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Background: Dose escalation of biologics may restore response in patients with Crohn's disease (CD) who experience inadequate response or loss of response, but the rates of dose escalation and subsequent adverse clinical outcomes have not been well characterized., Objective: To evaluate the rate of dose escalation of biologics and associated adverse clinical outcomes and economic outcomes in biologic-naive patients with CD., Methods: ODESSA-CD (real wOrld Dose EScalation and outcomeS with biologics in IBD pAtients with Crohn's Disease) was a retrospective cohort study conducted using claims data from IBM MarketScan databases. Adults with CD with at least 1 claim for an index drug (adalimumab, infliximab, ustekinumab, or vedolizumab) between January 1, 2017, and December 31, 2018, and no claims for biologics in the 6 months prior (ie, biologic naive) were included. Follow-up ended on June 30, 2020. Cox proportional hazards models and logistic regression models were used to compare the rate of dose escalation and the likelihood of adverse clinical outcomes and costs after dose escalation, respectively., Results: Of the 2,664 eligible patients, most (71.4%) were younger than 50 years and 50.5% were male. The rate of dose escalation was higher with the anti-tumor necrosis factor α (TNFα) treatments adalimumab (hazard ratio [HR] = 1.703; P < 0.0001) and infliximab (HR = 1.690; P < 0.0001) compared with vedolizumab, but there was no significant difference between ustekinumab and vedolizumab (HR = 0.842; P = 0.730). After dose escalation, the likelihood of infection, sepsis, and inflammatory bowel disease-related hospitalization did not differ among biologics (anti-TNFα vs vedolizumab: odds ratio [OR] = 1.141, P = 0.599; ustekinumab vs vedolizumab: OR = 0.891; P = 0.836); however, corticosteroid use was more likely with anti-TNFα treatment than with vedolizumab (OR = 1.740, P = 0.002). Among patients whose dose was escalated, index drug costs were likely to be higher with anti-TNFα treatment and ustekinumab than with vedolizumab (anti-TNFα vs vedolizumab: ratio of expected cost = 1.429, P = 0.002; ustekinumab vs vedolizumab: ratio of expected cost = 3.115, P < 0.0001)., Conclusions: Patients who were biologic naive and received ustekinumab or vedolizumab were less likely to undergo dose escalation than those who received anti-TNFα treatment. Adverse clinical outcomes after dose escalation were similar among these biologics but with different costs. These analyses may inform providers and payers of the clinical and economic implications of dose escalation.

Background: Evidence describing the types and annual costs of biological treatments for psoriasis in Latin America is scarce. This study aimed to estimate the frequency of use and costs of biologic therapy for psoriasis in Colombia in 2019., Methods: This secondary data analysis uses the International Classification of Diseases terms associated with psoriasis, excluding those related to psoriatic arthritis, based on data from the registry of the Colombian Ministry of Health. We estimated the prevalence of psoriasis per 100,000 inhabitants; then, we retrieved the frequency of use of biologic therapy in patients with psoriasis and estimated the cost per year of each and overall therapies in 2019 in US dollars (USD)., Results: There were 100,823 patients with psoriasis in Colombia in 2019, which amounts to a prevalence of 0.2% in the general population. Of those patients, 4.9% received biologic therapy, most frequently males (60%). The most commonly used biological therapies for psoriasis in Colombia in 2019 were ustekinumab (35.2%), with an annual cost per patient of $12,880 USD; adalimumab (26%), with a yearly cost per patient of $7130 USD; and secukinumab (19.8%), with an annual cost per patient of $6825 USD., Conclusion: This is the first study to describe the use and cost of biological therapy for psoriasis in Colombia. It provides valuable cost-awareness information for the Colombian health system., (© 2024 The Author(s). International Journal of Dermatology published by Wiley Periodicals LLC on behalf of the International Society of Dermatology.)

Background/aims: Real-world healthcare resource utilization (HCRU) of bio-naïve patients with Crohn's disease (CD) receiving ustekinumab was assessed., Methods: A multicentre, retrospective chart review study of bio-naïve Canadian adult patients with moderately-to-severely active CD treated with ustekinumab was conducted. CD-related HCRU (i.e., surgery, hospitalization, or emergency room [ER] visits) was evaluated at Months 4, 6, and 12 post-ustekinumab initiation, and associated costs were sourced from a provincial database. Proportion of patients with HCRU events and ustekinumab persistence were summarized at each timepoint. Paired analysis compared HCRU events and associated costs incurred by the same patient whilst in remission vs. when not in remission., Results: By Month 12, 11.1 % (17/153) of patients had record(s) of any CD-related HCRU event, with ER visits being the most common (7.7 %; 12/155). Hospitalization had the highest average cost (CAD $436.10; SD $2,089.25) across all patients, accounting for 82.2 % of the mean total annual cost/patient (CAD $530.47; SD $2,229.92). While in remission, ≤5 % of patients experienced some healthcare encounter, compared with 7 % when not in remission (P = 0.289). Finally, 93.5 % of patients persisted on ustekinumab at Month 12., Conclusions: HCRU rates and associated total annual costs were lower for bio-naïve CD patients receiving ustekinumab, and when patients were in remission. Most patients continued with ustekinumab at Month 12., Competing Interests: Conflicts of interest This study was funded by Janssen Inc. The sponsor was involved in the design, interpretation, and reporting of study results. Talat Bessissow acted as a speaker or advisor for AbbVie, Alimentiv (formerly Robarts Inc.), Amgen, Bristol-Myers-Squibb, Ferring, Gilead, Janssen, Merck, Pentax, Pfizer, Roche, Sandoz, Takeda, Viatris. Neeraj Narula has received honoraria from Janssen, AbbVie, Takeda, Pfizer, Merck, Sandoz, Novartis, and Ferring. Christopher Ma has received consulting fees from AbbVie, Alimentiv, Amgen, AVIR Pharma Inc, BioJAMP, Bristol Myers Squibb, Celltrion, Ferring, Fresenius Kabi, Janssen, McKesson, Mylan, Takeda, Pendopharm, Pfizer, Roche; speaker's fees from AbbVie, Amgen, AVIR Pharma Inc, Alimentiv, Ferring, Janssen, Takeda, and Pfizer; research support from Ferring, Pfizer. Vipul Jairath served on advisory boards, consulted or was an investigator for AbbVie, Alimentiv Inc. (formerly Robarts Clinical Trials Inc.), Amgen, Applied Strategic, Arena Pharmaceuticals, Asahi Kasei Pharma, Asieris, Astra Zeneca, BioJamp. Celgene/BMS, Celltrion, Eli Lilly, Ferring, F. Hoffman-La Roche Ltd., Flagship Pioneering, Fresenius Kabi, Galapagos, Genentech, Gilead, GlaxoSmithKline, Janssen, Organon (Merck), Landos BioPharma, Mylan, Pandion, Pendopharm, Pfizer, Protagonist Therapeutics, Reistone Biopharma, Roche, Sandoz, Second Genome, Takeda, Teva, Topivert, Ventyx Biosciences, and Vividion Therapeutics. Vipul Jairath acted as a speaker for AbbVie, Ferring, Galapagos, Janssen, Pfizer, and Takeda and is an employee of Western University. Tracy S.H. In and Eneda Pone are full-time employees of Janssen Inc. Maria Eberg is a full-time employee of IQVIA Solutions Canada Inc. (IQVIA). Janssen Inc. contracted IQVIA to manage the study., (Copyright © 2024 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Objective: To compare real-world treatment persistence, dose escalation, rates of opportunistic or serious infections, and healthcare costs in patients with Crohn's disease (CD) receiving vedolizumab (VDZ) vs ustekinumab (UST) in the United States., Methods: A retrospective observational study in adults with CD initiated on VDZ or UST on/after 26 September 2016, was performed using the IBM Truven Health MarketScan databases (1 January 2009-30 September 2018). Rates of treatment persistence, dose escalation, opportunistic or serious infection-related encounters, and healthcare costs per patient per month (PPPM) were evaluated. Entropy balancing was used to balance patient characteristics between cohorts. Event rates were assessed using weighted Kaplan-Meier analyses and compared between cohorts using log-rank tests. Healthcare costs were compared between cohorts using weighted 2-part models., Results: 589 VDZ and 599 UST patients were included (172 [29.2%] and 117 [19.5%] were bio-naïve, respectively). After weighting, baseline characteristics were comparable between cohorts. No significant difference in rates of treatment persistence (12-month: VDZ, 76.5%; UST, 82.1%; p  = .17), dose escalation (12-month: VDZ, 29.3%; UST, 32.7%; p  = .97), or opportunistic or serious infection-related encounters were observed between VDZ and UST. Total mean healthcare costs were significantly lower for patients treated with VDZ vs UST (mean cost difference = -$5051 PPPM; p  < .01). Findings were consistent in bio-naïve patients., Conclusions: In this real-world study, similar treatment persistence, dose escalation, and rates of opportunistic or serious infections were observed with VDZ- and UST-treated patients with CD. However, VDZ was associated with a significantly lower cost outlay for healthcare systems.

