Sarowar Golam - Academia.edu (original) (raw)

Papers by Sarowar Golam

Research paper thumbnail of S5 Mortality analyses on systemic corticosteroid use: a long-term observational study

CO 2 emission was calculated using CO 2 emission factor 13.8 kg/visit for ER/hospital visits 2 an... more CO 2 emission was calculated using CO 2 emission factor 13.8 kg/visit for ER/hospital visits 2 and CO 2 emission factor 140 g/ puff for rescue medication use. Results 1,842 patients were assessed for ER/hospital visits and 1,800 patients for rescue medication use. IND/GLY/MF highand medium-dose suggested reductions in ER/hospital visits (rate ratio [RR] 0.66, 0.43 to 1.01 and RR, 0.87, 0.57 to 1.33) versus SAL/FLU high-dose, which would corresponds to a change of 9.1 (5.9 to 13.9) and 12.0 (7.9 to 18.4) kg CO 2 emission per visit, respectively. The difference in mean daily puffs of rescue medication with IND/GLY/MF high-and medium-dose versus SAL/FLU high-dose, was À0.12 (À0.27 to 0.03) and À0.06 (À0.20 to 0.09), respectively, which corresponds to a change of 6.1 (À13.8 to 1.5) and 3.1 (À10.2 to 4.6) kg CO 2 emission per year, respectively. Conclusions All three-treatment arms of the study significantly reduced CO 2 emissions compared with MDIs. However, indacaterol/glycopyrronium/mometasone furoate resulted in numerical reductions of ER/hospital visits, which suggests increased CO 2 savings versus salmeterol/fluticasone. These results should be cautiously interpreted as our calculations are based on a limited number of variables that affect the carbon footprint. Nonetheless, these results might be used as a basis for conducting studies on carbon footprint in patients with asthma. The study was funded by Novartis Pharmaceuticals, East Hanover. Abstract S5 Figure 1 Association of cumulative SCS dose and average SCS daily exposure with risk of death among patients with asthma (N=9413) Spoken sessions

Research paper thumbnail of Healthcare Resource Use and Costs Associated with Organ Damage in Newly Diagnosed Adults with Systemic Lupus Erythematosus in the UK

Rheumatology and therapy, Jul 3, 2023

Introduction: This analysis compared healthcare resource use (HCRU) and costs associated with inc... more Introduction: This analysis compared healthcare resource use (HCRU) and costs associated with incident organ damage in a cohort of adult patients with systemic lupus erythematosus (SLE). Methods: Incident SLE cases were identified (Clinical Practice Research Datalink [CPRD] and Hospital Episode Statistics-linked healthcare databases; January 1, 2005-June 30, 2019). Annual incidence of 13 organ damage domains was calculated from SLE diagnosis through follow-up. Annualized HCRU and costs were compared between organ damage and nonorgan damage patient groups using generalized organ damage had greater resource use for all organ systems, excluding gonadal, versus those without it. Overall, mean (SD) annualized allcause HCRU was greater in patients with organ damage versus those without it (inpatient, 1.0 versus 0.2; outpatient, 7.3 versus 3.5; accident and emergency, 0.5 versus 0.2 days; primary care contacts, 28.7 versus 16.5; prescription medications, 62.3 versus 22.9). Adjusted mean annualized all-cause costs were significantly greater in both post-and pre-organ damage index periods for patients with organ damage versus those without it (all P \ 0.05, excluding gonadal). Overall organ damage was associated with significantly increased adjusted mean annualized per-patient cost (£4442 greater [P \ 0.0001]) ranging between £2709 and £7150 greater depending on the organ damage type. Conclusion: Organ damage was associated with higher HCRU and healthcare costs, before and after SLE diagnosis. More effective SLE management may slow disease progression, prevent organ damage onset, improve clinical outcomes, and reduce healthcare costs.

Research paper thumbnail of PRS68 The Humanistic Burden of Mild Asthma: Evidence from the Novelty Study

Research paper thumbnail of PRS24 Cost Effectiveness of Benralizumab for Severe, Uncontrolled Oral Corticosteroid-Dependent Asthma in Swededn

Value in Health, 2019

SSc-ILD patients (39.1% limited, 60.9% extended). In general, main cost drivers were the follow-u... more SSc-ILD patients (39.1% limited, 60.9% extended). In general, main cost drivers were the follow-up visits, prescribed maintenance treatment and exacerbation management (especially for PF-ILD). HCRU were higher in PF-ILD compared to non/ slow-progressive F-ILD, and in extended SSc-ILD as compared to limited SSc-ILD. In the first wave, consensus was obtained on the negative impact of PF-ILD on social life (94.3%) and financial status (88.6%). Also, the decline in lung function negatively impacts the patients' quality of life (91.4%). Conclusions: This study reveals a greater apparent economic burden associated with the management of extended vs. limited SSc-ILD and PF-ILD vs. non/slow-progressive forms of F-ILDs.

Research paper thumbnail of POS1403 CLINICAL Characteristics, Health Care Resource Utilization, and Costs Associated with Flares in Patients with Systemic Lupus Erythematosus in Germany

Annals of the Rheumatic Diseases

BackgroundLongitudinal data describing real-world systemic lupus erythematosus (SLE) disease char... more BackgroundLongitudinal data describing real-world systemic lupus erythematosus (SLE) disease characteristics, health care resource utilization (HCRU), and costs associated with flares in Germany are limited.ObjectivesTo evaluate the clinical characteristics of patients with SLE and estimate the impact of flares on HCRU and costs in a cohort of adults with SLE in Germany.MethodsCHaracteristics and impact of flares on clinicAl and econoMic OutcoMes In patients with systemic Lupus Erythematosus: a German Claims Database Study (CHAMOMILE) was an observational, retrospective cohort study. Adult patients with SLE were identified from the German Betriebskrankenkassen health insurance fund database between 1 July 2010 and 31 December 2013, and followed for up to 9 years. Baseline period was defined as the first year since the first quarter with the earliest SLE diagnosis during the identification period, including this quarter. Resource utilization measures included number of hospitalizatio...

