Ron Halbert - Academia.edu (original) (raw)

Papers by Ron Halbert

Research paper thumbnail of Determinants of quality of life changes among long-term cardiac transplant survivors: results from longitudinal data

The Journal of Heart and Lung Transplantation, 2003

Background: Cross-sectional analyses have identified significant associations between quality of ... more Background: Cross-sectional analyses have identified significant associations between quality of life (QOL), and comorbidities and adverse effects in cardiac transplant recipients. However, little is known about factors that influence changes in QOL over time. This study examines both cross-sectional and longitudinal data from long-term survivors to identify factors that affect differences in QOL among recipients and individual changes in QOL during a 1-year period. Methods: Self-selected enrollees completed questionnaires, including QOL scales, at 3-month intervals. Repeated measures multiple regression analysis was used to examine the association between the QOL scales and comorbidities, adverse effects, and compliance measures, controlling for other factors. Results: We included 569 participants in the analysis, with a mean time since transplantation of 8.6 years. Cross-sectional results showed that the number of comorbidities, treatment non-compliance, and several adverse effects were associated with low QOL. In longitudinal results, waiting to take medications and taking less medication because of lifestyle restrictions were associated with decreases in QOL over time. Hair loss, changes in face shape, and decreased sexual interest or ability also had the largest adverse effects on changes in QOL. Conclusions: These findings provide new opportunities for interventions to address factors related to decreases in QOL. Clinicians should actively solicit information about compliance with medication regimens. In addition, information about the adverse effects of medications should be considered when making therapeutic decisions.

Research paper thumbnail of Effect of multiple patient reminders in improving diabetic retinopathy screening. A randomized trial

Diabetes Care, 1999

OBJECTIVE: To determine whether multiple mailed patient reminders can produce an increase in the ... more OBJECTIVE: To determine whether multiple mailed patient reminders can produce an increase in the rate of diabetic retinal examinations (DRE) over that seen with a single reminder. RESEARCH DESIGN AND METHODS: All diabetic members > or = 18 years who were enrolled in a large network-based health maintenance organization (HMO) in California from August 1996 to July 1997 were identified using claims and pharmacy databases. Members who had no record of DRE in the HMO's claims database were then randomized into two groups. Both groups received mailed educational materials and a reminder to obtain the examination. Their physician groups also received a letter explaining the program, current guidelines for DRE, and a list of their diabetes patients with their DRE status. The single intervention group received no additional reminders. The multiple intervention group received additional reminders at 3, 6, and 9 months after baseline if they continued with no record of service, as dete...

Research paper thumbnail of Physical Score, General Health Perception, and Dyspnea Severity in COPD GOLD Stage1: The PLATINO Study

C24. EVALUATING DISEASE CONTROL AND QUALITY OF LIFE IN ASTHMA AND COPD, 2009

Research paper thumbnail of The Preventive Medicine Manager: A New Role for Preventive Medicine Specialists in Managed Care

American Journal of Preventive Medicine, 1996

Research paper thumbnail of Providing Health Care in War-Torn Rural Afghanistan

The Lancet, 1988

La situation depuis 1979 en Afghanistan. le programme du Corps Medical International (IMC): ensei... more La situation depuis 1979 en Afghanistan. le programme du Corps Medical International (IMC): enseignement medical et chirurgical pousse, installations et approvisionnements souterrains, transports par caravanes. Actuellement 30 unites medicochirurgicales fonctionnement, 100 autres cliniques sont prevues

Research paper thumbnail of Life satisfaction among kidney transplant recipients: demographic and biological factors

Progress in Transplantation, 2002

The Transplant Learning Center is a program providing education and support for solid-organ trans... more The Transplant Learning Center is a program providing education and support for solid-organ transplant recipients taking cyclosporine (Neoral or Sandimmune). One goal of the program is to improve patients' quality of life, which may be influenced by demographic and biological factors, and in turn influences adherence to prescribed medication regimens. We analyzed the results from the initial survey of enrollees to better understand life satisfaction and to test the validity and reliability of the satisfaction scale used in the program. Patients enter the program through self-selection: all enrollees who received a kidney transplant were included in this analysis. Satisfaction was measured using the Life Satisfaction Index, which includes 8 questions about aspects of satisfaction with the patient's life. Associations between the Life Satisfaction Index and demographic factors, comorbid medical conditions, adverse effects of immunosuppressants, and medication compliance were examined. All 3676 kidney transplant recipients who completed the initial survey were included. Mean satisfaction scores were highest in persons who were older than 64 years, men, and those who were married. Satisfaction scores were positively correlated with education and income. Mean satisfaction score was significantly lower among persons with medical comorbidities, persons who reported that adverse effects of medications were more frequent, and persons who reported noncompliance with their medication regimen. The Life Satisfaction Index is a transplant-specific measure of health-related quality of life that can be used to help detect areas of potential concern in the clinical management of kidney transplant recipients.

