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PubMed | Health Economics and Epidemiology, Strategy and Research, VeriTech Corporation, University of California at San Francisco and 2 more.
Type: Journal Article | Journal: Headache | Year: 2016

The objective of this study was to compare the societal direct and indirect costs of chronic and episodic migraine in the United States.Episodic and chronic migraine are distinguished by the frequency of headache-days. Chronic migraine has a greater overall impact on quality of life than does episodic migraine. Individuals with chronic migraine also use more healthcare resources (resulting in higher direct costs) and experience greater decreases in productivity (resulting in higher indirect costs) than those with episodic migraine as shown in the American Migraine Prevalence and Prevention (AMPP) Study.The International Burden of Migraine Study utilized a web-based questionnaire to elicit data on several topics related to the burden of migraine illness, including health resource utilization and productivity losses. Potential survey participants were identified by Synovate Healthcare (Chicago, IL, USA) from a pool of registered panelists from various countries. The panelists were screened online to determine eligibility and to identify individuals with migraine (episodic or chronic), based on reported symptoms. Participants from the United States were divided into episodic and chronic migraine groups, based on reported headache-day per month frequency. Direct and indirect costs were estimated by applying estimated unit costs to reported headache-related productivity losses and resource use. Costs were compared between participants with episodic and chronic migraine.Mean [standard deviation] total annual cost of headache among people with chronic migraine ($8243 [$10,646]) was over three times that of episodic migraine ($2649 [$4634], P<.001). Participants with chronic migraine had significantly greater direct medical costs ($4943 [$6382]) and indirect (lost productivity) costs ($3300 [$6907]) than did participants with episodic migraine (direct, $1705 [$3591]; indirect, $943 [$2084]) (P<.001 for each). Unlike previous findings, direct medical costs constituted the majority of total headache-related costs for both chronic migraine (60.0%, $4943 of $8243) and episodic migraine (64.3%, $1705 of $2649) participants. A large portion of direct medical costs are attributable to pharmaceutical utilization among both chronic migraine (80%, $3925 of 4943) and episodic migraine (70%, $1196 of $1705) participants.The results of this study build on previous results of the AMPP Study, demonstrating that headache-related direct, indirect, and total costs are significantly greater among individuals with chronic migraine than with episodic migraine in the United States.

PubMed | University of Kentucky, Health Economics and Epidemiology, University of Manchester, Glaxosmithkline and 7 more.
Type: Journal Article | Journal: Chronic obstructive pulmonary diseases (Miami, Fla.) | Year: 2015

In 2010 the COPD Foundation established the COPD Biomarkers Qualification Consortium (CBQC) as a partnership between the Foundation, the Food and Drug Administration (FDA), and the pharmaceutical industry to pool publicly-funded and industry data to develop innovative tools to facilitate the development and approval of new therapies for COPD. We present data from the initial project seeking regulatory qualification of fibrinogen as a biomarker for the stratification of COPD patients into clinical trials.This analysis pooled data from 4 publicly-funded studies and 1 industry study into a common database resulting in 6376 individuals with spirometric evidence of COPD. We used a threshold of 350 mg/dL to determine High fibrinogen levels at baseline were present in 2853 (44.7%) of individuals with COPD. High fibrinogen was associated with an increased risk of hospitalized COPD exacerbations within 12 months (hazard ratio [HR]: 1.64; 95% confidence interval [CI]: 1.39-1.93) among participants in the Atherosclerosis Risk in Communities Study (ARIC), the Cardiovascular Health Study (CHS), and the Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) study. High fibrinogen was associated with an increased risk of death within 36 months (HR: 1.94; 95% CI: 1.62-2.31) among all participants.Fibrinogen levels 350 mg/dL identify COPD individuals at an increased risk of exacerbations and death and could be a useful biomarker for enriching clinical trials in the COPD population.