Background and Aims: Anti-tumour necrosis factor alpha [anti-TNF] treatment accounts for 31% of health care expenditures associated with ulcerative colitis [UC]. Withdrawal of anti-TNF in patients with UC in remission may decrease side effects and infections, while promoting cost containment. Approximately 36% of patients relapse within 12-24 months of anti-TNF withdrawal, but reintroduction of treatment is successful in 80% of patients. We aimed to evaluate the cost-effectiveness of continuation versus withdrawal of anti-TNF in patients with UC in remission., Methods: We developed a Markov model comparing cost-effectiveness of anti-TNF continuation versus withdrawal, from a health care provider perspective. Transition probabilities were calculated from literature, or estimated by an expert panel of 11 gastroenterologists. Deterministic and probabilistic sensitivity analyses were performed to account for assumptions and uncertainty. The cost-effectiveness threshold was set at an incremental cost-effectiveness ratio of €80,000 per quality-adjusted life-year [QALY]., Results: At 5 years, anti-TNF withdrawal was less costly [-€10,781 per patient], but also slightly less effective [-0.04 QALY per patient] than continued treatment. Continuation of anti-TNF compared with withdrawal costs €300,390/QALY, exceeding the cost-effectiveness threshold. Continued therapy would become cost-effective if the relapse rate following anti-TNF withdrawal was ≥43% higher, or if adalimumab or infliximab [biosimilar] prices fell below €87/40 mg and €66/100 mg, respectively., Conclusions: Continuation of anti-TNF in UC patients in remission is not cost-effective compared with withdrawal. A stop-and-reintroduction strategy is cost-saving but is slightly less effective than continued therapy. This strategy could be improved by identifying patients at increased risk of relapse., (© The Author(s) 2020. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

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.

Objective: To review patients who were treated at Tokai University Hospital with biologic agents for psoriasis vulgaris and psoriatic arthritis and analyze the biological retention rate, reasons for switching biologics, and investigate possible clinical prognostic factor which may affect whether a patient preferred one biologic to another., Methods: Clinical courses of 63 patients who received biologic agents between Sep of 2010 to June of 2019 were investigated. Biological retention rate of each biologic agents, reasons of switching to another biologic agent, and prognostic factors, if any, between switched and non-switched patients were examined., Results: The biological retention rate of ustekinumab (UST) was significantly longer than that of infliximab (IFX) or adalimumab (ADA). The major reason of switching was due to secondary loss of efficacy. Patients being treated with UST were more likely to switch to another biologic when they exhibited nail lesions., Conclusion: These results suggested that biological retention rate of UST was superior than that of IFX or ADA. Furthermore, with patients administered UST, nail symptom suggested possible clinical prognostic factor for switching to other biologic agents.

Competing Interests: Nil.

Five biologics are approved for the treatment of ulcerative colitis (UC): infliximab, adalimumab, golimumab, vedolizumab, and ustekinumab. These drugs have varying levels of efficacy and are recommended as first-line treatment of moderate to severe UC. There has been only 1 head-to-head trial comparing the efficacy of the biologics, adalimumab and vedolizumab, which has important implications for management. Therapeutic drug monitoring of biologics, especially anti-TNF alpha agents, may improve the long-term efficacy of these agents. The future of treatment may include personalization of medications, based on patient-specific and disease-specific characteristics as well as biomarkers, along with appropriate therapeutic drug monitoring., Competing Interests: Disclosure A. Bhattacharya: none. M.T. Osterman: advisory board consultant for AbbVie, Elan, Janssen, Lycera, Merck, Pfizer, Takeda, and UCB; research grant support from UCB., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Introduction: Crohn's disease (CD) is a chronic inflammatory disease of the gastrointestinal tract. This real-world study evaluated persistence, dose titration, health care resource utilization (HCRU) and associated costs, and medication use among CD patients treated with ustekinumab (UST) in several pooled US commercial database populations., Methods: CD patients aged ≥ 18 years with medical or pharmacy claims for UST were selected from pooled data from 3 large, national commercial databases. The first observed medical or pharmacy claim for UST was the index date. Patients were required to have had ≥ 1 medical claim with a CD diagnosis during the 12 months prior to the index date and continuous health plan enrollment for a minimum of 12 months prior to and 12 months after the index date. Comparisons of outcomes during the baseline and follow-up periods were conducted using inferential statistical tests., Results: A total of 214 eligible UST patients were selected. The majority (74.8%) were biologic experienced (mean age: 41 years), and 83.6% remained treatment persistent during the 12-month post-index period. Among discontinuers, 25.7% restarted UST, and 8.6% switched from UST in the 12-month observation period. The mean treatment duration was 329 days. Most patients (77%) used the recommended UST dose, as defined as being within a 20% dose variation from label (90 mg/8 weeks ± 20%), 17.9% experienced dose escalation, and 5.1% experienced dose reduction. Post-index immunomodulator and corticosteroid use reduced by 20% and 28%, respectively, as compared with pre-index use among CD patients using UST. Annual all-cause ER visits and inpatient stays decreased by 20.5% and 30.3%, respectively, with similar downward trends for annual CD-related HCRU., Conclusions: The majority of CD patients prescribed UST were biologic experienced, and persistence was high over the 1-year follow-up. UST treatment initiation was associated with reductions in ER visits, inpatient stays, and steroid and other medication use.

