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1. Value Insider Season 1 Episode 3: How Does Budget Impact and Affordability in Healthcare Work? (BI and Affordability) [Podcast]

Author

Sullivan SD, Hartgers-Gubbels ES, and Chambers M

Subjects
market access, healthcare reimbursement, health technology assessment (hta), value demonstration, health economics and outcomes research, payer, Medicine (General), R5-920
Abstract

Sean D Sullivan,1 Elisabeth Sophia Hartgers-Gubbels,2 Michael Chambers3 1School of Pharmacy, University of Washington, Seattle, WA, USA; 2Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany; 3MC Healthcare Evaluation, London, UKCorrespondence: Elisabeth Sophia Hartgers-Gubbels, Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany, Email lisa.hartgers-gubbels@boehringer-ingelheim.comAbstract: How does budget impact and affordability in healthcare work? In this episode of the Value Insider podcast, host Mike Chambers speaks with Prof. Sean Sullivan about affordability and budget impact for the “payers” of healthcare interventions. Prof. Sullivan is Dean of the University of Washington School of Pharmacy. He is past president of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and served as chair of the health technology assessment (HTA) committee of US Health Insurer Premera Blue Cross, was part of the US Governmental Medicare coverage evidence committee and led the ISPOR Task Force on Methods for Conducting and Reporting Budget Impact Assessments. Prof. Sullivan explains how budget impact and affordability are intertwined and how this plays a role in decisions in the US, but also the rest of the world.Keywords: market access, healthcare reimbursement, health technology assessment, HTA, value demonstration, health economics and outcomes research, payer

Published
2022

2. Impact and factors associated with nighttime and early morning symptoms among patients with chronic obstructive pulmonary disease

Author

Stephenson JJ, Cai Q, Mocarski M, Tan H, Doshi JA, and Sullivan SD

Subjects
Diseases of the respiratory system, RC705-779
Abstract

Judith J Stephenson,1 Qian Cai,1 Michelle Mocarski,2 Hiangkiat Tan,1 Jalpa A Doshi,3 Sean D Sullivan4 1HealthCore, Inc., Wilmington, DE, USA; 2Forest Research Institute, Inc., an affiliate of Actavis, Inc., Jersey City, NJ, USA; 3University of Pennsylvania, Philadelphia, PA, USA; 4University of Washington, Seattle, WA, USA Abstract: Patients with chronic obstructive pulmonary disease (COPD) exhibit poor sleep quality and consider morning as the worst time of day for their symptoms. While work has been done to characterize nighttime (NT) and early morning (EM) symptoms in various populations, the impact and factors associated with NT/EM symptoms among patients with COPD in the United States is not well understood. Commercially insured patients aged ≥40 years with one or more medical claim for COPD and one or more pharmacy claim for COPD maintenance medication were identified from the HealthCore Integrated Research Database between September 1, 2010 and August 31, 2011. Consenting respondents were asked whether they had COPD symptoms on at least three nights or at least three mornings during the past week. Respondents were then either assigned to one of three symptom groups to complete the survey or excluded if their predefined group quota limit had been met. Survey completers completed the survey with questions about COPD symptoms and other commonly used patient-reported outcome measures. Respondents with NT/EM symptoms were asked about the frequency, severity, and impact of the symptoms on sleep, morning activities, and anxiety levels. Among respondents with symptoms, 73.1% of respondents with NT symptoms (N=376) and 83% of respondents with EM symptoms (N=506) experienced at least three distinct types of symptoms over the past week, with cough being the most frequently reported symptom. Approximately half of respondents with NT or EM symptoms perceived their symptoms as moderate to very severe, with a majority reporting their symptoms affected their NT sleep and morning activities, and more than half felt anxious due to their symptoms. Multinomial logistic regression showed COPD patients with both or either NT/EM symptoms were associated with poorer health status compared to those without. Improved disease management may reduce NT/EM symptoms and improve health status in patients with COPD. Keywords: chronic airflow obstruction, chronic limitation of activity, quality of life, sleep

Published
2015

3. An epidemiologic model to project the impact of changes in glomerular filtration rate on quality of life and survival among persons with chronic kidney disease

Author

Levy AR, Perkins RM, Johnston KM, Sullivan SD, Sood VC, Agnese W, and Schnitzler MA

Subjects
Diseases of the genitourinary system. Urology, RC870-923
Abstract

Adrian R Levy,1,2 Robert M Perkins,3 Karissa M Johnston,2 Sean D Sullivan,4 Vipan C Sood,5 Wendy Agnese,5 Mark A Schnitzler61Department of Community Health and Epidemiology, Dalhousie University, Halifax, NS, Canada; 2Oxford Outcomes Ltd, Vancouver, BC, Canada; 3Center for Health Research and Division of Nephrology, Geisinger Health System, Danville, PA, USA; 4School of Pharmacy, University of Washington, Seattle, WA, USA; 5Mitsubishi Tanabe Pharma America, Jersey City, NJ, USA; 6Departments of Internal Medicine and Community Health, Saint Louis University, St Louis, MO, USAPurpose: Predicting the timing and number of end-stage renal disease (ESRD) cases from a population of individuals with pre-ESRD chronic kidney disease (CKD) has not previously been reported. The objective is to predict the timing and number of cases of ESRD occurring over the lifetime of a cohort of hypothetical CKD patients in the US based on a range of baseline estimated glomerular filtration rate (eGFR) values and varying rates of eGFR decline.Methods: A three-state Markov model – functioning kidney, ESRD, and death – with an annual cycle length is used to project changes in baseline eGFR on long-term health outcomes in a hypothetical cohort of CKD patients. Using published eGFR-specific risk equations and adjusting for predictive characteristics, the probability of ESRD (eGFR