Research paper thumbnail of Adverse Outcomes, Healthcare Resource Utilization, and Costs Associated with Systemic Corticosteroid use Among Adults with Systemic Lupus Erythematosus in the UK

Rheumatology and Therapy

Introduction: This analysis was conducted to assess the incidence of adverse clinical outcomes, h... more Introduction: This analysis was conducted to assess the incidence of adverse clinical outcomes, healthcare resource use (HCRU), and the costs associated with systemic corticosteroid (SCS) use in adults with systemic lupus erythematosus (SLE) in the UK. Methods: We identified incident SLE cases using the Clinical Practice Research Datalink GOLD, Hospital Episode Statistics-linked healthcare, and Office for National Statistics mortality databases from January 1, 2005, to June 30, 2019. Adverse clinical outcomes, HCRU, and costs were captured for patients with and without prescribed SCS. Results: Of 715 patients, 301 (42%) had initiated SCS use (mean [standard deviation (SD)] 3.2 [6.0] mg/day) and 414 (58%) had no recorded SCS use post-SLE diagnosis. Cumulative incidence of any adverse clinical outcome over 10-year follow-up was 50% (SCS group) and 22% (non-SCS group), with osteoporosis diagnosis/fracture most frequently reported. SCS exposure in the past 90 days was associated with an adjusted hazard ratio of 2.41 (95% confidence interval 1.77-3.26) for any adverse clinical outcome, with increased hazard for osteoporosis diagnosis/fracture (5.26, 3.61-7.65)

Research paper thumbnail of The burden of mild asthma: Clinical burden and healthcare resource utilisation in the NOVELTY study

Respiratory Medicine

Background: Patients with mild asthma represent a substantial proportion of the population with a... more Background: Patients with mild asthma represent a substantial proportion of the population with asthma, yet there are limited data on their true burden of disease. We aimed to describe the clinical and healthcare resource utilisation (HCRU) burden of physician-assessed mild asthma. Methods: Patients with mild asthma were included from the NOVEL observational longiTudinal studY (NOVELTY; NCT02760329), a global, 3-year, real-world prospective study of patients with asthma and/or chronic obstructive pulmonary disease from community practice (specialised and primary care). Diagnosis and severity were based on physician discretion. Clinical burden included physician-reported exacerbations and patientreported measures. HCRU included inpatient and outpatient visits. Results: Overall, 2004 patients with mild asthma were included; 22.8% experienced ≥1 exacerbation in the previous 12 months, of whom 72.3% experienced ≥1 severe exacerbation. Of 625 exacerbations reported, 48.0% lasted >1 week, 27.7% were preceded by symptomatic worsening lasting >3 days, and 50.1% required oral corticosteroid treatment. Health status was moderately impacted (St George's Respiratory Questionnaire score: 23.5 [standard deviation ± 17.9]). At baseline, 29.7% of patients had asthma symptoms that were not well controlled or very poorly controlled (Asthma Control Test score <20), increasing to 55.6% for those with ≥2 exacerbations in the previous year. In terms of HCRU, at least one unscheduled ambulatory visit for exacerbations was required by 9.5% of patients, including 9.2% requiring ≥1 emergency department visit and 1.1% requiring ≥1 hospital admission. Conclusions: In this global sample representing community practice, a significant proportion of patients with physician-assessed mild asthma had considerable clinical burden and HCRU.

Research paper thumbnail of Letter in reply: indirect treatment comparison of anifrolumab efficacy versus belimumab in adults with systemic lupus erythematosus

Journal of Comparative Effectiveness Research

Research paper thumbnail of Indirect treatment comparison of anifrolumab efficacy versus belimumab in adults with systemic lupus erythematosus

Journal of Comparative Effectiveness Research

Aim: Assess the comparative efficacy of anifrolumab 300 mg versus belimumab 10 mg/kg in adults wi... more Aim: Assess the comparative efficacy of anifrolumab 300 mg versus belimumab 10 mg/kg in adults with moderate-to-severe systemic lupus erythematosus (SLE) receiving standard therapy. Patients and methods: Population-adjusted simulated treatment comparisons (primary analyses) and matching-adjusted indirect comparisons (supporting analyses) were conducted using individual patient data from TULIP-1/TULIP-2 and summary-level data from BLISS-52/BLISS-76. Results: Compared with belimumab-treated patients, anifrolumab-treated patients were more than twice as likely to achieve a reduction of four or more points in SLE Disease Activity Index 2000 score (simulated treatment comparison odds ratio: 2.47; 95% CI: 1.16–5.25) and SLE Responder Index-4 response (odds ratio: 2.61; 95% CI: 1.22–5.58) at 52 weeks. Conclusion: Patients with moderate-to-severe SLE are more likely to achieve an improvement in disease activity with anifrolumab than with belimumab.

Research paper thumbnail of Exacerbation burden in mild asthma: Evidence from the NOVELTY study

European Respiratory Journal, 2020

Background: Although 50–75% of patients with asthma are reported to have mild asthma, exacerbatio... more Background: Although 50–75% of patients with asthma are reported to have mild asthma, exacerbations may still play a significant role in their disease burden. NOVELTY (NCT02760329) is a global, prospective, observational study of patients with a physician-assigned diagnosis of asthma and/or COPD. Physicians were asked to classify asthma as mild, moderate or severe; no criteria were provided. Objective: To describe the exacerbation burden of patients with physician-assessed mild asthma in the NOVELTY study. Methods: Baseline characteristics of patients with physician-assessed mild asthma were described. Results: Baseline characteristics for 2,175 patients with physician-assessed mild asthma (of 5,940 with asthma) were reported (Table). By physician report, in the past 12 months 527 patients (24%) had ≥1 exacerbation; mean exacerbation rate was 0.4 events/year. Healthcare resource utilisation data were available for 714/867 physician-reported exacerbations; 8% lasted for >1 month a...

Research paper thumbnail of Elevated blood eosinophil level and costs for adults with persistent asthma

European Respiratory Journal, 2016

Background: We examined whether elevated blood eosinophil (eos) level, which is linked to increas... more Background: We examined whether elevated blood eosinophil (eos) level, which is linked to increased asthma exacerbations, is also related to increased all-cause and asthma-related costs. Methods: In this cohort study using administrative pharmacy and health care utilization data, we identified 2392 patients aged 18–64 years with persistent asthma and a blood eos determination in the baseline year. All-cause costs included hospitalization, emergency department (ED) and outpatient (OP) visits, laboratory, radiology, and asthma medications. Asthma-related costs included hospitalizations and ED visits with principal diagnosis of asthma, asthma-related OP visits, laboratory and radiology, and asthma medications. The relationship of baseline blood eos level to all-cause and asthma-related costs in the follow-up year was estimated by generalized linear models with gamma distribution, adjusted for demographics, comorbidities, prior exacerbation, step-care treatment, and baseline costs. Results: Greater blood eos counts at baseline were associated with increased total asthma-related costs, but not all-cause costs. The adjusted incremental increases in asthma-related costs were 377(400cells/μLcutoff)and377 (400 cells/μL cutoff) and 377(400cells/μLcutoff)and237 (300 cells/μL cutoff). Conclusions: Elevated blood eos count is an independent risk factor for increased asthma-related, but not all-cause costs for adults with persistent asthma, confirming the importance of blood eos in this group.

