LA SER Analytica

New York City, NY, United States

LA SER Analytica

New York City, NY, United States
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Chau I.,Royal Marsden Hospital | Casciano R.,LA SER Analytica | Willet J.,LA SER Analytica | Wang X.,Novartis | Yao J.C.,University of Houston
European Journal of Cancer Care | Year: 2013

Neuroendocrine tumours (NET) are often diagnosed at an advanced stage when the prognosis is poor for patients, who often experience diminished quality of life (QoL). As new treatments for NET become available, it is important to characterise the associated outcomes, costs and QoL. A comprehensive search was performed to systematically review available data in advanced NET regarding cost of illness/resource utilisation, economic studies/health technology assessment and QoL. Four rounds of sequential review narrowed the search results to 22 relevant studies. Most focused on surgical procedures and diagnostic tools and contained limited information on the costs and consequences of medical therapies. Multiple tools are used to assess health-related QoL in NET, but few analyses have been conducted to assess the comparative impact of available treatment alternatives on QoL. Limitations include English language and the focus on advanced NET; ongoing terminology and classification changes prevented pooled statistical analyses. This systematic review suggests a lack of comparative economic and outcomes data associated with NET treatments. Further research on disease costs, resource utilisation and QoL for patients with advanced NET is warranted. © 2013 The Authors.


Lopez M.F.,Complejo Hospitalario Universitario Of runa | Mingot M.E.,Hospital Regional Universitario Carlos Haya | Valcarcel D.,Hospital Vall DIHebron | Vicente Garcia V.,Hospital Universitario Morales Meseguer | And 2 more authors.
Medicina Clinica | Year: 2015

Background and objective Romiplostim, a thrombopoietin-receptor agonist, is approved for second-line use in idiopathic thrombocytopenic purpura (ITP) patients where surgery is contraindicated. Anti-CD20 rituximab, an immunosuppressant, is currently used off-label. This analysis compared the cost per responder for romiplostim versus rituximab in Spain. Materials and method A decision analytic model was constructed to estimate the 6-month cost per responding patient (achieving a platelet count ≥ 50 × 109/l) according to the most robust published data. A systematic literature review was performed to extract response rates from phase 3 randomized controlled trials. Romiplostim patients received weekly injections; rituximab patients received 4 weekly intravenous infusions. Medical resource costs were obtained from Spanish reimbursement lists. Treatment non-responders incurred bleeding-related event (BRE) management costs as reported in clinical trials. Medical resource utilization and clinical practice were based on Spanish treatment guidelines and validated by local clinical experts. Results The literature review identified phase 3 romiplostim trials with a response rate of 83%. Due to a lack of phase 3 controlled rituximab trials, a systematic review of studies was selected as the best source, reporting a response rate of 62.5%. The mean cost per patient for romiplostim was €16,289 and €13,459 for rituximab. Rituximab resulted in a 10% higher cost per responder (€21,535 versus €19,625 for romiplostim). Romiplostim use reduced drug administration, intravenous immunoglobulin, and bleeding-related costs compared to rituximab. Conclusions Due to its high level of efficacy leading to lower BRE costs, romiplostim represents an efficient use of resources for adult ITP patients in the Spanish Healthcare System. © 2013 Elsevier España, S.L.U.


PubMed | LA SER Analytica, Hospital Regional Universitario Carlos Haya, Amgen, Hospital Universitario Morales Meseguer and 2 more.
Type: Comparative Study | Journal: Medicina clinica | Year: 2015

Romiplostim, a thrombopoietin-receptor agonist, is approved for second-line use in idiopathic thrombocytopenic purpura (ITP) patients where surgery is contraindicated. Anti-CD20 rituximab, an immunosuppressant, is currently used off-label. This analysis compared the cost per responder for romiplostim versus rituximab in Spain.A decision analytic model was constructed to estimate the 6-month cost per responding patient (achieving a platelet count5010(9)/l) according to the most robust published data. A systematic literature review was performed to extract response rates from phase 3 randomized controlled trials. Romiplostim patients received weekly injections; rituximab patients received 4 weekly intravenous infusions. Medical resource costs were obtained from Spanish reimbursement lists. Treatment non-responders incurred bleeding-related event (BRE) management costs as reported in clinical trials. Medical resource utilization and clinical practice were based on Spanish treatment guidelines and validated by local clinical experts.The literature review identified phase 3 romiplostim trials with a response rate of 83%. Due to a lack of phase 3 controlled rituximab trials, a systematic review of studies was selected as the best source, reporting a response rate of 62.5%. The mean cost per patient for romiplostim was 16,289 and 13,459 for rituximab. Rituximab resulted in a 10% higher cost per responder (21,535 versus 19,625 for romiplostim). Romiplostim use reduced drug administration, intravenous immunoglobulin, and bleeding-related costs compared to rituximab.Due to its high level of efficacy leading to lower BRE costs, romiplostim represents an efficient use of resources for adult ITP patients in the Spanish Healthcare System.