Research paper thumbnail of Competencies for Population-Oriented Clinician Managers Survey

Research paper thumbnail of Payer and physician evidence and discount requirements for biosimilars in three Latin American countries

Generics and Biosimilars Initiative Journal, 2015

Study objectives: In Latin America, many governments have attempted to address biosimilar safety ... more Study objectives: In Latin America, many governments have attempted to address biosimilar safety and effi cacy concerns by developing abbreviated regulatory pathways to increase access while controlling quality. This study explores discount and evidence requirements for payers and physicians to provide access to and prescribe biosimilars in Argentina, Brazil and Mexico. Methods: We conducted targeted literature reviews, followed by exploratory qualitative interviews (N = 10) with payers and physician key opinion leaders (KOLs) selected based on input from regional industry experts (payers) and PubMed search (KOLs). Interviews were 60 minutes, using a structured set of questions, in local language. Results: Respondents place the budget impact of the originator product and clinicians' acceptability as the most relevant drivers for the adoption of biosimilars. Payers and KOLs alike expect biosimilars to demonstrate non-inferiority versus originator in phase 3 RCTs (randomized clinical trials) to support bioequivalence, safety and effi cacy claims. Payers' comfort in providing access to biosimilars across disease areas and expectations for cost savings vary by markets, according to previous experience with other biosimilars and confi dence in the regulatory evaluation. As a result, payer discount requirements for public access range from 5-30% across markets, with KOLs stating that they likely will consider biosimilars for all patients at discount levels greater than 20−25%. Conclusion: Although payers and physicians alike cited the importance of bioequivalent safety and effi cacy, they ultimately will look to regulators for guidance on which biosimilar products have provided suffi cient evidence, and for which indications. While the level of discount versus the branded originator varied by market, biosimilars have the potential to gain broad penetration with cost-sensitive public payers and also with clinically-oriented physicians across Latin American markets. Study objectives As with generic small-molecule medicines, the potential for cost savings resulting from the use of biosimilars is attractive to payers worldwide [1, 2]. This attraction has increased sharply in recent years as the impact of biological drugs on health plan budgets has exploded. In Brazil, for example, biotherapeutic products represented 2% of medicines prescribed, yet accounted for 41% of the annual Ministry of Health pharmaceutical budget in 2010 [3]. Biosimilars, however, are different than small molecule generics due to the inherent variability in the production process for biopharmaceutical products and the relatively limited experience that stakeholders have with them. Physicians in particular raise concerns about the degree to which this variability in production may result in differing levels of safety and effi cacy of biosimilars relative to their branded equivalents-and each other. Fear of potential immunogenicity issues arising from differences in the biological production process is a concern with biosimilars, and is associated with the need for post-launch pharmacovigilance programmes as seen in Europe. This complex production process is considerably more expensive than that of small molecules, adding to the costs of biosimilars. These factors, along with the matching of prices of biosimilars by originator companies, have resulted in a tempering effect on the launch and uptake of biosimilars as regulators seek to ensure the bioequivalence of biosimilar products through head-to-head demonstration of biosimilarity to their branded originator products.

Research paper thumbnail of A "clinic without walls": the Los Angeles Immunization Demonstration Project

American journal of public health, 1997

Research paper thumbnail of The cost of chronic obstructive pulmonary disease and its effects on managed care

Managed care interface, 2004

Chronic obstructive pulmonary disease (COPD) designates respiratory disorders characterized by ai... more Chronic obstructive pulmonary disease (COPD) designates respiratory disorders characterized by airway obstruction that is not fully reversible. An estimated 10 million adult Americans have COPD, and the prevalence is rising. Direct and indirect costs of managing COPD exceed dollars 32 billion annually, and this health care burden has provoked vigorous efforts by major public health organizations to evaluate and improve quality of care for COPD. The authors review the substantial effects of COPD on managed care and discuss evidence-based strategies for its effective management.

Research paper thumbnail of Incorporating Stakeholder Input into Budget Impact Models to Compare Stem Cell Mobilization Strategies

