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Ley B.,University of California at San Francisco | Bradford W.Z.,InterMune Inc. | Weycker D.,Policy Analysis Inc. PAI | Vittinghoff E.,University of California at San Francisco | And 2 more authors.
European Respiratory Journal | Year: 2015

The Gender-Age-Physiology (GAP) model is a validated, baseline-risk prediction model for mortality in idiopathic pulmonary fibrosis. Longitudinal variables have been shown to contribute to risk prediction in idiopathic pulmonary fibrosis and may improve the predictive performance of the baseline GAP model. Our aims were to further validate the GAP model and evaluate whether the addition of longitudinal variables improves its predictive performance. The study population was derived from a large clinical trials cohort of patients with idiopathic pulmonary fibrosis (n=1109). Model performance was determined by improvement in the C-statistic, net reclassification improvement, clinical net reclassification improvement, and a goodness-of-fit test. The GAP model had good discriminative performance with a C-statistic of 0.757 (95% CI 0.750-0.764). However, the original GAP model tended to overestimate risk in this cohort. A novel, easy to use model, consisting of the original GAP predictors plus history of respiratory hospitalisation and 24-week change in forced vital capacity (the longitudinal GAP model) improved model performance with a C-statistic of 0.785 (95% CI 0.780-0.790), net reclassification improvement of 8.5%, clinical net reclassification improvement of 25%, and a goodness-of-fit test of 0.929. The Longitudinal GAP model, along with the original GAP model, may unify baseline and longitudinal mortality risk prediction in idiopathic pulmonary fibrosis. Copyright © ERS 2015.


Weycker D.,Policy Analysis Inc. PAI | Strutton D.,Wyeth Research | Edelsberg J.,Policy Analysis Inc. PAI | Sato R.,Wyeth Research | Jackson L.A.,Group Health Research Institute
Vaccine | Year: 2010

We developed a model characterizing rates and costs of pneumococcal disease in the US to estimate the expected annual clinical and economic burden of this condition among older adults. Among the 91.5 million US adults aged ≥50 years, 29,500 cases of invasive pneumococcal disease, 502,600 cases of nonbacteremic pneumococcal pneumonia, and 25,400 pneumococcal-related deaths are estimated to occur yearly; annual direct and indirect costs are estimated to total $3.7 billion and $1.8 billion, respectively. Pneumococcal disease remains a substantial burden among older US adults, despite increased coverage with PPV23 and indirect benefits afforded by PCV7 vaccination of young children. © 2010 Elsevier Ltd.


Hagiwara M.,Policy Analysis Inc. PAI | Delea T.E.,Policy Analysis Inc. PAI | Chung K.,Amgen
Journal of Medical Economics | Year: 2014

Background: Patients with bone metastases secondary to breast cancer are pre-disposed to skeletal-related events (SREs), including spinal cord compression (SCC), pathologic fracture (PF), surgery to bone (SB), and radiotherapy to bone (RT). Objective: To document current patterns of healthcare utilization and costs of SREs in patients with breast cancer and bone metastases. Methods: This was a retrospective, observational study using the Thomson MedStat MarketScan Commercial Claims and Encounters database from 9/2002 to 6/2011. Study subjects included all persons with claims for breast cancer and for bone metastases, and 1 claims for an SRE. Unique SRE episodes were identified based on a gap of at least 90 days without an SRE claim, and classified by treatment setting (inpatient or outpatient) and SRE type (SCC, PF, SB, or RT). Results: Of 17,266 patients with breast cancer and bone metastases, 9142 (53%) had one or more SRE episodes. Among 5809 patients who met all other criteria, there were 7617 SRE episodes over mean (SD) follow-up of 17.2 (15.2) months. The percentage of episodes that required inpatient treatment ranged from 11% (RT) to 76% (SB). On average, inpatient SCC episodes (n=83 episodes) were most costly; while outpatient PF episodes (n=552 episodes) were least costly. Of the total SRE costs (mean [SE] $21,072 [$36,462]/episode), 36% were attributable to outpatient RT (n=5265 episodes) and 31% to inpatient PF (n=838 episodes). Limitations: The administrative claims data used in this study may lack sensitivity and specificity for identification of clinical events and may not be generalizable to other populations. Also, for some SRE episode categories, the number of events was small and cost estimates may lack precision. Conclusion: In patients with breast cancer and bone metastases, SREs are associated with high costs and hospitalizations. © 2014 All rights reserved.