Research paper thumbnail of Asthma-related healthcare utilization and costs by blood eosinophil levels among adults with persistent asthma

European Respiratory Journal, 2015

Background: Elevated blood eosinophil (EOS) count is a risk factor for future exacerbation in adu... more Background: Elevated blood eosinophil (EOS) count is a risk factor for future exacerbation in adults with persistent asthma. We investigated whether a relationship also exists between EOS and healthcare utilization (HRU) and cost in these patients. Methods: We conducted a retrospective cohort study using claims data on commercial and Medicare Advantage health plan adults (age≥18 years) who met the HEDIS persistent asthma criteria for 2 consecutive years during 2007-2012 and had a EOS determination at baseline; the index date was January 1 of the 3 rd year. Future (1-year post-index) asthma-related HRU and cost were described and compared between baseline EOS levels using different cut-off points (150, 300, or 400 cells/µL). Results: The study included 37,830 subjects. Patients with higher baseline EOS count at all cut-off points had higher frequency of future asthma-related office visits, emergency department (ED) visits, inpatients, and pharmacy fills. Asthma-related total, medical, and pharmacy costs were all higher in patients with higher EOS (Table). There is a trend toward higher future HRU and cost with increasing baseline EOS. Conclusions: Higher future disease burden was observed in asthma patients with increasing EOS count, consistent with previous findings that elevated EOS is a risk factor for future asthma exacerbations.

Research paper thumbnail of Dronedarone for the Treatment of Atrial Fibrillation

PharmacoEconomics, 2012

The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of dron... more The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of dronedarone (Multaq®, Sanofi-Aventis Limited, UK) to submit evidence on the clinical and cost effectiveness of the anti-arrhythmic drug (AAD) for the treatment of atrial fibrillation (AF) and atrial flutter, as part of the Institute&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s single technology appraisal (STA) process. The Centre for Reviews and Dissemination and the Centre for Health Economics, both at the University of York, were commissioned to act as the independent Evidence Review Group (ERG). This article provides a description of the company submission, the ERG review and NICE&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s subsequent decisions regarding the use of dronedarone within the UK NHS. The ERG review comprised a critique of the submitted evidence on the clinical effectiveness and cost effectiveness of dronedarone. The ERG examined the search strategy used to obtain relevant evidence, the selection of studies included in the assessment, outcome measures chosen and statistical methods employed. The ERG also validated the manufacturer&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s decision analytic model and used it to explore the robustness of the cost-effectiveness results to key assumptions. The main clinical effectiveness evidence supporting the use of dronedarone as a treatment for AF came from four randomized controlled trials. These trials were compared with a broader set of trials examining the effectiveness of other AADs for AF: amiodarone, sotalol and class 1c agents (flecainide and propafenone). The evidence suggested that all AADs decreased the recurrence of AF but dronedarone had the smallest effect. A mixed treatment comparison analysis of the trials showed that dronedarone was associated with a lower risk of all-cause mortality than other AADs, but this was highly uncertain. There was limited evidence to assess the effect of dronedarone on stroke, and no statistically significant differences between dronedarone and other AADs were found for treatment discontinuation. From the evidence presented by the manufacturer, dronedarone appeared highly cost effective in each of the population groups examined compared with using standard baseline therapy alone as first-line treatment, or compared with sotalol or amiodarone as first-line AAD, with incremental cost-effectiveness ratios (ICERs) well below £20,000 per QALY gained. The ICER for dronedarone relative to class 1c agents was around £19,000 per QALY. Although the evidence presented by the manufacturer indicated that dronedarone was cost effective, the estimates of treatment effect relative to other AADs and safety in the longer term were highly uncertain. The NICE Appraisal Committee in its preliminary guidance did not recommend the use of dronedarone for AF. However, following the response from a large number of…

Research paper thumbnail of Exacerbation utilities and durations by type: estimates from Phase III benralizumab studies

Monitoring Airway Disease, 2017

Research paper thumbnail of Healthcare resource use and costs of severe, uncontrolled eosinophilic asthma in the UK general population

Thorax, Feb 16, 2017

Little is known about the prevalence of severe, uncontrolled eosinophilic asthma (SUEA) and assoc... more Little is known about the prevalence of severe, uncontrolled eosinophilic asthma (SUEA) and associated costs. We sought to determine the prevalence of SUEA and compare asthma-related healthcare resource use (HCRU) and associated costs with overall means for a general asthma population. This cohort study evaluated anonymised medical record data (December 1989 through June 2015) from the Clinical Practice Research Datalink and the Optimum Patient Care Research Database to study UK patients with active asthma (diagnostic code and one or more drug prescriptions in the baseline year), aged 5 years and older, without concomitant COPD, and with recorded eosinophil count. SUEA was defined as two or more asthma attacks during 1 baseline year preceding a high blood eosinophil count (≥0.3×10(9)/L) for patients prescribed long-acting β2-agonist (LABA) and high-dosage inhaled corticosteroids (ICS) during baseline plus 1 follow-up year. We compared asthma-related HCRU and associated direct costs ...

Research paper thumbnail of Healthcare resource utilization and costs associated with incremental systemic corticosteroid exposure in asthma

Allergy, 2018

Background: Although systemic corticosteroid (SCS) treatment, irrespective of duration or dosage,... more Background: Although systemic corticosteroid (SCS) treatment, irrespective of duration or dosage, is associated with adverse outcomes for patients with asthma, the longitudinal effects of this treatment on adverse outcomes, healthcare resource utilization (HCRU), and healthcare costs are unknown. Methods: We identified patients initiating intermittent or long-term SCS who were diagnosed with active asthma from UK general practice with linked secondary care data. Control (non-SCS) patients were matched by sex and index date with those initiating SCS. Minimum baseline period was 1 year prior to index date; minimum follow-up duration was 2 years post-index date. Cumulative incidence of SCS-associated adverse outcomes and associated HCRU and costs were compared between SCS and non-SCS patient groups and among average SCS daily exposure categories. Associations between exposure and annualized HCRU and costs were assessed, adjusted for confounders. Results: Analyses included 9413 matched pairs. Median (interquartile range) follow up was as follows: SCS group: 7.1 (4.1-11.8) years; control group: 6.4 (3.8-10.0) years. Greater SCS dosages were correlated with greater cumulative incidence. For example, patients with type 2 diabetes receiving an average daily dosage of ≥7.5 mg had a 15-year cumulative incidence (37.5%) that was 1.5-5 times greater than those receiving lower dosages. HCRU and costs increased annually for SCS patients but not for non-SCS patients. Increases in all-cause adverse outcome (excluding asthma)-associated HCRU and costs were dose-dependent. Conclusions: Over the long term, adverse outcomes associated with SCS initiation were relatively frequent and costly, with a positive dosage-response relationship with SCS exposure.