Published
2014

4. Headache-related health resource utilisation in chronic and episodic migraine across six countries

Author

Goadsby, Peter, Sanderson, JC, Devine, EB, Lipton, RB, Bloudek, LM, Varon, SF, Blumenfeld, AM, Goadsby, PJ, Buse, DC, and Sullivan, SD

Abstract

Objective: To describe headache-related health resource usage in chronic and episodic migraine across six countries. Methods: A web-based questionnaire eliciting data on several topics, including health resource usage, was administered to panellists with m

Published
2013

9. Real-world outcomes of treatment with insulin glargine 300 U/mL versus standard-of-care in people with uncontrolled type 2 diabetes mellitus

Author

Freemantle, N, Mauricio, D, Giaccari, A, Bailey, T, Roussel, R, Franco, D, Berthou, B, Pilorget, V, Westerbacka, J, Bosnyak, Z, Bonnemaire, M, Cali, AMG, Nguyen-Pascal, ML, Penfornis, A, Perez-Maraver, M, Seufert, J, Sullivan, SD, Wilding, J, Wysham, C, Davies, M, REACH Investigator, and REGAIN Investigator

Subjects
Clinical trial, insulin, type 2 diabetes mellitus, nutritional and metabolic diseases, drug therapy
Abstract

Objective: To compare real-world outcomes with newer (insulin glargine 300 U/mL; Gla-300) versus standard of care (SoC) basal insulins (BIs) in the REACH (insulin-naive; NCT02967224) and REGAIN (basal insulin-treated; NCT02967211) studies in participants with uncontrolled type 2 diabetes (T2DM) in Europe and Brazil. Methods: In these open-label, parallel-group, pragmatic studies, patients (HbA(1c) > 7.0%) were randomized to Gla-300 or SoC BI for a 6-month treatment period (to demonstrate non-inferiority of Gla-300 vs SoC BIs for HbA(1c) change [non-inferiority margin 0.3%]) and a 6-month extension period (continuing with their assigned treatment). Insulin titration/other medication changes were at investigator/patient discretion post-randomization. Results: Overall, 703 patients were randomized to treatment in REACH (Gla-300, n = 352; SoC, n = 351) and 609 (Gla-300, n = 305, SoC, n = 304) in REGAIN. The primary outcome, non-inferiority of Gla-300 versus SoC for HbA(1c) change from baseline to month 6, was met in REACH (least squares [LS] mean difference 0.12% [95% CI -0.046 to 0.281]) but not REGAIN (LS mean difference 0.17% [0.015-0.329]); no between-treatment difference in HbA(1c) change was shown after 12 months in either study. BI dose increased minimally from baseline to 12 months in REACH (Gla-300, +0.17 U/kg; SoC, +0.15 U/kg) and REGAIN (Gla-300, +0.11 U/kg; SoC, +0.07 U/kg). Hypoglycemia incidence was low and similar between treatment arms in both studies. Conclusions: In both REACH and REGAIN, no differences in glycemic control or hypoglycemia outcomes with Gla-300 versus SoC BIs were seen over 12 months. However, the suboptimal insulin titration in REACH and REGAIN limits comparisons of outcomes between treatment arms and suggests that more titration instruction/support may be required for patients to fully derive the benefits from newer basal insulin formulations.

Published
2020

20. Cost Effectiveness of Peginterferon ??-2a Plus Ribavirin versus Interferon ??-2b Plus Ribavirin as Initial Therapy for Treatment-Naive???Chronic???Hepatitis???C

Author

Sullivan, Sd, Crax, A, Alberti, Alfredo, Giuliani, G, DE CARLI, C, Wintfeld, N, Patel, Kk, and Green, J.