Hagiwara M.,Policy Analysis Inc. PAI | Delea T.E.,Policy Analysis Inc. PAI | Saville M.W.,Amgen | Chung K.,Amgen
Prostate Cancer and Prostatic Diseases | Year: 2013

Background:Patients with bone metastases secondary to prostate cancer are predisposed to skeletal-related events (SREs), including spinal cord compression, pathological fracture, surgery to bone and radiotherapy to bone. The objective of this study was to document current patterns of healthcare utilization and costs of SREs in patients with prostate cancer and bone metastases.Methods:This was a retrospective, observational study using the Thomson MedStat MarketScan Commercial Claims and Encounters database from September 2002 to June 2011. Study subjects included all persons with claims for prostate cancer and for bone metastases, and one or more claims for an SRE. Unique SRE episodes were identified based on a gap of at least 90 days without an SRE claim, and classified by treatment setting (inpatient or outpatient) and SRE type (spinal cord compression, pathological fracture, surgery to bone or radiotherapy).Results:Of 3919 patients with prostate cancer and bone metastases, 2090 (53%) had one or more SRE episodes. Among 1237 patients who met all other criteria, there were 1623 SRE episodes over a mean (s.d.) follow-up of 16.1 (12.9) months. The percent of episodes that required inpatient treatment ranged from 14% (radiotherapy) to 82% (surgery to bone). On average, inpatient episodes with surgery to bone (n=36 episodes) were most costly (mean (s.e.) 88 838 (11 830)/episode), whereas outpatient episodes with surgery to bone (n=8 episodes) were least costly (mean (s.e.) 4749 (1690)/episode). Of the total SRE costs (mean (s.e.) 20 984 (951)/episode), 41% were attributable to outpatient radiotherapy (n=1169 episodes), 23% to inpatient radiotherapy (n=184 episodes), and 19% to inpatient treatment of pathological fractures (n=101 episodes).Conclusions:In patients with prostate cancer and bone metastases, SREs are associated with high costs and hospitalizations. © 2013 Macmillan Publishers Limited. All rights reserved.


Weycker D.,Policy Analysis Inc. PAI | Sato R.,Pfizer | Strutton D.,Pfizer | Edelsberg J.,Policy Analysis Inc. PAI | And 2 more authors.
Vaccine | Year: 2012

Background: A 13-valent pneumococcal conjugate vaccine (PCV13) was recently developed for use in older adults, and may be effective not only against invasive pneumococcal disease (IPD) but also nonbacteremic pneumococcal pneumonia. The potential public health and economic impact of PCV13 in this population is unknown. Methods: A microsimulation model depicting risk and costs of IPD and all-cause nonbacteremic pneumonia (NBP) in US adults aged ≥50. years (n= 96.1. million), as well as expected impact of vaccination, was developed. Effectiveness of PPSV23 was based on published literature, and for all-cause NBP, was zero; effectiveness of PCV13 was based on PCV7 data in children, and for all-cause NBP, was varied across a reasonable range. Lifetime outcomes and costs were projected assuming: (1) use of PCV13 in all subjects at model entry, with and without periodic revaccination; and (2) use of PPSV23 per current ACIP recommendations. Results: Use of PCV13 in all subjects at model entry without revaccination - in lieu of PPSV23 use per recommendations - reduced cases of IPD by 15,000 (95% CI 9000-21,000); cases of NBP by 1.2. million (0.9-1.5); total healthcare costs by $3.5. billion (1.9-5.2); and total societal costs by $7.4. billion (5.3-9.8). Use of PCV13 with revaccination every 5-10. years resulted in fewest cases of disease and lowest total costs. Findings were largely unchanged in sensitivity analyses. Conclusions: Assuming that the effectiveness of PCV13 in adults is comparable to that observed for PCV7 in children and under reasonable assumptions regarding the underlying risks and costs of IPD and NBP, model projections suggest that routine use of PCV13 - in lieu of PPSV23 - would result in a greater reduction in the overall burden of pneumococcal disease in older US adults. © 2012 Elsevier Ltd.


Hagiwara M.,Policy Analysis Inc. PAI | Delea T.E.,Policy Analysis Inc. PAI | Cong Z.,Amgen Inc. | Chung K.,Amgen Inc.
Supportive Care in Cancer | Year: 2014