Value in Health, 2013

A399 Objectives: Whilst the cost-effectiveness of everolimus + exemestane (EVE+EXE) versus placeb... more A399 Objectives: Whilst the cost-effectiveness of everolimus + exemestane (EVE+EXE) versus placebo + exemestane (PBO+EXE) in patients with ER+ HER2-metastatic breast cancer has been demonstrated elsewhere, this is the first analysis to assess the implications for health spending at a population level. MethOds: The model uses a cumulative cohort approach, allowing incident patients to enter the model each year over a five-year period. The incident population was based on several factors: (i) the female population aged > 15 years; (ii) the proportion of those women with advanced invasive breast cancer; (iii) the proportion who are post-menopausal; (iv) the proportion who are hormone receptor positive; (v) the proportion who are HER2-; (vi) the proportion with asymptomatic visceral disease, and (vii) the proportion for whom hormonal therapy is appropriate. Finally, the cohort was filtered to show those who had previously relapsed or progressed on NSAI. 'Per patient' treatment and adverse event costs were generated based on treatment-specific progression-free survival curves, and multiplied by the number of patients expected to receive each treatment according to market share data and likely uptake rates. An incremental analysis was performed, where two scenarios were compared: (i) a world without EVE+EXE, and (ii) a world with EVE+EXE. Results: It is expected that a total of 1,052 patients will be eligible to receive EVE+EXE over a five-year period. In a 'world without EVE+EXE', the total five year cost was estimated as £1,652,904. Assuming an annual uptake rate of 10%, in a 'world with EVE+EXE' the total cost over the same period was expected to be £2,271,606. Therefore, the incremental cost associated with the introduction of EVE+EXE in England and Wales is £618,702 over five years. cOnclusiOns: EVE+EXE was associated with modest increased health care costs but has, separately, been demonstrated to lead to incremental health benefits compared with other treatments.

Research paper thumbnail of PHP95 Payer Perspectives on Evidence for Formulary Decision Making in the United States

Research paper thumbnail of Questions for COPD diagnostic screening in a primary care setting

Respiratory Medicine, 2005

Objectives: To test questions usable in an ambulatory clinic to identify persons likely to have c... more Objectives: To test questions usable in an ambulatory clinic to identify persons likely to have chronic obstructive pulmonary disease (COPD). Methods: Analyses were performed as part of a study to identify patients with likely COPD in the Glenfield UK primary care clinic. Patients age 40 and older were recruited based on one of the following criteria: (1) respiratory medications in previous 2 years; (2) history of smoking or (3) history of asthma with no current medications based on case notes. Consenting patients reported smoking history, symptoms, and personal and family history of respiratory conditions. Spirometry with reversibility was conducted to ATS standards. Analyses were performed on this database to test questions for identifying patients with COPD from a sample of patients with a positive smoking history. Multivariate logistic regression identified the question set that best discriminated COPD from other conditions using receiver operating characteristic curves. The usefulness of a simple scoring system was assessed. Results: The study sample included 369 current and former smokers. Patients were diagnosed as: COPD ¼ 62 (16.8%); asthma ¼ 30 (8.1%); or no obstructive lung disease ¼ 277 (75.1%). The best questions for discriminating between persons with and without COPD included items on age, dyspnoea on exertion, and wheeze. This set of questions identified COPD patients with a sensitivity of 77.4-87.1% and specificity of 71.3-76.2%. Conclusions: A simple questionnaire can facilitate the diagnosis of COPD in a primary care setting.

Research paper thumbnail of Symptom-Based Questionnaire for Identifying COPD in Smokers

Respiration, 2006

Background: Symptom-based questionnaires may enhance chronic obstructive pulmonary disease (COPD)... more Background: Symptom-based questionnaires may enhance chronic obstructive pulmonary disease (COPD) screening in primary care. Objectives: We prospectively tested questions to help identify COPD among smokers without prior history of lung disease. Methods: Subjects were recruited via random mailing to primary care practices in Aberdeen, UK, and Denver, Colo., USA. Current and former smokers aged 40 or older with no prior respiratory diagnosis and no respiratory medications in the past year were enrolled. Participants answered questions covering demographics and symptoms and then underwent spirometry with reversibility testing. A study diagnosis of COPD was defined as fixed airway obstruction as measured by postbronchodilator FEV1/FVC <0.70. We examined the ability of individual questions in a multivariate framework to correctly discriminate between persons with and without COPD. Results: 818 subjects completed all investigations and proceeded to analysis. The list of 54 questions y...

Research paper thumbnail of Symptom-Based Questionnaire for Differentiating COPD and Asthma

Respiration, 2006

Background: Many patients with obstructive lung disease (OLD) carry an inaccurate diagnostic labe... more Background: Many patients with obstructive lung disease (OLD) carry an inaccurate diagnostic label. Symptom-based questionnaires could identify persons likely to need spirometry. Objectives: We prospectively tested questions derived from a comprehensive literature review and an international Delphi panel to help identify chronic OLD (COPD) in persons with prior evidence of OLD. Methods: Subjects were recruited via random mailing to primary-care practices in Aberdeen, Scotland, and Denver, Colorado. Persons aged 40 and older reporting any prior diagnosis of OLD or any respiratory medications in the past year were enrolled. Participants answered 54 questions covering demographics and symptoms and underwent spirometry with reversibility testing. A study diagnosis of COPD was defined by fixed airway obstruction as measured by post-bronchodilator FEV1/FVC <0.70. We examined ability of individual questions in a multivariate framework to discriminate between persons with and without the...