PubMed | The New York State Psychiatric Institute, Inwood Family Guidance & Psychological Services PLLC, LA SER ANALYTICA and Columbia University
Type: | Journal: General hospital psychiatry | Year: 2016

To evaluate a quality improvement intervention to improve the screening and management (e.g., referral to psychiatric care) of common mental disorders in small independent Latino primary care practices serving patient populations of predominantly low-income Latino immigrants.In seven practices, academic detailing and consultation/liaison psychiatry were first implemented (Stage 1) and then supplemented with appointment scheduling and reminders to primary care physicians (PCPs) by clinic staff (Stage 2). Acceptability and feasibility were assessed with independent patient samples during each stage.Participating PCP found the interventions acceptable and noted that referrals to language-matched specialty care and case-by-case consultation on medication management were particularly beneficial. The academic detailing and consultation/liaison intervention (Stage 1) did not significantly affect PCP screening, management or patient satisfaction with care. When support for appointment scheduling and reminders (Stage 2) was added, however, PCP referral to psychiatric services increased (P=.04), and referred patients were significantly more likely to follow through and have more visits to mental health professionals (P=.04).Improving the quality of mental health care in low-resourced primary care settings may require academic detailing and consultation/liaison psychiatric intervention supplemented with staff outreach to achieve meaningful improvement in the processes of care.


PubMed | Besancon University Hospital Center, University of Tampere, Skåne University Hospital, Netherlands Cancer Institute and 15 more.
Type: | Journal: The Lancet. Oncology | Year: 2016

Vascular-targeted photodynamic therapy, a novel tissue-preserving treatment for low-risk prostate cancer, has shown favourable safety and efficacy results in single-arm phase 1 and 2 studies. We compared this treatment with the standard of care, active surveillance, in men with low-risk prostate cancer in a phase 3 trial.This randomised controlled trial was done in 47 European university centres and community hospitals. Men with low-risk, localised prostate cancer (Gleason pattern 3) who had received no previous treatment were randomly assigned (1:1) to vascular-targeted photodynamic therapy (4 mg/kg padeliporfin intravenously over 10 min and optical fibres inserted into the prostate to cover the desired treatment zone and subsequent activation by laser light 753 nm with a fixed power of 150 mW/cm for 22 min 15 s) or active surveillance. Randomisation was done by a web-based allocation system stratified by centre with balanced blocks of two or four patients. Best practice for active surveillance at the time of study design was followed (ie, biopsy at 12-month intervals and prostate-specific antigen measurement and digital rectal examination at 3-month intervals). The co-primary endpoints were treatment failure (histological progression of cancer from low to moderate or high risk or death during 24 months follow-up) and absence of definite cancer (absence of any histology result definitely positive for cancer at month 24). Analysis was by intention to treat. Treatment was open-label, but investigators assessing primary efficacy outcomes were masked to treatment allocation. This trial is registered with ClinicalTrials.gov, number NCT01310894.Between March 8, 2011, and April 30, 2013, we randomly assigned 206 patients to vascular-targeted photodynamic therapy and 207 patients to active surveillance. Median follow-up was 24 months (IQR 24-25). The proportion of participants who had disease progression at month 24 was 58 (28%) of 206 in the vascular-targeted photodynamic therapy group compared with 120 (58%) of 207 in the active surveillance group (adjusted hazard ratio 034, 95% CI 024-046; p<00001). 101 (49%) men in the vascular-targeted photodynamic therapy group had a negative prostate biopsy result at 24 months post treatment compared with 28 (14%) men in the active surveillance group (adjusted risk ratio 367, 95% CI 253-533; p<00001). Vascular-targeted photodynamic therapy was well tolerated. The most common grade 3-4 adverse events were prostatitis (three [2%] in the vascular-targeted photodynamic therapy group vs one [<1%] in the active surveillance group), acute urinary retention (three [2%] vs one [<1%]) and erectile dysfunction (two [1%] vs three [1%]). The most common serious adverse event in the vascular-targeted photodynamic therapy group was retention of urine (15 patients; severe in three); this event resolved within 2 months in all patients. The most common serious adverse event in the active surveillance group was myocardial infarction (three patients).Padeliporfin vascular-targeted photodynamic therapy is a safe, effective treatment for low-risk, localised prostate cancer. This treatment might allow more men to consider a tissue-preserving approach and defer or avoid radical therapy.Steba Biotech.