Research paper thumbnail of Matching-adjusted indirect comparison of benralizumab versus interleukin-5 inhibitors for the treatment of severe asthma: a systematic review

European Respiratory Journal

Benralizumab is an interleukin-5 receptor α-directed cytolytic monoclonal antibody that directly ... more Benralizumab is an interleukin-5 receptor α-directed cytolytic monoclonal antibody that directly depletes eosinophils. Its relative efficacy versus other IL-5-targeted treatments for patients with severe, uncontrolled asthma is not yet fully characterised.We performed a matching-adjusted indirect comparison (MAIC) of benralizumab versus mepolizumab and reslizumab. Trials were selected through systematic review and evaluation of trial methods. Benralizumab patient-level data were weighted to match treatment-effect-modifying patient characteristics of comparator trials before indirect efficacy comparisons.After matching adjustment, benralizumab and mepolizumab reduced exacerbations versus placebo by 52% and 49%, respectively (rate ratio [RR] 0.94, 95% CI 0.78–1.13; n=1524) and reduced the rate of exacerbations requiring hospitalisation/emergency department visit by 52% and 52%, respectively (RR 1.00, 95% CI 0.57–1.75; n=1524). Benralizumab and mepolizumab similarly improved pre-bronch...

Research paper thumbnail of Systematic literature review of the clinical, humanistic, and economic burden associated with asthma uncontrolled by GINA Steps 4 or 5 treatment

Current medical research and opinion, Jan 16, 2018

This study sought to characterize the epidemiologic, clinical, humanistic, and economic burden of... more This study sought to characterize the epidemiologic, clinical, humanistic, and economic burden of patients with asthma uncontrolled by GINA Steps 4 or 5 treatment (severe, uncontrolled asthma [SUA]). A systematic literature review adhering to PRISMA guidelines was performed. Relevant publications were searched for in MEDLINE and EMBASE from January 2004 to September 2016 and in a conference proceedings database from January 2012 to October 2016. Studies were screened using the Population, Intervention, Comparator, Outcomes, Study Design, and Time (PICOS-T) framework. Studies of SUA with observational (prospective and retrospective), randomized, or nonrandomized study designs; adult patient populations; sample sizes ≥20 patients; epidemiologic or clinical outcomes, patient-reported outcomes (PROs), or economic outcomes were included. For our analysis, SUA was defined as inadequate control of asthma, despite the use of medium- to high-dosage inhaled corticosteroids and at least one ad...

Research paper thumbnail of The cost-effectiveness of as-needed budesonide-formoterol versus low-dose inhaled corticosteroid maintenance therapy in patients with mild asthma in Canada

Allergy, Asthma & Clinical Immunology

Background The Global Initiative for Asthma recommends the use of as-needed low-dose inhaled cort... more Background The Global Initiative for Asthma recommends the use of as-needed low-dose inhaled corticosteroid (ICS)-formoterol as a preferred controller therapy for patients with mild asthma. These recommendations were based, in part, on evidence from the SYGMA 1 and 2 studies of as-needed budesonide-formoterol. This analysis aimed to compare the cost-effectiveness of as-needed budesonide-formoterol to low-dose maintenance ICS plus as-needed short-acting β2-agonist (SABA) in patients with mild asthma. Methods A Markov cohort model was designed that included three possible health states (non-exacerbation, severe exacerbation, and death) to compare as-needed budesonide-formoterol 200–6 μg to twice-daily budesonide 200 μg maintenance therapy (low-dose ICS) plus as-needed terbutaline 0.5 mg (SABA). The deterministic base-case analysis used severe exacerbation, adverse event (AE), and healthcare resource use data from SYGMA 2, and was conducted from a Canadian public payer perspective with...

Research paper thumbnail of Cost effectiveness of benralizumab for severe, uncontrolled oral corticosteroid–dependent asthma in Sweden

Journal of Medical Economics

Aim: We investigated cost effectiveness of benralizumab vs. standard of care (SOC) plus oral cort... more Aim: We investigated cost effectiveness of benralizumab vs. standard of care (SOC) plus oral corticosteroids (OCS) for patients with severe, eosinophilic OCS-dependent asthma in Sweden. Materials and methods: A three-state, cohort-based Markov model of data from three Phase III benralizumab clinical trials (ZONDA [NCT02075255], SIROCCO [NCT01928771], and CALIMA [NCT01914757]) was used to assess the incremental cost-effectiveness ratio of benralizumab vs. SOC plus OCS. Health outcomes were estimated in terms of quality-adjusted life-years (QALYs). The model included costs and disutilities associated with extrapolated OCS-related adverse events. Patients with severe asthma were defined as those receiving OCS !5 mg/day. Results: Benralizumab demonstrated a cost-effectiveness ratio vs. SOC plus OCS of 2018 Swedish Kronor (SEK) 366,855 (e34,127) per QALY gained, based on increases of 1.33 QALYs and SEK 488,742 (e45,344) per patient. Benralizumab treatment costs contributed most to incremental costs. The probability of benralizumab's being cost-effective with willingness-to-pay (WTP) thresholds between SEK 429,972 (e40,000) and SEK 752,452 (e70,000) ranged from 75% to 99%. Limitations: Potential limitations of these analyses include the use of combined data from three different clinical trials, a one-way sensitivity analysis that did not include mortality and transition estimates, and Observational & Pragmatic Research Institute (OPRI) data from the UK as a proxy of the Swedish health care system. Conclusions: The results of these analyses demonstrate that benralizumab has a high probability of being cost-effective compared with SOC plus OCS for a subgroup of patients with severe, eosinophilic asthma receiving regular OCS treatment and may support clinicians, payers and patients in making treatment decisions.

