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Objective: This study aimed to evaluate the cost-effectiveness (CE) of minimally invasive interventions for pain associated with articular temporomandibular dysfunction from the Brazilian Public Health System (SUS) perspective., Methods: This is a CE study with a 1-year time horizon. Effectiveness data were extracted from a network meta-analysis, and 2 treatments with moderate levels of evidence certainty were evaluated: arthrocentesis (ARTRO) plus intra-articular corticosteroid (CO) injection and ARTRO plus intra-articular injection of sodium hyaluronate (SH). For CE analysis, the costs of 2 types of SH (low and high molecular weight) and 4 COs (betamethasone [B], dexamethasone acetate [D], methylprednisolone sodium succinate [M], or triamcinolone hexacetonide [T]) were considered. Modeling was conducted using TreeAge Pro Healthcare software, with the construction of a decision tree representing a hypothetical cohort of adults with articular temporomandibular dysfunction. Deterministic and probabilistic sensitivity analyses were performed. In addition, an acceptability curve was developed., Results: The total costs per joint for ARTRO plus low- and high-molecular-weight SH and ARTRO plus COs B, D, M, and T were, respectively, R$583.32, R$763.85, R$164.39, R$133.93, R$138.57, and R$159.86. ARTRO plus dexamethasone acetate was considered cost-effective, with lower cost and higher net monetary benefit than other technologies. In all sensitivity analysis scenarios, it remained cost-effective. It also showed greater acceptability., Conclusion: ARTRO plus dexamethasone acetate was considered the cost-effective technology, exhibiting higher net monetary benefit and higher acceptability from the SUS perspective., Competing Interests: Author Disclosures Author disclosure forms can be accessed below in the Supplemental Material section., (Copyright © 2024 International Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Rationale: High costs of controller therapies may be a barrier to guideline-recommended asthma treatment. Objectives: We determined whether eliminating out-of-pocket (OOP) payments among low-income patients with asthma impacted controller medication use. Methods: We applied a controlled interrupted time series design to administrative claims data in British Columbia, Canada from 2017 to 2020. Cases were individuals with an annual household income <$13,750 in whom copays were eliminated in January 2019; there was no change in public coverage for the control group with annual income >$45,000. We evaluated trends in asthma medication costs, use, the ratio of inhaled corticosteroid-containing medications to all asthma medications, excessive use of short-acting β-agonists (more than one canister per month), and the proportion of days covered by controller therapies. Results: There were 12,940 cases (62% female; mean age, 30.3 yr; standard deviation [SD], 14.9) and 71,331 controls (55% female; mean age, 31.3 yr; SD, 16.3). Removal of OOP payments increased monthly mean medication costs by $3.32 (95% confidence interval [CI], $0.08 to $6.56, 2020 Canadian dollars), days' supply of controller medications by 1.50 days (95% CI, 0.61 to 2.40 d), and the ratio of inhaled corticosteroid-containing medications to total medications by 4.20% (95% CI, 0.73% to 7.66%) compared with the control group. The policy had no effect on the proportion of days covered by controller therapies (0.01; 95% CI, -0.01 to 0.04), but nonsignificantly decreased the percentage of patients with excessive short-acting β-agonist use (-6.37%; 95% CI, -12.90% to 0.16%). Conclusions: Removal of OOP payments increased the dispensation of controller therapies, suggesting cost-related nonadherence could impair optimal asthma management.

Background: Bevacizumab shows superior efficacy in cerebral radiation necrosis (CRN) therapy, but its economic burden remains heavy due to the high drug price. This study aims to evaluate the cost-effectiveness of bevacizumab for CRN treatment from the Chinese payers' perspective., Methods: A decision tree model was developed to compare the costs and health outcomes of bevacizumab and corticosteroids for CRN therapy. Efficacy and safety data were derived from the NCT01621880 trial, which compared the effectiveness and safety of bevacizumab monotherapy with corticosteroids for CRN in nasopharyngeal cancer patients, and demonstrated that bevacizumab invoked a significantly higher response than corticosteroids (65.5% vs. 31.5%, P < 0.001) with no significant differences in adverse events between two groups. The utility value of the "non-recurrence" status was derived from real-world data. Costs and other utility values were collected from an authoritative Chinese network database and published literature. The primary outcomes were total costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER). The uncertainty of the model was evaluated via one-way and probabilistic sensitivity analyses., Results: Bevacizumab treatment added 0.12 (0.48 vs. 0.36) QALYs compared to corticosteroid therapy, along with incremental costs of $ 2010 ($ 4260 vs. $ 2160). The resultant ICER was $ 16,866/QALY, which was lower than the willingness-to-pay threshold of $ 38,223/QALY in China. The price of bevacizumab, body weight, and the utility value of recurrence status were the key influential parameters for ICER. Probabilistic sensitivity analysis revealed that the probability of bevacizumab being cost-effectiveness was 84.9%., Conclusion: Compared with corticosteroids, bevacizumab is an economical option for CRN treatment in China., (© 2024. Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: The risk of developing strongyloidiasis hyperinfection syndrome appears to be elevated among individuals who initiate corticosteroid treatment. Presumptive treatment or treatment after screening for populations from Strongyloides stercoralis-endemic areas has been suggested before initiating corticosteroids. However, potential clinical and economic impacts of preventative strategies have not been evaluated., Methods: Using a decision tree model for a hypothetical cohort of 1000 individuals from S. stercoralis-endemic areas globally initiating corticosteroid treatment, we evaluated the clinical and economic impacts of two interventions, 'Screen and Treat' (i.e. screening and ivermectin treatment after a positive test), and 'Presumptively Treat', compared to current practice (i.e. 'No Intervention'). We evaluated the cost-effectiveness (net cost per death averted) of each strategy using broad ranges of pre-intervention prevalence and hospitalization rates for chronic strongyloidiasis patients initiating corticosteroid treatment., Results: For the baseline parameter estimates, 'Presumptively Treat' was cost-effective (i.e. clinically superior with cost per death averted less than a threshold of $10.6 million per life) compared to 'No Intervention' ($532 000 per death averted) or 'Screen and Treat' ($39 000 per death averted). The two parameters contributing the most uncertainty to the analysis were the hospitalization rate for individuals with chronic strongyloidiasis who initiate corticosteroids (baseline 0.166%) and prevalence of chronic strongyloidiasis (baseline 17.3%) according to a series of one-way sensitivity analyses. For hospitalization rates ≥0.022%, 'Presumptively Treat' would remain cost-effective. Similarly, 'Presumptively Treat' remained preferred at prevalence rates of ≥4%; 'Screen and Treat' was preferred for prevalence between 2 and 4% and 'No Intervention' was preferred for prevalence <2%., Conclusions: The findings support decision-making for interventions for populations from S. stercoralis-endemic areas before initiating corticosteroid treatment. Although some input parameters are highly uncertain and prevalence varies across endemic countries, 'Presumptively Treat' would likely be preferred across a range for many populations, given plausible parameters., (Published by Oxford University Press on behalf of International Society of Travel Medicine 2023.)

Background: COPD causes substantial economic burden on healthcare. Alternative treatment strategies for COPD can be associated with different costs dependent upon their relative safety and effectiveness. We compared costs and healthcare resource utilization (HCRU) associated with LAMA or LABA/ICS initiation., Methods: Using the Korean National Health Insurance Service database, we enrolled COPD patients initiating treatment with LAMA or LABA/ICS between January 2005 and April 2015. Propensity score matched individuals were compared on all-cause and COPD-related medical costs and HCRU over a three-year follow-up period., Results: A total of 2444 patients were enrolled in each treatment group. LAMA group was associated with significantly lower costs than LABA/ICS group, both in all-cause (403.08 vs 474.50 USD per patient per month [PPPM], cost ratio 1.18, 95% confidence interval [CI]=1.10-1.26, p <0.0001) and COPD-related (216.37 vs 267.32 USD PPPM, cost ratio 1.24, 95% CI=1.13-1.35, p <0.0001) medical costs. All-cause HCRU was not significantly different between groups, while COPD-related HRCU was higher in LAMA group (0.66 vs 0.60 medical visits PPPM, p <0.0001)., Conclusion: COPD patients initiating treatment with LAMA were associated with lower all-cause and COPD-related medical costs than those starting with LABA/ICS despite the similar all-cause HCRU and higher COPD-related HCRU. Initiation with LAMA is a cost-efficient option for the treatment of COPD., Competing Interests: Chin Kook Rhee received consulting and lecture fees from Merck & Co., Inc., AstraZeneca plc, GSK plc, Novartis AG, Takeda Pharmaceutical Company Limited, Mundipharma International Limited, Boehringer-Ingelheim Korea, Teva Pharmaceutical Industries Ltd., Sanofi S.A., and Bayer AG. Kwang Ha Yoo has conducted clinical trials on Asthma, COPD, and Pneumonia with GSK plc, AstraZeneca plc, Boehringer-Ingelheim Korea, Novartis AG, Takeda Pharmaceutical Company Limited, Nycomed, Teva Pharmaceutical Industries Ltd., Merck & Co., Inc., Mundipharma International Limited, Hyundai Pharmaceutical Co., Ltd., Anguk Pharmaceutical Co., Ltd., Chong Kun Dang Holdings Corp., Hanmi Pharm Co., Ltd., and Hanlim, Pharm Co., Ltd. He received consulting fees from GSK plc, AstraZeneca plc, Boehringer-Ingelheim Korea, Novartis AG, Mundipharma International Limited, Anguk Pharmaceutical Co., Ltd., Chong Kun Dang Holdings Corp., Hanmi Pharm Co., Ltd., and Hanlim Pharm Co., Ltd. Yong Bum Park received consulting and lecture fees from AstraZeneca plc, GSK plc, Novartis AG, Mundipharma International Limited, Boehringer-Ingelheim Korea, and Sanofi S.A. Youlim Kim received consulting and lecture fees from Merck & Co., Inc., GSK plc, Boehringer-Ingelheim Korea, and Hanlim Pharm Co., Ltd. Yong Il Hwang has conducted clinical trials on Asthma, COPD, and bronchitis with GSK plc, AstraZeneca plc, Boehringer-Ingelheim Korea, Novartis AG, Anguk Pharmaceutical Co., Ltd., Chong Kun Dang Holdings Corp., Hanmi Pharm Co., Ltd., and Hanlim Pharm Co., Ltd. He received consulting fees from GSK plc, AstraZeneca plc, Boehringer-Ingelheim Korea, Novartis AG, Anguk Pharmaceutical Co., Ltd., Chong Kun Dang Holdings Corp., Hanmi Pharm Co., Ltd., and Hanlim Pharm Co., Ltd. So Eun Lee is an employee of Boehringer-Ingelheim Korea. Jung-Ae Kim is an employee of IQVIA Korea. The authors report no other conflicts of interest in this work., (© 2024 Choi et al.)