Research paper thumbnail of Systematic Review and Meta-analysis of Real-World Adherence to Drug Therapy for Osteoporosis

Mayo Clinic Proceedings, 2007

This review assessed patient adherence to drug therapy for osteoporosis. The authors concluded th... more This review assessed patient adherence to drug therapy for osteoporosis. The authors concluded that up to one half of patients fail to take medication as directed and this pattern occurred shortly after treatment initiation. Variations within the included studies, unclear study quality, and other methodological limitations in the review process, mean that the reliability of this conclusion is questionable.

Research paper thumbnail of US Payer Perspectives on Evidence for Formulary Decision Making

Journal of Oncology Practice, 2012

To improve formulary design processes and support payers in providing more effective health care,... more To improve formulary design processes and support payers in providing more effective health care, policy makers should consider involving commercial payers in the development of comparative effectiveness research and creation of research and treatment guidelines.

Research paper thumbnail of Compliance with US asthma management guidelines and specialty care: a regional variation or national concern?

Journal of Evaluation in Clinical Practice, 1999

The objective of this study was to examine the compliance with the National Asthma Education Prog... more The objective of this study was to examine the compliance with the National Asthma Education Program (NAEP) guidelines among asthmatic members of eight health plans (regions) in seven states, as well as the factors related to the compliance. Information was gathered by means of a cross-sectional survey in a managed care environment. The participants were 6703 respondents (ages 14-65) with moderate or severe asthma. The main outcome measures were compliance with the NAEP guidelines on the use of inhaled steroids, inhaled beta2-agonists, peak flow measurement, and allergy evaluations. Among the results of this survey we found that although these health plans are located from the West Coast to the East Coast and the socioeconomic status of their members varied greatly, compliance with the NAEP guidelines was low among asthmatic members across all geographical regions. The major areas of low compliance identified were inappropriate pharmacological therapy, lack of objective measurement of lung function through peak flow meter, and insufficient environmental trigger control. The regression analyses indicated that the effect of the health plan explained little of the variation in compliance across these regions (only 0.3% at maximum). Low compliance was associated with young age, smoking, moderate asthma, being asthmatic for a few years, currently working, and being treated by a generalist rather than a specialist. In conclusion, this study showed that the compliance with the national guidelines for asthma care was consistently low across different geographical regions in the nation. Improvement in care for asthmatics will require greater commitment and involvement by all stakeholders including physicians, patients, health plans, and employers. We suggest a need for a national strategy to disseminate clinical guidelines not only to the medical community but also to patients themselves.

Research paper thumbnail of Misdiagnosis of COPD and Asthma in Primary Care Patients 40 Years of Age and Over

Journal of Asthma, 2006

Chronic obstructive pulmonary disease (COPD) is often misdiagnosed as asthma, leading to inapprop... more Chronic obstructive pulmonary disease (COPD) is often misdiagnosed as asthma, leading to inappropriate treatment and suboptimal patient outcomes. As part of a prospective study of patients with a history consistent with obstructive lung disease, we compared prior diagnostic labels with a study diagnosis based on spirometric results. We enrolled persons 40 years of age or older with prior diagnoses or medications consistent with obstructive lung disease. Patients were recruited via random mailing to primary care practices in Aberdeen, Scotland, and Denver, Colorado. Prior diagnoses of chronic bronchitis or emphysema (CBE) and asthma were reported by the subjects. Participants underwent pre- and post-bronchodilator spirometry. A study diagnosis of COPD was defined using post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV(1)/FVC) &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.70. Spirometric examination was complete in 597 patients, of whom 235 (39.4%) had a study diagnosis of COPD. Among subjects with a spirometry-based study diagnosis of COPD, 121 (51.5%) reported a prior diagnosis of asthma without concurrent CBE diagnosis, 89 (37.9%) reported a prior diagnosis of CBE, and 25 (10.6%) reported no prior diagnosis of obstructive lung disease. Despite the availability of consensus guideline diagnostic recommendations, diagnostic confusion between COPD and asthma appears common. Increased awareness of the differences between the two conditions is needed to promote optimal patient management and treatment.

Research paper thumbnail of Improving the Management of Chronic Obstructive Pulmonary Disease

Journal for Healthcare Quality, 2005

As the fourth leading cause of death in the United States, chronic obstructive pulmonary disease ... more As the fourth leading cause of death in the United States, chronic obstructive pulmonary disease (COPD) represents a major burden to the healthcare system and society at large. Underdiagnosis and undertreatment lead to an increased economic burden, with exacerbations being a key driver of costs. COPD symptoms compromise quality of life (QOL), which affects both patients and caregivers. Appropriate management decreases healthcare utiization and improves QOL. This article provides an overview of COPD and promotes understanding of opportunities to optimize patient health and outcomes for those with the disease. Specific interventions that have been demonstrated to improve clinical and economic outcomes for COPD include improved implementation of guidelines, optimized pharmacologic treatment, and risk-factor reduction.