Aims: Adalimumab, infliximab, and ustekinumab have been approved for patients with moderate-to-severe Crohn's disease in Japan. This study compared the relative efficacy and cost-effectiveness of adalimumab, infliximab, and ustekinumab in patients with Crohn's disease based on data from randomized controlled trials. Methods: Data were extracted from four phase 3 clinical trials: CHARM, NCT00445432, ACCENT I, and IM-UNITI. A network meta-analysis (NMA) compared 1-year clinical remission rates in patients who responded to treatment during an induction phase. Remission was defined as a Crohn's Disease Activity Index score <150. The number needed to treat (NNT) was defined as the inverse of the risk reduction (compared with placebo) estimated from the NMA among initial responders. Cost per incremental remitter was calculated based on the projected per patient drug cost (2018 Japanese Yen [¥]) and the NNT. Results: Among initial responders, the remission rates were 45.2%, 31.9%, 27.4%, 24.1%, and 15.6% for adalimumab 40 mg every other week (EOW), infliximab 5 mg/kg every 8 weeks, ustekinumab 90 mg every 8 weeks, ustekinumab 90 mg every 12 weeks, and placebo, respectively. The NNT was the lowest for adalimumab 40 mg EOW. Compared with adalimumab, the incremental cost per remitter was numerically higher for infliximab (¥5,375,470) and statistically higher for ustekinumab 90 mg every 8 weeks and ustekinumab 90 mg every 12 weeks (¥42,788,597 and ¥41,495,543, respectively). Limitations: Indirect comparisons are limited by the availability of suitable clinical evidence and there may be residual heterogeneity that could not be adjusted for. Conclusion: Adalimumab was associated with a numerically lower cost per remitter compared with infliximab and a statistically lower cost per remitter compared with ustekinumab in patients with moderate-to-severe Crohn's disease in Japan.

Background and Objectives: Psoriasis is a chronic inflammatory skin disease with an estimated prevalence in Spain of 2.3% of the population. Approximately 30% of patients have moderate-to-severe forms. Treatment with biologic agents is proving to be a step forward in the management of the disease, although these treatments are very expensive. The objective of this study was to determine the efficiency, in terms of cost per number needed to treat (NNT), of the biologic drugs available in Spain for the treatment of moderate to severe plaque psoriasis., Methods: NNT data were obtained from a network meta-analysis that included all randomized clinical trials of biologic drugs sold in Spain. The cost of each treatment was calculated based on the approved dosage for the first year of treatment, as indicated in the Summary of Product Characteristics. These data were used to calculate the cost per NNT of the drugs for various PASI scores (75, 90, and 100). A sensitivity analysis was performed taking into consideration only the PASI-response measurement time (after 10, 12, or 16 weeks, depending on the drug)., Results: The order of efficiency, from most to least efficient, in the case of a PASI 75 response was ixekizumab > ustekinumab 45mg > ustekinumab 90mg > secukinumab > infliximab > etanercept > adalimumab. The order for PASI 90 was ixekizumab >secukinumab >ustekinumab 45mg > ustekinumab 90mg > infliximab > adalimumab > etanercept. The order for PASI 100 was ixekizumab > secukinumab > infliximab > ustekinumab 90mg > ustekinumab 45mg > adalimumab > etanercept. The sensitivity analysis showed some changes in the order, depending on the response-assessment period., Conclusions: The findings show a link between the efficacy of the biologic therapies available in Spain for the treatment of moderate-to-severe plaque psoriasis and their efficiency. Ixekizumab had the lowest cost per NNT for all PASI-response scores (75, 90, and 100) during the first year of treatment., (Copyright © 2018 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.)

Introduction: Our aim was to study drug survival and associated costs of biologic treatment in a German real-world cohort of biologic-naïve psoriasis patients., Methods: We utilized a German claims database base with 3,682,561 enrolled patients between 2001 and 2015. Kaplan-Meier curves were plotted to show the persistence of different biologics. To determine factors that influence persistence, a Cox regression analysis was performed. In addition, associated costs were calculated 12 months before and after treatment start with biologics., Results: Among 75,561 patients with a diagnosis of psoriasis, we identified 347 patients who received a biologic; 176 of them were biologic-naïve prior to initiating therapy. Overall, the 1-year persistence rate was 56%. The highest persistence rate was observed for ustekinumab (80%). Younger patients, and those with a high comorbidity index, had a numerically increased risk of treatment discontinuation. However, parameter values were not statistically significant. While the overall costs after treatment start increased due to the acquisition costs of biologics, we found a strong decrease (- 41%) in sick leave after treatment with biologics had been initiated., Conclusion: Observed drug survival rates in this real-world setting were relatively low. In line with previous studies, ustekinumab had a higher persistence rate than other biologics., Funding: Janssen-Cilag.

Background: There is limited evidence regarding biologics dosing patterns and its costs among psoriasis patients in the United Kingdom (UK). Objective: This retrospective study assessed biologics dose increase beyond labelled dose and associated UK pharmacy costs in moderate to severe psoriasis patients. Methods: Adult psoriasis patients on biologic prescription for ≥12 continuous months between January 2010 and March 2015 with their diagnosis recorded in the UK Hospital Treatment Insights Database within one month of such prescription were included. The proportion of patients receiving ≥30% higher the average daily maintenance dose as per the UK product label, and associated 12-month costs were reported. Results: The study included 362 patients, receiving adalimumab (48%), etanercept (17%), ustekinumab (12%), and infliximab (23%). Beyond labelled dose increase was noted in 14% adalimumab, 20% etanercept, 18% ustekinumab and 28% infliximab patients with an associated mean annual extra cost per patient of £7936, £5912, £2422 and £2275, respectively. Conclusion: Dose increase beyond labelled dose of biologics was commonly observed in moderate to severe psoriasis in the UK and resulted in substantial annual incremental pharmacy costs.

Study Objective: Ustekinumab was recently approved by the United States U.S. Food and Drug Administration for the treatment of Crohn's disease. In this analysis, we aimed to compare the cost-effectiveness of ustekinumab, infliximab, or adalimumab for the treatment of moderate-severe Crohn's disease in patients who failed conventional therapy (i.e., corticosteroids and immunomodulators) but were naïve to tumor necrosis factor antagonists (i.e., biologic drugs)., Design: Cost-effectiveness analysis using a hybrid model structure (decision tree and Markov model)., Measurements and Main Results: A decision tree simulated biologic induction, and a Markov model simulated biologic and conventional therapy maintenance. Cycle length was 2 weeks with a discounted 5-year time horizon and a limited U.S. societal perspective in the base case; results from a payer perspective are also reported. Transition probabilities, direct costs, indirect costs, and utilities were obtained from the literature. To measure relative treatment value (i.e., order of treatment cost-effectiveness), net monetary benefits were reported for a $150,000 willingness-to-pay threshold per quality-adjusted life-year in the base case. Infliximab dominated both adalimumab and ustekinumab, with a net monetary benefit (NMB) of $9943 and $29,798, respectively, in the base case. Adalimumab dominated ustekinumab, with an NMB of $19,855. All biologics yielded similar quality-adjusted life-years (~3.5), whereas costs varied substantially ($50,510, $54,985, and $72,921 for infliximab, adalimumab, and ustekinumab, respectively). The payer perspective, alternate time horizons, and scenario analyses consistently showed infliximab dominance. One-way, threshold, and probabilistic sensitivity analyses confirmed the robustness of these results with respect to all parameters. Although biosimilars were not explicitly modeled as comparators, one-way sensitivity analysis showed that drug acquisition costs could alter relative treatment value but would have to be varied by at least 50%., Conclusion: For moderate-severe Crohn's disease, infliximab yields significantly more NMBs compared with both adalimumab and ustekinumab. Additional clinical (e.g., empiric dosing, biologic cycling) and quality-of-life (e.g., lost productivity, disutility of home injections) research is needed to allow for model frameworks and parameters that more accurately reflect the nuances of Crohn's disease treatment., (© 2018 Pharmacotherapy Publications, Inc.)