Objectives: To evaluate cost-effective pharmacological treatment in adult kidney transplant recipients from the perspective of the Colombian health system., Methods: A decision tree model for the induction phase and a Markov model for the maintenance phase were built. A review of the clinical literature was conducted to extract probabilities, and the life-years were used as the outcome. Costs were calculated using the administrative databases. The evaluating treatment schemes are organized by groups of evidence with direct comparisons., Results: In the induction phase, anti-thymocyte immunoglobulin+ methylprednisolone is dominant, more effective, and less expensive, compared with basiliximab+methylprednisolone. In the maintenance phase, azathioprine (AZA) is dominant in contrast to mycophenolate mofetil (MFM) both with cyclosporine (CIC)+ corticosteroids (CE); CIC is dominant relative to sirolimus (SIR) and tacrolimus (TAC) (both with MFM+CE or AZA+CE), and TAC is dominant compared with SIR (in addition with MFM+CE or mycophenolate sodium [MFS]+CE); MFM is dominant in relation to MFS and everolimus, and SIR is more effective MFM but it does not exceed the threshold (in sum with TAC+CE); MFS and MFM are dominant relative to everolimus, and SIR is more effective than MFM, but it does not exceed the threshold (in addiction with CIC+CE); MFM is dominant in relation to TAC (in sum with SIR+CE), and CIC+AZA+CE is dominant in relation to TAC+MFM+CE., Conclusions: The base-case results for all evidence groups are consistent with the different sensitivity analyses., Competing Interests: Author Disclosures Author disclosure forms can be accessed below in the Supplemental Material section., (Copyright © 2024 International Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Atopic dermatitis (AD) is a chronic inflammatory skin disease with a significant clinical, economic, and human burden. The JAK1 Atopic Dermatitis Efficacy and Safety (JADE) program's Phase 3 trials demonstrated that as a treatment for moderate-to-severe AD in adults with previous exposure to immunotherapy, abrocitinib showed superior efficacy and safety compared with standard of care (SoC), consisting of topical corticosteroids. This study assessed the cost-effectiveness of abrocitinib with SoC versus SoC alone for this patient population in Japan from a societal perspective. A hybrid decision tree and Markov model were used to capture the initial treatment and long-term maintenance phases. Clinical inputs at 16 weeks were obtained through a Bayesian network meta-analysis of four pivotal trials from the JADE program. Clinical inputs at 52 weeks were derived from the JADE EXTEND trial. Response-specific utility inputs were obtained from published literature. Resource use, costs, and productivity inputs were gathered from Japanese claims analysis, literature, public documents, and expert opinion. Costs and quality-adjusted life years (QALYs) were discounted at 2.0% per year and incremental cost-effectiveness ratios (ICERs) were calculated. Sensitivity and scenario analyses were performed to validate the base case results and explore a payer perspective. Over a lifetime horizon and with the base-case societal perspective, abrocitinib produced a mean gain of 0.75 QALYs, incremental costs of JPY (¥) 2 270 386 (USD [$] 17 265.6), and a resulting ICER of ¥3 034 514 ($23 076.5) per QALY compared with SoC. From a payer perspective, the incremental costs increased to ¥4 476 777 ($34 044.4), with an ICER of ¥5 983 495 ($45 502.6) per QALY. The results were most sensitive to treatment-specific, response-based utility weights, drug costs, and productivity-related inputs. From a Japanese societal perspective, abrocitinib demonstrated superior QALYs and with a willingness-to-pay threshold of ¥5 000 000 ($38 023.4) per QALY, can be considered cost-effective compared with SoC as a treatment for moderate-to-severe AD in adult patients with previous immunosuppressant exposure., (© 2024 The Authors. The Journal of Dermatology published by John Wiley & Sons Australia, Ltd on behalf of Japanese Dermatological Association.)

Background: Data on cost-effectiveness of first-line infliximab in paediatric patients with Crohn's disease are limited. Since biologics are increasingly prescribed and accompanied by high costs, this knowledge gap needs to be addressed., Aim: To investigate the cost-effectiveness of first-line infliximab compared to conventional treatment in children with moderate-to-severe Crohn's disease., Methods: We included patients from the Top-down Infliximab Study in Kids with Crohn's disease randomised controlled trial. Children with newly diagnosed moderate-to-severe Crohn's disease were treated with azathioprine maintenance and either five induction infliximab (biosimilar) infusions or conventional induction treatment (exclusive enteral nutrition or corticosteroids). Direct healthcare consumption and costs were obtained per patient until week 104. This included data on outpatient hospital visits, hospital admissions, drug costs, endoscopies and surgeries. The primary health outcome was the odds ratio of being in clinical remission (weighted paediatric Crohn's disease activity index<12.5) during 104 weeks., Results: We included 89 patients (44 in the first-line infliximab group and 45 in the conventional treatment group). Mean direct healthcare costs per patient were €36,784 for first-line infliximab treatment and €36,874 for conventional treatment over 2 years (p = 0.981). The odds ratio of first-line infliximab versus conventional treatment to be in clinical remission over 104 weeks was 1.56 (95%CI 1.03-2.35, p = 0.036)., Conclusions: First-line infliximab treatment resulted in higher odds of being in clinical remission without being more expensive, making it the dominant strategy over conventional treatment in the first 2 years after diagnosis in children with moderate-to-severe Crohn's disease., Trial Registration Number: NCT02517684., (© 2024 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.)

Introduction: Despite adherence to inhaled corticosteroid/long-acting β 2 -agonist (ICS/LABA) therapy, many patients with asthma experience moderate exacerbations. Data on the impact of moderate exacerbations on the healthcare system are limited. This study assessed the frequency and economic burden of moderate exacerbations in patients receiving ICS/LABA., Methods: Retrospective, longitudinal study analyzed data from Optum's de-identified Clinformatics® Data Mart Database recorded between October 1, 2015, and December 31, 2019. Eligibility criteria included patients ≥18 years of age with ≥1 ICS/LABA claim and ≥1 medical claim for asthma in the 12 months pre-index (first ICS/LABA claim). Primary objectives included describing moderate exacerbation frequency, and associated healthcare resource utilization (HRU) and costs. A secondary objective was assessing the relationship between moderate exacerbations and subsequent risk of severe exacerbations. Patients were stratified by moderate exacerbation frequency in the 12 months post index. Moderate exacerbations were identified using a newly developed algorithm., Results: In the first 12 months post index 61.6% of patients experienced ≥1 moderate exacerbation. Mean number of asthma-related visits was 4.1 per person/year and median total asthma-related costs was $3544. HRU and costs increased with increasing exacerbation frequency. Outpatient and inpatient visits accounted for a similar proportion of these costs. Moderate exacerbations were associated with an increased rate and risk of future severe exacerbations (incidence rate ratio, 1.56; hazard ratio, 1.51 [both p < 0.001])., Conclusions: This study highlighted that a high proportion of patients continue to experience moderate exacerbations despite ICS/LABA therapy and subsequently experience increased economic burden and risk of future severe exacerbations., Competing Interests: Declaration of competing interest MSD, WYC, PT-L, AG, and AZ are employees of Analysis Group, Inc, a consulting company that received research funds from GSK to conduct this study. MHR received research funds from Analysis Group for this study. KJR, SZ, and DS are employees of GSK and hold stocks or shares in GSK. AC was an employee of GSK at the time of the study. DM has received research grant funding from AstraZeneca, GSK, and Sunovion Pharmaceuticals, and has served as a consultant to AstraZeneca, GSK, Theravance, and Novartis., (Copyright © 2024. Published by Elsevier Ltd.)

Background: Recent asthma guidelines, such as the Global Initiative for Asthma (GINA), recommend in adult patients as-needed inhaled corticosteroids (ICS)-formoterol as an alternative to maintenance ICS in mild to moderate persistent asthma. The introduction of these recommendations concerns whether using as-needed budesonide-formoterol would be more cost-effective than to maintenance ICS. This study aimed to evaluate the cost-effectiveness of as-needed combination low-dose budesonide-formoterol compared to short-acting β2-agonist (SABA) reliever therapy in patients with mild asthma., Methods: A probabilistic Markov model was created to estimate the cost and quality-adjusted life-years (QALYs) of patients with mild asthma in Colombia. Total costs and QALYs of low-dose budesonide-formoterol compared to short-acting β2-agonist (SABA) were calculated over a lifetime horizon. Multiple sensitivity analyses were conducted. Cost-effectiveness was evaluated at a willingness-to-pay value of $19,000., Results: The model suggests a potential gain of 0.37 QALYs and per patient per year on as-needed ICS-formoterol and a reduction in the discounted cost per person-year, of as-needed ICS-formoterol to maintenance ICS, of US$40. This position of dominance of as-needed ICS-formoterol negates the need to calculate an incremental cost-effectiveness ratio. In the deterministic and probabilistic sensitivity analysis, our base-case results were robust to variations in all assumptions and parameters., Conclusion: Low-dose budesonide-formoterol as a reliever was cost-effective when added to usual care in patients with mild asthma. Our study provides evidence that should be used by decision-makers to improve clinical practice guidelines and should be replicated to validate their results in other middle-income countries., (© 2021. The Author(s).)

Background: An important proportion of asthma patients remain uncontrolled despite using inhaled corticosteroids and long-acting beta-agonists. Clinical guidelines recommend, in these patients, using add-on long-acting muscarinic antagonists (triple therapy) to treatment with high doses of inhaled corticosteroids-long-acting beta2-agonist (dual therapy). The purpose of this study was to assess the cost-effectiveness of triple therapy versus dual therapy for patients with severe asthma., Methods: A probabilistic Markov model was created to estimate the cost and quality-adjusted life-years (QALYs) of patients with severe asthma in Colombia. Total costs and QALYS of dual and triple therapy were calculated over a lifetime horizon. Multiple sensitivity analyses were conducted. Cost-effectiveness was evaluated at a willingness-to-pay value of $19,000., Results: The model suggests a potential gain of 1.55 QALYs per patient per year on triple therapy with respect to dual therapy. We observed a difference of US$304 in discounted cost per person-year on triple therapy with respect to dual therapy. The incremental cost-effectiveness ratio was US$196 in the probabilistic model. In the sensitivity analysis, our base-case results were robust to variations in all assumptions and parameters., Conclusion: In conclusion, triple therapy in patients with moderate-severe asthma was cost-effective. Using triple therapy emerges with our results as an alternative before using oral corticosteroids or biologics, especially in resource-limited settings., (© 2021. The Author(s).)