Tanios N.,University of Montréal | Wagner M.,LASER Analytica | Tony M.,EVIDEM Collaboration | Tony M.,University of Montréal | And 5 more authors.
International Journal of Technology Assessment in Health Care | Year: 2013

Objectives: The aim of this study was to gather qualitative and quantitative data on criteria considered by healthcare decision makers. Methods: Using snowball sampling and an online questionnaire with forty-three criteria organized into ten clusters, decision makers were invited by an international task force to report which criteria they consider when making decisions on healthcare interventions in their context. Respondents reported whether each criterion is currently considered, should be considered, and its relative weight (scale 0-5). Differences in proportions of respondents were explored with inferential statistics across levels of decision (micro, meso, macro), decision maker perspectives, and world regions. Results: A total of 140 decision makers (1/3 clinical, 2/3 policy) from 23 countries in five continents completed the survey. The most relevant criteria (top ranked for Currently considered, Should be considered, and weights) were Clinical efficacy/effectiveness, Safety, Quality of evidence, Disease severity, and Impact on healthcare costs. Organizational and skill requirements were frequently considered but had relatively low weights. For almost all criteria, a higher proportion of decision makers reported that they Should be considered than that they are Currently considered (p <.05). For more than 74 percent of criteria, there were no statistical differences in proportions across levels of decision, perspectives and world regions. Statistically significant differences across several comparisons were found for: Population priorities, Stakeholder pressure/interests, Capacity to stimulate research, Impact on partnership and collaboration, and Environmental impact. Conclusions: Results suggest convergence among decision makers on the relevance of a core set of criteria and on the need to consider a wider range of criteria. Areas of divergence appear to be principally related to contextual factors. © 2013 Cambridge University Press.


Cassado J.,Hospital Universitari Mutua Terrassa | Espuna-Pons M.,University of Barcelona | Diaz-Cuervo H.,LA SER Analytica | Rebollo P.,LA SER Analytica
Ultrasound in Obstetrics and Gynecology | Year: 2015

Objectives To compare bladder volumes determined by three different formulae using measurements obtained from two-dimensional translabial ultrasound (2D-US), with true bladder volumes, in women with advanced pelvic organ prolapse (POP). Methods This was a prospective observational multicenter study of consecutive women on the waiting list for prolapse surgery in 24 gynecology departments. All women had a symptomatic genital prolapse Stage 2 or higher according to the Pelvic Organ Prolapse Quantification System (POP-Q). Bladder volumes were calculated before and after spontaneous voiding by 2D-US, and true bladder volumes were determined by micturition and catheterization. Volumes determined by US were calculated using three formulae (Haylen, Dietz and Dicuio). Correlation was calculated between the volume determined by US measurement before micturition and the true volume, and also between the volume determined by US measurements after micturition and the true volume. Correlations (Spearman's rho) and concordance (intraclass correlation coefficient (ICC)) were estimated for each of the three formulae considered. Results One-hundred and eighty-six women with POP were included in the study. A total of 349 bladder volumes (186 before micturition and 163 after micturition) were obtained. Good correlation (rho, 0.818-0.849) and concordance (ICC, 0.827-0.898) were found between total measured volume (volume of spontaneous bladder voiding + volume obtained from catheterization) and the volume determined by US using the three different formulae, as well as between the post-void residual volume measured by catheterization and the post-void volume calculated by US using the three formulae (rho, 0.739-0.777; ICC, 0.840-0.877). Conclusions Bladder volumes in women with advanced POP can be measured easily by 2D-US. Volumes determined using the three different formulae show good correlations and concordance with true bladder volume. Copyright © 2014 ISUOG. Published by John Wiley & Sons Ltd.