Background: Secukinumab, a fully human monoclonal antibody that selectively neutralizes interleukin 17A, has demonstrated strong and sustained efficacy in adults with moderate to severe psoriasis in clinical trials., Objective: This analysis compared the cost per responder of secukinumab as first biologic treatment of moderate to severe psoriasis, with adalimumab, infliximab, etanercept and ustekinumab in Germany., Methods: A 52-week decision-tree model was developed. Response to treatment was assessed based on the likelihood of achieving a predefined Psoriasis Area and Severity Index (PASI) response to separate the cohort into responders (PASI ≥75), partial responders (PASI 50 to 74) and non-responders (PASI <50). Responders at week 16 continued initial treatment, whereas partial responders and non-responders were switched to standard of care, which included methotrexate, cyclosporine, phototherapy and topical corticosteroids. Sustained response was defined as 16-week response maintained at week 52. A German healthcare system perspective was adopted. Clinical efficacy data were obtained from a mixed-treatment comparison; 2016 resource unit costs from national sources; and adverse events and discontinuation rates from the literature. We calculated cost per PASI 90 responder over week 16 and week 52, as well as cost per sustained responder between weeks 16 and 52., Results: Secukinumab had the lowest cost per PASI 90 responder over 16 weeks (€18 026) compared with ustekinumab (€18 080), adalimumab (€23 499), infliximab (€29 599) and etanercept (€34 037). Over 52 weeks, costs per PASI 90 responder ranged from €42 409 (secukinumab) to €70 363 (etanercept). Likewise, secukinumab had the lowest cost per sustained 52-week PASI 90 responder (€22 690) compared with other biologic treatments. Sensitivity analyses, excluding patient copayments, showed similar results., Conclusions: First biologic treatment with secukinumab for moderate to severe psoriasis is cost-effective, with lowest cost per responder compared with other biologic treatments in Germany., (© 2018 European Academy of Dermatology and Venereology.)

Purpose: To compare the cost-effectiveness of the newly approved biologic drug, brodalumab, with other commonly used biologics for the treatment of moderate-to-severe psoriasis in the United States., Methods: An economic model was constructed in Excel to compare average costs to achieve Psoriasis Area and Severity Index (PASI) 75, 90 and 100 among moderate-to-severe psoriasis patients treated with biologics. Total annual costs to health plans associated with treatment with five different biologics were estimated and cost-effectiveness compared using the estimated average cost per PASI 75, PASI 90 and PASI 100., Results: Total annual costs to a health plan per patient with adalimumab, brodalumab, ixekizumab, secukinumab and ustekinumab were estimated at $51,246, $38,538, $65,484, $57,510 and $57,013. Mean annual treatment costs per PASI 75, 90 and 100 were the lowest for brodalumab, with the annual cost per PASI 75 for brodalumab, adalimumab, ixekizumab, secukinumab and ustekinumab estimated at $48,782, $82,655, $77,957, $75,671 and $87,243, per PASI 90 at $51,383, $119,178, $94,904, $108,509 and $130,615, and per PASI 100 at $87,585, $284,702, $176,983, $205,393, and $366,645., Conclusions: Brodalumab, which had the lowest drug cost and high drug efficacy, was associated with the lowest cost per PASI 75, 90 and 100 among the biologics evaluated.

The National Institute for Health and Care Excellence invited Eli Lilly and Company Ltd, the company manufacturing ixekizumab (tradename Taltz ® ), to submit evidence for the clinical and cost effectiveness of ixekizumab. Ixekizumab was compared with tumour necrosis factor-α inhibitors (etanercept, infliximab, adalimumab), ustekinumab, secukinumab, best supportive care and, if non-biological treatment or phototherapy is suitable, also compared with systemic non-biological therapies and phototherapy with ultraviolet B radiation for adults with moderate-to-severe plaque psoriasis. Kleijnen Systematic Reviews Ltd, in collaboration with Maastricht University Medical Center, was commissioned as the independent Evidence Review Group. This article presents a summary of the company submission, the Evidence Review Group report and the development of the National Institute for Health and Care Excellence guidance for the use of this drug in England and Wales by the Appraisal Committee. The Evidence Review Group produced a critical review of the clinical and cost effectiveness of ixekizumab based on the company submission. The company submission presented three randomised controlled trials identified in a systematic review. All randomised controlled trials were phase III, multicentre placebo-controlled trials including 3866 participants with moderate-to-severe psoriasis. Two trials also included an active comparator (etanercept). All randomised controlled trials showed statistically significant increases in two primary outcomes, static Physician Global Assessment (0,1) and improvement of 75% from baseline in the Psoriasis Area and Severity Index. Ixekizumab was generally well tolerated in the randomised controlled trials, with similar discontinuation rates because of adverse events as placebo or etanercept. The most frequent adverse events of special interest were infections and injection-site reactions. The company submission also included a network meta-analysis of relevant comparators. The Evidence Review Group highlighted some issues regarding the systematic review process and an issue with the generalisability of the findings in that the trials failed to include patients with moderate psoriasis according to a widely used definition. This issue was considered by the Appraisal Committee and the population was deemed generalisable to patients in England and Wales. Based on the network meta-analysis, the Appraisal Committee concluded that ixekizumab was more clinically effective than adalimumab and ustekinumab, and agreed it was likely that ixekizumab was similarly effective compared with secukinumab and infliximab while tolerability was similar to other biological treatments approved for treating psoriasis. The Evidence Review Group's critical assessment of the company's economic evaluation highlighted a number of concerns, including (1) the use of relative outcomes such as Psoriasis Area and Severity Index response to model the cost effectiveness; (2) the exclusion of the consequences of adverse events; (3) the assumption of no utility gain in the induction phase; (4) equal annual discontinuation rates for all treatments; (5) the selection of treatment sequences for consideration in the analyses and; (6) the transparency of the Visual Basic for Applications code used to develop the model. Although some of these issues were adjusted in the Evidence Review Group base case, the Evidence Review Group could not estimate the impact of all of these issues, and thus acknowledges that there are still uncertainties concerning the cost-effectiveness evidence. In the Evidence Review Group base-case incremental analysis, the treatment sequence incorporating ixekizumab in the second line has an incremental cost-effectiveness ratio of £25,532 per quality-adjusted life-year gained vs. the etanercept sequence. Ixekizumab in the first-line sequence has an incremental cost-effectiveness ratio of £39,129 per quality-adjusted life-year gained compared with the treatment sequence incorporating ixekizumab in the second line. Consistent with its conclusion regarding clinical effectiveness, the Appraisal Committee concluded that the cost effectiveness of ixekizumab for treating moderate-to-severe plaque psoriasis was similar to that of other biological treatments, already recommended in previous National Institute for Health and Care Excellence guidance. The committee concluded that the incremental cost-effectiveness ratio was within the range that could be considered a cost-effective use of National Health Service resources.