Objectives: To determine whether physiotherapist-led exercise intervention and US-guided subacromial CS injection is cost-effective when compared with standard advice and exercise leaflet and unguided injection in patients with subacromial pain (impingement) syndrome., Methods: An incremental cost-utility analysis using patient responses to the five-level EuroQoL-5D (EQ-5D-5L) questionnaire was undertaken from a healthcare perspective alongside a 2 × 2 factorial randomized trial with 256 participants over a 12-month follow-up period. Uncertainty was explored through the use of cost-effectiveness acceptability curves., Results: The cost-utility analysis indicated that physiotherapist-led exercise was associated with an incremental cost of £155.99 (95% CI 69.02, 241.93) and 0.031 (95% CI -0.01, 0.07) additional quality-adjusted life-years (QALYs), an incremental cost-effectiveness ratio (ICER) of £5031 per QALY gained and an 85% chance of being cost-effective at a threshold of £20 000 per QALY gained compared with the advice and exercise leaflet. US-guided injection was associated with an incremental cost of £15.89 (95% CI -59.36, 109.86) and 0.024 (95% CI -0.02, 0.07) additional QALYs, an ICER of £662 per QALY gained and a 83% chance of being cost-effective at a threshold of £20 000 per QALY gained compared with unguided injection., Conclusion: Physiotherapist-led exercise was cost-effective compared with the advice and exercise leaflet, and US-guided injection was cost-effective when compared with unguided injection., Clinical Trial Registration: ISRCTN, http://www.isrctn.com, ISRCTN42399123., (© The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

BACKGROUND: The Global Initiative for Chronic Obstructive Lung Disease (GOLD) report for the management of chronic obstructive pulmonary disease (COPD) focuses on reducing existing symptoms, decreasing the risk of future exacerbations, and improving health status by recommending specific drug therapy based on exacerbation risk and symptoms. However, disparities exist between evidence-based recommendations and clinical practice. Research that quantifies the real-world effect of COPD regimen alignment with the GOLD recommendations on clinical and economic outcomes is needed. OBJECTIVE: To compare COPD-related health care resource utilization (HRU) and costs, as well as exacerbation rates, among patients with COPD on maintenance therapy based on 2017 GOLD treatment recommendation compliance status per GOLD ABCD risk group classification in a U.S. commercially insured/Medicare Advantage population. METHODS: This retrospective cohort study utilized administrative claims data in the HealthCore Integrated Research Database. The COPD population was identified using a previously validated claims-based predictive model. Among this population, patients with ≥ 1 claim for a COPD maintenance medication (earliest maintenance fill-date = index date) between January 1, 2014, and March 31, 2017, were identified. Patients were required to be aged ≥ 40 years, have ≥ 12 months of pre-index and ≥ 30 days of post-index health plan enrollment, with no diagnosis for asthma, cystic fibrosis, and/or lung cancer at any time from January 1, 2013, to March 31, 2018. Patients were categorized into exacerbation risk/symptomatology groups according to the 2017 GOLD ABCD assessment recommendations and were then classified into treatment-compliance status based on their maintenance therapy. Multivariable analyses were conducted to examine post-index COPD-related HRU, costs, and exacerbations by compliance status. RESULTS: The primary analytical study sample included 38,382 patients in the GOLD A/B group and 6,525 in the GOLD C/D group. Patients were further categorized into GOLD A (n = 19,345), B (n = 19,037), C (n = 1,865), and D (n = 4,670). GOLD-compliant regimens were observed in 32.9% of patients in the GOLD A/B group and in 58.9% of patients in the GOLD C/D group. Inhaled corticosteroid-containing regimens were the most commonly observed noncompliant regimen. Patients on compliant regimens had significantly fewer COPD-related inpatient and emergency department visits and therefore had significantly lower COPD-related medical costs in both the GOLD A/B and C/D cohorts. Similar results were observed for individual GOLD cohorts B, C, and D. These savings were offset by increased pharmacy expenditures. Being on GOLD guideline-compliant regimens significantly reduced the risk of exacerbation by 8% (hazard ratio [HR] = 0.92; P < 0.0001) in the GOLD A/B cohort and by 12% (HR = 0.88; P = 0.0005) in the GOLD C/D cohort, and was also associated with a significantly reduced exacerbation rate in the GOLD A/B (rate ratio [RR] = 0.93; P < 0.0001) and GOLD C/D (RR = 0.93; P = 0.0129) groups. CONCLUSIONS: This study suggests a continuing trend of high prevalence of suboptimal prescriber compliance to GOLD treatment recommendations. Treatment regimens compliant with GOLD recommendations were associated with improvement in exacerbations, reduced COPD-related HRU, and COPD-related medical cost offsets. DISCLOSURES: This study was funded by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI). BIPI was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations. Palli and Shaikh are employees of BIPI. Willey is an employee of HealthCore, which was contracted by BIPI to conduct this study. Zhou was an employee of HealthCore at the time of study execution. Data were presented in part during an AMCP webinar (recording not made public) held in lieu of the Spring 2020 AMCP conference, which was canceled due to the COVID-19 pandemic.

Objective: To describe resource use and costs of severe exacerbations in patients with severe asthma. Method: Secondary analysis of an observational, longitudinal, retrospective study that estimated the economic impact of severe asthma. The study was carried out in severe asthma units of the pulmonology and allergy services of 20 public hospitals (inclusion period: June to November 2016). The study included adult patients diagnosed with severe asthma according to the European Respiratory Society/American Thoracic Society consensus in the stable phase (no exacerbation during the last 2 months), and with at least one severe exacerbation during the study period (12 months). Healthcare resource use due to severe exacerbations (emergency visits, hospitalizations and pharmacological treatment) was recorded. The direct health costs associated with severe exacerbations were calculated by multiplying the resources used by the corresponding unit cost (in 2018 euros). Results: 134 patients with ≥1 severe exacerbation were included: 63% were female and the mean age was 54 years. 249 severe exacerbations were registered. There were 1.5 physician visits at primary care, hospital care and/or emergency room per episode, 13% of episodes required hospitalization, with a mean hospital stay of 7.2 days. Systemic corticosteroids were prescribed in 92% of exacerbations. The mean direct cost was €758.7/exacerbation (95% confidence interval: 556.8-1,011.1), of which 82% was due to hospitalizations (€623.3/episode). Considering only episodes requiring hospital admission, the mean cost increased by €4,997/exacerbation. Conclusions: It was estimated that the economic impact of a severe exacerbation in Spanish patients with severe asthma was €758.7/exacerbation.

Aim: To analyse the cost-effectiveness of MEP with standard of care (SoC) versus other anti-IL-5 therapies approved for the treatment of severe eosinophilic asthma (SEA) patients, within the Spanish National Health System (NHS) perspective., Methods: A Markov model with a 4-week cycle length was used to compare MEP with BEN and RES as therapies added to SoC in the management of SEA, in terms of cost per QALY gained and incremental cost-effectiveness ratio (ICER). Costs (€2019) were obtained from public sources, while utilities and transition probabilities were retrieved from literature, e.g. network meta-analysis. Continuation criteria for biological treatment and reduction of oral corticosteroids (OCS) was set at 50% minimum reduction of exacerbation rate. Adverse events related to chronic OCS use included diabetes, osteoporosis, cataracts, acute myocardial infarct, and peptic ulcer. The analysis was performed over a 5-year time horizon from the National Healthcare System (NHCS) perspective, with a yearly discount rate of 3% applied to both costs and QALYs. Probabilistic sensitivity analysis and univariate deterministic sensitivity analysis were performed to address uncertainty around the cost-effectiveness results., Results: On top of SoC, the model indicates that MEP is dominant (lower cost, higher benefit) compared to BEN and RES: For BEN and RES, respectively, treatment with MEP had a point estimate of 0.076 and 0.075 additional QALYs, and savings of €3,173.47 and €7,772.95 per patient. The findings were robust to variation as estimated using sensitivity analysis., Conclusions: MEP is a cost-effective treatment in comparison with BEN and RES added to SoC for patients with SEA in the Spanish setting.

Pemphigus vulgaris is the most common form of pemphigus affecting an estimated 30,000-40,000 people in the United States. Costs of systemic and immunoglobulin therapies for pemphigus vulgaris have remained persistently high. Herein, we address the current costs and changes in costs of immunosuppressive treatments, anti-inflammatory treatments, and immunoglobulin treatments covered by Medicaid for pemphigus vulgaris from 2013-2020.

Background: Hospitalization is a major cause of medical expenditure for asthma. Budesonide inhalation suspension (BIS) may assist in reducing asthma-related symptoms in severe asthma exacerbation. However, its effectiveness for hospitalized patients remains poorly known. The objective of this study is to determine associations of BIS with asthma hospitalization., Methods: We retrospectively analyzed 98 patients who were admitted to our hospital due to severe asthma exacerbation (24 treated with BIS in combination with procaterol) from April 2014 to January 2019. Length of stay, recovery time from symptoms (wheezes), and hospitalization costs were compared between the 2 groups according to clinical factors including the use of BIS and sings of respiratory infections (i.e. C-reactive protein, the presence of phlegm, and the use of antibiotics). Multivariate logistic regression analysis was performed to determine factors contributing to hospitalization outcomes., Results: The use of BIS was associated with shorter length of stay, faster recovery time from symptoms, and more reduced hospitalization costs (6.0 vs 8.5 days, 2.5 vs 5.0 days, and 258,260 vs 343,350 JPY). Signs of respiratory infection were also associated with hospitalization outcomes. On a multivariate regression analysis, the use of BIS was a determinant of shortened length of stay and reduced symptoms and medical costs for asthma hospitalization along with signs of respiratory infection., Conclusions: BIS may contribute to shorten length of hospital stay and to reduce symptoms and medical expenditure irrespective of the presence or absence of respiratory infection., (Copyright © 2020 Japanese Society of Allergology. Production and hosting by Elsevier B.V. All rights reserved.)