PubMed | Medical University of South Carolina, Health Economics and Epidemiology, Ohio State University and Medtronic
Type: Journal Article | Journal: JACC. Heart failure | Year: 2015

This study sought to assess the lifelong extrapolated patient outcomes with cardiac resynchronization therapy (CRT) in mild heart failure (HF), beyond the follow-up of randomized clinical trials (RCTs).RCTs have demonstrated short-term survival and HF hospitalization benefits of CRT in mild HF. We used data from the 5-year follow-up of the REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) study to extrapolate survival and HF hospitalizations. We compared CRT-ON versus CRT-OFF and CRT defibrillators (CRT-D) versus CRT pacemakers (CRT-P).Multivariate regression models were used to estimate treatment-specific all-cause mortality, disease progression, and HF-related hospitalization rates. Rank-preserving structural failure time (RPSFT) models were used to adjust for protocol-mandated crossover in the survival analysis.CRT-ON was predicted to increase survival by 22.8% (CRT-ON 52.5% vs. CRT-OFF 29.7%; hazard ratio [HR]: 0.45; p = 0.21), leading to an expected survival of 9.76 years (CRT-ON) versus 7.5 years (CRT-OFF). CRT-D showed a significant improvement in survival compared with CRT-P (HR: 0.47; 95% confidence interval [CI]: 0.25 to 0.88; p = 0.02) and were predicted to offer 2.77 additional life-years. New York Heart Association (NYHA) functional class II patients had a 30.6% higher HF hospitalization risk than class I (I vs. II incident rate ratio [IRR]: 0.69; 95% CI: 0.57 to 0.85; p < 0.001) and 3 times lower rate compared with class III (III vs.2.98; 95% CI: 2.29 to 3.87; p < 0.001).RPSFT estimates yielded results demonstrating clinically important long-term benefit of CRT in mild HF. CRT was predicted to reduce mortality, with CRT-D prolonging life more than CRT-P. NYHA functional class I/II patients were shown to have a significantly reduced risk of HF hospitalization compared with class III, leading to CRT reducing HF hospitalization rates.

Nalysnyk L.,United Biosource Corporation | Papapetropoulos S.,Allergan, Inc. | Rotella P.,Health Economics and Epidemiology | Simeone J.C.,Health Economics and Epidemiology | And 3 more authors.
BMC Neurology | Year: 2013

Background: OnabotulinumtoxinA has demonstrated significant benefit in adult focal spasticity. This study reviews the injection patterns (i.e., muscle distribution, dosing) of onabotulinumtoxinA for treatment of adult spasticity, as reported in published studies.Methods: A systematic review of clinical trials and observational studies published between 1990 and 2011 reporting data on muscles injected with onabotulinumtoxinA in adult patients treated for any cause of spasticity. Results: 28 randomized, 5 nonrandomized, and 37 single-arm studies evaluating 2,163 adult patients were included. The most frequently injected upper-limb muscles were flexor carpi radialis (64.0% of patients), flexor carpi ulnaris (59.1%), flexor digitorum superficialis (57.2%), flexor digitorum profundus (52.5%), and biceps brachii (38.8%). The most frequently injected lower-limb muscles were the gastrocnemius (66.1% of patients), soleus (54.7%), and tibialis posterior (50.5%). The overall dose range reported was 5-200 U for upper-limb muscles and 10-400 U for lower-limb muscles. Conclusions: The reviewed evidence indicates that the muscles most frequently injected with onabotulinumtoxinA in adults with spasticity were the wrist, elbow, and finger flexors and the ankle plantar flexors. OnabotulinumtoxinA was injected over a broad range of doses per muscle among the studies included in this review, but individual practitioners should be mindful of local regulatory approvals and regulations. © 2013 Nalysnyk et al.; licensee BioMed Central Ltd.

Sorensen S.,Health Economics and Epidemiology | Ellis L.,Health Economics and Outcomes Research | Wu Y.,Oncology Nephrology Outcomes Research | Hutchins V.,United Biosource Corporation | And 2 more authors.
Journal of Managed Care Pharmacy | Year: 2013