Research paper thumbnail of S5 Mortality analyses on systemic corticosteroid use: a long-term observational study

CO 2 emission was calculated using CO 2 emission factor 13.8 kg/visit for ER/hospital visits 2 an... more CO 2 emission was calculated using CO 2 emission factor 13.8 kg/visit for ER/hospital visits 2 and CO 2 emission factor 140 g/ puff for rescue medication use. Results 1,842 patients were assessed for ER/hospital visits and 1,800 patients for rescue medication use. IND/GLY/MF highand medium-dose suggested reductions in ER/hospital visits (rate ratio [RR] 0.66, 0.43 to 1.01 and RR, 0.87, 0.57 to 1.33) versus SAL/FLU high-dose, which would corresponds to a change of 9.1 (5.9 to 13.9) and 12.0 (7.9 to 18.4) kg CO 2 emission per visit, respectively. The difference in mean daily puffs of rescue medication with IND/GLY/MF high-and medium-dose versus SAL/FLU high-dose, was À0.12 (À0.27 to 0.03) and À0.06 (À0.20 to 0.09), respectively, which corresponds to a change of 6.1 (À13.8 to 1.5) and 3.1 (À10.2 to 4.6) kg CO 2 emission per year, respectively. Conclusions All three-treatment arms of the study significantly reduced CO 2 emissions compared with MDIs. However, indacaterol/glycopyrronium/mometasone furoate resulted in numerical reductions of ER/hospital visits, which suggests increased CO 2 savings versus salmeterol/fluticasone. These results should be cautiously interpreted as our calculations are based on a limited number of variables that affect the carbon footprint. Nonetheless, these results might be used as a basis for conducting studies on carbon footprint in patients with asthma. The study was funded by Novartis Pharmaceuticals, East Hanover. Abstract S5 Figure 1 Association of cumulative SCS dose and average SCS daily exposure with risk of death among patients with asthma (N=9413) Spoken sessions

Research paper thumbnail of Healthcare Resource Use and Costs Associated with Organ Damage in Newly Diagnosed Adults with Systemic Lupus Erythematosus in the UK

Rheumatology and therapy, Jul 3, 2023

Introduction: This analysis compared healthcare resource use (HCRU) and costs associated with inc... more Introduction: This analysis compared healthcare resource use (HCRU) and costs associated with incident organ damage in a cohort of adult patients with systemic lupus erythematosus (SLE). Methods: Incident SLE cases were identified (Clinical Practice Research Datalink [CPRD] and Hospital Episode Statistics-linked healthcare databases; January 1, 2005-June 30, 2019). Annual incidence of 13 organ damage domains was calculated from SLE diagnosis through follow-up. Annualized HCRU and costs were compared between organ damage and nonorgan damage patient groups using generalized organ damage had greater resource use for all organ systems, excluding gonadal, versus those without it. Overall, mean (SD) annualized allcause HCRU was greater in patients with organ damage versus those without it (inpatient, 1.0 versus 0.2; outpatient, 7.3 versus 3.5; accident and emergency, 0.5 versus 0.2 days; primary care contacts, 28.7 versus 16.5; prescription medications, 62.3 versus 22.9). Adjusted mean annualized all-cause costs were significantly greater in both post-and pre-organ damage index periods for patients with organ damage versus those without it (all P \ 0.05, excluding gonadal). Overall organ damage was associated with significantly increased adjusted mean annualized per-patient cost (£4442 greater [P \ 0.0001]) ranging between £2709 and £7150 greater depending on the organ damage type. Conclusion: Organ damage was associated with higher HCRU and healthcare costs, before and after SLE diagnosis. More effective SLE management may slow disease progression, prevent organ damage onset, improve clinical outcomes, and reduce healthcare costs.

Research paper thumbnail of PRS68 The Humanistic Burden of Mild Asthma: Evidence from the Novelty Study

Research paper thumbnail of PRS24 Cost Effectiveness of Benralizumab for Severe, Uncontrolled Oral Corticosteroid-Dependent Asthma in Swededn

Value in Health, 2019

SSc-ILD patients (39.1% limited, 60.9% extended). In general, main cost drivers were the follow-u... more SSc-ILD patients (39.1% limited, 60.9% extended). In general, main cost drivers were the follow-up visits, prescribed maintenance treatment and exacerbation management (especially for PF-ILD). HCRU were higher in PF-ILD compared to non/ slow-progressive F-ILD, and in extended SSc-ILD as compared to limited SSc-ILD. In the first wave, consensus was obtained on the negative impact of PF-ILD on social life (94.3%) and financial status (88.6%). Also, the decline in lung function negatively impacts the patients' quality of life (91.4%). Conclusions: This study reveals a greater apparent economic burden associated with the management of extended vs. limited SSc-ILD and PF-ILD vs. non/slow-progressive forms of F-ILDs.

Research paper thumbnail of POS1403 CLINICAL Characteristics, Health Care Resource Utilization, and Costs Associated with Flares in Patients with Systemic Lupus Erythematosus in Germany

Annals of the Rheumatic Diseases

BackgroundLongitudinal data describing real-world systemic lupus erythematosus (SLE) disease char... more BackgroundLongitudinal data describing real-world systemic lupus erythematosus (SLE) disease characteristics, health care resource utilization (HCRU), and costs associated with flares in Germany are limited.ObjectivesTo evaluate the clinical characteristics of patients with SLE and estimate the impact of flares on HCRU and costs in a cohort of adults with SLE in Germany.MethodsCHaracteristics and impact of flares on clinicAl and econoMic OutcoMes In patients with systemic Lupus Erythematosus: a German Claims Database Study (CHAMOMILE) was an observational, retrospective cohort study. Adult patients with SLE were identified from the German Betriebskrankenkassen health insurance fund database between 1 July 2010 and 31 December 2013, and followed for up to 9 years. Baseline period was defined as the first year since the first quarter with the earliest SLE diagnosis during the identification period, including this quarter. Resource utilization measures included number of hospitalizatio...