Purpose: Cancer patients with bone metastases (BMets) are predisposed to skeletal complications. Bone-targeted therapies such as denosumab or intravenous bisphosphonates (IVBs) reduce the risk of these complications. This study characterized patterns of IVB use in these patients in the USA. Methods: This was a retrospective, observational study using the Truven Health MarketScan Commercial and Medicare databases (2002-2011). Subjects with ≥1 claims of diagnosis of breast, lung, or prostate cancer (BC, LC, or PC) and ≥1 claims of BMets diagnosis were included. The date of first BMet diagnosis claim was the "index date." Key exclusion criteria were diagnosis of other primary cancer, receipt of IVB, or <6 months continuous enrollment pre-index. Cumulative incidence of treatment initiation, interruption, and discontinuation were estimated. Proportions of IVB claims with chemotherapy administered on the same day and with renal monitoring within 2 weeks prior were summarized. Multivariate regressions assessing factors associated with IVB initiation were conducted. Results: Cumulative incidence of IVB initiation at 12 months post-index was greatest for BC followed by PC and LC, and it declined with age in all tumor types, e.g., in BC from 62 % at age <50 years to 47 % at age ≥75 years. At 12 months, IVB treatment interruption ranged from 16 % (LC) to 31 % (PC), with discontinuation ranging from 46 % (BC) to 83 % (LC). Conclusions: IVBs are used more frequently in patients with BMets secondary to BC than PC or LC. Many patients interrupt or discontinue IVB therapy within 12 months of initiation potentially impacting effectiveness. © 2013 Springer-Verlag Berlin Heidelberg.


Weycker D.,Policy Analysis Inc. PAI | Barron R.,Amgen Inc. | Edelsberg J.,Policy Analysis Inc. PAI | Kartashov A.,Policy Analysis Inc. PAI | Lyman G.H.,Duke University
Breast Cancer Research and Treatment | Year: 2012

Chemotherapy is widely used to treat early stage breast cancer (ESBC). Reductions and delays in dose administered-e.g., due to advanced age or febrile neutropenia (FN)-are generally believed to increase risk of disease progression and reduce survival. Little is known about incidence of reduced chemotherapy dose intensity among women with ESBC in the current era of US clinical practice. This study employed a retrospective cohort design and electronic medical records from >65 community oncology/hematology clinics in >35 states (2004-2010). The study population comprised adult women who received myelosuppressive chemotherapy for ESBC (stages I-IIIA). For each such woman, each unique cycle of chemotherapy within their first observed course was identified. Incidence of chemotherapy dose delays (7 days for any drug in 1 cycles), chemotherapy dose reductions (15% for any drug in 1 cycles), and low chemotherapy relative dose intensity (RDI <85% over the course) relative to published reference standards were descriptively analyzed for the seven most-frequently planned regimens in the study database. A total of 2,228 women (70% of the subjects who received chemotherapy for ESBC and met other selection criteria) initiated 1 of the 7 most-frequently planned regimens. Mean age of subjects was 54 years and 69% received primary prophylaxis against FN with a colony-stimulating factor. Incidence of dose delays, dose reductions, and low RDI was 31, 24, and 26%, respectively; low RDI typically was due to premature treatment discontinuation. For patients (n = 626) receiving the most common regimen (dose-dense AC-T: doxorubicin/cyclophosphamide, Q2 × 4 cycles, paclitaxel or docetaxel, Q2 × 4 cycles), incidence of dose delays, dose reductions, and low RDI was 42, 29, and 32%, respectively. In the current era of US clinical practice, chemotherapy dose delays and dose reductions are common among women with ESBC receiving frequently used myelosuppressive dose-dense, as well as conventional, chemotherapy regimens. © 2012 Springer Science+Business Media, LLC.


Berger A.,Policy Analysis Inc. PAI | Sadosky A.,Pfizer | Dukes E.,Pfizer | Edelsberg J.,Policy Analysis Inc. PAI | Oster G.,Policy Analysis Inc. PAI
BMC Neurology | Year: 2012

Background: Clinical characteristics and patterns of healthcare utilization in patients with painful neuropathic disorders (PNDs) who are under the care of general practitioners (GPs) in the UK are not well understood.Methods: Using a large electronic UK database, we identified all adults (age ≥ 18 years) with any GP encounters between 1 January 2006 - 31 December 2006 at which a diagnosis of PND was noted ("PND patients"). An age-and gender-matched comparison group also was constituted consisting of randomly selected patients with one or more GP encounters-but no mention of PNDs-during this period. Characteristics and patterns of healthcare utilization of patients in the two groups were then examined over the one-year study period.Results: The study sample consisted of 31,688 patients with mention of PNDs and an equal number of matched comparators; mean age was 56 years, and 62% were women. The prevalence of various comorbidities was higher among patients in the PND group, including digestive disorders (31% vs. 17% for comparison group), circulatory disorders (29% vs. 22%), and depression (4% vs. 3%) (all p < 0.01). Receipt of prescriptions for pain-related pharmacotherapy also was higher among PND patients, including nonsteroidal anti-inflammatory drugs (56% of PND patients had one or more such prescriptions vs. only 22% in the comparison group), opioids (49% vs. 12%), tricyclic antidepressants (20% vs. 1%), and antiepileptics (12% vs. 1%) (all p < 0.01). PND patients also averaged significantly more GP visits (22.8 vs. 14.2) and referrals to specialists (2.8 vs. 1.4) over one year (both comparisons p < 0.01).Conclusions: Patients with PNDs under the care of GPs in the UK have relatively high levels of use of healthcare services and pain-related pharmacotherapy. © 2012 Berger et al; licensee BioMed Central Ltd.