BACKGROUND: Abiraterone acetate, an androgen biosynthesis inhibitor, received FDA approval in 2011 for metastatic castration-resistant prostate cancer (mCRPC) patients who have received prior chemotherapy containing docetaxel. OBJECTIVE: To estimate the projected budgetary impact of adopting abiraterone for mCRPC patients from a U.S. health plan perspective. METHODS: A decision analytic model compared mCRPC treatment cost before and after abiraterone acetate adoption based on a hypothetical 1,000,000-member plan. Plan mCRPC prevalence was derived from prostate cancer incidence reported in U.S. epidemiology statistics and disease progression data from published trials. Market shares for comparator mCRPC treatments (prednisone alone; cabazitaxel + prednisone; mitoxantrone + prednisone; docetaxel retreatment + prednisone) were derived from market research simulation. Abiraterone + prednisone uptake (8% - scenario 1 to 55% - scenario 3) was based on assumptions for illustrative purposes. Treatment costs were computed using prescribing information, treatment duration from phase III trials, and drug costs considering common U.S. cost listing and reimbursement schemes. Prevalence and costs of managing treatment-related toxicities were estimated from literature, treatment guidelines, and expert clinical opinion. The model evaluated the perspectives of a commercial payer with no Medicare beneficiaries and a commercial payer with a subset of Medicare beneficiaries. Sensitivity analyses were conducted to assess changing input values. RESULTS: In each modeled scenario, 57 patients with prior docetaxel therapy received treatment for mCRPC. For the commercial perspective, the incremental per-member-per-month (PMPM) cost attributable to abiraterone ranged from $0.0019 in scenario 1 to $0.0133 in scenario 3. For the commercial/Medicare perspective, the incremental PMPM ranged from $0.0026 in scenario 1 to $0.0176 in scenario 3. The average incremental PMPM cost over 3 scenarios is $0.0112. When testing key sensitivity scenarios, the model indicated that abiraterone treatment duration and cabazitaxel market share were the main drivers of cost. CONCLUSIONS: The model results indicate that reimbursement for abiraterone may have a neutral impact on a U.S. health plan budget given the relatively small size of the eligible prostate cancer population and expected lower toxicity-related costs as compared with chemotherapy. The sensitivity analyses addressing the components of uncertainty in the model show that the budgetary impact of abiraterone is likely low. © 2013, Academy of Managed Care Pharmacy.

Wu N.,Health Economics and Epidemiology | Yu X.,Health Economics and Epidemiology | Greene M.,Boehringer Ingelheim Pharmaceuticals | Oderda G.,University of Utah
International Journal of Nephrology | Year: 2014

This retrospective study assessed the prevalence of moderate to severe chronic kidney disease (CKD) among nursing home (NH) residents with type 2 diabetes. The pattern of oral antidiabetic drug (OAD) use and their concordance with the National Kidney Foundation (NKF) guideline and prescribing information (PI) was also assessed. About half (47%) of diabetic residents had moderate to severe CKD. A little over a quarter of the 186 residents using OADs received at least one NKF-discordant OAD prescription. Metformin was the most commonly misused OAD. PI nonconcordance was observed in 58.6% of residents and was highest in glipizide and metformin users. With the high prevalence of moderate to severe CKD in NH residents with diabetes, physicians should consider residents' renal function when choosing treatment plans and review treatments regularly to check compliance with the NKF guidelines or PIs. © 2014 Ning Wu et al.

Chen S.-Y.,Health Economics and Epidemiology | Wu N.,Health Economics and Epidemiology | Lee Y.-C.,Health Economics and Epidemiology | Zhao Y.,Novartis
Journal of Pain Research | Year: 2013

Purpose: The aim of the study reported here was to examine health care resource utilization, costs, and risk of rehospitalization for total knee replacement (TKR) patients with and without muscle atrophy/weakness (MAW). Patients and methods: Individuals aged 50-64 years with commercial insurance or 65+ years with Medicare Supplemental Insurance (Medicare) who had a hospitalization for TKR between January 1, 2006 and September 30, 2009 were identified from a large US claims database. First hospitalization for TKR was defined as the index stay. All patients were classified into three cohorts according to when MAW was diagnosed relative to TKR: pre-MAW, post-MAW, and no MAW. The association between MAW and health care costs over the 12-month post-index period and the probability of rehospitalization were assessed via multivariate regressions. Results: The study sample included 53,696 Medicare and 46,058 commercial insurance TKR patients. Controlling for cross-cohort differences, both the pre- and post-MAW cohorts had significantly higher total health care costs (Medicare US$4,201 and US$9,404 higher, commercial insurance US$2,737 and US$6,640 higher, respectively) than the no MAW cohort (all P < 0.05). The post-MAW cohort in both populations was also more likely to have any all-cause or replacement-related rehospitalization compared with the no MAW cohort. Conclusion: Among US patients undergoing TKR, those with MAW had higher health care utilization and costs than patients without MAW. © 2013 Chen et al, publisher and licensee Dove Medical Press Ltd.