Aims: Patients with psoriasis often undergo treatment with a sequence of biologic agents because of poor/loss of response to initial therapy. With the availability of newer agents like ixekizumab and secukinumab, there is a need for cost-effectiveness analyses to better reflect current clinical practice. This study aimed to assess the cost-effectiveness of a sequence of biologic therapies containing first-line ixekizumab vs first-line secukinumab in patients with moderate-to-severe plaque psoriasis in the UK., Materials and Methods: A Markov model with a lifetime horizon was developed to compare the cost-effectiveness of ixekizumab and secukinumab treatment sequences: ixekizumab → ustekinumab → infliximab → best supportive care (BSC) vs secukinumab → ustekinumab → infliximab → BSC. The model used monthly cycles, and included four health states: trial period, treatment maintenance, BSC, and death. At the end of the trial period, responders transitioned to maintenance therapy; non-responders transitioned to the next biologic in the sequence. An annual discontinuation rate of 20% was assumed for maintenance therapy., Results: The ixekizumab sequence provided cost savings of £898 (£176,203 vs 177,101) [year 2015 values] and gained 0.03 more quality-adjusted life-years (QALYs: 1.45 vs 1.42) vs the secukinumab sequence over the lifetime horizon. Probabilistic sensitivity analysis showed an 89.8% likelihood that the ixekizumab sequence would be cost-effective at a threshold of £20,000 per QALY gained., Limitations: The analysis used list prices for drugs rather than confidential, preferentially priced Patient Access Scheme costs. In addition, efficacy input data were based on a network meta-analysis, as there were no head-to-head trials comparing ixekizumab and secukinumab., Conclusion: First-line treatment with ixekizumab as part of a specific sequential biologic therapy for moderate-to-severe plaque psoriasis in the UK provided slight advantages in cost savings and QALYs gained over a similar treatment sequence initiated with secukinumab. In view of the small magnitude of these differences, factors such as patient preferences (e.g. for number of injections) and long-term safety (e.g. related to time on the market) may also be important for clinical decision-making.

The role of biologic therapies in the field of dermatology continues to evolve as newer drugs and biosimilars are introduced to the U.S. market. Prescribing patterns and expenditures regarding biologic drugs are not well described. To address this knowledge gap, a retrospective review was conducted using the Medicare Provider Utilization and Payment Data: Part D Prescriber dataset between January 1st, 2013 and December 31st, 2015. The primary outcome was claims per provider per calendar year. Secondary outcomes included drug cost, shared cost per dermatologist, and practice location. Median claims per provider remained stable between 2013 and 2014 (24 versus 23, respectively; P=0.64). The majority of 2015 claims were for adalimumab (50.1%) and etanercept (41.4%). Total spending from Medicare payment data for biologic drugs prescribed by Ohio dermatologists increased by $3 million during the study period. The Gini coefficient for provider contributions to overall costs was 0.47, indicating moderate inequality among Ohio dermatologists. Spending associated with biologic drugs used for dermatologic indications is increasing in Ohio. As the market changes, providers should be aware of these patterns to better care for patients in need of biologic therapies.

Background: Biological therapies (BTs) including infliximab (IFX), adalimumab (ADL), secukinumab (SCK) and ustekinumab (UST) are approved in Japan for the treatment of psoriasis. Although the persistence rates and medical costs of BTs treatment have been investigated in multiple foreign studies in recent years, few such studies have been conducted in Japan and the differences between patients who adhered to treatment and those who did not have not been reported. This study is aimed at investigating the persistence rates and medical costs of BTs in the treatment of psoriasis in Japan, using the real-world data from a large-scale claims database., Methods: Claims data from the JMDC database (August 2009 to December 2016) were used for this analysis. Patient data were extracted using the ICD10 code for psoriasis and claims records of BT injections. Twelve-month and 24-month persistence rates of BTs were estimated by Kaplan-Meier methodology, and 12-month-medical costs before and after BT initiation were compared between persistent and non-persistent patient groups at 12 months., Results: A total of 205 psoriasis patients treated with BTs (BT-naïve patients: 177) were identified. The 12-month/24-month persistence rates for ADL, IFX, SCK, and UST in BT-naïve patients were 46.8% ± 16.6%/46.8 ± 16.6%, 53.0% ± 14.9%/41.0% ± 15.5%, 55.4%/55.4% (95% CI not available) and 79.4% ± 9.9%/71.9% ± 12.2%, respectively. Statistically significant differences in persistence were found among different BT treatments, and UST was found to have the highest persistence rate. The total medical costs during the 12 months after BT initiation in BT-naïve patients were (in 1000 Japanese Yen): 2218 for ADL, 3409 for IFX, 465 for SCK, 2824 for UST (average: 2828). Compared with the 12-month persistent patient group, the total medical costs in the persistent group was higher (Δ:+ 118), but for some medications such as IFX or UST cost increases were lower for persistent patients., Conclusions: UST was found to have the highest persistence rate among all BTs for psoriasis treatment in Japan. The 12-month medical costs after BT initiation in the persistent patient group may not have increased as much as in the non-persistent patient group for some medications.

Objective: The aim was to evaluate the cost-effectiveness of Crohn's disease (CD) treatment with vedolizumab and ustekinumab after failure of therapy with tumor necrosis factor-α antagonists (anti-TNFs)., Methods: The Markov model incorporated the lifetime horizon, synthesis-based estimates of biologics' efficacy in relation to anti-TNF exposure, and administration of biologics reflecting clinical practice (e.g., sequence of biologics, retreatment, 12-month treatment). The utilities, non-medical costs and indirect costs were derived from a study of 200 adult patients with CD, while the healthcare costs were from a study of 1393 adults with CD who used biologics in Poland. The quality-adjusted life years (QALYs) and costs (the societal perspective) were discounted with the annual rates of 3.5 and 5%, respectively., Results: The addition of vedolizumab (ustekinumab) to the sequence of available anti-TNFs (after first-line infliximab or after second-line adalimumab) led to a gain of 0.364 (0.349) QALYs at an additional cost of €5600.24 (€6593.82). The incremental cost-effectiveness ratios (ICERs) were €15,369 [95% confidence interval (CI) 7496-61,354] and €18,878 (95% CI 9213-85,045) per QALY gained with vedolizumab and ustekinumab, respectively. Sensitivity analyses revealed a high impact on the ICERs of the relapse rate after discontinuation of biologic treatment. The highest value of vedolizumab/ustekinumab was estimated after the failure of therapies with both anti-TNFs., Conclusions: CD treatment with ustekinumab or vedolizumab after failure of anti-TNF therapy appears to be cost-effective at a threshold of €31,500. The replacement of the second-line anti-TNF with ustekinumab/vedolizumab and the course of the disease after discontinuation of biologics are influential drivers of the cost-effectiveness.

Background: Treatment with biologics may be indicated for patients with moderate-to-severe plaque psoriasis, but comparative evidence on cost-effectiveness is limited. Switching of biologics is common, but it is unclear what the effect is of differences in sequences of biologics., Objectives: To evaluate the cost-effectiveness of different biologic treatment sequences for psoriasis based on real-world evidence., Patients and Methods: A sequence model was developed to evaluate the costs and health effects of three consecutive lines of biologic treatments [for example adalimumab-etanercept-ustekinumab (Ada-Eta-Ust) vs. Eta-Ust-Ada] over a 10-year time horizon in the Netherlands. The model was populated with data from the Dutch BioCAPTURE registry and scientific literature. Analyses were conducted of cost per quality-adjusted life year (QALY) and uncertainty was addressed by probabilistic as well as scenario analyses., Results: Treatment of psoriasis with biologics for a 10-year period was estimated to be associated with a cost of €141 962 to €148 442 per patient depending on the treatment sequence used. Cumulative health effects ranged from 7·79 to 8·03 QALYs. Starting with Ada or Ust seems favourable concerning cost and utilities compared with strategies starting with Eta, although credible intervals were partly overlapping., Conclusions: The order in which biologics are used influences treatment cost-effectiveness, both in terms of costs and health effects. Initiation of a biologic treatment sequence for psoriasis might best be done with Ada or Ust; Eta seems less optimal from a health-economic perspective., (© 2017 British Association of Dermatologists.)