Background: As-needed budesonide/formoterol is effective in patients with mild asthma for whom low-dose inhaled corticosteroid (ICS) maintenance therapy is appropriate. We assessed the cost-effectiveness of this regimen versus maintenance low-dose ICS plus as-needed short-acting β2-agonist (SABA)., Methods: A probabilistic Markov cohort model was developed that simulated time within/outside severe asthma exacerbations, conducted from a UK NHS perspective with a 70-year time horizon. Clinical efficacy inputs were derived from the SYGMA 2 trial. Patients with mild asthma eligible for low-dose maintenance ICS therapy received as-needed budesonide/formoterol 200/6 μg or twice-daily budesonide 200 μg maintenance therapy plus as-needed terbutaline 0.5 mg. A severe exacerbation was defined as worsening asthma requiring systemic corticosteroid use alone/in combination with an emergency department visit, or hospitalisation for acute asthma. Utility values were derived from SYGMA 2 EQ-5D-5L data, and all-cause- and asthma-related mortality, reduction in utility of an exacerbation, and costs were based on published data. The base-case analysis discount rate was 3.5%. Model robustness was evaluated with one-way sensitivity, probabilistic sensitivity, and two scenario analyses., Results: On average, as-needed budesonide/formoterol was associated with a £292.99 cost saving and quality-adjusted life year (QALY) gains of 0.001 versus ICS + SABA. At a willingness-to-pay of £20,000/QALY, as-needed budesonide/formoterol had >85% probability of being cost-effective versus ICS + SABA. Key drivers were budesonide/formoterol and budesonide maintenance annual exacerbation rates, mean daily budesonide/formoterol inhalations, and costs and outcomes discount rates., Conclusions: From a UK healthcare payer perspective, as-needed budesonide/formoterol is a cost-effective option for the treatment of mild asthma versus regular ICS., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Background: Guidelines recommend stepping down asthma treatment to the minimum effective dose to achieve symptom control, prevent adverse side effects, and reduce costs. Limited data exist on asthma prescription patterns in a real-world setting. We aimed to evaluate the appropriateness of doses prescribed to a UK general asthma population and assess whether stepping down medication increased exacerbations or reliever use, as well as its impact on costs., Methods and Findings: We used nationwide UK primary care medical records, 2001-2017, to identify 508,459 adult asthma patients managed with preventer medication. Prescriptions of higher-level medication: medium/high-dose inhaled corticosteroids (ICSs) or ICSs + add-on medication (long-acting β2-agonist [LABA], leukotriene receptor antagonist [LTRA], theophylline, or long-acting muscarinic antagonist [LAMA]) steadily increased over time (2001 = 49.8%, 2017 = 68.3%). Of those prescribed their first preventer, one-third were prescribed a higher-level medication, of whom half had no reliever prescription or exacerbation in the year prior. Of patients first prescribed ICSs + 1 add-on, 70.4% remained on the same medication during a mean follow-up of 6.6 years. Of those prescribed medium/high-dose ICSs as their first preventer, 13.0% already had documented diabetes, cataracts, glaucoma, or osteopenia/osteoporosis. A cohort of 125,341 patients were drawn to assess the impact of stepping down medication: mean age 50.4 years, 39.4% males, 39,881 stepped down. Exposed patients were stepped down by dropping their LABAs or another add-on or by halving their ICS dose (halving their mean-daily dose or their inhaler dose). The primary and secondary outcomes were, respectively, exacerbations and an increase in reliever prescriptions. Multivariable regression was used to assess outcomes and determine the prognostic factors for initiating stepdown. There was no increased exacerbation risk for each possible medication stepdown (adjusted hazard ratio, 95% CI, p-value: ICS inhaler dose = 0.86, 0.77-0.93, p < 0.001; ICS mean daily = 0.80, 0.74-0.87, p < 0.001; LABA = 1.01, 0.92-1.11, p = 0.87, other add-on = 1.00, 0.91-1.09, p = 0.79) and no increase in reliever prescriptions (adjusted odds ratio, 95% CI, p-value: ICS inhaler dose = 0.99, 0.98-1.00, p = 0.59; ICS mean daily = 0.78, 0.76-0.79, p < 0.001; LABA = 0.83, 0.82-0.85, p < 0.001; other add-on = 0.86, 0.85-0.87, p < 0.001). Prognostic factors to initiate stepdown included medication burden, but not medication side effects. National Health Service (NHS) indicative prices were used for cost estimates. Stepping down medication, either LABAs or ICSs, could save annually around £17,000,000 or £8,600,000, respectively. Study limitations include the possibility that prescribed medication may not have been dispensed or adhered to and the reason for stepdown was not documented., Conclusion: In this UK study, we observed that asthma patients were increasingly prescribed higher levels of treatment, often without clear clinical indication for such high doses. Stepping down medication did not adversely affect outcomes and was associated with substantial cost savings., Competing Interests: I have read the journal's policy and the authors of this manuscript have the following competing interests. CIB reports financial support outside the submitted work from Asthma UK, Chiesi, and AstraZeneca. AS reports that his institution received research support from Asthma UK for the Asthma UK Centre for Applied Research, outside the submitted work. AS is a member of the Editorial Board of PLOS Medicine. JKQ reports grants from MRC, GSK, BLF, Asthma UK, The Health Foundation, IQVIA, AstraZeneca, Chiesi, BI, Bayer; personal fees from AZ, Chiesi, BI, Bayer, and TEVA, outside the submitted work. LDP declares no competing interests associated with this manuscript.

The high rates of mortality and hospitalization among elderly asthmatics, as well as their increasing healthcare costs have become an important public health issue. It would be worthwhile to assess whether inhaled corticosteroid (ICS) can resolve these problems. To explore ICS prescription rates for elderly asthmatics and the factors influencing them and to investigate their association with hospitalization and healthcare costs, we analyzed data from the National Health Insurance Claims Database for the same time frame (December 1 to February 28) across three different periods (2011-2012; 2014-2015; and 2017-2018), from which we identified 6,619, 5,619, and 6,880 elderly individuals, respectively. The prescription rates of ICS increased (52.8%, 65.5% and 68.8%, in the first, second and third survey period, respectively) and inversely the hospital admission rates declined (3.7%, 3.2% and 2.5%, in the first, second and third survey period, respectively). The total healthcare costs per month were significantly lower for patients who received ICS-containing regimens than for those who did not. A multivariate analysis revealed that increasing age, rural residence, receiving a prescription from a clinic, hospital admission, and prescription of asthma medications other than ICS were associated with non-prescription of ICS, whereas cross-boundary treatment increased the ICS-prescription rate. Our study suggests that increases in the prescription rate of ICS are associated with reduced hospital admission rates and lower medical costs in the real-world. ICS prescription rates in rural areas and at clinics, which remain low, need to be increased.

Objective: To estimate the costs and outcomes associated with treating non-asthmatic adults (nor suffering from other lung-disease) presenting to primary care with acute lower respiratory tract infection (ALRTI) with oral corticosteroids compared with placebo., Design: Cost-consequence analysis alongside a randomised controlled trial. Perspectives included the healthcare provider, patients and productivity losses associated with time off work., Setting: Fifty-four National Health Service (NHS) general practices in England., Participants: 398 adults attending NHS primary practices with ALRTI but no asthma or other chronic lung disease, followed up for 28 days., Interventions: 2× 20 mg oral prednisolone per day for 5 days versus matching placebo tablets., Outcome Measures: Quality-adjusted life years using the 5-level EuroQol-5D version measured weekly; duration and severity of symptom. Direct and indirect resources related to the disease and its treatment were also collected. Outcomes were measured for the 28-day follow-up., Results: 198 (50%) patients received the intervention (prednisolone) and 200 (50%) received placebo. NHS costs were dominated by primary care contacts, higher with placebo than with prednisolone (£13.11 vs £10.38) but without evidence of a difference (95% CI £3.05 to £8.52). The trial medication cost of £1.96 per patient would have been recouped in prescription charges of £4.30 per patient overall (55% participants would have paid £7.85), giving an overall mean 'profit' to the NHS of £7.00 (95% CI £0.50 to £17.08) per patient. There was a quality adjusted life years gain of 0.03 (95% CI 0.01 to 0.05) equating to half a day of perfect health favouring the prednisolone patients; there was no difference in duration of cough or severity of symptoms., Conclusions: The use of prednisolone for non-asthmatic adults with ALRTI, provided small gains in quality of life and cost savings driven by prescription charges. Considering the results of the economic evaluation and possible side effects of corticosteroids, the short-term benefits may not outweigh the long-term harms., Trial Registration Numbers: EudraCT 2012-000851-15 and ISRCTN57309858; Pre-results., Competing Interests: Competing interests: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Thompson reports that he has received funding from Alere Inc to conduct research on C-reactive protein point-of-care tests, has received funding from Roche Molecular Diagnostics for consultancy work., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

Objective: To summarize patients' preferences for disease-modifying antirheumatic drug (DMARD) therapy in rheumatoid arthritis (RA)., Methods: We conducted a systematic review to identify English-language studies of adult patients with RA that measured patients' preferences for DMARD or health states and treatment outcomes relevant to DMARD decisions. Study quality was assessed using a published quality assessment tool. Data on the importance of treatment attributes and associations with patient characteristics were summarized across studies., Results: From 7951 abstracts, we included 36 studies from a variety of countries. Most studies were in patients with established RA and were rated as medium- (n = 19) or high-quality (n = 12). The methods to elicit preferences varied, with the most common being discrete choice experiment (DCE; n = 13). Despite the heterogeneity of attributes in DCE studies, treatment benefits (disease improvement) were usually more important than both non-serious (6 of 8 studies) and serious adverse events (5 of 8), and route of administration (7 of 9). Among the non-DCE studies, some found that patients placed high importance on treatment benefits, while others (in patients with established RA) found that patients were quite risk averse. Subcutaneous therapy was often but not always preferred over intravenous therapy. Patient preferences were variable and commonly associated with the sociodemographic characteristics., Conclusion: Overall, the results showed that many patients place a high value on treatment benefits over other treatment attributes, including serious or minor side effects, cost, or route of administration. The variability in patient preferences highlights the need to individualize treatment choices in RA.

Background: The aim of the present study was to estimate the societal costs and the key cost drivers for patients with severe asthma in Sweden. In addition, health-related quality of life (HRQOL) and morbidity of patients with severe asthma is described., Methods: The study population comprised adults with severe asthma recruited from a large asthma cohort within the Obstructive Lung Disease in Northern Sweden (OLIN) studies. During 2017, patients were interviewed quarterly over telephone regarding their resource utilization and productivity losses., Results: Estimated mean annual asthma-related costs per patient with severe asthma amounted to €6,500, of which approximately €2400 and €4100 were direct and indirect costs, respectively. The main cost drivers for direct costs were hospitalizations followed by drugs: approximately €1000 and €800, respectively. Patients on treatment with regular oral corticosteroids (OCS) had greater direct costs compared with those without regular OCS treatment. Co-morbid conditions were common and the costs were substantial also for co-morbid conditions, with a total cost of approximately €4200. The OCS group had significantly lower HRQOL compared to the non-OCS group., Conclusions: The societal costs due to severe asthma were substantial. Costs for co-morbid conditions contributed substantially to both direct and indirect costs. The direct costs were significantly higher in the maintenance OCS-group compared to the non-maintenance OCS-group. These results indicate a need for improved management and treatment regimens for patients with severe asthma., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Purpose: The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2018 recommendations support maintenance treatment with long-acting bronchodilators in most symptomatic patients with chronic obstructive pulmonary disease (COPD). While restricting the overuse of inhaled corticosteroids (ICS) may influence healthcare utilization required to treat inadvertent respiratory (exacerbations and pneumonia) and diabetes-related events, it may also change the total medication cost. This analysis was performed to estimate the 5-year budget impact of switching from ICS-containing treatment combinations to dual bronchodilation, in line with the recommendations., Methods: The model quantified the budget impact of treatment and healthcare resource utilization when COPD patients were anticipated to switch from ICS-containing treatments to dual bronchodilation. Three switch scenarios were calculated with increasing proportions of patients on dual long-acting bronchodilators, to the detriment of ICS-containing double and triple combinations. Clinical and cost input data were based on results from clinical trials and Greek and Portuguese healthcare cost databases., Results: Healthcare resource use to manage exacerbations, pneumonia and diabetes-related events were projected to increase between 2019 and 2023 in parallel with the growing COPD patient population and associated costs were estimated at 52-57% of the total disease cost in the Greek and Portuguese base case scenarios. Total cost savings between 21 and 112 million EUR were projected when the proportion of patients on double and triple ICS-containing treatments was gradually reduced to 50% in scenario A, 20% in scenario B and 7% in scenario C. Sensitivity analyses showed that none of the model assumptions had a major impact on the projected savings., Conclusion: The alignment of COPD treatment with current recommendations may bring clinical benefits to patients, without substantial cost increases and even cost savings for payers. The reviews of this paper are available via the supplemental material section.

Aims: Systemic lupus erythematosus (SLE) is a multifaceted autoimmune disease involving multiple organs systems and places a significant economic burden on SLE patients. There is a literature gap regarding the standard of care and economic burden in SLE patients, their families, and society. This study assessed medication use patterns among SLE patients and generated the annual and total economic burden associated with the illness. Materials and methods: Adult patients with ≥2 medical claims on different dates for SLE diagnoses were identified from 01 January 2013 to 31 December 2015 using two large administrative claims databases representative of the commercially insured US population. Patient demographics and clinical characteristics during 1-year pre-SLE diagnosis were assessed. Outcomes including the proportion of patients who used SLE medications and annual costs were assessed 1-year post-SLE diagnosis. Total costs related to SLE were extrapolated to the US population to estimate the economic burden based on SLE prevalence. Results: A total of 30,086 SLE patients were identified. The most common baseline comorbidities were hypertension and infections. Corticosteroids and hydroxychloroquine were the most common SLE medications. Biologics utilization was minimal. SLE patients had, on average, 26.0 physician visits, 23.7 prescription claims, 1.7 inpatient admissions, and 2.0 hospital days per patient 1-year post-SLE diagnosis. Annual all-cause median costs among all SLE patients were $8712 per patient per year. Total costs ranged between $1.4-1.6 and $2.8-3.2 billion per year, depending on prevalence estimates. Conclusions: Our findings indicate a nominal use of biologics (∼2%) among SLE patients; despite belimumab being one of the few approved treatments for SLE in the USA. These data reveal an unmet need for availability of advanced SLE therapy, and future studies are warranted concerning the underlying causes. SLE is also associated with a substantial economic burden of ≤3.2 billion per year. These findings may assist in future planning and resource allocation.