Subjects
medicine.medical_specialty, Cost effectiveness, Interferon α-2b, Peginterferon α 2a, Interferon alpha-2, Antiviral Agents, Gastroenterology, Therapy naive, chemistry.chemical_compound, Internal medicine, Ribavirin, medicine, Humans, Pharmacology, Clinical Trials as Topic, business.industry, Health Policy, Public health, Public Health, Environmental and Occupational Health, Interferon-alpha, Health Care Costs, Hepatitis C, Hepatitis C, Chronic, medicine.disease, Recombinant Proteins, chemistry, Peginterferon alfa-2b, Drug Therapy, Combination, business, medicine.drug
Published
2004

26. Outcomes for COPD pharmacological trials: from lung function to biomarkers

Author

Cazzola, M, Macnee, W, Martinez, Fj, Rabe, Kf, Franciosi, Lg, Barnes, Pj, Brusasco, Vito, Burge, Ps, Calverley, Pm, Celli, Br, Jones, Pw, Mahler, Da, Make, B, Miravitlles, M, Page, Cp, Palange, P, Parr, D, Pistolesi, M, Rennard, Si, Rutten van Mölken MP, Stockley, R, Sullivan, Sd, Wedzicha, Ja, Wouters, Ef, American Thoracic Society, European Respiratory Society Task Force on outcomes of COPD, Pulmonologie, and RS: NUTRIM - R3 - Chronic inflammatory disease and wasting

Subjects
Male, Settore MED/10 - Malattie dell'Apparato Respiratorio, cost of illness, health status, sputum analysis, law.invention, cause of death, disease marker, Pulmonary Disease, Chronic Obstructive, hydrocarbon, Randomized controlled trial, Adrenal Cortex Hormones, law, blood analysis, inflammatory cell, medical society, bronchodilating agent, carbon monoxide, corticosteroid, nitric oxide, biological marker, body weight, bronchus biopsy, chronic obstructive lung disease, cost effectiveness analysis, disease course, disease exacerbation, disease severity, dyspnea, exercise test, expired air, forced expiratory volume, gas exchange, health survey, human, lung function, lung parenchyma, lung volume, mortality, muscle function, priority journal, quality of life, quantitative analysis, rating scale, respiratory failure, review, treatment outcome, advisory committee, blood, clinical trial, female, lung function test, male, practice guideline, prognosis, risk assessment, survival, Advisory Committees, Biological Markers, Bronchodilator Agents, Clinical Trials as Topic, Female, Humans, Practice Guidelines as Topic, Prognosis, Respiratory Function Tests, Risk Assessment, Societies, Medical, Survival Analysis, Treatment Outcome, Lung function, COPD, Respiratory disease, Risk assessment, therapeutic use, Pulmonary Disease, Chronic Obstructive, diagnosis/drug therapy/mortality, Societies, Medical, medicine.drug, Pulmonary and Respiratory Medicine, medicine.medical_specialty, MEDLINE, Quality of life (healthcare), medicine, Intensive care medicine, business.industry, medicine.disease, Physical therapy, Indacaterol, business, Biomarkers
Abstract

The American Thoracic Society/European Respiratory Society jointly created a Task Force on "Outcomes for COPD pharmacological trials: from lung function to biomarkers" to inform the chronic obstructive pulmonary disease research community about the possible use and limitations of current outcomes and markers when evaluating the impact of a pharmacological therapy. Based on their review of the published literature, the following document has been prepared with individual sections that address specific outcomes and markers, and a final section that summarises their recommendations.

Published
2008

29. Quantifying losses to the donated blood supply due to donor deferral and miscollection

Author

Custer, B, Johnson, ES, Sullivan, SD, Hazlet, TK, Ramsey, SD, Hirschler, NV, Murphy, EL, and Busch, MP

Subjects
Adult, Male, Blood Specimen Collection, Fever, Adolescent, Clinical Sciences, Immunology, Common Cold, Pharyngitis, Blood Pressure, Blood Donors, Middle Aged, Cardiorespiratory Medicine and Haematology, Hematocrit, Cardiovascular System & Hematology, Humans, Blood Banks, Female, Pulse
Abstract

BackgroundDonors are deferred for multiple reasons. Losses related to disease marker rates are well established. Donor and donation losses for other reasons, however, have not been extensively quantified.Study design and methodsTo quantify these losses, three data sets from the Blood Centers of the Pacific were combined, permitting detailed analysis of year 2000 allogeneic whole-blood donations.ResultsDuring 2000, 13.6 percent of 116,165 persons who presented for donation were deferred at presentation. Short-term deferral accounted for 68.5 percent (hematocrit was most common at 60%); long-term deferral accounted for 21 percent (travel to a malarial area and tattoo or other nonintravenous drug use needle exposure were most common at 59 and 29%, respectively); and multiple-year or permanent deferral accounted for 10.5 percent (UK travel [variant Creutzfeldt-Jakob disease] risk and emigration from a malarial area were most common at 38 and 11%, respectively). Disease-marker-reactive donations represented 0.9 percent of donor outcomes. The prevalence of deferral and also miscollection (under- and overweight units) varied by age, sex, and first-time versus repeat donor status. Overall, miscollection led to a loss of 3.8 percent of 100,141 collections, ranging from 1.9 percent in repeat male donors 40 to 54 years of age to 10.7 percent in first-time female donors 16 to 24 years of age.ConclusionLoss of units from both first-time and repeat donors due to temporary deferral and loss of units from miscollection are more common events than losses due to disease marker testing. Some of these losses may be avoidable and could increase the blood supply without having to recruit new donors.

Published
2004

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