Research paper thumbnail of Adverse Outcomes, Healthcare Resource Utilization, and Costs Associated with Systemic Corticosteroid use Among Adults with Systemic Lupus Erythematosus in the UK

Rheumatology and Therapy

Introduction: This analysis was conducted to assess the incidence of adverse clinical outcomes, h... more Introduction: This analysis was conducted to assess the incidence of adverse clinical outcomes, healthcare resource use (HCRU), and the costs associated with systemic corticosteroid (SCS) use in adults with systemic lupus erythematosus (SLE) in the UK. Methods: We identified incident SLE cases using the Clinical Practice Research Datalink GOLD, Hospital Episode Statistics-linked healthcare, and Office for National Statistics mortality databases from January 1, 2005, to June 30, 2019. Adverse clinical outcomes, HCRU, and costs were captured for patients with and without prescribed SCS. Results: Of 715 patients, 301 (42%) had initiated SCS use (mean [standard deviation (SD)] 3.2 [6.0] mg/day) and 414 (58%) had no recorded SCS use post-SLE diagnosis. Cumulative incidence of any adverse clinical outcome over 10-year follow-up was 50% (SCS group) and 22% (non-SCS group), with osteoporosis diagnosis/fracture most frequently reported. SCS exposure in the past 90 days was associated with an adjusted hazard ratio of 2.41 (95% confidence interval 1.77-3.26) for any adverse clinical outcome, with increased hazard for osteoporosis diagnosis/fracture (5.26, 3.61-7.65)

Research paper thumbnail of The burden of mild asthma: Clinical burden and healthcare resource utilisation in the NOVELTY study

Respiratory Medicine

Background: Patients with mild asthma represent a substantial proportion of the population with a... more Background: Patients with mild asthma represent a substantial proportion of the population with asthma, yet there are limited data on their true burden of disease. We aimed to describe the clinical and healthcare resource utilisation (HCRU) burden of physician-assessed mild asthma. Methods: Patients with mild asthma were included from the NOVEL observational longiTudinal studY (NOVELTY; NCT02760329), a global, 3-year, real-world prospective study of patients with asthma and/or chronic obstructive pulmonary disease from community practice (specialised and primary care). Diagnosis and severity were based on physician discretion. Clinical burden included physician-reported exacerbations and patientreported measures. HCRU included inpatient and outpatient visits. Results: Overall, 2004 patients with mild asthma were included; 22.8% experienced ≥1 exacerbation in the previous 12 months, of whom 72.3% experienced ≥1 severe exacerbation. Of 625 exacerbations reported, 48.0% lasted >1 week, 27.7% were preceded by symptomatic worsening lasting >3 days, and 50.1% required oral corticosteroid treatment. Health status was moderately impacted (St George's Respiratory Questionnaire score: 23.5 [standard deviation ± 17.9]). At baseline, 29.7% of patients had asthma symptoms that were not well controlled or very poorly controlled (Asthma Control Test score <20), increasing to 55.6% for those with ≥2 exacerbations in the previous year. In terms of HCRU, at least one unscheduled ambulatory visit for exacerbations was required by 9.5% of patients, including 9.2% requiring ≥1 emergency department visit and 1.1% requiring ≥1 hospital admission. Conclusions: In this global sample representing community practice, a significant proportion of patients with physician-assessed mild asthma had considerable clinical burden and HCRU.

Research paper thumbnail of Letter in reply: indirect treatment comparison of anifrolumab efficacy versus belimumab in adults with systemic lupus erythematosus

Journal of Comparative Effectiveness Research

Research paper thumbnail of Indirect treatment comparison of anifrolumab efficacy versus belimumab in adults with systemic lupus erythematosus

Journal of Comparative Effectiveness Research

Aim: Assess the comparative efficacy of anifrolumab 300 mg versus belimumab 10 mg/kg in adults wi... more Aim: Assess the comparative efficacy of anifrolumab 300 mg versus belimumab 10 mg/kg in adults with moderate-to-severe systemic lupus erythematosus (SLE) receiving standard therapy. Patients and methods: Population-adjusted simulated treatment comparisons (primary analyses) and matching-adjusted indirect comparisons (supporting analyses) were conducted using individual patient data from TULIP-1/TULIP-2 and summary-level data from BLISS-52/BLISS-76. Results: Compared with belimumab-treated patients, anifrolumab-treated patients were more than twice as likely to achieve a reduction of four or more points in SLE Disease Activity Index 2000 score (simulated treatment comparison odds ratio: 2.47; 95% CI: 1.16–5.25) and SLE Responder Index-4 response (odds ratio: 2.61; 95% CI: 1.22–5.58) at 52 weeks. Conclusion: Patients with moderate-to-severe SLE are more likely to achieve an improvement in disease activity with anifrolumab than with belimumab.

Research paper thumbnail of Exacerbation burden in mild asthma: Evidence from the NOVELTY study

European Respiratory Journal, 2020

Background: Although 50–75% of patients with asthma are reported to have mild asthma, exacerbatio... more Background: Although 50–75% of patients with asthma are reported to have mild asthma, exacerbations may still play a significant role in their disease burden. NOVELTY (NCT02760329) is a global, prospective, observational study of patients with a physician-assigned diagnosis of asthma and/or COPD. Physicians were asked to classify asthma as mild, moderate or severe; no criteria were provided. Objective: To describe the exacerbation burden of patients with physician-assessed mild asthma in the NOVELTY study. Methods: Baseline characteristics of patients with physician-assessed mild asthma were described. Results: Baseline characteristics for 2,175 patients with physician-assessed mild asthma (of 5,940 with asthma) were reported (Table). By physician report, in the past 12 months 527 patients (24%) had ≥1 exacerbation; mean exacerbation rate was 0.4 events/year. Healthcare resource utilisation data were available for 714/867 physician-reported exacerbations; 8% lasted for >1 month a...

Research paper thumbnail of Elevated blood eosinophil level and costs for adults with persistent asthma

European Respiratory Journal, 2016

Background: We examined whether elevated blood eosinophil (eos) level, which is linked to increas... more Background: We examined whether elevated blood eosinophil (eos) level, which is linked to increased asthma exacerbations, is also related to increased all-cause and asthma-related costs. Methods: In this cohort study using administrative pharmacy and health care utilization data, we identified 2392 patients aged 18–64 years with persistent asthma and a blood eos determination in the baseline year. All-cause costs included hospitalization, emergency department (ED) and outpatient (OP) visits, laboratory, radiology, and asthma medications. Asthma-related costs included hospitalizations and ED visits with principal diagnosis of asthma, asthma-related OP visits, laboratory and radiology, and asthma medications. The relationship of baseline blood eos level to all-cause and asthma-related costs in the follow-up year was estimated by generalized linear models with gamma distribution, adjusted for demographics, comorbidities, prior exacerbation, step-care treatment, and baseline costs. Results: Greater blood eos counts at baseline were associated with increased total asthma-related costs, but not all-cause costs. The adjusted incremental increases in asthma-related costs were 377(400cells/μLcutoff)and377 (400 cells/μL cutoff) and 377(400cells/μLcutoff)and237 (300 cells/μL cutoff). Conclusions: Elevated blood eos count is an independent risk factor for increased asthma-related, but not all-cause costs for adults with persistent asthma, confirming the importance of blood eos in this group.