Background: Despite the low prevalence for all patients with asthma, those with severe disease account for a disproportionately large economic burden., Objective: To evaluate current direct health care and productivity loss costs associated with patients with asthma receiving Global Initiative for Asthma Step 4/5 therapy ("G4/5 asthma") in the United States., Methods: Asthma patients aged 12 years or older were identified in the IBM MarketScan Research Databases between January 1, 2012 and December 31, 2015. Patients were indexed on their earliest medical claim for asthma and were required to have at last 2 years of continuous eligibility. The G4/5 asthma classification required 1 or more medium- or high-dosage inhaled corticosteroids (ICS)/long-acting beta-agonist (LABA) claims, 1 or more omalizumab claims, or systemic corticosteroids covering at least 50% of the 12-month baseline period. The European Respiratory Society/American Thoracic Society criteria for severe uncontrolled asthma were modified for claims data and used to identify patients with exacerbations or high rescue medication use ("Ex/R″). Direct health care costs and productivity loss costs attributable to workplace absence or short-term or long-term disability were measured during the 12-month post-index period., Results: A total of 605,614 patients with asthma were identified. Annual health care costs were $4,384 greater for G4/5 asthma vs non-G4/5 patients with asthma; asthma-related costs contributed $2,183 of this difference (P < .001). Differences were primarily driven by G4/5 patients with asthma with Ex/R, whose costs were $5,019 greater than G4/5 patients without Ex/R (P < .001). For patients with 1 or more absences or short-term disability claims, G4/5 patients missed 7.2 more work hours for absence and had 3.9 more days of work lost for short-term disability than non-G4/5 patients with asthma, respectively (P < .05)., Conclusion: G4/5 patients with asthma incurred significantly greater direct and indirect costs than non-G4/5 patients with asthma. Differences were largely driven by those with Ex/R., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Oral corticosteroids (OCSs) are often used to achieve asthma control. OCS-related comorbidities increase the burden of disease for patients and healthcare providers. Most studies characterizing OCS use and risk of adverse events (AEs) are in non-asthma patients. We sought to systematically review the literature on the burden of OCS use among adults with asthma. Methods: We systematically reviewed the literature including MEDLINE (1946-May 2017), EMBASE (1974-May 2017), and the Cochrane Library (2005-May 2017) to identify studies that considered AEs due to OCS treatment of adults with asthma, their burden on healthcare utilization, and costs. Results: We retrieved 9,589 citations; and 15 studies were included. AEs were significantly higher among OCS-users compared with non-OCS users with pooled adjusted odds ratio (OR) 1.68 (95% CI 1.15-2.46) for diabetes mellitus and 1.34 (95% CI 1.23-1.46) for hypertension. Among high dose OCS-users (>10 mg) compared with non-OCS users, the pooled adjusted ORs for development of any complication was 3.35 (95% CI 2.94-3.82), and bone and muscle complications 2.30 (95% CI 2.18-2.42). The risk of any complication increased with higher doses of OCS, with pooled adjusted OR from 2 studies of 2.26 (95% CI 1.37-3.72), 2.94 (95% CI 2.62-3.29) and 3.35 (95% CI 2.94-3.82) for low dose (<6 mg), medium dose (5-12 mg) and high dose (>10 mg) respectively compared with no OCS use. Conclusions: The use of OCS in the management of asthma is associated with a higher risk of complications. This risk is higher as the OCS dose increases.

Background: Common treatments for chronic migraine headaches include injection of corticosteroid and anesthetic agents at local trigger sites. However, the effects of therapy are short term, and lifelong treatment is often necessary. In contrast, surgical decompression of migraine trigger sites accomplishes the same goal yet demonstrates successful long-term elimination of chronic migraines., Objectives: Our primary objective was to perform a cost-utility analysis to determine which patients would benefit most from available treatment options in a cost-conscious model., Methods: A cost-utility analysis was performed, taking into consideration costs, probabilities, and health state utility scores of various interventions., Results: Injection therapy offered a minor improvement in quality-adjusted life-years (QALYs) compared with surgical decompression (QALY Δ = 0.6). However, long-term injection therapy was significantly costlier to society than surgical decompression: injection treatment was estimated to cost $106,887.96 more than surgery. The results of our cost-utility analysis thus conferred a positive incremental cost-utility ratio of $178,163.27 in favor of surgical decompression., Conclusions: Surgery provides a durable intervention and has been shown in this study to be extremely cost effective despite a very minor QALY deficit compared with injection therapy. If patients are identified who require treatment in the form of injections for less than 8.25 years, they may fall into a group that should not be offered surgery., (© 2019 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.)

Aim: To compare health plan-paid costs, exacerbations and pneumonia outcomes for patients with chronic obstructive pulmonary disease (COPD) initiating combination tiotropium olodaterol (TIO + OLO) versus triple therapy (TT: long-acting muscarinic antagonist + long-acting β 2 agonists + inhaled corticosteroid). Patients & methods: COPD patients initiating TIO + OLO or TT between 1 January 2014 and 30 June 2016 were identified from a managed care Medicare database and balanced for baseline characteristics using inverse probability of treatment weighting before assessment of outcomes. Results: Annual COPD-related and all-cause costs were US$4118 (35%) and US$5384 (23%) lower for TIO + OLO versus TT (both p ≤ 0.001). TIO + OLO patients had nearly half the severe exacerbations (8.3 vs 15.5%; p = 0.014) and pneumonia was also less common (18.9 vs 30.9%; p < 0.001). Conclusion: TIO + OLO was associated with improved economic and COPD health outcomes versus TT.

Introduction: Psoriasis is an immune-mediated, chronic, inflammatory disease, which has a substantial humanistic and economic burden. This study aimed to assess the impact of this disease on health-related quality of life (HRQoL), work productivity, and direct and indirect costs from a societal perspective among Brazilian patients., Methods: This is a cross-sectional, observational, multicenter study, enrolling patients with moderate to severe plaque psoriasis according to physician evaluation. Data collection was performed from December 2015 to November 2016 through face-to-face interviews using a structured questionnaire and five standardized patient-reported outcomes instruments. Direct costs were estimated by multiplying the amount of resources used (12-month recall period) by the corresponding unit cost. Indirect costs were grouped in two time horizons: annual costs (income reduction and absenteeism) and lifetime costs (demission and early retirement)., Results: A total of 188 patients with moderate to severe plaque psoriasis were included, with mean age of 48.0 (SD 13.1). "Anxiety and depression" and "pain and discomfort" were the most impaired dimensions, according to the EuroQol Five-Dimension-Three-Level (EQ-5D-3L). The highest effect was found for "symptoms and feelings" [mean (SD) 2.4 (1.7)] Dermatology Life Quality Index (DLQI) subscale. Psoriatic arthritis (PsA) presence and biologic-naïve status were associated with worse HRQoL. Presenteeism was more frequent than absenteeism, according to the Work Productivity and Activity Impairment questionnaire-General Health (WPAI-GH) [17.4% vs. 6.3%], while physical demands and time management were the most affected Work Limitations Questionnaire (WLQ) subscales [means (SD) 23.5 (28.5) and 17.7 (24.9), respectively]. The estimated annual cost per patient was USD 4034. Direct medical costs accounted for 87.7% of this estimate, direct non-medical costs for 2.4%, and indirect costs for 9.9%., Conclusions: Results evidenced that moderate to severe plaque psoriasis imposes substantial costs to society. Our data showed that this disease negatively affects both work productivity and HRQoL of Brazilian patients. Subgroups with PsA and biologic-naïve patients presented lower HRQoL, showing the impact of this comorbidity and the relevance of biologics in psoriasis treatment., Funding: Novartis Biociências S.A.

Objectives: To assess the budget impact of restricting inappropriate inhaled corticosteroids (ICS) use according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD)-guidelines indication for ICS use in the chronic obstructive pulmonary disease (COPD)-population, taking The Netherlands as a reference case., Methods: A budget impact model was developed and closely aligned with the International Society for Pharmacoeconomics and Outcomes Research best-practice guidelines. The model estimates the impact of pharmacologic COPD maintenance treatments on clinical events (exacerbations and pneumonias) and associated healthcare utilization and costs. The current treatment mix included all maintenance treatments including long-acting muscarinic antagonists (LAMA), long-acting β2-agonists (LABA), LABA/ICS, LABA/LAMA, and triple therapy (LABA/LAMA/ICS). We modeled a situation where 25% of patients would use ICS-containing treatments and compared this to the current Dutch situation with 60% ICS use. A 5-year time horizon with a Dutch healthcare payer's perspective was used. In sensitivity analyses, a range of values for absolute ICS reduction (20%-40%), relative risks of exacerbations and pneumonia events, and other input parameters were explored., Results: Over a period of 5 years, the new treatment mix with Global Initiative for Chronic Obstructive Lung Disease guideline recommended ICS, and LABA/LAMA use resulted in potential avoidance of 17 405 exacerbations and 11 984 pneumonias and accompanied savings of €84 million in the base-case scenario. Savings were consistent in various sensitivity analyses, indicating cost savings between €30 and €200 million., Conclusion: Reducing inappropriate ICS use and increasing use of LABA/LAMA in COPD patients could result in a reduction of exacerbations and pneumonias, corresponding with a reduction in total costs for COPD in The Netherlands., (Copyright © 2019 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Purpose: Guidelines recommend the use of triple therapy with an inhaled corticosteroid (ICS), a long-acting β 2 agonist (LABA) and a long-acting muscarinic antagonist (LAMA) to reduce the risk of future exacerbations in symptomatic COPD patients with a history of exacerbations. This study aimed to estimate COPD-related healthcare resource use and costs, and subsequent exacerbation rates, for patients initiating multiple-inhaler triple therapy (MITT) early (≤30 days) versus late (31-180 days) following an exacerbation, in a real-world clinical setting., Patients and Methods: This was an observational, longitudinal, retrospective study using electronic medical records from the Spanish database of the Red de Investigación en Servicios Sanitarios Foundation. Patients ≥40 years old with a confirmed COPD diagnosis who were newly prescribed MITT up to 180 days after an exacerbation between January 2013 and December 2015 were included. Patients were followed from the date of MITT initiation for up to 12 months to assess COPD-related health care resource use (routine and emergency visits, hospitalizations, pharmacologic treatment), exacerbation rate, and costs (€2017); these endpoints were compared between early versus late groups., Results: The study included 1280 patients who met selection criteria: mean age 73 years, 78% male, and 41% had severe/very severe lung function impairment. The proportion of patients initiating MITT early versus late was 61.6% versus 38.4%, respectively. There were no statistically significant differences in baseline characteristics between groups. During follow-up, health care resource consumption was lower in the early versus late group, especially primary care and ED visits, leading to lower total costs (€1861 versus €1935; P <0.05). In the follow-up period, 28.0% of the patients in the early group experienced ≥1 exacerbation versus 36.4% in the late group ( P =0.002), with an exacerbation rate of 0.5 versus 0.6 per person per year ( P =0.022), respectively., Conclusion: Initiating MITT early (≤30 days after an exacerbation) may reduce health care costs and exacerbation rate compared with late MITT initiation., Competing Interests: ASI is employe of, and hold stocks in, GlaxoSmithKline plc. ASI is also unpaid part-time faculty at McMaster University, ON, Canada. SHL and AH were employees of GlaxoSmithKline plc. at the time of the study. ASM and EM received fees for their participation in the study. The authors report no other conflicts of interest in this work., (© 2019 Sicras Mainar et al.)