Research paper thumbnail of Determinants of quality of life changes among long-term cardiac transplant survivors: results from longitudinal data

The Journal of Heart and Lung Transplantation, 2003

Background: Cross-sectional analyses have identified significant associations between quality of ... more Background: Cross-sectional analyses have identified significant associations between quality of life (QOL), and comorbidities and adverse effects in cardiac transplant recipients. However, little is known about factors that influence changes in QOL over time. This study examines both cross-sectional and longitudinal data from long-term survivors to identify factors that affect differences in QOL among recipients and individual changes in QOL during a 1-year period. Methods: Self-selected enrollees completed questionnaires, including QOL scales, at 3-month intervals. Repeated measures multiple regression analysis was used to examine the association between the QOL scales and comorbidities, adverse effects, and compliance measures, controlling for other factors. Results: We included 569 participants in the analysis, with a mean time since transplantation of 8.6 years. Cross-sectional results showed that the number of comorbidities, treatment non-compliance, and several adverse effects were associated with low QOL. In longitudinal results, waiting to take medications and taking less medication because of lifestyle restrictions were associated with decreases in QOL over time. Hair loss, changes in face shape, and decreased sexual interest or ability also had the largest adverse effects on changes in QOL. Conclusions: These findings provide new opportunities for interventions to address factors related to decreases in QOL. Clinicians should actively solicit information about compliance with medication regimens. In addition, information about the adverse effects of medications should be considered when making therapeutic decisions.

Research paper thumbnail of Effect of multiple patient reminders in improving diabetic retinopathy screening. A randomized trial

Diabetes Care, 1999

OBJECTIVE: To determine whether multiple mailed patient reminders can produce an increase in the ... more OBJECTIVE: To determine whether multiple mailed patient reminders can produce an increase in the rate of diabetic retinal examinations (DRE) over that seen with a single reminder. RESEARCH DESIGN AND METHODS: All diabetic members > or = 18 years who were enrolled in a large network-based health maintenance organization (HMO) in California from August 1996 to July 1997 were identified using claims and pharmacy databases. Members who had no record of DRE in the HMO's claims database were then randomized into two groups. Both groups received mailed educational materials and a reminder to obtain the examination. Their physician groups also received a letter explaining the program, current guidelines for DRE, and a list of their diabetes patients with their DRE status. The single intervention group received no additional reminders. The multiple intervention group received additional reminders at 3, 6, and 9 months after baseline if they continued with no record of service, as dete...

Research paper thumbnail of Physical Score, General Health Perception, and Dyspnea Severity in COPD GOLD Stage1: The PLATINO Study

C24. EVALUATING DISEASE CONTROL AND QUALITY OF LIFE IN ASTHMA AND COPD, 2009

Research paper thumbnail of The Preventive Medicine Manager: A New Role for Preventive Medicine Specialists in Managed Care

American Journal of Preventive Medicine, 1996

Research paper thumbnail of Providing Health Care in War-Torn Rural Afghanistan

The Lancet, 1988

La situation depuis 1979 en Afghanistan. le programme du Corps Medical International (IMC): ensei... more La situation depuis 1979 en Afghanistan. le programme du Corps Medical International (IMC): enseignement medical et chirurgical pousse, installations et approvisionnements souterrains, transports par caravanes. Actuellement 30 unites medicochirurgicales fonctionnement, 100 autres cliniques sont prevues

Research paper thumbnail of Life satisfaction among kidney transplant recipients: demographic and biological factors

Progress in Transplantation, 2002

The Transplant Learning Center is a program providing education and support for solid-organ trans... more The Transplant Learning Center is a program providing education and support for solid-organ transplant recipients taking cyclosporine (Neoral or Sandimmune). One goal of the program is to improve patients&#39; quality of life, which may be influenced by demographic and biological factors, and in turn influences adherence to prescribed medication regimens. We analyzed the results from the initial survey of enrollees to better understand life satisfaction and to test the validity and reliability of the satisfaction scale used in the program. Patients enter the program through self-selection: all enrollees who received a kidney transplant were included in this analysis. Satisfaction was measured using the Life Satisfaction Index, which includes 8 questions about aspects of satisfaction with the patient&#39;s life. Associations between the Life Satisfaction Index and demographic factors, comorbid medical conditions, adverse effects of immunosuppressants, and medication compliance were examined. All 3676 kidney transplant recipients who completed the initial survey were included. Mean satisfaction scores were highest in persons who were older than 64 years, men, and those who were married. Satisfaction scores were positively correlated with education and income. Mean satisfaction score was significantly lower among persons with medical comorbidities, persons who reported that adverse effects of medications were more frequent, and persons who reported noncompliance with their medication regimen. The Life Satisfaction Index is a transplant-specific measure of health-related quality of life that can be used to help detect areas of potential concern in the clinical management of kidney transplant recipients.