Research paper thumbnail of Asthma-related healthcare utilization and costs by blood eosinophil levels among adults with persistent asthma

European Respiratory Journal, 2015

Background: Elevated blood eosinophil (EOS) count is a risk factor for future exacerbation in adu... more Background: Elevated blood eosinophil (EOS) count is a risk factor for future exacerbation in adults with persistent asthma. We investigated whether a relationship also exists between EOS and healthcare utilization (HRU) and cost in these patients. Methods: We conducted a retrospective cohort study using claims data on commercial and Medicare Advantage health plan adults (age≥18 years) who met the HEDIS persistent asthma criteria for 2 consecutive years during 2007-2012 and had a EOS determination at baseline; the index date was January 1 of the 3 rd year. Future (1-year post-index) asthma-related HRU and cost were described and compared between baseline EOS levels using different cut-off points (150, 300, or 400 cells/µL). Results: The study included 37,830 subjects. Patients with higher baseline EOS count at all cut-off points had higher frequency of future asthma-related office visits, emergency department (ED) visits, inpatients, and pharmacy fills. Asthma-related total, medical, and pharmacy costs were all higher in patients with higher EOS (Table). There is a trend toward higher future HRU and cost with increasing baseline EOS. Conclusions: Higher future disease burden was observed in asthma patients with increasing EOS count, consistent with previous findings that elevated EOS is a risk factor for future asthma exacerbations.

Research paper thumbnail of Dronedarone for the Treatment of Atrial Fibrillation

PharmacoEconomics, 2012

The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of dron... more The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of dronedarone (Multaq®, Sanofi-Aventis Limited, UK) to submit evidence on the clinical and cost effectiveness of the anti-arrhythmic drug (AAD) for the treatment of atrial fibrillation (AF) and atrial flutter, as part of the Institute&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s single technology appraisal (STA) process. The Centre for Reviews and Dissemination and the Centre for Health Economics, both at the University of York, were commissioned to act as the independent Evidence Review Group (ERG). This article provides a description of the company submission, the ERG review and NICE&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s subsequent decisions regarding the use of dronedarone within the UK NHS. The ERG review comprised a critique of the submitted evidence on the clinical effectiveness and cost effectiveness of dronedarone. The ERG examined the search strategy used to obtain relevant evidence, the selection of studies included in the assessment, outcome measures chosen and statistical methods employed. The ERG also validated the manufacturer&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s decision analytic model and used it to explore the robustness of the cost-effectiveness results to key assumptions. The main clinical effectiveness evidence supporting the use of dronedarone as a treatment for AF came from four randomized controlled trials. These trials were compared with a broader set of trials examining the effectiveness of other AADs for AF: amiodarone, sotalol and class 1c agents (flecainide and propafenone). The evidence suggested that all AADs decreased the recurrence of AF but dronedarone had the smallest effect. A mixed treatment comparison analysis of the trials showed that dronedarone was associated with a lower risk of all-cause mortality than other AADs, but this was highly uncertain. There was limited evidence to assess the effect of dronedarone on stroke, and no statistically significant differences between dronedarone and other AADs were found for treatment discontinuation. From the evidence presented by the manufacturer, dronedarone appeared highly cost effective in each of the population groups examined compared with using standard baseline therapy alone as first-line treatment, or compared with sotalol or amiodarone as first-line AAD, with incremental cost-effectiveness ratios (ICERs) well below £20,000 per QALY gained. The ICER for dronedarone relative to class 1c agents was around £19,000 per QALY. Although the evidence presented by the manufacturer indicated that dronedarone was cost effective, the estimates of treatment effect relative to other AADs and safety in the longer term were highly uncertain. The NICE Appraisal Committee in its preliminary guidance did not recommend the use of dronedarone for AF. However, following the response from a large number of…

Research paper thumbnail of Exacerbation utilities and durations by type: estimates from Phase III benralizumab studies

Monitoring Airway Disease, 2017

Research paper thumbnail of Healthcare resource use and costs of severe, uncontrolled eosinophilic asthma in the UK general population

Thorax, Feb 16, 2017

Little is known about the prevalence of severe, uncontrolled eosinophilic asthma (SUEA) and assoc... more Little is known about the prevalence of severe, uncontrolled eosinophilic asthma (SUEA) and associated costs. We sought to determine the prevalence of SUEA and compare asthma-related healthcare resource use (HCRU) and associated costs with overall means for a general asthma population. This cohort study evaluated anonymised medical record data (December 1989 through June 2015) from the Clinical Practice Research Datalink and the Optimum Patient Care Research Database to study UK patients with active asthma (diagnostic code and one or more drug prescriptions in the baseline year), aged 5 years and older, without concomitant COPD, and with recorded eosinophil count. SUEA was defined as two or more asthma attacks during 1 baseline year preceding a high blood eosinophil count (≥0.3×10(9)/L) for patients prescribed long-acting β2-agonist (LABA) and high-dosage inhaled corticosteroids (ICS) during baseline plus 1 follow-up year. We compared asthma-related HCRU and associated direct costs ...

Research paper thumbnail of Healthcare resource utilization and costs associated with incremental systemic corticosteroid exposure in asthma

Allergy, 2018

Background: Although systemic corticosteroid (SCS) treatment, irrespective of duration or dosage,... more Background: Although systemic corticosteroid (SCS) treatment, irrespective of duration or dosage, is associated with adverse outcomes for patients with asthma, the longitudinal effects of this treatment on adverse outcomes, healthcare resource utilization (HCRU), and healthcare costs are unknown. Methods: We identified patients initiating intermittent or long-term SCS who were diagnosed with active asthma from UK general practice with linked secondary care data. Control (non-SCS) patients were matched by sex and index date with those initiating SCS. Minimum baseline period was 1 year prior to index date; minimum follow-up duration was 2 years post-index date. Cumulative incidence of SCS-associated adverse outcomes and associated HCRU and costs were compared between SCS and non-SCS patient groups and among average SCS daily exposure categories. Associations between exposure and annualized HCRU and costs were assessed, adjusted for confounders. Results: Analyses included 9413 matched pairs. Median (interquartile range) follow up was as follows: SCS group: 7.1 (4.1-11.8) years; control group: 6.4 (3.8-10.0) years. Greater SCS dosages were correlated with greater cumulative incidence. For example, patients with type 2 diabetes receiving an average daily dosage of ≥7.5 mg had a 15-year cumulative incidence (37.5%) that was 1.5-5 times greater than those receiving lower dosages. HCRU and costs increased annually for SCS patients but not for non-SCS patients. Increases in all-cause adverse outcome (excluding asthma)-associated HCRU and costs were dose-dependent. Conclusions: Over the long term, adverse outcomes associated with SCS initiation were relatively frequent and costly, with a positive dosage-response relationship with SCS exposure.