Fraeman K.H.,Health Economics and Epidemiology | Nordstrom B.L.,Evidera | Luo W.,Evidera | Landis S.H.,Glaxosmithkline | Shantakumar S.,Glaxosmithkline
International Journal of Hypertension | Year: 2013

This retrospective cohort study was conducted to estimate incidence rates of new-onset hypertension in adult cancer patients identified from the Varian Medical Oncology outpatient database. Incidence rates of increasing levels of hypertension severity were calculated overall and for periods of chemotherapy exposure and nonexposure. Cox models sought predictors of new-onset hypertension severity among baseline and chemotherapy exposure variables. New-onset hypertension was observed in about one-third of 25,090 patients with various cancer types. The incidence rates (IR) of severe and crisis-level hypertension, respectively, were the highest in patients with gastric (18.5 cases per 100 person-years (PY), 5.6 per 100 PY) and ovarian cancer (20.2 per 100 PY, 4.8 per 100 PY). The highest IR of moderate hypertension was observed in patients with renal cancer (46.7 per 100 PY). Across all cancers, chemotherapy exposure was associated with a 2-3.5-fold increase in risk of any degree of hypertension compared to periods of no chemotherapy; higher hypertension levels showed greater variability in relative risks by type and line of therapy but indicated an overall increase associated with chemotherapy exposure. These results help to elucidate the factors influencing HTN among cancer patients and the incidence of HTN relative to chemotherapy exposure. © 2013 Kathy H. Fraeman et al.

Chen S.-Y.,Health Economics and Epidemiology | Shah S.N.,Pfizer | Lee Y.-C.,Health Economics and Epidemiology | Boulanger L.,Health Economics and Epidemiology | And 2 more authors.
Journal of Managed Care Pharmacy | Year: 2014

BACKGROUND: Statins are efficacious in reducing the risk of major cardiovascular events for both primary and secondary prevention, yet long-term adherence is poor. Their effectiveness could be compromised in actual practice when patients are not adherent to the treatments. Higher copayments have been shown to be associated with lower adherence to statins. OBJECTIVE: To assess the effect on patient adherence of moving branded atorvastatin and rosuvastatin from the second to the first tier by a Medicare Part D plan sponsor. METHODS: Pharmacy claims and eligibility records between July 1, 2009, and July 31, 2011, of Medicare Part D members not receiving the lowincome subsidy were analyzed. New atorvastatin and rosuvastatin users in January 2010 (2010 cohort) were compared with those in January 2011 (2011 cohort) after this formulary tier change (tier-reduction group). Adherence was defined by the proportion of days covered (PDC) over 6 months. The impact of tier reduction on adherence was evaluated via logistic regression for binary outcome (PDC≥0.8) and generalized linear regression for continuous PDC by comparing the 2011 cohort with the 2010 cohort, adjusting for demographic and clinical characteristics. Other statin users (97% on generic statins) were also analyzed, serving as a nontierreduction comparator group. RESULTS: We identified 12,437 members in the tier-reduction group. Between the 2010 and 2011 cohorts, mean PDC increased from 0.77 to 0.83, and the proportion of members with high adherence increased from 62.0% to 72.9% (both P < 0.001). After regression adjustment, members in the 2011 cohort were more likely to be adherent (OR=1.68; 95% CI=1.55-1.82) and had a 5.9% increase in PDC (P < 0.05). There was no significant increase in adherence observed in the comparator nontier-reduction group. CONCLUSION: Findings from this study suggest that financial incentives may improve medication adherence. Future studies should evaluate whether such formulary strategies improve long-term adherence and patient outcomes. © 2014, Academy of Managed Care Pharmacy.

Engelman W.,Health Economics and Epidemiology | Hammond F.M.,Indiana University | Malec J.F.,Indiana University
Neuropsychiatric Disease and Treatment | Year: 2014

Pseudobulbar affect (PBA) is defined by episodes of involuntary crying and/or laughing as a result of brain injury or other neurological disease. Epidemiology studies show that 5.3%–48.2% of people with traumatic brain injury (TBI) may have symptoms consistent with (or suggestive of) PBA. Yet it is a difficult and often overlooked condition in individuals with TBI, and is easily confused with depression or other mood disorders. As a result, it may be undertreated and persist for longer than it should. This review presents the signs and symptoms of PBA in patients with existing TBI and outlines how to distinguish PBA from other similar conditions. It also compares and contrasts the different diagnostic criteria found in the literature and briefly mentions appropriate treatments. This review follows a composite case with respect to the clinical course and treatment for PBA and presents typical challenges posed to a provider when diagnosing PBA. © 2014 Engelman et al.

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