Purposes: Following a hospitalization for COPD, dual and triple therapies were compared in terms of persistence and relations with outcomes (exacerbations, health care resource use and costs)., Methods: This was a historical observational database study. All patients aged ≥45 hospitalized for COPD between 2007 and 2015 were identified in a 1/97 th random sample of French claims data. Patients receiving dual therapy within 60 days after hospitalization were compared to patients receiving triple therapy, after propensity score matching on disease severity., Results: Of the 3,089 patients hospitalized for COPD, 1,538 (49.8%) received either dual or triple therapy in the 2 months following inclusion, and 1,500 (48.6%) had at least 30 days of follow-up available; 846 (27.4%) received dual therapy, and 654 (21.2%) received triple therapy. After matching, the number of exacerbations was 2.4 per year in the dual vs 2.3 in the triple group ( p =0.45). Among newly treated patients (n=206), persistence at 12 months was similar in the dual and triple groups (48% vs 41%, respectively, p =0.37). As compared to patients on dual therapy, more patients on triple therapy received oral corticosteroids (49.1 vs 40.4%, p =0.003) or were hospitalized for any reason (67% vs 55.8%, p =0.0001) or for COPD (35.3 vs 25.1%, p =0.0002) during follow-up. Cost of care was higher for patients on triple than for those on dual therapy (€11,877.1 vs €9,825.1, p =0.01)., Conclusion: Following hospitalizations for COPD, patients on dual and triple therapy experienced recurrent exacerbations, limited adherence to therapies and high cost of care. Patients on triple therapy appeared more severe than those on dual therapy, as reflected by exacerbations and health care resource use., Competing Interests: EVG is Scientific Advisor of PELyon, he reports personal fees from PELyon, during the conduct of the study; personal fees from PELyon, outside the submitted work. MN, FD and MB (employees of PELyon) conducted the study through sponsorship by Chiesi SAS, and were not paid for manuscript development. NR reports grants and personal fees from Boehringer Ingelheim, Novartis, Pfizer and personal fees from Teva, GSK, AstraZeneca, Mundipharma, Cipla, Sanofi, Sandoz, 3M, Zambon and Chiesi. PD has received consulting fees, honoraria for lectures and/or research funding from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, and Novartis during the last 3 years. He reports personal fees from Chiesi, during the conduct of the study; personal fees from Astra Zeneca, personal fees from Boehringer Ingelheim, personal fees from Chiesi, personal fees from GlaxoSmithKline, personal fees from Novartis, personal fees from Sanofi, outside the submitted work. BH received honorarium from Boehringer Ingelheim, Pfizer, Novartis, Teva, GSK, AstraZeneca and Chiesi for his participation in scientific committees or conferences. He reports personal fees from Chiesi, during the conduct of the study; personal fees from GSK, personal fees from Boehringer Ingelheim, personal fees from Novartis, outside the submitted work. HP received honorarium from Boehringer Ingelheim, Novartis, Teva, GSK, AstraZeneca and Chiesi for his participation in scientific committees or conferences, is on the board for Chiesi and Novartis, and received an invitation to 2019 American Thoracic Society International Conference in Arizona, USA.  GD received research funding from BTG/PneumRx and received honorarium from Boehringer Ingelheim, AstraZeneca, Chiesi, Novartis, BTG/PneumRx for his participation in scientific committees or conferences. He reports personal fees from Chiesi, during the conduct of the study; personal fees from AstraZeneca, personal fees from Boehringer Ingelheim, personal fees from BTG/PneumRx, and personal fees from Nuvaira, outside the submitted work. The authors report no other conflicts of interest in this work., (© 2019 Dalon et al.)

Background: Corticosteroids are used in the management of castration-resistant prostate cancer (CRPC) to reduce tumor-related symptoms because of CRPC therapies. Since corticosteroids have been associated with a range of toxicities, their use may increase the economic burden sustained by patients with CRPC. However, the economic impact of using corticosteroids in patients with CRPC has not been well characterized., Objective: To assess the effect of previous corticosteroid use on health care resource utilization (HRU) and health care costs among men with CRPC., Methods: Using administrative claims data (2007-2016), adult chemotherapy-naive patients who initiated CRPC treatment following surgical or medical castration were identified. Based on the cumulative corticosteroid dose during the 12 months before CRPC treatment initiation, patients were grouped into 4 cohorts: no corticosteroid (0 gm), low corticosteroid (< 0.5 gm), medium corticosteroid (0.5-2.0 gm), and high corticosteroid (> 2.0 gm). All-cause HRU and costs (2017 U.S. dollars) were compared between cohorts during the 1-year study period following CRPC treatment initiation using the no corticosteroid cohort as reference. Multivariable regression models were used to adjust for baseline covariates, including age, region, index year, Charlson Comorbidity Index score, presence of bone metastases, baseline all-cause HRU, and corticosteroid-related clinical events during baseline., Results: 9,425 patients were included (no corticosteroid = 6,765, low corticosteroid = 1,660, medium corticosteroid = 655, and high corticosteroid = 345). On average, patients in the no corticosteroid cohort were older and had a lower baseline HRU and comorbidity burden than patients in the other 3 cohorts. During the study period, patients with corticosteroid exposure (across all corticosteroid cohorts) had significantly more inpatient admissions (high corticosteroid vs. no corticosteroid adjusted incidence rate ratio [IRR] = 1.56; P < 0.001), emergency department visits (high corticosteroid vs. no corticosteroid adjusted IRR = 1.30; P = 0.001), and outpatient visits (high corticosteroid vs. no corticosteroid adjusted IRR = 1.11; P < 0.001). In addition, compared with the no corticosteroid cohort, patients with corticosteroid exposure had significantly higher monthly total costs (high corticosteroid vs. no corticosteroid adjusted difference = $2,600; P < 0.001), including medical service costs (high corticosteroid vs. no corticosteroid adjusted difference = $1,564; P < 0.001) and pharmacy costs (high corticosteroid vs. no corticosteroid adjusted difference = $825; P < 0.001)., Conclusions: Cumulative corticosteroid exposure before CRPC treatment initiation was associated with significantly higher HRU and costs. This increase in economic burden was more prominent among patients with annual cumulative corticosteroid doses of more than 2.0 gm. These results suggest that previous corticosteroid use may result in a higher economic burden among patients with CRPC., Disclosures: This study was funded by Astellas Pharma (Northbrook, IL) and Medivation, a Pfizer Company (San Francisco, CA), the codevelopers of enzalutamide. The study sponsor was involved in the study design, data interpretation, and review. All authors contributed to the development of the manuscript and maintained control over the final content. Schultz and Wilson are employed by Astellas Pharma. Schultz owns stock in Gilead Sciences and Shire. Song and Yang are employed by Analysis Group, which received consultancy fees from Astellas Pharma. Ramaswamy is employed by Pfizer, and Lowentritt is employed by Chesapeake Urology and has served as a speaker and consultant for Astellas Pharma, Pfizer, Bayer, Dendreon, and Janssen. A synopsis of the current research was presented in poster format at the AMCP Managed Care & Specialty Pharmacy Annual Meeting 2019, which took place in San Diego, CA, on March 25-28, 2019.

Objective Out-of-pocket costs strongly affect patient adherence with medicines. For asthma, guidelines recommend that most patients should be prescribed regular low-dose inhaled corticosteroids (ICS) alone, but in Australia most are prescribed combination ICS-long-acting β2-agonists (LABA), which cost more to patients and government. The present qualitative study among general practitioners (GPs) explored the acceptability, and likely effect on prescribing, of lower patient copayments for ICS alone. Methods Semistructured telephone interviews were conducted with 15 GPs from the greater Sydney area; the interviews were transcribed and thematically analysed. Results GPs reported that their main criteria for selecting medicines were appropriateness and effectiveness. They did not usually discuss costs with patients, had low awareness of out-of-pocket costs and considered that these were seldom prohibitive for asthma patients. GPs strongly believed that patient care should not be compromised to reduce cost to government. They favoured ICS-LABA combinations over ICS alone because they perceived that ICS-LABA combinations enhanced adherence and reduced costs for patients. GPs did not consider that lower patient copayments for ICS alone would affect their prescribing. Conclusion The results suggest that financial incentives, such as lower patient copayments, would be unlikely to encourage GPs to preferentially prescribe ICS alone, unless accompanied by other strategies, including evidence for clinical effectiveness. GPs should be encouraged to discuss cost barriers to treatment with patients when considering treatment choices. What is known about the topic? Australian guidelines recommend that most patients with asthma should be treated with low-dose ICS alone to minimise symptom burden and risk of flare ups. However, most patients in Australian general practice are instead prescribed combination ICS-LABA preventers, which are indicated if asthma remains uncontrolled despite treatment with ICS alone. It is not known whether GPs are aware that the combination preventers have a higher patient copayment and a higher cost to government. What does this paper add? This qualitative study found that GPs favoured combination ICS-LABA inhalers over ICS alone because they perceived ICS-LABA combinations to have greater effectiveness and promote patient adherence. This aligned with GPs' views that their primary responsibility was patient care rather than generating cost savings for government. However, it emerged that GPs rarely discussed medicine costs with patients, had low knowledge of medicine costs to patients and the health system and reported that patients rarely volunteered cost concerns. GPs believed that lower patient copayments for asthma preventer medicines would have little effect on their prescribing practices. What are the implications for practitioners? This study suggests that, when considering asthma treatment choices, GPs should empathically explore with the patient whether cost-related medication underuse is an issue, and should be aware of the option of lower out-of-pocket costs with guideline-recommended ICS alone treatment. Policy makers must be aware that differential patient copayments for ICS preventer medicines are unlikely to act as an incentive for GPs to preferentially prescribe ICS alone preventers, unless the position of these preventers in guidelines and evidence for their clinical effectiveness are also reiterated.

