 30, 2017 and six months of follow-up after the first diagnosis were included. Patient characteristics described include age, gender, and comorbid conditions. Treatment patterns assessed include the types of treatment, sequence of treatment, and rates of discontinuation, switching, persistence and use of concomitant medications. RESULTS: A total of 5,162 adult patients met all inclusion criteria. Mean (SD) patient age was 49.7 (11.6) years and 43.2% were male. A total of 2441 patients (47.8%) received systemic non-biologic drugs during the entire follow up period, 2,366 (46.4%) were prescribed topical therapy, 273 (5.4%) were prescribed phototherapy, while 18 (0.4%) of patients with other autoimmune comorbidities were eligible for prescribed biologics. For treatment-naïve patients with mild PPP, topical therapy was most commonly (77.1%) prescribed, whereas in moderate to severe cases of PPP, systemic non-biologic drugs (65%) were most often used. The frequency of switching was similar (64.3% to 75.3%) across various therapies and treatment lines. CONCLUSION: This study describes the treatment patterns and health care resource utilization for Japanese PPP patients using a large claims database, and highlights an unmet need to derive better treatment strategies for PPP and address disease burden in Japan.

The clinical, humanistic, and economic burden of palmoplantar pustulosis: a structured review.

Introduction: Palmoplantar pustulosis (PPP) is a chronic, relapsing and refractory disease characterized by sterile pustules appearing on the palms and/or soles, accompanied by erythema, blistering, scales and/or keratinization. The overall burden of PPP in terms of its clinical impact, effect on patients and families, and economic consequences has not previously been investigated in a structured manner.Areas covered: A structured search focused on identification of studies in PPP using specific search terms in PubMed and EMBASE® from 2005 onwards, with additional back-referencing and pragmatic searches. Outcomes of interest included clinical burden, humanistic burden, and economic burden.Expert opinion: In cross-sectional studies, approximately 75% of all PPP patients suffer from active disease, with risk of relapse remaining constant over time. Patients' health-related quality of life is significantly impaired, as expected for a disease affecting hands and feet. Tools have been described that assess the clinical as well as patient-reported burden of PPP; their performance in larger cohorts and/or clinical trials remains to be investigated. The key data limitations identified include inconsistent definitions for characterizing remission/relapse, and limited humanistic and economic burden data; future studies are required to address these evidence gaps.

The clinical, humanistic, and economic burden of generalized pustular psoriasis: a structured review.

Introduction: Generalized pustular psoriasis (GPP) is characterized by widespread erythema and edema, superficial sterile coalescing pustules, and lakes of pus. Although the impact of GPP is thought to be substantial, emerging literature on its clinical, humanistic, and economic burden has not previously been described in a structured way.Areas covered: A structured search focused on the identification of studies in GPP using specific search terms in PubMed and EMBASE® from 2005 onwards, with additional back-referencing and pragmatic searches. Outcomes of interest included clinical, humanistic, and economic burden.Expert opinion: Despite its significant clinical, humanistic, and economic burden, GPP is poorly classified and inadequately studied. A recent European (ERASPEN) consensus classifies GPP into relapsing and persistent disease and classifies patients on the presence or absence of psoriasis vulgaris. Classification of GPP lesions involving >30% body surface area or use of hospitalization as a surrogate may be a way to identify significant flares. Given the frequency of flares, the impaired quality of life during the post-flare period, and safety/tolerability issues, it is clear that current treatment options are not sufficient. Long-term studies utilizing the European consensus statement with subclassifiers are required to supplement our current understanding of the burden of GPP.

Medical resource consumption of moderate/severe psoriasis in a private health organization of Buenos Aires, Argentina,

Abstract Background: Despite the economic burden of psoriasis for patients and societies, scant information exists regarding the impact and burden of the disease in Argentina. Objective: The objective of this study was to estimate medical resource consumption and direct health care costs for patients with moderate/severe psoriasis in Buenos Aires, Argentina from the perspective of the payer. Methods: Adults with moderate/severe psoriasis (severity was defined as receiving systemic treatment), during January 2010-January 2014, aged 18 years and older, members of the Italian Hospital Medical Care Program with at least 18 months of follow-up were included. All data on hospitalizations, drug prescription, outpatient episodes, consultations, and investigations/tests in the 12 months before inclusion in the study were considered for the estimation of medical resource consumption and direct health care costs. First-quarter 2018 costs were obtained from the IHMCP and converted into US dollars (using the January 2018 exchange rate). Results: A total of 791 patients were included. The mean age at diagnosis was 34 ± 12 years. Almost 65% of the patients had a dermatologist as their usual source of care, 43% had internists, and 14% had rheumatologists. The average yearly direct cost was US$ 5326 (95% CI: 4125-7896) per patient per year. Study limitation: The single center design and the retrospective nature are the main limitations. Conclusion: This is the first Argentine study that evaluated the costs of moderate/severe psoriasis by taking into consideration the direct medical costs of the disease.