Research paper thumbnail of Competencies for Population-Oriented Clinician Managers Survey

Research paper thumbnail of Payer and physician evidence and discount requirements for biosimilars in three Latin American countries

Generics and Biosimilars Initiative Journal, 2015

Study objectives: In Latin America, many governments have attempted to address biosimilar safety ... more Study objectives: In Latin America, many governments have attempted to address biosimilar safety and effi cacy concerns by developing abbreviated regulatory pathways to increase access while controlling quality. This study explores discount and evidence requirements for payers and physicians to provide access to and prescribe biosimilars in Argentina, Brazil and Mexico. Methods: We conducted targeted literature reviews, followed by exploratory qualitative interviews (N = 10) with payers and physician key opinion leaders (KOLs) selected based on input from regional industry experts (payers) and PubMed search (KOLs). Interviews were 60 minutes, using a structured set of questions, in local language. Results: Respondents place the budget impact of the originator product and clinicians' acceptability as the most relevant drivers for the adoption of biosimilars. Payers and KOLs alike expect biosimilars to demonstrate non-inferiority versus originator in phase 3 RCTs (randomized clinical trials) to support bioequivalence, safety and effi cacy claims. Payers' comfort in providing access to biosimilars across disease areas and expectations for cost savings vary by markets, according to previous experience with other biosimilars and confi dence in the regulatory evaluation. As a result, payer discount requirements for public access range from 5-30% across markets, with KOLs stating that they likely will consider biosimilars for all patients at discount levels greater than 20−25%. Conclusion: Although payers and physicians alike cited the importance of bioequivalent safety and effi cacy, they ultimately will look to regulators for guidance on which biosimilar products have provided suffi cient evidence, and for which indications. While the level of discount versus the branded originator varied by market, biosimilars have the potential to gain broad penetration with cost-sensitive public payers and also with clinically-oriented physicians across Latin American markets. Study objectives As with generic small-molecule medicines, the potential for cost savings resulting from the use of biosimilars is attractive to payers worldwide [1, 2]. This attraction has increased sharply in recent years as the impact of biological drugs on health plan budgets has exploded. In Brazil, for example, biotherapeutic products represented 2% of medicines prescribed, yet accounted for 41% of the annual Ministry of Health pharmaceutical budget in 2010 [3]. Biosimilars, however, are different than small molecule generics due to the inherent variability in the production process for biopharmaceutical products and the relatively limited experience that stakeholders have with them. Physicians in particular raise concerns about the degree to which this variability in production may result in differing levels of safety and effi cacy of biosimilars relative to their branded equivalents-and each other. Fear of potential immunogenicity issues arising from differences in the biological production process is a concern with biosimilars, and is associated with the need for post-launch pharmacovigilance programmes as seen in Europe. This complex production process is considerably more expensive than that of small molecules, adding to the costs of biosimilars. These factors, along with the matching of prices of biosimilars by originator companies, have resulted in a tempering effect on the launch and uptake of biosimilars as regulators seek to ensure the bioequivalence of biosimilar products through head-to-head demonstration of biosimilarity to their branded originator products.

Research paper thumbnail of A "clinic without walls": the Los Angeles Immunization Demonstration Project

American journal of public health, 1997

Research paper thumbnail of The cost of chronic obstructive pulmonary disease and its effects on managed care

Managed care interface, 2004

Chronic obstructive pulmonary disease (COPD) designates respiratory disorders characterized by ai... more Chronic obstructive pulmonary disease (COPD) designates respiratory disorders characterized by airway obstruction that is not fully reversible. An estimated 10 million adult Americans have COPD, and the prevalence is rising. Direct and indirect costs of managing COPD exceed dollars 32 billion annually, and this health care burden has provoked vigorous efforts by major public health organizations to evaluate and improve quality of care for COPD. The authors review the substantial effects of COPD on managed care and discuss evidence-based strategies for its effective management.

Research paper thumbnail of Incorporating Stakeholder Input into Budget Impact Models to Compare Stem Cell Mobilization Strategies