Objective: Eczema, a chronic dermatologic disease, has been recognized as an economic burden in publications all over the word but only minimally as such in Vietnam. The aim of this prospective study was to quantify the financial hardships and impairments suffered by eczema patients., Methods: This cross-sectional prevalence-based study involved 136 patients, whose conditions were classified into three severity levels on the basis of the medications that they were prescribed. Prescription therapy was administered for a month, after which there was patient-oriented assessment of effectiveness. The work productivity and activity impairment (WPAI) questionnaire was used to evaluate productivity loss, which was expressed in percentage form. Bootstrapping was conducted to determine continuous variables and demographybased differences in cost values among the patient groups., Results: For the month-long treatment, each eczema patient needed an average of US$68.1 (range: US$56.2- US$81.5) with the highest proportion being spent on cosmetic treatments. There is noticeable difference between groups among which patients' symptoms demonstrated in distinct levels. The estimates indicated that eczema resulted in 27.8% and 23.1% impairments in work and daily activities, respectively., Conclusions: The aggravation of disease symptoms can increase the direct costs borne by eczema patients. A decrease in productivity, which is one of the most serious consequences of the condition, should be paid adequate attention to minimize burdens to society.

Objectives: Eczema, which is synonymous with atopic eczema, is classified as a complex, chronic, and relapsing inflammatory skin condition, affecting both adults and children. However, there has not been any research into health-care expenditure to evaluate the medical cost of eczema from patients' perspective in Vietnam. This retrospective study aimed to fill in the gap concerning the medical cost of eczema treatment from patients' perspective., Methods: Data from Ho Chi Minh City Hospital of Dermato Venereology's electronic medical database on demographics and drug therapy from June 2016 to May 2017 were collected. The patients who met the study's criteria were included in the study and were then categorized as mild, moderate, and severe according to received treatment level. Bootstrapping methods were used to evaluate average and emphasized the difference of cost burden adjusted by factors., Results: A total of 6,212 patients (52.1% women and 85% urban residents) participated in the study; they were divided into three groups according to treatment stage: mild (n = 3,159, 50.9%), moderate (n = 599, 9.6%), and severe (n = 2,454, 39.5%). The evaluated total cost for the three groups was 5,255.82, 1,064.03, and 5,8154.60 US dollars, respectively; the average expenditure per patient per year was around $12.11 ($11.63-12.59)., Conclusions: The results suggested that the estimated direct medical cost of eczema treatment was much lower than that in the Western countries, mostly because of insurance coverage. The findings provide useful insights into health economic evaluations and treatment costs of eczema in Vietnam.

Purpose: Chronic obstructive pulmonary disease (COPD) is characterized by persistent respiratory symptoms and is a leading cause of disability in China. Acute exacerbations of COPD (AECOPD) are a leading cause of hospitalizations, and account for a substantial proportion of medical expenditure. Corticosteroids are commonly used to manage AECOPD in hospitalized patients, so our objective was to analyze the total medical expenditure associated with nebulized budesonide (nBUD) vs. systemic corticosteroids (SCS) in this population. Patients and methods: A post-hoc analysis was carried out in 1,577 and 973 patients diagnosed with COPD who had received "any" nBUD or SCS regimen for AECOPD during hospitalization, respectively. Regimens included monotherapy, sequential therapy, and sequential-combination therapy. Comparative total medical expenditure was analyzed using a generalized linear model controlling for age, gender, comorbidities, smoking history, and respiratory failure or pneumonia on admission. Results: The total medical expenditure per capita with any nBUD or SCS regimen was CN¥11,814 (US$1,922) and CN¥12,153 (US$1,977), respectively. Any nBUD regimen was associated with a significant saving of 5.1% in expenditure compared with any SCS regimen ( P =0.0341). Comorbidities, Type II respiratory failure, or pneumonia were patient factors associated with higher total medical expenditure ( P <0.0001). In a subgroup analysis of the patients who received monotherapy, total medical expenditure was CN¥10,900 (US$1,773) for nBUD and CN¥11,581 (US$1,884) for SCS; nBUD was associated with a significant saving of 8.7% in expenditure compared with SCS ( P =0.0013). Similarly, in patients with respiratory failure, treatment with any nBUD regimen was associated with a 10.6% saving in expenditure over any SCS regimen ( P =0.0239); however, the same comparison was not significant in patients without respiratory failure (3.4%; P =0.2299). Conclusion: AECOPD is a leading cause of hospitalization in China, which places substantial burden on the healthcare system. This post-hoc analysis suggests that nBUD regimens are associated with lower medical expenditure than SCS regimens in hospitalized patients with AECOPD, and may reduce the financial burden of COPD. However, prospective studies evaluating the effectiveness of nBUD therapies are warranted., Competing Interests: A proportion of results in this manuscript was presented at the 23rd International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Annual International Meeting as a poster presentation. The abstract was published in “Poster abstracts” in Value in Health 2018;21(Suppl 1): S236 (available at: https://doi.org/10.1016/j.jval.2018.04.1598). XY, TL, and YL are employees of AstraZeneca, China. This study was supported by AstraZeneca, China. The authors report no other conflicts of interest in this work.

Objectives: To determine if symptoms changed after changing chronic obstructive pulmonary disease (COPD) triple-therapy inhalers to a less expensive regimen., Study Design: Retrospective observational case-series analysis., Methods: A quality improvement program was instituted to reduce drug costs associated with COPD inhalers between fall 2016 and spring 2017. Patients identified as taking an inhaled corticosteroid (ICS)/long-acting β agonist (LABA) inhaler and a long-acting muscarinic agonist (LAMA) inhaler were changed to a LAMA/LABA inhaler and an ICS inhaler. Symptoms were assessed at baseline and subsequent follow-up using the COPD Assessment Test (CAT), with lower scores representing better symptom control. Then, a retrospective observational case-series analysis of 118 patient charts was completed. The primary outcome was mean difference in CAT score. Data were analyzed using a paired t test with an α value of 0.05., Results: Of 118 patients included in the quality improvement program, 19 met the inclusion and exclusion criteria. The mean (SD) CAT score prior to the change was 15.53 (5.36), and the mean (SD) CAT score after the change was 14.68 (6.98). Symptom scores improved after the change, with an average difference in postchange and prechange CAT scores of -0.84, although this difference was not statistically significant (95% CI, -3.57 to 1.89; P = .525)., Conclusions: Based on the results of this observational review, changing COPD triple-therapy inhalers did not result in a significant change in patient-reported symptom scores. Patients may use triple-therapy inhalers that are most affordable without a significant change in symptom control.

Background: The use of corticosteroids as adjunct treatment for community-acquired pneumonia (CAP) is associated with potential clinical benefits. The aim of this study was to evaluate the cost-effectiveness of this approach., Methods: We constructed a decision-analytic model comparing the use of corticosteroids + antibiotics with that of placebo + antibiotics for the treatment of CAP. Cost-effectiveness was determined by calculating deaths averted and incremental cost-effectiveness ratios. Uncertainty was addressed by plotting cost-effectiveness planes and acceptability curves for various willingness-to-pay thresholds., Results: In the base-case analysis, corticosteroids + antibiotics resulted in savings of $142,795 per death averted. In the probabilistic analysis, at a willingness to pay of $50,000, corticosteroids + antibiotics had a 86.4% chance of being cost-effective compared with placebo + antibiotics. In cost-effectiveness acceptability curves, the corticosteroids + antibiotics strategy was cost-effective in 87.6% to 94.3% of simulations compared with the placebo + antibiotics strategy for a willingness to pay ranging from $0 to $50,000. In patients with severe CAP (Pneumonia Severity Index classes IV/V) the corticosteroids + antibiotics strategy resulted in savings of $70,587 and had a 82.6% chance of being cost-effective compared with the placebo + antibiotics strategy., Conclusions: The use of corticosteroids + antibiotics is a cost-effective strategy and results in considerable health care cost-savings, especially among patients with severe CAP (Pneumonia Severity Index classes IV/V)., (Copyright © 2018 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)

Background: Inhaler usability and deposition differ between devices. Change of device may therefore have an impact on clinical and economic outcomes., Objective: To characterize clinical and economic asthma outcomes surrounding the change from a dry powder inhaler (DPI) to a pressurized metered-dose inhaler (pMDI) for fixed-dose combination inhaled corticosteroid/long-acting β agonist (FDC ICS/LABA) treatment., Methods: Three retrospective cohort substudies using 2010 to 2015 data from the Korean Health Insurance and Review Assessment Service database were performed. Patients with asthma who received an FDC ICS/LABA pMDI for the first time after initially being on FDC ICS/LABA DPI were included. The following outcomes were assessed: (1) persistence of change to pMDI over 6 months, (2) clinical outcomes during the year after the change compared with the baseline year; and (3) noninferiority comparison of costs and effectiveness between patients changing to a pMDI and matched patients who continued their DPI., Results: Patients who change inhalers seem to represent a more severe subpopulation. Fifty-eight percent of patients (95% CI, 56-60) persisted with the change. After the change in therapy, an increased proportion of patients (58.3%) remained free from severe exacerbations compared with the year before (47.4%; P < .001). Patients who changed to pMDIs had significantly less severe exacerbations, acute respiratory events, and lower short-acting β agonist inhaler average daily dose, but higher average ICS daily dose (all P < .05), compared with matched patients remaining on a DPI. Total costs were similar between patients who changed to pMDI therapy compared with those remaining on a DPI., Conclusion: Changing from a DPI to a pMDI for FDC ICS/LABA asthma treatment can be as effective and cost-effective as remaining on a DPI., (Copyright © 2018 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: In Australia, many patients who are initiated on asthma controller inhalers receive combination inhaled corticosteroid/long-acting beta 2 -agonist (ICS/LABA) despite having asthma of sufficiently low severity that ICS-alone would be equally effective and less costly for the government., Methods: We conducted a discrete choice experiment (DCE) in a nationally representative sample of adults (n = 792) and parents of children (n = 609) with asthma. Mixed multinomial models were estimated and calibrated to reflect the estimated market shares of ICS-alone, ICS/LABA and no controller. We then simulated the impact of varying patient co-payment on demand and the financial impact on government pharmaceutical expenditure., Results: Preference for inhaler decreased with increasing costs to the patient or government, increasing chance of a repeat visit to the doctor, and if fewer symptoms were present. Adults preferred high-strength controllers, but parents preferred low-strength inhalers for children (general beneficiaries only). The DCE predicted a higher proportion choosing controller treatment (89%) compared to current levels (57%) at the current co-payment level, with proportionately higher uptake of ICS-alone and a lower average cost per patient [32.73 Australian dollars (AU$) c.f. AU$38.54]. Reducing the co-payment on ICS-alone by 50% would increase its market share to 50%, whilst completely removing the co-payment would only have a small marginal impact on market share, but increased average cost of treatment to the government to AU$41.04 per person., Conclusions: Patient-directed financial incentives are unlikely to encourage much switching of medicines, and current levels of under-treatment are not explained by patient preferences. Interventions directed at prescribers are more likely to promote better use of asthma medicines.

Objectives: Patients with chronic obstructive pulmonary disease (COPD) who experience acute exacerbations usually require treatment with oral steroids or antibiotics, depending on the etiology of the exacerbation. Current management is based on clinician's assessment and judgement, which lacks diagnostic accuracy and results in overtreatment. A test to guide these decisions in primary care is in development. We developed an early decision model to evaluate the cost-effectiveness of this treatment stratification test in the primary care setting in the United Kingdom., Methods: A combined decision tree and Markov model was developed of COPD progression and the exacerbation care pathway. Sensitivity analysis was carried out to guide technology development and inform evidence generation requirements., Results: The base case test strategy cost GBP 423 (USD 542) less and resulted in a health gain of 0.15 quality-adjusted life-years per patient compared with not testing. Testing reduced antibiotic prescriptions by 30 percent, potentially lowering the risk of antimicrobial resistance developing. In sensitivity analysis, the result depended on the clinical effects of treating patients according to the test result, as opposed to treating according to clinical judgement alone, for which there is limited evidence. The results were less sensitive to the accuracy of the test., Conclusions: Testing may be cost-saving in primary care, but this requires robust evidence on whether test-guided treatment is effective. High quality evidence on the clinical utility of testing is required for early modeling of diagnostic tests generally.