PubMed | Novartis and LA SER Analytica
Type: Journal Article | Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology | Year: 2017

390 Background: Several targeted therapies (TTs) have become available in mRCC in recent years for first- and second-line use, including sorafenib (So), sunitinib (Su), bevacizumab (Be), temsirolimus (Te), everolimus (Ev), pazopanib (Pa), and most recently, axitinib (Ax). This study aimed to examine the current treatment patterns in mRCC patients who fail second-line therapy.Data were obtained from a large national U.S. claims database for patients with an RCC diagnosis and at least 3 lines of TT between January 1, 2004, and June 30, 2011. Patients were age 18 or older at diagnosis with at least 3 months of follow-up prior to initiation of third-line therapy. Patient characteristics and treatment patterns were examined for the final population.A total of 812 mRCC patients initiated third-line therapy with So, Su, Be, Te, Ev, or Pa. The sample was majority male (70%) with a mean age of 60 years (SD=10.7). A large proportion of patients were from the South (42%), and the majority of the sample (72%) had commercial insurance. The most common sites of metastases at any time were lung (71%) and bone (52%). The most common first-line agent was Su (52%) and the most common second-line single agents were Te (25%) and Ev (17%). The most frequently used single-agents in third-line were Te (21%) and Ev (19%). Third-line treatment choice differed by year; Te (51%) was most common in 2007 while Ev and Pa were most common between 2009 and 2011. Additionally, the most frequently prescribed sequences of single agents were VEGFmTORVEGF (25%), VEGFmTORmTOR (25%), and VEGFVEGFmTOR (22%).The results demonstrate a rapidly changing therapeutic scenario for mRCC in the United States. The number of targeted therapies prescribed in third-line increased from 1 in 2006 to 4 in 2007 and 6 in 2011. This evolution of third-line therapies is possibly due to physicians adapting their practice with the advent of novel mRCC treatment options. These results are in line with the NCCN guidelines, with VEGF and mTOR being the most commonly prescribed first- and second-line single agents, respectively.


PubMed | Allergan, Inc., University of Bristol, Allergan Holdings Ltd., University College London and LA SER ANALYTICA
Type: Journal Article | Journal: The European journal of health economics : HEPAC : health economics in prevention and care | Year: 2016

The cost-effectiveness of onabotulinumtoxinA (BOTOX()) 100U+best supportive care (BSC) was compared with BSC alone in the management of idiopathic overactive bladder in adult patients who are not adequately managed with anticholinergics. BSC included incontinence pads and, for a proportion of patients, anticholinergics and/or occasional clean intermittent catheterisation. A five-state Markov model was used to estimate total costs and outcomes over a 10-year period. The cohort was based on data from two placebo-controlled trials and a long-term extension study of onabotulinumtoxinA. After discontinuation of initial treatment, a proportion of patients progressed to downstream sacral nerve stimulation (SNS). Cost and resource use was estimated from a National Health Service perspective in England and Wales using relevant reference sources for 2012 or 2013. Results showed that onabotulinumtoxinA was associated with lower costs and greater health benefits than BSC in the base case, with probabilistic sensitivity analysis indicating an 89% probability that the incremental cost-effectiveness ratio would fall below 20,000. OnabotulinumtoxinA remained dominant over BSC in all but two scenarios tested; it was also economically dominant when compared directly with SNS therapy. In conclusion, onabotulinumtoxinA appears to be a cost-effective treatment for overactive bladder compared with BSC alone.


PubMed | Hospital Universitari Mutua Terrassa, University of Barcelona and LA SER Analytica
Type: Journal Article | Journal: Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology | Year: 2015

To compare bladder volumes determined by three different formulae using measurements obtained from two-dimensional translabial ultrasound (2D-US), with true bladder volumes, in women with advanced pelvic organ prolapse (POP).This was a prospective observational multicenter study of consecutive women on the waiting list for prolapse surgery in 24 gynecology departments. All women had a symptomatic genital prolapse Stage 2 or higher according to the Pelvic Organ Prolapse Quantification System (POP-Q). Bladder volumes were calculated before and after spontaneous voiding by 2D-US, and true bladder volumes were determined by micturition and catheterization. Volumes determined by US were calculated using three formulae (Haylen, Dietz and Dicuio). Correlation was calculated between the volume determined by US measurement before micturition and the true volume, and also between the volume determined by US measurements after micturition and the true volume. Correlations (Spearmans rho) and concordance (intraclass correlation coefficient (ICC)) were estimated for each of the three formulae considered.One-hundred and eighty-six women with POP were included in the study. A total of 349 bladder volumes (186 before micturition and 163 after micturition) were obtained. Good correlation (rho, 0.818-0.849) and concordance (ICC, 0.827-0.898) were found between total measured volume (volume of spontaneous bladder voiding+volume obtained from catheterization) and the volume determined by US using the three different formulae, as well as between the post-void residual volume measured by catheterization and the post-void volume calculated by US using the three formulae (rho, 0.739-0.777; ICC, 0.840-0.877).Bladder volumes in women with advanced POP can be measured easily by 2D-US. Volumes determined using the three different formulae show good correlations and concordance with true bladder volume.

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