Value in Health, 2013

A399 Objectives: Whilst the cost-effectiveness of everolimus + exemestane (EVE+EXE) versus placeb... more A399 Objectives: Whilst the cost-effectiveness of everolimus + exemestane (EVE+EXE) versus placebo + exemestane (PBO+EXE) in patients with ER+ HER2-metastatic breast cancer has been demonstrated elsewhere, this is the first analysis to assess the implications for health spending at a population level. MethOds: The model uses a cumulative cohort approach, allowing incident patients to enter the model each year over a five-year period. The incident population was based on several factors: (i) the female population aged > 15 years; (ii) the proportion of those women with advanced invasive breast cancer; (iii) the proportion who are post-menopausal; (iv) the proportion who are hormone receptor positive; (v) the proportion who are HER2-; (vi) the proportion with asymptomatic visceral disease, and (vii) the proportion for whom hormonal therapy is appropriate. Finally, the cohort was filtered to show those who had previously relapsed or progressed on NSAI. 'Per patient' treatment and adverse event costs were generated based on treatment-specific progression-free survival curves, and multiplied by the number of patients expected to receive each treatment according to market share data and likely uptake rates. An incremental analysis was performed, where two scenarios were compared: (i) a world without EVE+EXE, and (ii) a world with EVE+EXE. Results: It is expected that a total of 1,052 patients will be eligible to receive EVE+EXE over a five-year period. In a 'world without EVE+EXE', the total five year cost was estimated as £1,652,904. Assuming an annual uptake rate of 10%, in a 'world with EVE+EXE' the total cost over the same period was expected to be £2,271,606. Therefore, the incremental cost associated with the introduction of EVE+EXE in England and Wales is £618,702 over five years. cOnclusiOns: EVE+EXE was associated with modest increased health care costs but has, separately, been demonstrated to lead to incremental health benefits compared with other treatments.

Research paper thumbnail of PHP95 Payer Perspectives on Evidence for Formulary Decision Making in the United States

Research paper thumbnail of Questions for COPD diagnostic screening in a primary care setting

Respiratory Medicine, 2005

Objectives: To test questions usable in an ambulatory clinic to identify persons likely to have c... more Objectives: To test questions usable in an ambulatory clinic to identify persons likely to have chronic obstructive pulmonary disease (COPD). Methods: Analyses were performed as part of a study to identify patients with likely COPD in the Glenfield UK primary care clinic. Patients age 40 and older were recruited based on one of the following criteria: (1) respiratory medications in previous 2 years; (2) history of smoking or (3) history of asthma with no current medications based on case notes. Consenting patients reported smoking history, symptoms, and personal and family history of respiratory conditions. Spirometry with reversibility was conducted to ATS standards. Analyses were performed on this database to test questions for identifying patients with COPD from a sample of patients with a positive smoking history. Multivariate logistic regression identified the question set that best discriminated COPD from other conditions using receiver operating characteristic curves. The usefulness of a simple scoring system was assessed. Results: The study sample included 369 current and former smokers. Patients were diagnosed as: COPD ¼ 62 (16.8%); asthma ¼ 30 (8.1%); or no obstructive lung disease ¼ 277 (75.1%). The best questions for discriminating between persons with and without COPD included items on age, dyspnoea on exertion, and wheeze. This set of questions identified COPD patients with a sensitivity of 77.4-87.1% and specificity of 71.3-76.2%. Conclusions: A simple questionnaire can facilitate the diagnosis of COPD in a primary care setting.

Research paper thumbnail of Symptom-Based Questionnaire for Identifying COPD in Smokers

Respiration, 2006

Background: Symptom-based questionnaires may enhance chronic obstructive pulmonary disease (COPD)... more Background: Symptom-based questionnaires may enhance chronic obstructive pulmonary disease (COPD) screening in primary care. Objectives: We prospectively tested questions to help identify COPD among smokers without prior history of lung disease. Methods: Subjects were recruited via random mailing to primary care practices in Aberdeen, UK, and Denver, Colo., USA. Current and former smokers aged 40 or older with no prior respiratory diagnosis and no respiratory medications in the past year were enrolled. Participants answered questions covering demographics and symptoms and then underwent spirometry with reversibility testing. A study diagnosis of COPD was defined as fixed airway obstruction as measured by postbronchodilator FEV1/FVC <0.70. We examined the ability of individual questions in a multivariate framework to correctly discriminate between persons with and without COPD. Results: 818 subjects completed all investigations and proceeded to analysis. The list of 54 questions y...

Research paper thumbnail of Symptom-Based Questionnaire for Differentiating COPD and Asthma

Respiration, 2006

Background: Many patients with obstructive lung disease (OLD) carry an inaccurate diagnostic labe... more Background: Many patients with obstructive lung disease (OLD) carry an inaccurate diagnostic label. Symptom-based questionnaires could identify persons likely to need spirometry. Objectives: We prospectively tested questions derived from a comprehensive literature review and an international Delphi panel to help identify chronic OLD (COPD) in persons with prior evidence of OLD. Methods: Subjects were recruited via random mailing to primary-care practices in Aberdeen, Scotland, and Denver, Colorado. Persons aged 40 and older reporting any prior diagnosis of OLD or any respiratory medications in the past year were enrolled. Participants answered 54 questions covering demographics and symptoms and underwent spirometry with reversibility testing. A study diagnosis of COPD was defined by fixed airway obstruction as measured by post-bronchodilator FEV1/FVC <0.70. We examined ability of individual questions in a multivariate framework to discriminate between persons with and without the...