Purpose: The aim of this study was to examine real-world differences in health care resource use (HRU) and costs among COPD patients in the USA treated with a dry powder inhaler (DPI) or pressurized metered-dose inhaler (pMDI) following a COPD-related hospitalization., Methods: This retrospective analysis used the Truven MarketScan ® databases. Eligibility criteria included 1) age ≥40 years, 2) COPD diagnosis, 3) inpatient admission with a diagnosis of COPD exacerbation, 4) inhaled corticosteroid (ICS)/long-acting β 2 -agonist (LABA) prescription within 10 days of hospital discharge (index date), and 5) continuous enrollment for 12 months preindex and 90 days postindex. Outcomes included pre- and postindex HRU and costs. DPI and pMDI groups were compared on postindex outcomes via multivariate models controlling for demographic and baseline characteristics., Results: The sample included 1,960 DPI and 1,086 pMDI ICS/LABA patients. During the preindex period, pMDI patients were significantly more likely to be prescribed a short-acting β-agonist, experienced more COPD exacerbation-related hospital days, and had a greater number of pulmonologist visits compared to DPI patients ( P <0.05), all suggestive of greater disease severity. However, multivariate models revealed that pMDI patients incurred 10% lower all-cause postindex costs (predicted mean costs [2016 US dollars]: $2,673 vs $2,956) and 19% lower COPD-related costs (predicted mean costs: $138 vs $169; P <0.05). Additionally, pMDI patients were 28% less likely to experience a COPD exacerbation-related hospital readmission within 60 days postdischarge compared to the DPI patients (OR: 0.72, 95% CI: 0.52-0.99, P <0.05)., Conclusion: Despite greater COPD-related HRU and costs preceding index hospitalization, US patients using a pMDI after hospital discharge incurred significantly lower all-cause and COPD-related health care costs compared with those using a DPI, in addition to a decreased likelihood of a COPD exacerbation-related hospital readmission. Results suggest that inhaler device type may influence COPD outcomes and that COPD patients may derive greater clinical benefit from treatment delivered via pMDI vs DPI., Competing Interests: Disclosure ETW and LAM are employed by AstraZeneca. KAE, MB, and JT are employed by IBM Watson Health as consultants and received funding from AstraZeneca to conduct this study. GTF is a paid consultant of AstraZeneca. All authors report no other conflicts of interest in this work.

Background: Asthma exacerbations affect the quality of life of patients with asthma and have a major effect on the overall costs of asthma care. An asthma self-management plan that advises the temporary quadrupling of inhaled corticosteroid dose may prevent asthma exacerbations, but this needs to be confirmed before being adopted widely., Objectives: To compare the clinical effectiveness and cost-effectiveness of an asthma self-management plan that advises patients to temporarily quadruple the dose of inhaled corticosteroid when asthma control starts to deteriorate with a standard self-management plan., Design: A multicentre, parallel-group, pragmatic randomised trial, with follow-up for 12 months., Setting: Primary and secondary care across 207 sites in the UK., Participants: Asthma patients aged ≥ 16 years treated with an inhaled corticosteroid who had experienced at least one exacerbation in the previous 12 months., Interventions: Participants were randomised (1 : 1) to a usual-care self-management plan or to a modified self-management plan that advised a temporary quadrupling of the inhaled corticosteroid at the point of asthma deterioration, both of which were actively implemented and supported by local research staff., Primary Outcome: The primary outcome of 'time to first asthma exacerbation' was defined as the need for systemic corticosteroids (for at least 3 consecutive days) and/or unscheduled health-care consultations for asthma (i.e. reaching zone 3 or 4 of the Asthma UK self-management plan)., Results: A total of 1922 participants were randomised: the primary analysis included 938 participants (97%) in the usual-care group and 933 participants (97%) in the modified self-management group. The number of participants having at least one exacerbation of asthma in the year after randomisation was 484 (51.6%) in the usual-care group and 420 (45.0%) in the modified self-management group [adjusted hazard ratio 0.81, 95% confidence interval (CI) 0.71 to 0.92; p  = 0.002]. There were fewer serious adverse events reported in the modified self-management group than in the usual-care group (11 vs. 32, respectively). Eight and six events of pneumonia, lower respiratory tract infections or influenza were reported in the usual-care group and the modified self-management group, respectively. Health-care-related costs were lower in the modified self-management group. The modified self-management group was £24 (bootstrapped 95% CI -£122 to £71) less costly than usual care, with a greater quality-adjusted life-year gain of 0.02 (bootstrapped 95% CI -0.005 to 0.04). Therefore, the modified self-management group was 'dominant', with a 94-95% probability of being cost-effective at the £20,000-30,000 threshold., Limitations: As the Fourfold Asthma STudy (FAST) was an open-label pragmatic trial, the possibility of treatment bias that may have affected the participants in the modified self-management group cannot be ruled out. Poorer than expected completion of participant diary cards, particularly within the usual-care self-management group, could have led to a null bias, underestimating the true effect of the intervention., Conclusions: An asthma self-management plan that advises patients to temporarily quadruple their dose of inhaled corticosteroid at the point of asthma symptoms worsening does reduce clinically important asthma exacerbations. In addition, the plan is cost-effective compared with the usual-care self-management plan., Future Work: To effectively implement asthma self-management plans that advise a temporary quadrupling of inhaled steroid at asthma deterioration into routine practice., Trial Registration: Current Controlled Trials ISRCTN15441965., Funding: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 22, No. 70. See the NIHR Journals Library website for further project information., Competing Interests: David Price reports board membership fees paid to the Observational and Pragmatic Research Institute from Aerocrine AB, Amgen Inc., AstraZeneca plc, C.H. Boehringer Sohn AG & Ko. KG, Chiesi Farmaceutici S.p.A., Mylan N.V., Mundipharma GmbH, Napp Pharmaceutical Group Ltd, Novartis Pharmaceutical Company and Teva Pharmaceutical Industries Ltd; consultancy agreement fees paid to the Observational and Pragmatic Research Institute from Almirall S.A., Amgen Inc., AstraZeneca plc, C.H. Boehringer Sohn AG & Ko. KG, Chiesi Farmaceutici S.p.A., GlaxoSmithKline plc, Mylan N.V., Mundipharma GmbH, Napp Pharmaceutical Group Ltd, Novartis Pharmaceutical Company, Pfizer Inc., Teva Pharmaceutical Industries and Theravance Biopharma; grants from Aerocrine AB, AKL Research and Development Ltd, AstraZeneca plc, C.H. Boehringer Sohn AG & Ko. KG, the British Lung Foundation, Chiesi Farmaceutici S.p.A., Mylan N.V., Mundipharma GmbH, Napp Pharmaceutical Group Ltd, Novartis Pharmaceutical Company, Pfizer Inc., the Respiratory Effectiveness Group, Teva Pharmaceutical Industries, Theravance Biopharma, the UK National Health Service and Zentiva N.V.; lecture/speaking engagement fees paid to the Observational and Pragmatic Research Institute from Almirall S.A., AstraZeneca plc, C.H. Boehringer Sohn AG & Ko. KG, Chiesi Farmaceutici S.p.A., Cipla Ltd, GlaxoSmithKline plc, KYORIN Pharmaceutical Co., Ltd, Mylan N.V., Merck & Company, Inc., Mundipharma GmbH, Novartis Pharmaceutical Company, Pfizer Inc., Skyepharma and Teva Pharmaceutical Industries; manuscript preparation fees paid to the Observational and Pragmatic Research Institute from Mundipharma GmbH and Teva Pharmaceutical Industries; travel expenses fees paid to the Observational and Pragmatic Research Institute from Aerocrine AB, AstraZeneca plc, C.H. Boehringer Sohn AG & Ko. KG, Mundipharma GmbH, Napp Pharmaceutical Group Ltd, Novartis Pharmaceutical Company and Teva Pharmaceutical Industries; funding for patient enrolment or completion of research fees paid to the Observational and Pragmatic Research Institute from Chiesi Farmaceutici S.p.A., Novartis Pharmaceutical Company, Teva Pharmaceutical Industries and Zentiva N.V.; and payment for developing educational materials fees paid to the Observational and Pragmatic Research Institute from Mundipharma GmbH and Novartis Pharmaceutical Company. David Price is a peer reviewer for grant committees for the Efficacy and Mechanism Evaluation and Health Technology Assessment (HTA) programmes. He has stock/stock options from AKL Research and Development Ltd that produces phytopharmaceuticals, and owns 74% of the social enterprise Optimum Patient Care Ltd (in Australia, Singapore and the UK) and 74% of the Observational and Pragmatic Research Institute Pte Ltd (Singapore). Ian Pavord reports grants from GlaxoSmithKline during the conduct of the study; has received speaker’s honoraria from AstraZeneca plc, C.H. Boehringer Sohn AG & Ko. KG, Aerocrine AB, Almirall S.A., Novartis Pharmaceutical Company and GlaxoSmithKline; has received honoraria for attending advisory board panels from Almirall S.A., AstraZeneca plc, C.H. Boehringer Sohn AG & Ko. KG, Dey Pharma, L.P., GlaxoSmithKline, Merck Sharp & Dohme, Schering-Plough, Novartis Pharmaceutical Company, Napp Pharmaceutical Group Ltd and RespiVert Ltd; and has received sponsorship for attending international scientific meetings from AstraZeneca plc, C.H. Boehringer Sohn AG & Ko. KG, GlaxoSmithKline and Napp Pharmaceutical Group Ltd. Mike Thomas received speaker’s honoraria for speaking at sponsored meetings or satellite symposia at conferences from Aerocrine AB, GlaxoSmithKline and Novartis Pharmaceutical Company. He has received honoraria for attending advisory panels with Aerocrine AB, Boehringer Ingelheim, GlaxoSmithKline, Merck Sharp & Dohme, Novartis Pharmaceutical Company and Pfizer Inc. during the conduct of the study. He reports grants from the National Institute for Health Research during the conduct of the study; being a member of the HTA Primary Care Community and Preventative Interventions Panel during the conduct of the study; and personal fees from GlaxoSmithKline, Novartis Pharmaceutical Company, Boehringer Ingelheim and Aerocrine AB outside the submitted work. He is a member of the British Thoracic Society/Scottish Intercollegiate Guidelines Network’s Asthma Guideline Steering Group and the National Institute for Health and Care Excellence’s Asthma Diagnosis and Monitoring Guideline Development Group. Christopher Brightling received payment via his institution of grants and personal fees from AstraZeneca plc/MedImmune, LLC, GlaxoSmithKline plc, F. Hoffmann-La Roche AG/Genentech, Inc., Novartis Pharmaceutical Company, Chiesi Farmaceutici S.p.A., Pfizer Inc., Teva Pharmaceutical Industries, Sanofi S.A./Regeneron Pharmaceuticals, Inc., Glenmark Pharmaceuticals, Mologic Ltd and Vectura Group plc.