As part of the single technology appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited Janssen to submit evidence on the clinical and cost effectiveness of their drug ustekinumab, an interleukin-12/23 inhibitor, for treating moderate-to-severe active Crohn's disease (CD). The Centre for Reviews and Dissemination (CRD) and Centre for Health Economics (CHE) Technology Appraisal Group at the University of York was commissioned to act as the independent Evidence Review Group (ERG). This article provides a description of the Company's submission, the ERG's critical review of submitted evidence, and the resulting NICE guidance. The main supporting clinical evidence was derived from four well conducted, randomised controlled trials, comparing ustekinumab with placebo in two sub-populations (conventional care failure and anti-TNFα failure patients) of adults with moderate-to-severe CD. Three trials assessed treatment induction over 8 weeks, while the fourth recruited successfully induced patients into a maintenance trial for 1 year. These trials showed ustekinumab to be more effective than placebo in terms of its ability to induce and maintain clinical response and remission. In the absence of any direct head-to-head data, the Company conducted a network meta-analysis (NMA), which synthesised induction trial data on ustekinumab and relevant comparators (vedolizumab, adalimumab and infliximab) using placebo data as a common comparator. This analysis found ustekinumab to be of comparable efficacy to previously approved biologics in treatment induction. A 'treatment sequence analysis' compared long-term treatment efficacy, finding ustekinumab to be comparable in maintaining treatment response and remission to the three other biologic therapies. However, the ERG had identified many limitations and potential bias in this analysis, and urged caution when interpreting the results. The Company's economic model estimated ustekinumab to be dominant in both sub-populations compared with conventional care; however, the ERG's preferred base-case estimated an incremental cost-effectiveness ratio of £109,279 in the conventional care failure sub-population, and £110,967 in the anti-TNFα failure sub-population when compared with conventional care. However, the ERG identified significant failings in both the model structure and data inputs, which could not be addressed without complete restructuring. The ERG considered that the economic analysis presented by the Company failed to adequately address the decision problem specified in NICE's scope. The NICE Appraisal Committee recommended ustekinumab within its market authorisation, on the grounds of sufficiently similar efficacy and costs to previously recommended biologic therapies. However, the ERG's analyses demonstrated that all currently recommended biologics are unlikely to be cost effective relative to conventional care, raising broader questions regarding the appropriateness of cost-comparison exercises for decision making.

Background: Biologics have been shown to improve the outcomes of patients with psoriasis but their cost is an issue., Objective: Determine the number needed to treat (NNT) to achieve a 75%/90% reduction in the Psoriasis Area and Severity Index (PASI-75/90) and evaluate the incremental cost per PASI-75/90 responder (CPR) relative to placebo in Japan., Methods: A network meta-analysis was conducted to estimate the relative probabilities of achieving PASI-75/90 and NNTs. Drug costs were assessed based on Pharmaceutical and Medical Device Agency-approved dosing. The CPR was estimated for a short-term induction period and first year of treatment., Results: Compared with placebo, the PASI-75 NNT was 1.27 for adalimumab 80 mg, 1.29 for secukinumab 150 mg, 1.36 for secukinumab 300 mg, 1.57 for adalimumab 40 mg, 1.68 for ustekinumab 90 mg, 1.97 for ustekinumab 45 mg and 2.00 for infliximab 5 mg/kg. The short-term PASI-75 CPR relative to placebo was $5,062 for secukinumab 150 mg, $8209 for adalimumab 40 mg, $10,654 for secukinumab 300 mg, $11,754 for adalimumab 80 mg, $15,407 for ustekinumab 45 mg, $19,147 for infliximab 5 mg/kg and $26,257 for ustekinumab 90 mg. A similar ranking was observed for one-year PASI-75 CPRs and PASI-90 NNTs and CPRs., Conclusion: Adalimumab 40 mg/80 mg and secukinumab 150 mg/300 mg were the most efficacious and cost-efficient for patients with psoriasis in Japan.

Background: Evidence of the cost-efficacy of ixekizumab for the treatment of moderate-to-severe plaque psoriasis (PsO) in the US is limited., Objective: To estimate the number needed to treat (NNT) and monthly cost of achieving one additional Psoriasis Area and Severity Index (PASI) 75, 90, and 100 responder for ixekizumab and other Food and Drug Administration (FDA)-approved biologics in PsO., Methods: A network meta-analysis estimated the probability of achieving PASI 75, 90, or 100 response during induction for each biologic. NNTs were calculated using response difference of each respective biologic vs placebo at the end of induction. Monthly costs per additional PASI responder were based on FDA-approved doses, wholesale acquisition costs, and induction NNTs., Results: Induction NNTs for ixekizumab 80 mg once every 2 weeks (Q2W) relative to placebo were consistently lower across all levels of clearance compared with the other biologics. Monthly cost per additional responder was lowest for ustekinumab 45 mg at PASI 75 and for secukinumab 300 mg and ixekizumab 80 mg Q2W at PASI 90. Ixekizumab 80 mg Q2W had the lowest cost for PASI 100., Conclusion: In this analysis, ixekizumab is the most cost-efficient biologic in the US when targeting complete resolution, as measured by PASI 100 in PsO.

Objective: To compare the cost consequence of biologic drugs for moderate-to-severe psoriasis from the perspective of the Spanish National Health System., Methods: We built a decision tree with a two-year time horizon. Efficacy data for biologics (etanercept, infliximab, adalimumab, ustekinumab and secukinumab) were drawn from published meta-analyses: PASI75 for the induction phase and PASI90 for the rest of follow-up. Patients with PASI < 75 at week 10-16 were switched to another biologic agent. Efficacy at week 24 was considered the highest possible efficacy for each drug and assumed to remain constant throughout the two-year period. Only drug treatment costs were used. The number needed to treat (NNT), annual cost per patient, annual cost per patient with PASI90 (cost per responder) and cost of primary failure (PASI < 75 at first efficacy evaluation) were calculated., Results: Secukinumab monotherapy was associated with the lowest cost per responder, followed by infliximab and ustekinumab. Treatment sequences starting with secukinumab were the most efficient, having the lowest NNT and cost per responder. Although the annual cost per treatment is similar for all drugs, there are huge differences in the cost per responder., Conclusions: Secukinumab as first-line biologic treatment is the most efficient treatment for moderate-to-severe plaque psoriasis in the short-to-medium term.

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.