Research paper thumbnail of Matching-adjusted indirect comparison of benralizumab versus interleukin-5 inhibitors for the treatment of severe asthma: a systematic review

European Respiratory Journal

Benralizumab is an interleukin-5 receptor α-directed cytolytic monoclonal antibody that directly ... more Benralizumab is an interleukin-5 receptor α-directed cytolytic monoclonal antibody that directly depletes eosinophils. Its relative efficacy versus other IL-5-targeted treatments for patients with severe, uncontrolled asthma is not yet fully characterised.We performed a matching-adjusted indirect comparison (MAIC) of benralizumab versus mepolizumab and reslizumab. Trials were selected through systematic review and evaluation of trial methods. Benralizumab patient-level data were weighted to match treatment-effect-modifying patient characteristics of comparator trials before indirect efficacy comparisons.After matching adjustment, benralizumab and mepolizumab reduced exacerbations versus placebo by 52% and 49%, respectively (rate ratio [RR] 0.94, 95% CI 0.78–1.13; n=1524) and reduced the rate of exacerbations requiring hospitalisation/emergency department visit by 52% and 52%, respectively (RR 1.00, 95% CI 0.57–1.75; n=1524). Benralizumab and mepolizumab similarly improved pre-bronch...

Research paper thumbnail of Systematic literature review of the clinical, humanistic, and economic burden associated with asthma uncontrolled by GINA Steps 4 or 5 treatment

Current medical research and opinion, Jan 16, 2018

This study sought to characterize the epidemiologic, clinical, humanistic, and economic burden of... more This study sought to characterize the epidemiologic, clinical, humanistic, and economic burden of patients with asthma uncontrolled by GINA Steps 4 or 5 treatment (severe, uncontrolled asthma [SUA]). A systematic literature review adhering to PRISMA guidelines was performed. Relevant publications were searched for in MEDLINE and EMBASE from January 2004 to September 2016 and in a conference proceedings database from January 2012 to October 2016. Studies were screened using the Population, Intervention, Comparator, Outcomes, Study Design, and Time (PICOS-T) framework. Studies of SUA with observational (prospective and retrospective), randomized, or nonrandomized study designs; adult patient populations; sample sizes ≥20 patients; epidemiologic or clinical outcomes, patient-reported outcomes (PROs), or economic outcomes were included. For our analysis, SUA was defined as inadequate control of asthma, despite the use of medium- to high-dosage inhaled corticosteroids and at least one ad...

Research paper thumbnail of The cost-effectiveness of as-needed budesonide-formoterol versus low-dose inhaled corticosteroid maintenance therapy in patients with mild asthma in Canada

Allergy, Asthma & Clinical Immunology

Background The Global Initiative for Asthma recommends the use of as-needed low-dose inhaled cort... more Background The Global Initiative for Asthma recommends the use of as-needed low-dose inhaled corticosteroid (ICS)-formoterol as a preferred controller therapy for patients with mild asthma. These recommendations were based, in part, on evidence from the SYGMA 1 and 2 studies of as-needed budesonide-formoterol. This analysis aimed to compare the cost-effectiveness of as-needed budesonide-formoterol to low-dose maintenance ICS plus as-needed short-acting β2-agonist (SABA) in patients with mild asthma. Methods A Markov cohort model was designed that included three possible health states (non-exacerbation, severe exacerbation, and death) to compare as-needed budesonide-formoterol 200–6 μg to twice-daily budesonide 200 μg maintenance therapy (low-dose ICS) plus as-needed terbutaline 0.5 mg (SABA). The deterministic base-case analysis used severe exacerbation, adverse event (AE), and healthcare resource use data from SYGMA 2, and was conducted from a Canadian public payer perspective with...

Research paper thumbnail of Cost effectiveness of benralizumab for severe, uncontrolled oral corticosteroid–dependent asthma in Sweden

Journal of Medical Economics

Aim: We investigated cost effectiveness of benralizumab vs. standard of care (SOC) plus oral cort... more Aim: We investigated cost effectiveness of benralizumab vs. standard of care (SOC) plus oral corticosteroids (OCS) for patients with severe, eosinophilic OCS-dependent asthma in Sweden. Materials and methods: A three-state, cohort-based Markov model of data from three Phase III benralizumab clinical trials (ZONDA [NCT02075255], SIROCCO [NCT01928771], and CALIMA [NCT01914757]) was used to assess the incremental cost-effectiveness ratio of benralizumab vs. SOC plus OCS. Health outcomes were estimated in terms of quality-adjusted life-years (QALYs). The model included costs and disutilities associated with extrapolated OCS-related adverse events. Patients with severe asthma were defined as those receiving OCS !5 mg/day. Results: Benralizumab demonstrated a cost-effectiveness ratio vs. SOC plus OCS of 2018 Swedish Kronor (SEK) 366,855 (e34,127) per QALY gained, based on increases of 1.33 QALYs and SEK 488,742 (e45,344) per patient. Benralizumab treatment costs contributed most to incremental costs. The probability of benralizumab's being cost-effective with willingness-to-pay (WTP) thresholds between SEK 429,972 (e40,000) and SEK 752,452 (e70,000) ranged from 75% to 99%. Limitations: Potential limitations of these analyses include the use of combined data from three different clinical trials, a one-way sensitivity analysis that did not include mortality and transition estimates, and Observational & Pragmatic Research Institute (OPRI) data from the UK as a proxy of the Swedish health care system. Conclusions: The results of these analyses demonstrate that benralizumab has a high probability of being cost-effective compared with SOC plus OCS for a subgroup of patients with severe, eosinophilic asthma receiving regular OCS treatment and may support clinicians, payers and patients in making treatment decisions.