Research paper thumbnail of Systematic Review and Meta-analysis of Real-World Adherence to Drug Therapy for Osteoporosis

Mayo Clinic Proceedings, 2007

This review assessed patient adherence to drug therapy for osteoporosis. The authors concluded th... more This review assessed patient adherence to drug therapy for osteoporosis. The authors concluded that up to one half of patients fail to take medication as directed and this pattern occurred shortly after treatment initiation. Variations within the included studies, unclear study quality, and other methodological limitations in the review process, mean that the reliability of this conclusion is questionable.

Research paper thumbnail of US Payer Perspectives on Evidence for Formulary Decision Making

Journal of Oncology Practice, 2012

To improve formulary design processes and support payers in providing more effective health care,... more To improve formulary design processes and support payers in providing more effective health care, policy makers should consider involving commercial payers in the development of comparative effectiveness research and creation of research and treatment guidelines.

Research paper thumbnail of Compliance with US asthma management guidelines and specialty care: a regional variation or national concern?

Journal of Evaluation in Clinical Practice, 1999

The objective of this study was to examine the compliance with the National Asthma Education Prog... more The objective of this study was to examine the compliance with the National Asthma Education Program (NAEP) guidelines among asthmatic members of eight health plans (regions) in seven states, as well as the factors related to the compliance. Information was gathered by means of a cross-sectional survey in a managed care environment. The participants were 6703 respondents (ages 14-65) with moderate or severe asthma. The main outcome measures were compliance with the NAEP guidelines on the use of inhaled steroids, inhaled beta2-agonists, peak flow measurement, and allergy evaluations. Among the results of this survey we found that although these health plans are located from the West Coast to the East Coast and the socioeconomic status of their members varied greatly, compliance with the NAEP guidelines was low among asthmatic members across all geographical regions. The major areas of low compliance identified were inappropriate pharmacological therapy, lack of objective measurement of lung function through peak flow meter, and insufficient environmental trigger control. The regression analyses indicated that the effect of the health plan explained little of the variation in compliance across these regions (only 0.3% at maximum). Low compliance was associated with young age, smoking, moderate asthma, being asthmatic for a few years, currently working, and being treated by a generalist rather than a specialist. In conclusion, this study showed that the compliance with the national guidelines for asthma care was consistently low across different geographical regions in the nation. Improvement in care for asthmatics will require greater commitment and involvement by all stakeholders including physicians, patients, health plans, and employers. We suggest a need for a national strategy to disseminate clinical guidelines not only to the medical community but also to patients themselves.

Research paper thumbnail of Misdiagnosis of COPD and Asthma in Primary Care Patients 40 Years of Age and Over

Journal of Asthma, 2006

Chronic obstructive pulmonary disease (COPD) is often misdiagnosed as asthma, leading to inapprop... more Chronic obstructive pulmonary disease (COPD) is often misdiagnosed as asthma, leading to inappropriate treatment and suboptimal patient outcomes. As part of a prospective study of patients with a history consistent with obstructive lung disease, we compared prior diagnostic labels with a study diagnosis based on spirometric results. We enrolled persons 40 years of age or older with prior diagnoses or medications consistent with obstructive lung disease. Patients were recruited via random mailing to primary care practices in Aberdeen, Scotland, and Denver, Colorado. Prior diagnoses of chronic bronchitis or emphysema (CBE) and asthma were reported by the subjects. Participants underwent pre- and post-bronchodilator spirometry. A study diagnosis of COPD was defined using post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV(1)/FVC) &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.70. Spirometric examination was complete in 597 patients, of whom 235 (39.4%) had a study diagnosis of COPD. Among subjects with a spirometry-based study diagnosis of COPD, 121 (51.5%) reported a prior diagnosis of asthma without concurrent CBE diagnosis, 89 (37.9%) reported a prior diagnosis of CBE, and 25 (10.6%) reported no prior diagnosis of obstructive lung disease. Despite the availability of consensus guideline diagnostic recommendations, diagnostic confusion between COPD and asthma appears common. Increased awareness of the differences between the two conditions is needed to promote optimal patient management and treatment.

Research paper thumbnail of Improving the Management of Chronic Obstructive Pulmonary Disease

Journal for Healthcare Quality, 2005

As the fourth leading cause of death in the United States, chronic obstructive pulmonary disease ... more As the fourth leading cause of death in the United States, chronic obstructive pulmonary disease (COPD) represents a major burden to the healthcare system and society at large. Underdiagnosis and undertreatment lead to an increased economic burden, with exacerbations being a key driver of costs. COPD symptoms compromise quality of life (QOL), which affects both patients and caregivers. Appropriate management decreases healthcare utiization and improves QOL. This article provides an overview of COPD and promotes understanding of opportunities to optimize patient health and outcomes for those with the disease. Specific interventions that have been demonstrated to improve clinical and economic outcomes for COPD include improved implementation of guidelines, optimized pharmacologic treatment, and risk-factor reduction.