Systemic treatments of moderate-to-severe psoriasis differ substantially in terms of effectiveness and costs. Comprehensive economic-evaluations of all systemic treatments for psoriasis from a societal perspective are missing. The objective of our study was to compare the cost-effectiveness all systemic treatments approved for moderate-to-severe psoriasis from a societal perspective, by including all cost categories. An incremental cost-effectiveness-analysis was performed for all systemic treatments for psoriasis, currently recommended by the German S3-Guideline i.e. methotrexate, cyclosporine, fumaric acid esters, and retinoids, adalimumab, etanercept, infliximab and ustekinumab. We used a Markov model with time-dependent transition probabilities and a time horizon of 2 years to investigate incremental cost-effectiveness ratios. Both direct and indirect costs were considered to reflect the societal perspective. Effectiveness outcome was PASI-75 response. One-way and probabilistic sensitivity analyses explored the effect of treatment duration, discount rate, effectiveness, and the perspective (societal vs. healthcare system) on the findings. According to the base-case analysis a cost-effective treatment pathway for moderate-to-severe psoriasis starts with methotrexate, followed by ustekinumab 90 mg and infliximab, if methotrexate does not achieve or maintain PASI-75 response. Sensitivity analyses confirmed the general robustness of these findings with methotrexate being most cost-effective. However, from a third-party-payer perspective (without indirect cost) conventional therapies were generally more cost-effective than biologics. From a value-based healthcare perspective, methotrexate should be the systemic treatment of first choice, ustekinumab 90 mg second choice and infliximab third choice for patients with moderate-to-severe psoriasis. From a societal perspective, the other treatments are less efficient according to our model. From a third-party-payer perspective conventional therapies are more cost-effective than biologics.

Objective: The objective was to evaluate the efficiency (relation between the cost and the results in health) of the treatments in psoriasis, seeking a higher quality of economic evaluations, consistency and transparency in these studies., Methods: We developed a model of economic evaluation in psoriasis collecting all the many direct and indirect costs of each treatment. The effectiveness indicator used was Psoriasis Area Severity Index [PASI 75] which is generally acceptable in studies of psoriasis. The effectiveness indicator was a PASI 75.Subsequently we calculated the Incremental Cost-Effectiveness Ratio (ICER) for the period of 12 weeks and PASI 75, ordering treatments by level of effectiveness at the expense of treatment costs., Results: The most cost effective treatment was methotrexate (ICER -7.5) followed by acitretin (ICER 29.5). The least cost has proved effective PUVA (ICER 4,651), followed by UVB narrow band (2,886.1)., Conclusions: when taking into account both direct and indirect costs together with efficiency, methotrexate is the most cost effective treatment.

The National Institute for Health and Care Excellence (NICE) invited the manufacturer of ustekinumab (Janssen) to submit evidence for the clinical and cost effectiveness of ustekinumab for the treatment of active psoriatic arthritis (PsA) as part of the Institute's single technology appraisal (STA) process. The Centre for Reviews and Dissemination and the Centre for Health Economics Technology Appraisal Group at the University of York were commissioned to act as the independent Evidence Review Group (ERG). This article provides a description of the ERG review of the manufacturer's evidence submission, and summarises the NICE Appraisal Committee's final guidance (TA340) issued in June 2015. The manufacturer presented evidence on ustekinumab for two patient populations: (1) a tumour necrosis factor-α (TNFα)-inhibitor-naïve population who had not previously received any TNFα inhibitors (biologics); and (2) a TNFα-inhibitor-exposed population who had previously received at least one TNFα inhibitor. The clinical evidence for ustekinumab was derived from two randomised controlled trials (PSUMMIT 1 and 2), in which a total of 927 patients who had not responded to previous disease-modifying antirheumatic drug therapies received ustekinumab 45 mg, ustekinumab 90 mg, or placebo. These data suggested that ustekinumab is more effective than placebo over 16-24 weeks in terms of both joint and skin response. In the absence of head-to-head comparisons between different biologics (ustekinumab, golimumab, etanercept, adalimumab and infliximab), the manufacturer conducted a network meta-analysis to estimate the relative efficacy of treatments for the TNFα-inhibitor-naïve population. Results of this analysis were marked as academic in confidence and are therefore not reported. For the TNFα-inhibitor-exposed population, the clinical analysis was limited to ustekinumab versus conventional management only, and was based on a subgroup of 180 patients from the PSUMMIT 2 trial. The ERG raised concerns relating to the lack of data on the long-term efficacy of ustekinumab, the limited data available for the exposed population, and the lack of consideration of the sequential use of treatments. Based on the manufacturer's original model, the ERG found ustekinumab to be dominated by golimumab in the anti-TNF-inhibitor-naïve population, and had an incremental cost-effectiveness ratio (ICER) of £29,843/quality-adjusted life-years versus conventional management in the exposed population. The ERG's analyses highlighted the fact that there is significant uncertainty around the model results. In addition, the ERG's exploratory cost-effectiveness analysis, which incorporated the sequential use of TNFα inhibitors, suggested that ustekinumab would not be cost effective if it were used as second-line treatment. The initial NICE recommendations asserted that ustekinumab was not recommended for treating active PsA. However, the manufacturer submitted a post-consultation model that included a Patient Access Scheme (PAS), halving the unit cost of ustekinumab 90 mg to £2147 (the same as a 45 mg dose). The NICE final recommendations were that, dependent on the inclusion of the PAS, ustekinumab is recommended as an option, along or in combination with methotrexate, for treating active PsA in adults only when treatment with TNFα inhibitors is contraindicated but would otherwise be considered, or the person has previously had treatment with one or more TNFα inhibitors, which has failed.

Background: This study described the number of patients with psoriasis receiving flexible (continuous/intermittent) dosing with etanercept (ETN) and the real-world economic impact., Methods: BeFlex was a prospective, observational study with a ≥1 year follow-up. Patients ≥18 years with moderate-to-severe psoriasis who were starting or re-starting treatment with ETN in alignment with Belgian reimbursement criteria were included. Cost of ETN was compared with cost of adalimumab, ustekinumab and infliximab using estimates from the National Institute for Sickness and Disability Insurance (INAMI/RIZIV)., Results: In the flexible-dosing cohort (n = 121 with dose-regimen data), 66% were treated continuously and 34% intermittently. Baseline characteristics were similar across dosing cohorts. In the per-protocol cohort (n = 138), average ETN treatment duration/year was 40 weeks; 43 weeks continuous and 33 weeks intermittent. The overall mean interruption duration was 3.9 weeks/treatment cycle; 0.2 week continuous and 11.1 weeks intermittent. Mean dose/year was 2065 mg; 2182 mg continuous and 1660 mg intermittent. Flexible ETN dosing reduced the cost by 20% versus INAMI/RIZIV estimates. The theoretical cost of the other continuously-dosed biologics was 28-44% higher than that of flexible ETN., Conclusion: Approximately one-third of Belgian patients received intermittent ETN treatment. Flexible ETN dosing was more cost-effective than treatment with biologic agents that require continuous dosing.

Secukinumab represents the first IL-17A antagonist among the available biologic therapies approved for moderate-to-severe plaque psoriasis management. Secukinumab demonstrated greater efficacy over placebo, etanercept and ustekinumab in patients that had limited benefit from non-biologic systemic therapies and phototherapy. Despite standard-of-care systemic therapies being more likely to be cost-effective at this time, a Canadian cost-utility analysis found secukinumab to display benefit in quality-of-life gains in moderate-to-severe plaque psoriasis patients, and greater cost-effectiveness when compared to other biologic systemic therapies. Determination of the true economic value of secukinumab amongst the available therapies for moderate-to-severe plaque psoriasis will require continued economic evaluation.

Background: It is not clear how to best use biologics in the treatment of psoriasis. Our objective was to assess use of a protocol for biological therapies (BT) in psoriasis., Methods: A consensus protocol was established that included the indications for BT and dose optimization. Patient's characteristics, effectiveness, and cost of BT were analyzed before and after the implementation with two cross-sectional studies to assess its impact., Results: About 106 were treated before the protocol and 118 patients were treated after. After implementing the protocol, the dose was reduced in 43.4% of the patients receiving adalimumab, in 37.5% for etanercept, in 28.6% for infliximab, and in 14.7% for ustekinumab. No statistically significant differences were found in PASI score after the implementation of the protocol, except for the percentage of patients that achieved PASI 75 with ustekinumab, which was slightly higher. The global yearly savings achieved with the protocol implementation were 115,969 €., Conclusions: The protocol helped to increase the efficiency of BT, with decreasing doses of BT without affecting treatment effectiveness.