Shea K.M.,Boston University | Weycker D.,Policy Analysis Inc. PAI | Stevenson A.E.,Boston University | Strutton D.R.,Pfizer | Pelton S.I.,Boston University
Vaccine | Year: 2011

We hypothesized that following the introduction of PCV7, the exchange of vaccine serotypes (VST) for non-vaccine serotypes (NVST) in the nasopharynx has resulted in fewer episodes of pneumococcal acute otitis media (AOM) due to the reduced capacity for common NVST strains to cause disease. We modeled the change in the proportion of children colonized with S. pneumoniae who would develop pneumococcal AOM that would occur due to serotype replacement, and projected the future impact of PCV13. Our model is based on observed changes in the nasopharyngeal pneumococcal serotype distribution from the pre- to post-PCV7 era, and an estimated capacity of each serotype to produce pneumococcal AOM given colonization; the latter was derived by dividing serotype-specific disease prevalence by serotype-specific carriage prevalence in the same population. Our results indicate a 12% (95% CI 0.5-26) decline in the number of AOM episodes attributable to S. pneumoniae in children less than 3 years of age between 2000 and 2007 due to the combined effects of PCV7 vaccine efficacy and vaccine-induced serotype replacement, and predicts that PCV13 will further decrease pneumococcal AOM an additional 27% (95% CI 13-40) from 2007 to 2013. Evaluation of changes in VST disease revealed a 91% (95% CI 83-97) decrease in PCV7-VST AOM from 2000 to 2007, and predicted an additional 65% (95% CI 57-74) decrease in PCV13-VST AOM from 2007 to 2013. Our model indicates that following vaccination, nasopharyngeal replacement of VST by NVST has led to a decrease in the amount of pneumococcal AOM despite a consistent rate of S. pneumoniae colonization, and that pneumococcal AOM may continue to decrease as pneumococcal serotypes with greater capacity to cause disease are replaced by less locally invasive serotypes. © 2011 Elsevier Ltd.


Hagiwara M.,Policy Analysis Inc. PAI | Hackshaw M.D.,Glaxosmithkline | Oster G.,Policy Analysis Inc. PAI
Journal of Medical Economics | Year: 2013

Objective: To estimate the costs of adverse events (AEs) in patients aged 65 years with metastatic renal cell carcinoma (mRCC). Methods: Retrospective study using the linked Surveillance, Epidemiology and End Results (SEER) Medicare database. Study subjects consisted of persons in SEER-Medicare, aged 65 years, with evidence of newly diagnosed mRCC between January 1, 2007 and December 31, 2007. Adverse events of interest consisted of Grade 3 or 4 toxicities that have been reported with frequency 5% in randomized controlled trials of sunitinib, sorafenib, bevacizumab, and pazopanib (i.e., targeted therapies for mRCC), and included abdominal pain, back pain, diarrhea, dyspnea, extremity pain, fatigue/asthenia, hand-foot syndrome, hypertension, lymphopenia, nausea/vomiting, neutropenia, proteinuria, and thrombocytopenia. Patients in SEER-Medicare with these events were identified based on ICD-9-CM diagnosis codes on Medicare claims. For each AE of interest, costs were tallied among evented patients over 30 days, beginning with the date of each patient's first mention of the AE, and were compared with those of non-evented patients over a similar 30-day period beginning with an identical 'shadow' index date. Total costs were compared on an unadjusted basis and with adjustment for differences in baseline characteristics using a generalized linear model. Results: A total of 881 patients with mRCC met study entry criteria; 60% of these patients had Medicare claims with mention of one or more AEs of interest. Events occurring with frequency >20% included abdominal pain, dyspnea, and fatigue/asthenia; 10-20% of study subjects had encounters for back pain, extremity pain, and nausea/vomiting. Mean (standard deviation) total cost of care over 30 days was substantially higher among patients with AEs ($13,944 [$14,529]) compared with those without mention of these events ($1878 [$5264]). Adjusting for differences in baseline characteristics, the mean (95% confidence interval) difference in costs between evented and non-evented patients was $12,410 ($9217-$16,522). Study limitations include problems in event ascertainment due to inaccuracies in ICD-9-CM coding on Medicare claims data, and restriction of the study population to patients with metastatic involvement at initial diagnosis of RCC. Conclusions: Costs of care are substantially higher in patients aged 65 years with mRCC who experience AEs commonly associated with sunitinib, sorafenib, bevacizumab, and pazopanib. Efforts to prevent and/or better manage these events potentially can reduce healthcare costs. © 2013 Informa UK Ltd.

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