Introduction: In biologic therapy, dose modification in carefully selected patients when psoriasis is in remission could reduce treatment costs and the risks associated with drug exposure., Material and Methods: Observational, descriptive, crosssectional study, performed in January 2014, of 112 patients with moderate to severe psoriasis who had been on biologic therapy for at least 6 months. The therapeutic objective in all cases was to achieve and maintain a 75% reduction in Psoriasis Area and Severity Index (PASI 75). All the patients had started treatment with the standard regimen. During treatment, the dose had been reduced in patients who achieved the therapeutic objective and escalated in those who failed to respond adequately to standard doses., Results: At the time of the study, 42.9% of the patients were receiving the standard dose, 50% were on a reduced dose, and 7.1% were on an escalated regimen. The agent with which the dose was most often reduced was adalimumab (57.7%), and the agents with which therapy was most often escalated were ustekinumab (17.9%) and infliximab (12.5%). Patients who received reduced doses had significantly longer-standing disease (P=.049) and longer treatment duration with the same biologic agent (P=.009). In the group that did not fulfill the criteria for dose reduction, the proportion of patients with psoriatic arthritis was significantly higher (P=.023). Cost savings were as follows: 21.5% with adalimumab, 13.8% with etanercept, .9% with ustekinumab, and .55% with infliximab., Conclusions: Patients with longer-standing disease and longer treatment duration with the same biologic agent were significantly more likely to be candidates for dose reduction. The proportion of patients with psoriatic arthritis was greater in the group of patients who did not fulfill the conditions for dose reduction. The overall cost saving achieved using the dose modification algorithm described in this study was 13%. Controlled studies are needed to define the profile of the patients best suited for dose reduction strategies without loss of treatment efficacy., (Copyright © 2014 Elsevier España, S.L.U. and AEDV. All rights reserved.)

Background: Dose escalations of biologic agents may be attempted in the management of moderate-to-severe psoriasis. This has implications for the real-world cost of treatment., Objective: To examine the utilization patterns and costs associated with the use of etanercept, adalimumab, and ustekinumab among patients with moderate-to-severe psoriasis., Methods: This was a retrospective cross-sectional study. Patients with 2 or more medical claims with a diagnosis of psoriasis (excluding psoriatic arthritis) who were enrolled in large employer-sponsored health plans (including a pharmacy benefit) in the United States from January 2007 to March 2012 were identified and extracted from the MarketScan Commercial Encounters Database. Patients aged at least 18 years were required to have 2 or more pharmacy claims for etanercept, adalimumab, or ustekinumab; the index date was the first biologic fill date. Demographics and comorbidities were identified during the 1-year pre-index period, and medication utilization and costs were evaluated in the 1-year post-index period after a titration period according to the product prescribing information (2 weeks to 12 weeks). Medication utilization parameters such as dose escalation, dose reduction, persistence, switching, discontinuation, and restarts were assessed at 6, 9, and 12 months from the end of the dose titration window., Results: A total of 4,309 patients were included with a mean average age of 46 years, and 55% were male. Fifty-seven percent of the patients were started on etanercept, 39% on adalimumab, and 5% on ustekinumab. Patients had substantial dose escalation rates (etanercept: 41%; adalim-umab: 37%; ustekinumab: 36%, P  less than  0.05) and discontinuation rates (etanercept: 35%; adalimumab: 27%; ustekinumab: 16%, P  less than  0.05) over the 12-month post-titration period. Many patients also restarted the same biologic (etanercept: 37%; adalimumab: 10%; ustekinumab: 6%, P  less than  0.05) or switched to another biologic (etanercept: 15%; adalimumab: 10%; ustekinumab: 5%, P  less than  0.05) over the 12-month post-titration period. The persistence rates over 12 months were 19%, 53%, and 71% for etanercept, adalimumab, and ustekinumab, respectively (P  less than  0.05). Close to one-third of the patients at 6 months and 39% at 12 months postdose titration experienced a dose escalation. Approximately half of the patients who experienced a dose escalation also had a discontinuation or a dose reduction over the 12-month post-titration period., Conclusions: Over one-third of psoriasis patients experienced a dose escalation of their biologic agents, and most of the dose escalation occurred during the first 6 months. Restarting, switching, and discontinuing index biologics were also common.

Given its chronicity and impact on quality of life, psoriasis is a costly disease. As new and better treatments are developed, the cost of treating psoriasis has risen. In this drug profile, the authors discuss ustekinumab, its pharmacokinetics, safety profile, and direct and indirect costs to determine its cost-efficacy. The authors searched PubMed with specific search phrases for clinical trials investigating this issue over 5 years. Eleven articles analyzed cost-effectiveness of ustekinumab, and the references of these articles were included. Studies limited to 12 weeks reported that ustekinumab may not be cost-effective as it has high cost per injection and is costly when loading doses are required. Studies that went beyond 12 weeks documented that, with ustekinumab's infrequent dosing, it is cost-effective during the maintenance period.

Purpose: Pharmacy benefits management companies have emerged as the national standard for the management of prescription drugs in the United States. The objective of this study was to estimate the annual costs per treated patient of 8 biologics indicated for select immune-mediated inflammatory diseases: moderate to severe rheumatoid arthritis, moderate to severe plaque psoriasis, active psoriatic arthritis, and/or active ankylosing spondylitis., Methods: Using the Medco pharmacy benefits-management database, data from patients aged 18 to 63 years with ≥1 claim for abatacept, adalimumab, certolizumab, etanercept, golimumab, infliximab, rituximab, or ustekinumab, dated between January 1, 2008 and August 31, 2011, were collected. Eligible patients were continuously enrolled for ≥180 days before and 360 days after the date of the first biologic claim (index date), and had ≥1 claim associated with a diagnosis of rheumatoid arthritis, moderate to severe plaque psoriasis, active psoriatic arthritis, and/or active ankylosing spondylitis in the 180 days before or 30 days after the index date. The annual total costs per treated patient were calculated as the total dose of the index biologic and all other biologics for which there was a claim in the postindex period, multiplied by the wholesale acquisition cost as of October 1, 2013, plus the costs associated with administrations (calculated as number of infusions multiplied by the 2013 Medicare Physician Fee Schedule costs)., Findings: Within the study population (N = 8306; 5356 (64.5%) women, 2950 men (35.5%), average age: 42.3 years (SD: 10.0)), the most commonly used biologics were etanercept (43.1%), adalimumab (31.0%), and infliximab (17.0%), which accounted for 91.1% of all biologic prescriptions. Total costs per treated patient across indications were as follows: adalimumab, $23,427 to $26,304; infliximab, $22,824 to $28,907; and etanercept, $21,468 to $27,748, whereas abatacept, certolizumab, golimumab, rituximab, and ustekinumab were associated with a larger range: $17,017 to $41,888., Implications: The present study provides insight into the prescribing patterns and cost differences among 8 biologic agents used for the treatment of immune-mediated inflammatory diseases. This information may prove useful when designing a pharmacy benefits-management formulary., (Copyright © 2014 Elsevier HS Journals, Inc. All rights reserved.)